As filed with the Securities and Exchange Commission on February 142, ~~2024.~~2026

Registration No. 333-~~______~~

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1
REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933

SS INNOVATIONS INTERNATIONAL, INC.

(Exact name of registrant as specified in its charter)

Florida		3841		47-3478854
(State or other jurisdiction of incorporation or organization)		(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification No.)

405, 3^rd Floor, iLabs Info Technology Centre

Udyog Vihar, Phase III

Gurugram, Haryana 122016, India

+91 73375 53469

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive ~~officer~~offices)

~~Sudhir Srivastava,~~Registered MAgents Inc.D.

~~Chairman and~~7901 ~~Chief~~4th ~~Executive~~St ~~Officer~~N, Suite 300

~~SS Innovations~~St. ~~International~~Petersburg, ~~Inc.~~Florida 33702

~~1600 SE 15th Street, #512~~307-200-2803

Fort Lauderdale, Florida

+91 73375 53469

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Dale S. Bergman Andrew Zuckerman Lewis Brisbois Bisgaard & Smith LLP 110 SE 6th Street, Suite 2600 Fort Lauderdale, FL 33301 (954) 728-1280 ~~Joshua~~Steven AM. ~~Kaufman~~Skolnick ~~Daniel~~Tracy IF. ~~Goldberg~~Buffer ~~Cooley~~Lowenstein Sandler LLP 551251 ~~Hudson~~Avenue ~~Yards~~of the Americas New York, NY ~~10001~~10020 (~~212~~646) ~~479~~414-~~6000~~6947

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act, check the following box. ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☒☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED FEBRUARY 142, ~~2024~~ 2026

PRELIMINARY PROSPECTUS

~~Shares~~$50,000,000

11,286,681 Shares of Common Stock

We are offering 11,286,681 shares of common stock, par value $0.0001 ~~par value~~ per share ~~(“Shares”), of SS Innovations International, Inc~~.~~, a Florida corporation (the “Company”), in a underwritten public offering at a public offering price of $ per Share (this “Offering”).~~

Our common stock is ~~currently~~listed ~~quoted~~ on the ~~OTC~~Nasdaq ~~Pink tier of the over-the-counter~~Capital ~~market~~Market (“~~OTCPink~~Nasdaq”) ~~maintained by OTC Markets Group, Inc. (“OTC Markets”)~~ under the symbol “SSII.” ~~However,~~ ~~the trading market for our common stock is sporadic and extremely limited.~~ On January ~~February 13~~28, ~~2024~~2026, the closing price offor our common ~~stock~~ ~~on the OTC Pink~~ stock was $54.~~50.~~43 Weper ~~have~~share ~~applied~~as toreported ~~list~~by ~~our common stock on the~~ Nasdaq ~~Capital Market under the symbol “SSII~~.~~” There can be no assurance that we will be successful in listing our common stock on the Nasdaq Capital Market.~~

	Per Share	Total
Public offering price	$	$
Underwriting discounts and commissions(1)	$	$
Proceeds, before expenses, to us	$	$

Certain information in this prospectus is based on an assumed public offering price of $4.43 per share (the last reported sale price of our common stock on Nasdaq on January 28, 2026). The actual public offering price per share will be determined between us and the underwriters based on market conditions at the time of pricing, and may be at a discount to the current market price of our common stock.

~~(1)~~ We ~~have~~are ~~also~~a ~~agreed~~“smaller reporting company” as defined under federal securities laws and, as such, have elected to ~~reimburse~~comply ~~the~~with ~~underwriters~~certain reduced public company reporting requirements for ~~certain~~this ~~expenses~~prospectus and may elect to comply with reduced public company reporting requirements in future filings. See “~~Underwriting”~~Prospectus Summary––Implications ~~for~~of ~~additional~~Being ~~information~~a ~~regarding~~Smaller ~~total~~Reporting ~~underwriter compensation~~Company.”

~~We have~~As ~~granted~~of the ~~underwriters~~date anof ~~option~~this ~~for~~prospectus, aDr. ~~period~~Sudhir ofSrivastava, 45our ~~days~~Chairman of ~~from~~ the ~~date~~board of ~~this~~directors ~~prospectus~~and toChief ~~purchase~~Executive upOfficer, tothrough anhis ~~additional~~Bahamian ~~Shares~~holding company, Sushruta Pvt Ltd. (“Sushruta”), ~~solely~~beneficially toowns ~~cover~~approximately ~~overallotments~~58.35% of our issued and outstanding common stock. In addition, athe beneficially owns all the ~~public~~outstanding shares ~~offering~~of ~~price~~our Series A Non-Convertible Preferred Stock (the “Series A Preferred Shares”), ~~less~~which ~~any~~votes ~~underwriting~~together ~~discounts~~with the common stock as a single class and ~~commissions.~~affords Ifthe holder 51% of the ~~underwriters~~total ~~exercise~~voting power of the Company, regardless of the number of shares ~~their~~of ~~option~~common instock ~~full~~outstanding. As a result, Dr. Srivastava holds approximately 58.35% of the total ~~underwriting~~voting ~~discounts~~power of the Company and ~~commissions~~is ~~payable~~the principal byand uscontrolling shareholder of the Company. Following this offering, Dr. Sudhir Srivastava will behold $ approximately 55.23% ,of ~~and~~the total voting power of the Company (or 54.78% of the total ~~proceeds~~voting power if the underwriters’ option to ~~us,~~purchase ~~before~~additional shares ~~expenses,~~is ~~will~~exercised bein full) based upon an assumed offering price of $ 4.43 per share (the last reported sale price of our common stock on Nasdaq on January 28, 2026).

~~We are~~Although aneligible, ~~“emerging~~we ~~growth~~have ~~company”~~elected asnot ~~that~~to ~~term~~take advantage ~~is used in the Jumpstart Our Business Startups Act~~ of ~~2012~~Nasdaq’s ~~and,~~controlled ascompany ~~such,~~governance ~~have elected~~exemptions applicable to ~~comply~~the ~~with~~composition ~~certain~~of ~~reduced~~our ~~public~~board ~~company~~of ~~reporting~~directors ~~requirements~~and ~~for~~compensation and ~~this~~nominating ~~prospectus~~ and ~~future~~corporate ~~filings~~governance committees.

Investing in our securities involves significant risks. You should ~~review~~ carefully review the “Risk Factors” beginning on page 108 of this prospectus for a discussion of information that should be considered in connection with an investment in our securities.

The Securities and Exchange Commission and state securities regulators have not approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

	Per Share	Total
Public offering price	$	$
Underwriting discounts and commissions ⁽¹⁾	$	$
Proceeds to us, before expenses	$	$

~~The underwriters~~(1) ~~expect~~We have agreed to ~~deliver~~reimburse the ~~Shares~~underwriters for certain expenses. We have also agreed to ~~purchasers~~issue onto orRoth ~~about~~ Capital Partners, ~~2024~~LLC warrants to purchase a number of shares of our common stock equal to 5.0% of the aggregate number of shares of our common stock sold in this offering, ~~subject~~including any shares issued pursuant to ~~customary~~the ~~closing~~underwriters’ ~~conditions~~over-allotment option (the “Representative Warrants”). See “Underwriting” for additional information regarding total underwriter compensation.

~~Sole~~We have granted the underwriters an option for ~~Book~~a period of 45 days from the date of this prospectus to purchase up to an additional 1,693,002 shares of common stock, solely to cover over-~~Running~~allotments, ~~Manager~~at the public offering price, less the underwriting discounts and commissions. If the underwriters exercise their option in full, the total underwriting discounts and commissions payable by us will be $ , and the total proceeds to us, before expenses, will be $ .

~~FREEDOM~~Neither the Securities and Exchange Commission nor ~~CAPITAL~~any ~~MARKETS~~state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The underwriters expect to deliver the shares ~~date~~to ofpurchasers ~~this~~on ~~prospectus~~or is about , ~~2024~~2026, subject to satisfaction of customary closing conditions.

Joint-Book-Running Managers

Roth Capital Partners

Needham & Company

The date of this prospectus is , 2026

TABLE OF CONTENTS

		Page
About this Prospectus		ii
Market, Industry and Other Data		ii
Prospectus Summary		1
Risk Factors		108
Special Note Regarding Forward-Looking Statements		2729
Use of Proceeds		2830
Dividend Policy		2931
Capitalization		3031
Dilution		3132
Business		3233
Management’s Discussion and Analysis of Financial Condition and Results of Operations		5055
Directors, Executive Officers and Corporate Governance		5465
Executive Compensation		5971
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters		62
Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters		74
Certain Relationships and Related Transactions, and Director Independence		6375
Description of the Securities we are Offering
Description of Capital Stock		76
Material U.S. Federal Income Tax Considerations for Holder of our Common Stock		6678
Shares Available for Future Sales		70
Underwriting		83
Underwriting		71
Legal Matters		90
Legal Matters		78
Experts		90
Experts		78
Where You Can Find More Information		90
Where You Can Find More Information		78
Index to Financial Statements		F-1

ABOUT THIS PROSPECTUS

The registration statement of which this prospectus forms a part that we have filed with the Securities and Exchange Commission (the “SEC”) includes exhibits that provide more detail of the matters discussed in this prospectus. You should read this prospectus and the related exhibits ~~filed with the SEC~~, together with the additional information described under the heading “Where You Can Find More Information.”

You should rely only on the information contained in this prospectus ~~and in any free writing prospectus prepared by or on behalf of us~~. We have not, and the underwriters have not, authorized anyone to provide you with information different from, or in addition to, that contained in this prospectus ~~or any related free writing prospectus~~. This prospectus is an offer to sell only the securities offered hereby but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus is current only as of its date. Our business, financial condition, results of operations and prospects may have changed since that date.

WeFor investors ~~are~~outside ~~not~~the ~~offering~~United States: toWe ~~sell~~have ornot, ~~seeking~~and ~~offers to purchase these securities in any jurisdiction where~~ the ~~offer~~underwriters ~~or sale is not permitted. We~~ have not, done anything that would permit this ~~Offering~~offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States . Persons outside the United States who come into possession of this ~~prospectus~~ ~~and any free writing~~ prospectus ~~related~~must ~~to this Offering in jurisdictions outside the United States are required to~~ inform themselves about, and to observe any restrictions relating to, ~~this~~the ~~Offering~~offering of the securities and the distribution of this prospectus ~~and~~outside ~~any~~the ~~such free writing prospectus applicable to that jurisdiction~~United States.

Unless the context otherwise requires, the terms “SSi,” “the Company,” “we,” “us,” and “our” refer to SS Innovations International, Inc., and where appropriate, our subsidiaries.

“SSi,” “SSi Mantra,” SSi logos and other trade names, trademarks or service marks of the Company appearing in this prospectus are the property of SSi. Other trade names, trademarks or service marks appearing in this prospectus are the property of their respective holders. Solely for convenience, trade names, trademarks and service marks referred to in this prospectus appear without the ^®, ^™ and ^SM symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trade names, trademarks and service marks.

MARKET, INDUSTRY AND OTHER DATA

Unless otherwise indicated, information contained in this prospectus concerning our industry and the market in which we operate, including our general expectations and market position, market opportunity, and market size, is based on information from various third-party industry and research sources, on assumptions that we have made based on that data and other similar sources, and on our knowledge of the markets for our services. This information involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.

In addition, industry publications, studies, and surveys generally state that they have been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. The industry in which we operate is subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section captioned “Risk Factors” and elsewhere in this prospectus. These and other factors could cause our actual results to differ materially from those expressed in the estimates made by the independent parties and by us.

PROSPECTUS SUMMARY

This summary highlights information contained in greater detail elsewhere in this prospectus. This summary does not contain all the information that you should consider before investing. You should read the entire prospectus carefully, including the sections titled “Risk Factors”,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and “Special Note Regarding Forward-Looking Statements,"” and our financial statements and related notes included elsewhere in this prospectus, before making an investment decision.

Business Overview

We are a commercial-stage surgical robotics ~~company~~ company focused on transforming patient lives by democratizing access to advanced surgical robotics technologies. We design, manufacture and market an advanced, next-generation and affordable surgical robotic system called the SSi Mantra Surgical Robotic System (the “SSi Mantra”) intended for use in urology, general, gynecology, colorectal, gastroenterology, head and neck, thoracic and cardiac surgeries. While surgical robotic systems have gained acceptance globally in the past two decades for providing greater efficiency, better clinical outcomes and reducing healthcare costs, access to such systems remains largely limited to developed countries such as the United States (the “U.S.”), the European Union (the “EU”) and Japan. With the SSi Mantra, we are breaking down barriers and accelerating access to surgical robotics technologies in underserved regions of the world.

WeLed ~~design~~and developed by Dr. Sudhir P Srivastava, our ~~manufacture~~founder, Chairman and ~~market~~Chief anExecutive ~~advanced~~Officer with a visionary team of engineers, surgeons and industry veterans, the SSi Mantra includes ~~next-~~several innovative features to address shortcomings of the current generation of robotic surgery systems. The SSi Mantra marks the realization of Dr. Srivastava’s vision to develop and ~~affordable~~commercialize ~~robotic~~a surgical robotic system ~~called~~which would facilitate making robotic surgery affordable and accessible to a global population. We commenced development of the SSi Mantra in 2014, received regulatory approval by the Central Drugs Standard Control Organization (“CDSCO”) India’s equivalent of the U.S. Food and Drug Administration (“FDA”), for its sale and use in India and commercially launched sales in late 2022. We also received ISO 13485 (quality management system) approval for the SSi Mantra in November 2021. The latest generation SSi Mantra 3 was introduced in India with telesurgery and tele-proctoring capabilities along with advanced energy instrumentation. The SSi Mantra 3 received CDSCO approval in November 2024 and has been clinically validated for safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries.

~~While~~As ~~robotic~~of ~~surgical~~December ~~systems~~31, 2025, we have ~~gained~~installed ~~acceptance~~168 ~~globally~~systems, of which 154 are located in ~~the~~India, ~~past~~and ~~two~~14 ~~decades~~at ~~for~~overseas ~~providing~~locations. ~~greater~~Including ~~efficiency~~our strong foundational market of India, ~~better~~the ~~clinical~~SSi ~~outcomes~~Mantra ~~and~~installed ~~reducing~~base ~~healthcare~~currently ~~costs,~~spans ~~access~~10 tocountries. We are currently focusing our efforts on marketing our latest generation ~~such~~SSi ~~systems~~Mantra ~~remains~~3 ~~largely~~in ~~limited~~international tomarkets ~~developed~~and ~~countries~~anticipate ~~such~~receiving asEU ~~the~~and ~~United~~U.S. ~~States,~~regulatory approvals to market in those regions in the EUfirst half ~~and~~of ~~Japan~~2026, however, there can be no assurance as to when or if we will secure such regulatory approvals.

~~With~~Our commercially installed SSi Mantra systems have been used to perform more than 7,800 wesurgical ~~are~~procedures ~~breaking~~including ~~down~~approximately ~~barriers~~400 cardiac robotic surgeries across 153 hospitals as of December 31, 2025. The SSi Mantra has been clinically validated for safety, efficacy and ~~accelerating~~effectiveness ~~access~~for its intended use to ~~surgical~~perform robotically ~~robotics~~assisted ~~technologies~~surgeries in ~~underserved~~more ~~regions~~than 100 different types of ~~the~~surgical ~~world~~procedures without any device-related adverse events. These procedures have spanned across the following nine surgical specialties:

Developed by a visionary team of surgeons, engineers and industry veterans, the SSi Mantra includes several innovative features to address shortcomings of current generation robotic surgery systems.

Type of Surgical Procedure	No. of Procedures performed as of December 31, 2025		% of total procedures
General Surgery		3,409		43.2	%
Urology		2,004		25.4	%
Gynecology		1,247		15.8	%
Colorectal		444		5.6	%
Cardiac		390		4.9	%
Gastroenterology		217		2.8	%
Head and Neck		93		1.2	%
Thoracic		73		0.9	%
Plastic/Reconstructive		8		0.1	%
Total		*7,885		100	%

~~Surgeon~~* ~~Console~~Includes: ~~The~~121 ~~SSi~~pediatric ~~Mantra includes an innovative open-faced console~~surgeries, ~~featuring~~120 atelesurgeries ~~large 32-inch 4K monitor with a head tracking safety feature that provides a 3DHD image of the surgical field~~ and ~~with~~232 upsurgeries tooutside 10x magnification. The console also has a second 23-inch touch monitor for system controls and DICOM applications. The open console provides significant ergonomic benefits with the surgeon sitting straight instead of ~~leaning his head into the console. The open-faced console improves team communication and teaching during the procedure.~~India

Patient-Side Robotic Arm Carts: The SSi Mantra features modular robotic arms mounted on independent self-balancing carts in 3, 4 and 5-arm configurations for enhanced stability and operability. The mobile carts can be quickly customized to improve utilization. The system provides surgeons with greater flexibility and the ability to adapt to clinical workflows and individual patient requirements.

Vision Cart. The vision cart provides an additional 32-inch 3D 4K resolution monitor, for the operating room staff, thereby expanding the surgeon’s high definition (“3DHD”) view to the entire operating staff.

Tele-Proctoring Capabilities. The SSi Mantra has a built-in live streaming platform that provides an advanced remote proctoring solution for training and teaching purposes.

~~SSi~~In ~~Mudra:~~December We2024, ~~offer~~we abecame ~~comprehensive~~the ~~suite of~~first ~~stapling, energy~~ and ~~core~~only company ~~instrumentation~~in ~~for~~India ~~our~~to ~~surgical~~receive ~~systems,~~CDSCO ~~under~~regulatory ~~the~~approval ~~brand~~for ~~name~~use of ~~SSi~~a ~~Mudra.~~robotic ~~SSi~~surgical ~~Mudra~~system ~~instruments~~in ~~can~~the ~~be utilized~~performance ~~for~~of ~~over~~Telesurgery 50and ~~different surgical~~ Tele-proctoring procedures. WeSince ~~also~~receiving ~~have~~such ~~developed~~approvals, awe ~~number~~have ofperformed ~~specific~~more ~~instruments~~than ~~for~~120 ~~cardiac~~telesurgeries ~~surgery.~~using ~~The~~ our SSi ~~Mudra~~Mantra ~~instruments include advanced features such~~ as ~~motion scaling for precision and control~~ of ~~delicate~~December ~~tasks~~31, ~~and embedded programmed~~2025, ~~chips~~including toa ~~monitor~~robotic ~~and~~cardiac ~~track~~surgery ~~procedures~~over asa ~~well~~distance ~~as usage and interaction~~ of ~~the~~more ~~instruments~~than ~~with~~5,000 ~~the SSi Mantra system~~miles.

~~These~~In ~~features~~addition ~~provide~~to ~~superior~~India, ~~outcomes~~the ~~across~~SSi Mantra has also abeen ~~variety~~granted ofregulatory ~~disease~~approval ~~states~~in Colombia, ~~which~~Ecuador, isGuatemala, ~~critical~~Indonesia, inKenya, ~~order~~Oman, ~~for~~Philippines, ~~robotic~~Sri ~~surgery~~Lanka, toUkraine, ~~become~~and the ~~global~~United Arab ~~standard of care~~Emirates.

~~The~~Our ~~SSi~~ISO ~~Mantra~~13485 (quality management system) ~~has~~approval, CDSCO ~~been~~approval ~~clinically~~for ~~validated~~the inmanufacture, ~~over~~sale 50and ~~types~~ distribution of ~~surgeries~~our systems and ~~surgeons~~related devices and our Indian export license allow us to market ~~date~~our ~~have~~systems ~~performed~~and ~~over~~related ~~700~~devices ~~surgical~~in ~~procedures~~50 ~~using~~non-FDA ~~the~~and ~~SSi~~non-EU ~~Mantra~~countries ~~system~~without further regulatory approvals, including Chile, Nepal and Nigeria. An additional 79 countries require only minimal registration. Our marketing efforts outside India have been limited to date.

~~The~~On December 5, 2025, we submitted a 510(k) premarket notification to the FDA for the SSi Mantra ~~Surgical~~for ~~Robotic~~multiple ~~System~~specialty ~~has~~procedure ~~been~~types, ~~granted~~including: ~~regulatory~~general, urological, colorectal, gynecological, and ~~import~~cardiac surgery. We believe that the 510(k) regulatory pathway offers potential speed and cost advantages. The FDA has stated that its goal is to complete reviews of 510(k) submissions within 90 days of receipt. However, time to approval incould ~~India~~be longer due to factors such as the 15-day acceptance review, the ~~United~~submission ~~Arab~~of ~~Emirates~~additional information, and ~~Guatemala~~a submitter’s response time. ~~Based~~We onhave ~~regulatory~~engaged RQM+, ~~approval~~a ~~obtained~~leading inMedTech-focused ~~India~~CRO, to assist with the 510(k) submission. If approved by the FDA, the SSi Mantra ~~has~~would ~~automatic~~be cleared to market in the U.S. Submission of a 510(k) premarket notification request does not guarantee FDA approval. ~~and~~We ~~registration~~have also submitted our technical files to Szutest, an EU Notified Body for the CE certification, which if obtained will allow us to market the SSi Mantra in 50the ~~countries~~EU. We believe that we will be able to secure FDA approval and EU certification in 2026. However, there ~~are~~can anbe ~~additional~~no 79assurance ~~countries~~as ~~which~~to ~~require~~when aor ~~minimal~~if we ~~registration~~will secure such regulatory approvals.

We ~~have~~generate ~~initiated~~revenues from the ~~process~~sale toof ~~obtain~~the ~~regulatory~~SSi ~~approvals~~Mantra. inWe ~~the~~offer ~~United~~our ~~States~~SSi Mantra through three selling models: (i) outright purchase, where revenue is realized upfront; (ii) purchase on a deferred or installment payment basis; and (iii) purchase on a pay-per-procedure basis, where revenue is recognized over time. We also earn recurring revenue from the ~~Food~~sales of instruments, accessories and ~~Drug~~services. ~~Administration~~We ~~(the~~sell ~~“FDA”)~~our systems and inrelated ~~the~~devices ~~European~~directly to ~~Union~~customers ~~(CE)~~as well as through distributors.

AsWe ofbelieve the ~~date~~SSi ofMantra ~~this~~improves ~~prospectus,~~patient ~~we have installed 23 systems~~experience, of ~~which~~reduces 21variabilities ~~are~~and ~~located~~disruption inand ~~India,~~lowers ~~one~~per-procedure incosts. ~~Dubai~~We ~~and~~believe ~~one~~that at the ~~Johns~~SSi ~~Hopkins~~Mantra ~~Hospital~~benefits ~~in Baltimore~~patients, ~~Maryland~~physicians ~~for~~and hospitals ~~clinical~~by ~~training~~providing ~~and~~access ~~ongoing research~~to an advanced and ~~development~~optimized robotic system.

WeRecent generate revenues from the sale of the SSi Mantra system. We offer our SSi Mantra through three selling models— outright purchase where revenue is realized upfront, purchase on a deferred or installment payment basis, and purchase on a pay per procedure basis where revenue is recognized over time. We also earn recurring revenue from the sales of instruments, accessories, and services. We sell our products directly to customers as well as through distributors.Development

~~The~~On ~~system~~January ~~improves~~13, ~~patient experience~~2026, ~~reduces~~we ~~variabilities~~announced ~~and disruption~~preliminary ~~and~~unaudited ~~lowers~~revenue ~~per-procedure~~and ~~costs.~~other Weselect ~~believe~~operating ~~that~~metrics ~~SSi~~for ~~Mantra~~the ~~benefits~~three ~~patients, physicians~~ and ~~hospitals~~twelve bymonths ~~providing~~ended ~~access~~December to31, ~~an advanced and optimized robotic system~~2025.

For the fourth quarter of 2025, we expect to report:

●

Revenue of approximately $15.0 million, up 85% from revenue of $8.1 million in the fourth quarter of 2024.

●

SSi Mantra installations of 37, up 68% from 22 installations in the fourth quarter of 2024.

For the year ended December 31, 2025, we expect to report:

●

Revenue of approximately $43.0 million, up 108% from revenue of $20.6 million in 2024.

●

SSi Mantra installations of 103, up 119% from 47 installations in 2024.

The SSi Mantra cumulative installed base totaled 168 as of December 31, 2025, up 158% from 65 as of December 31, 2024.

The estimated financial and operating results set forth above are preliminary, unaudited and subject to completion, and may change as a result of management’s continued review. Such preliminary results are subject to the finalization of quarter-end financial and accounting procedures and the completion of the audit of our financial statements for the twelve months ended December 31, 2025. As a result, investors should exercise caution in relying on this information and should not draw any inferences from this information. This preliminary financial information should not be viewed as a substitute for full financial statements prepared in accordance with GAAP and reviewed by our independent registered public accounting firm.

Corporate History

We were incorporated in the state of Florida on February 4, 2015, under the name “Avra Surgical Microsystems, Inc.,” and changed its name to “Avra Medical Robotics, Inc.” on November 5, 2015.

From inception through April 13, 2023, we were engaged in developing a fully autonomous medical robotic system using proprietary software which integrated Artificial Intelligence and Deep Learning, or Machine Learning. Our research and development efforts were based in Orlando, Florida, where we established a research partnership with the University of Central Florida.

~~Macro~~On ~~Healthcare~~April ~~Trends~~14, 2023, we consummated the acquisition of CardioVentures, Inc., a Delaware corporation (“CardioVentures”), pursuant to a Merger Agreement dated November 7, 2022 (the “Merger Agreement”), by and among the Company, a wholly owned subsidiary of the Company (“Merger Sub”), CardioVentures and Dr. Sudhir Srivastava, who, through his Bahamian holding company, Sushruta, Pvt. Ltd. (“Sushruta”) owned a controlling interest in CardioVentures.

~~Increasing~~CardioVentures, ~~demand~~through ~~for~~a ~~healthcare:~~subsidiary, ~~The~~owned ~~increasing~~a ~~demand~~controlling ~~for~~interest ~~healthcare~~ in ~~emerging~~Sudhir ~~markets~~Srivastava ~~such~~Innovations asPvt. ~~India~~Ltd., isan ~~driven~~Indian byprivate ~~population~~limited ~~growth~~company (“SSI-India”), which developed and amanufactures ~~growing~~and ~~middle~~markets ~~class~~the SSi Mantra, ~~rising~~an advanced, yet cost-effective ~~per~~surgical ~~capita~~robotic ~~incomes,~~system ~~growing~~designed ~~health~~to ~~insurance~~make ~~penetration~~the ~~and~~benefits ~~changing~~of ~~lifestyles~~robotic surgery available to a larger part of the global population.

~~These~~Pursuant ~~trends~~to ~~are~~the ~~resulting~~Merger inAgreement, ~~patients~~at ~~demanding specialized~~Closing, Merger-Sub ~~higher~~merged ~~quality~~with ~~products~~ and ~~services~~into CardioVentures (the “CardioVentures Merger”). In the CardioVentures Merger, ~~with~~holders of ~~improved~~the ~~efficiency~~outstanding ~~and~~shares ~~outcomes~~of ~~for~~common anstock ~~overall~~of ~~better~~CardioVentures ~~healthcare~~(including ~~experience. India’s~~certain ~~healthcare~~parties ~~industry~~who isprovided ~~expected~~interim toconvertible ~~grow~~financing ~~from~~during the ~~$370~~pendency ~~billion~~of inthe ~~2022~~merger, towere ~~$610~~issued ~~billion~~135,808,884 inshares ~~20261.~~of ~~The~~SSi ~~proportion~~common stock, representing approximately 95% of ~~population~~ inissued ~~India~~and inoutstanding shares ~~the~~of ~~working~~SSi ~~age-group~~common 15stock post-59merger, ~~years~~with isthe ~~expected~~existing toshareholders ~~rise~~of ~~from~~SSi ~~60.7~~holding ~~percent~~approximately in6,545,531 ~~2011~~shares toof ~~65.1~~SSi ~~percent~~common ~~in 20362.~~stock ~~This~~representing ~~demographic~~approximately ~~segment~~5% ~~demands,~~of issued and isoutstanding ~~willing~~shares toof ~~spend~~SSi oncommon ~~high-quality~~stock ~~healthcare services~~post-merger.

~~Growing~~In ~~adoption~~addition, the holder of ~~technology:~~CardioVentures ~~Patients~~common ~~and~~stock ~~hospitals~~also ~~are~~received ~~increasingly~~shares ~~focused~~of onnewly ~~improving~~designated ~~clinical~~Series ~~outcomes~~A ~~while~~Preferred ~~enhancing~~Shares, ~~patient~~which ~~experience.~~affords ~~Hospitals~~the ~~aim~~holder to51% ~~achieve~~of ~~these~~our total voting power. As a ~~goals~~result byof ~~customizing~~the ~~care~~foregoing, ~~improving~~a ~~provider~~“Change ~~efficiency~~in byControl” ~~lowering~~of the ~~amount~~Company ofoccurred, ~~time~~with ~~required~~Dr. toSudhir ~~treat~~Srivastava ~~patients,~~becoming our principal and ~~reducing~~controlling ~~overall costs~~shareholder. ~~Shorter~~The ~~recovery~~Series ~~times~~A ~~with~~Preferred ~~robotic-assisted~~Shares ~~surgery~~are ~~maximizes~~automatically redeemed by us for nominal consideration at such time as the ~~operational~~holder ~~efficiency~~owns less than 50% of the ~~bed~~shares ~~capacity,~~issued ~~along~~to ~~with~~it ~~reduction~~ in ~~complications~~connection with the CardioVentures Merger.

~~Significant~~Contemporaneously ~~unmet~~with ~~need:~~the ~~India~~closing ~~has~~of ~~70,000~~the CardioVentures ~~hospitals~~Merger ~~and~~on ~~approximately~~April ~~21 million major surgeries are performed in India every year3. However~~14, ~~only~~2023we ~~10,000~~changed –our ~~12,000 robotic~~name ~~surgeries~~to ~~are~~“SS ~~done~~Innovations ~~in India annually~~International, ~~representing less than 0~~Inc.~~1 percent of the global volume4. Furthermore~~,” ~~laparoscopy is~~effected ~~well entrenched in India, leading to~~ a ~~large~~one-for-10 ~~pool~~reverse stock ofsplit ~~laparoscopic~~and ~~surgeons.~~increased ~~This~~our ~~will~~authorized ~~facilitate~~common astock ~~faster transition from laparoscopy~~ to ~~robotic surgery. There is a large unmet need for surgical robotic systems that are affordable~~250,000,000 ~~accessible and have aftermarket support~~shares.

~~Increasing~~In ~~health~~connection ~~insurance~~with ~~penetration:~~the ~~Health~~consummation ~~insurance~~of ~~coverage~~the CardioVentures isMerger, anDr. ~~important~~Sudhir ~~determinant~~Srivastava, ofthrough ~~access~~Sushruta, toassigned ~~and~~all ~~demand~~patents, ~~for~~trademarks ~~healthcare~~and ~~services.~~other ~~Health~~intellectual ~~insurance~~property ~~coverage~~used in ~~India~~the ~~has steadily grown in~~development, ~~recent years~~commercialization, ~~covering~~manufacturing 70and ~~percent~~sale of ~~the~~its ~~population~~medical ~~with~~and ~~nearly~~surgical ~~950~~robotic ~~million~~systems ~~people~~and ~~with~~related ~~either~~devices ~~private~~to ~~health~~one ~~insurance~~ or ~~government subsidized~~more ~~schemes~~wholly ~~such as Ayushman Bharat5. Currently, Indians spend approximately 20 percent of their health spending as~~owned ansubsidiaries ~~out-~~of~~-pocket~~ ~~expenditure compared to 55 percent in 20196~~SSi. ~~Key elements of the positive transformation of India’s healthcare system are the National Health Mission, Ayushman Bharat, and medical tourism.~~

Medical value travel: India has emerged as a leading destination for medical tourism, attracting patients from around the world. The Indian medical tourism market was valued at $2.89 billion in 2020 and is expected to reach $13.42 billion by 20267. The medical tourism sector has emerged as a key growth driver for surgical procedures in India. The factors contributing to the growth of medical tourism include availability of advanced treatments at relatively lower costs, the availability of skilled doctors, advanced technology in private hospitals, English language proficiency, and ease of travel. The Indian Government has played a pivotal role in paving the way for these international patients to enter the country and avail their desired medical treatments. It has implemented a number of policies, including the introduction of an e-Medical visa, multiple entry visas, and longer stays as needed for treatment.

Favorable regulatory environment: Recently, several policy measures were implemented to drive the growth of India’s healthcare sector. These include increase in public health expenditure to 2.5% of GDP by 20258; an implementation of several large-scale and ambitious initiatives like Ayushman Bharat – the world’s largest universal health coverage scheme covering 500 million people; commitment from the Government to invest $200 billion in medical infrastructure by 2024, as well as the roll out of various schemes under the AatmaNirbhar Bharat Abhiyaan. In particular, the Performance-Linked Incentive (PLI) Scheme and the Scheme for Promotion of Medical Device Parks offers significant financial incentives for investors to manufacture in India. A new PLI 2.0 scheme is also being prepared for promotion of the in-vitro diagnostics market.

1 https://www.trade.gov/country-commercial-guides/india-healthcare-and-life-science

2 India National Health Profile https://www.cbhidghs.nic.in/showfile.php?lid=1160

3 At the rate of 1,500 surgeries per 100,000 people. https://www.praxisga.com/PraxisgaImages/ReportImg/surgical-volume-market-in-india-Report-3.pdf

4 https://bwhealthcareworld.businessworld.in/article/India-At-Inflection-Point-In-Robotic-Surgeries-Pace- Will-Only-Accelerate-Mandeep-Singh-Intuitive-Surgical/16-12-2022-458354/

5 https://www.niti.gov.in/sites/default/files/2021- 11/HealthInsuranceforIndia%E2%80%99sMissingMiddle_01-11-2021_digital%20pub.pdf

6 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10292032/

7 https://www.ibef.org/industry/healthcare-india

8 https://www.niti.gov.in/sites/default/files/2021-03/InvestmentOpportunities_HealthcareSector_0.pdf

Corporate Information

~~The~~Our ~~Company~~principal ~~was~~executive ~~incorporated~~offices inare ~~the~~located ~~state~~at 404-405, of3rd Floor, ~~Florida on~~iLabs ~~February~~Info 4Technology Centre, ~~2015~~Udyog ~~under~~Vihar, ~~the~~Phase ~~name~~III, ~~“Avra~~Gurugram, ~~Surgical~~Haryana ~~Microsystems~~122016, ~~Inc~~India.,” ~~and~~Our telephone ~~changed~~number ~~its~~is ~~name~~+91 to73375 ~~“Avra~~53469. ~~Medical Robotics,~~Our ~~Inc~~corporate website is https://ssinnovations.”com. Information appearing on ~~November~~our 5,corporate ~~2015~~website is not part of this prospectus and is not incorporated by reference herein. We have included our website address as an inactive textual reference only.

On April 14, 2023, we consummated the acquisition of CardioVentures, Inc., a Delaware corporation (“CardioVentures”), pursuant to a Merger Agreement dated November 7, 2022 (the “Merger Agreement”), by and among the Company, a wholly owned subsidiary of the Company (“Merger Sub”), CardioVentures and Dr. Sudhir Srivastava, who, through his holding company, owned a controlling interest in CardioVentures.

CardioVentures, through a subsidiary, owned a controlling interest in Sudhir Srivastava Innovations Pvt. Ltd., an Indian private limited company, which developed and manufactures and markets the SSi Mantra, which is designed to provide an advanced, yet cost-effective surgical robotic system which make the benefits of robotic surgery available to a larger part of the global population.

Pursuant to the Merger Agreement, at Closing, Merger Sub merged with and into CardioVentures (the “CardioVentures Merger”). In the CardioVentures Merger, holders of the outstanding shares of common stock of CardioVentures (including certain parties who provided interim convertible financing during the pendency of the Merger Agreement, were issued 135,808,884 shares of SSi common stock, representing approximately 95% of issued and outstanding shares of SSi common stock post-merger, with the existing stockholders of SSi holding approximately 6,544,344 shares of SSi common stock representing approximately 5% of issued and outstanding shares of SSi common stock post-merger.

In addition, the holder of CardioVentures common stock also received shares of newly designated Series A Non-Convertible Preferred Stock (the “Series A Preferred Shares”), which affords the holder 51% of the total voting power of the Company. As a result of the foregoing, a “Change in Control” of the Company occurred, with Dr. Sudhir Srivastava becoming the Company’s principal and controlling stockholder. The Series A Preferred Shares are automatically redeemed by the Company for nominal consideration at such time as the holder owns less than 50% of the shares issued to it in connection with the CardioVentures Merger.

Contemporaneously with the Closing on April 14, 2023, the Company changed its name to “SS Innovations International, Inc.,” effected a one-for-ten reverse stock split and increased its authorized common stock to 250,000,000 shares.

In connection with the consummation of the CardioVentures Merger, Dr. Sudhir Srivastava, through his holding company, assigned all patents, trademarks and other intellectual property used in the development, commercialization, manufacturing and sale of its medical and surgical robotic systems and products to one or more wholly owned subsidiaries of SSi. Our principal executive offices are located at 404-405, 3rd Floor, iLabs Info Technology Centre, Udyog Vihar, Phase III, Gurugram, Haryana 122016, India. Our telephone number is +91 73375 53469. Our corporate website is https://ssinnovations.com. Information appearing on our corporate website is not part of this prospectus and is not incorporated by reference herein. We have included our website address as an inactive textual reference only.

Summary Risk Factors

Our business is subject to numerous risks, as more fully described in the “Risk Factors” section immediately following this prospectus summary. These risks include, among others:

●

We are an early-stage revenue company with a limited operating history. We have incurred losses since our inception, we anticipate that we will continue to incur operating losses and negative cash flow for the foreseeable future, and we may never achieve or maintain profitability.

● We ~~may~~will require significant additional financing to expand marketing of ~~our~~the SSi Mantra ~~system~~, obtain regulatory approvals in the ~~United States~~U.S., the ~~European Union (the “~~EU”) and other countries where we wish to market our ~~products,~~systems and related devices and develop and commercialize enhancements to ~~our~~the ~~surgical~~SSi ~~robotic system~~Mantra, as well as other related products. A failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our marketing and product development activities.

● If our SSi Mantra ~~Surgical Robotic System~~ and ~~other~~related ~~products~~devices do not achieve market acceptance in India and abroad, we will not be able to generate the revenue necessary to support our business.

●

We may encounter resistance from customers to the effort required to be trained to use the SSi Mantra and other problems or delays with respect to training that could result in lost revenue.

● The SSi Mantra and our ~~other~~related ~~products~~devices and operations have not been approved for marketing in the ~~United~~U.S. ~~States~~ or the EU, and are and will be subject to extensive and rigorous government regulation ~~in India~~ by the ~~Central~~CDSCO ~~Drugs~~in ~~Standard Control Organization (the “CDSCO”)~~India, by ~~the Food and Drug Administration (the “~~FDA”) in the ~~United~~U.S. ~~States,~~ and by similar agencies in the EU and in many other countries where we plan to market our ~~products.~~systems Inand ~~particular,~~related ~~complying~~devices. ~~with~~If ~~FDA~~we ~~regulations~~do isnot aobtain ~~complex process,~~ and ~~our~~maintain ~~failure~~the tonecessary ~~obtain~~international ~~any~~regulatory ~~necessary~~ approvals ~~could~~or ~~subject~~certifications, uswe towill ~~significant~~not ~~delay~~be inable ~~marketing~~to sell our ~~products~~systems ~~in the U.S.~~ and ~~could~~related ~~have~~devices ain ~~material~~other ~~adverse effect on the Company~~countries.

~~● Even if we obtain regulatory approval, we will be subject to ongoing post-market regulatory scrutiny.~~3

● IfWe ~~defects~~may ~~are~~encounter ~~discovered~~delays inor ~~our~~may ~~robotic~~not ~~surgical~~be ~~system~~able ~~and~~to ~~other~~obtain ~~products,~~regulatory weapproval ~~may~~in ~~incur~~the ~~additional~~U.S. ~~unforeseen~~the ~~costs~~EU ~~stemming from physicians, hospitals~~ and other ~~potential~~countries ~~customers~~for ~~possibly~~the ~~not~~SSi ~~purchasing~~Mantra ~~our~~and ~~products~~related ~~and~~devices. ~~our~~● ~~reputation~~Even ~~may~~if ~~suffer.~~we ~~This~~obtain ~~would~~regulatory ~~have~~approval, awe ~~material~~will ~~adverse~~be ~~effect~~subject onto ~~our~~ongoing ~~business~~post-market regulatory scrutiny.

● ~~The~~If ~~use~~defects ofare discovered in our surgical robotic ~~systems~~system ~~could~~and ~~result~~related indevices, ~~product~~we ~~liability~~may ~~and~~incur ~~negligence~~additional ~~claims~~unforeseen ~~that~~costs ~~could~~stemming befrom ~~expensive~~physicians, ~~divert~~hospitals ~~management’s~~and ~~attention~~other potential customers possibly not purchasing our systems and ~~harm~~related devices and our reputation may suffer. This would have a material adverse effect on our business.

●

The use of our surgical robotic systems exposes us to significant product liability and negligence risks, and our insurance coverage may be inadequate or unavailable; we may be unable to obtain or expand coverage as our business grows.

●

We may encounter manufacturing problems or delays that could result in lost revenue.

●

We could be subject to significant, uninsured losses, which may have a material adverse impact on our business, financial condition, or results of operations.

●

We rely heavily on the consistent supply of components from overseas suppliers for our manufacturing operations.

5● Our reliance on sole- and single-sourced suppliers and ability to purchase at acceptable prices a sufficient supply of materials could harm our ability to meet product demand in a timely manner or within budget.

● Reliance on sole- and single-sourced suppliers and ability to purchase at acceptable prices a sufficient supply of materials could harm our ability to meet product demand in a timely manner or within budget.

●

We need to expand our sales and marketing capabilities and clinical and technical support team and the failure to do so could impair our ability to achieve profitability.

●

Our markets are highly competitive and many of our competitors have significantly greater experience, longer operating histories and greater financial resources. If we cannot compete effectively, our business, prospects, financial condition or results of operations will be materially adversely impacted.

●

If we lose our key personnel or are unable to attract and retain additional personnel, our ability to compete will be harmed.

●

We are subject to a variety of risks due to the substantial portions of our operations which are conducted in India.

● If hospitals are unable to obtain coverage and reimbursement for procedures using our ~~products~~systems and related devices, if reimbursement is insufficient to cover the costs of purchasing our ~~products,~~systems and related devices or if limitations are imposed by governments on the amount hospitals can charge for certain procedures, we may be unable to generate sufficient sales to support our business.

● IfTariff wepolicies ~~are~~could ~~unable~~hamper toour ~~protect~~ability ~~the~~to ~~intellectual~~import ~~property~~our ~~for~~surgical ~~our~~robotic ~~products~~systems ~~from~~and ~~use~~related bydevices ~~third~~and ~~parties,~~otherwise market our ~~ability~~surgical torobotic ~~compete~~systems and related devices in the ~~market~~U.S. ~~will~~● beOur ~~harmed~~business is subject to complex and evolving laws and regulations regarding data privacy, data protection, artificial intelligence, and responsible use of data.

● ~~Others~~If ~~may~~we ~~assert~~are ~~that~~unable ~~our~~to ~~products~~protect ~~infringe~~the ~~on their~~ intellectual property ~~rights,~~for ~~which~~our ~~may~~systems ~~cause us to engage in costly disputes~~ and, ifrelated wedevices ~~are~~from ~~not~~use ~~successful~~by inthird ~~defending ourselves~~parties, ~~could~~our ~~also~~ability ~~require us~~ to ~~pay~~compete ~~substantial~~in ~~damages,~~the ~~prohibiting~~market uswill ~~from~~be ~~selling our products~~harmed.

●

Others may assert that our systems and related devices infringe on their intellectual property rights, which may cause us to engage in costly disputes and, if we are not successful in defending ourselves, could also require us to pay substantial damages, prohibiting us from selling our systems and related devices.

●

We may be forced to litigate to enforce or defend our intellectual property rights.

●

Intellectual property disputes could cause us to spend substantial resources and distract our personnel from their normal responsibilities.

● The rights and measures we rely on to protect the intellectual property underlying our ~~products~~systems and related devices may not be adequate to prevent third parties from using our technology, which could harm our ability to compete in the market.

● Obtaining and maintaining patent protection depend on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.4

●

Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.

●

We may be subject to claims by third parties claiming ownership of what we regard as our own intellectual property.

● We may be unsuccessful in licensing or acquiring intellectual property rights from third parties that may be necessary to develop, manufacture and/or commercialize our current and/or future ~~products~~systems and related devices or services.

● Our ~~products~~management ~~rely~~has onreported ~~licenses~~that ~~from~~our ~~third~~disclosure ~~parties,~~controls and ifprocedures weand ~~lose~~our ~~access~~internal tocontrol ~~these~~over ~~technologies~~financial reporting were not effective, which could cause our ~~revenues~~financial ~~could~~reporting ~~decline~~to be unreliable and lead to misinformation being disseminated to the public.

6● Our Chairman and Chief Executive Officer, who is our principal and controlling shareholder, holds approximately 58.35% of the combined voting power of the Company, which gives him the ability to control our business and may limit or eliminate minority shareholders’ ability to influence corporate affairs. ● You will experience immediate and substantial dilution in the book value per share of common stock you purchase. ● If you purchase our securities in this offering, you may experience future dilution as a result of future equity offerings or other equity issuances. ● A substantial number of shares of common stock may be sold in the market following this offering, which may depress the market price for our common stock. ● The offering price per share in this offering is not an indication of the fair value of our common stock. ● FINRA sales practice requirements may limit a shareholder’s ability to buy and sell our securities.

Implications of ~~Our~~ Being ana ~~“Emerging~~Smaller ~~Growth~~Reporting Company”

As We are a smaller reporting company ~~with~~as defined in the Securities Exchange Act of 1934, as amended (the “Exchange Act”). We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as (i) the market value of our voting and non-voting common stock held by non-affiliates is less than $~~1.235~~250 million ~~billion~~measured inon ~~revenues~~the last business day of our second fiscal quarter or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our voting and non-voting common stock held by non-affiliates is less than $700 million measured on the last business day of our second fiscal ~~year~~quarter. Specifically, as a smaller reporting company, we ~~qualify~~may aschoose anto ~~“emerging~~present ~~growth~~only ~~company”~~the two most recent ~~under~~fiscal years ~~the~~of ~~Jumpstart~~audited ~~Our~~financial ~~Business~~statements ~~Startups~~in ~~Act~~our ofannual ~~2012~~reports ~~(the~~on ~~“JOBS~~Form 10-K ~~Act”).~~and Ashave anreduced ~~emerging~~disclosure ~~growth~~obligations regarding executive compensation, and if we are a smaller reporting company with less than $100 million in annual revenue, we would not be required to obtain an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. We have elected to take advantage of certain of the reduced ~~reporting~~disclosure ~~requirements~~obligations ~~and~~in ~~are~~the ~~relieved~~registration statement of ~~certain~~which this prospectus is a part and may elect to take advantage of other ~~significant~~reduced reporting requirements ~~that~~in ~~are~~future ~~otherwise~~filings. ~~generally~~As a result, the information that ~~applicable~~we provide to our shareholders may be different than what you might receive from other public reporting companies. Asin anwhich ~~emerging~~you ~~growth~~hold ~~company:~~equity interests.

● we may present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations; ● we are not required to provide a detailed narrative disclosure discussing our compensation principles, objectives and elements and analyzing how those elements fit with our principles and objectives, which is commonly referred to as “compensation discussion and analysis”; ● we are not required to obtain an attestation and report from our auditors on our management’s assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act; ● we are not required to obtain a non-binding advisory vote from our stockholders on executive compensation or golden parachute arrangements (commonly referred to as the “say-on-pay,” “say-on-pay frequency” and “say-on-golden-parachute” votes); ● we are exempt from certain executive compensation disclosure provisions requiring a pay-for-performance graph and CEO pay ratio disclosure; ● we are eligible to claim longer phase-in periods for the adoption of new or revised financial accounting standards under §107 of the JOBS Act; and ● we are not required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation.5

We may take advantage of any or all of these provisions until the last day of the fiscal year following the fifth (5th) anniversary of this Offering if we continue to be an emerging growth company. We would cease to be an emerging growth company if we have $1.235 billion or more in annual gross revenues, have $700 million or more in aggregate worldwide market value of our shares held by non-affiliates as of the last business day of any second fiscal quarter or issue more than $1.0 billion of non-convertible debt over a three-year (3-year) period.

The Offering

Shares Offered by Us		We are offering shares of our common stock, $0.0001 par value per share (“Shares”).
Securities we are offering		11,286,681 shares
Offering Price		$ per Share.
Option to purchase additional shares		We have granted the underwriters an option, exercisable for forty-five (45) days after the date of this prospectus, to purchase up to an additional 1,693,002 shares of Common Stock at the public offering price, less the underwriting discounts and commissions.
Option to Purchase Additional Shares		We have granted the underwriters an option, exercisable for forty-five (45) days after the date of this prospectus, to purchase up to an additional Shares at a price of $ per Share, less the underwriting discount, solely to cover overallotments, if any.
Common stock outstanding before this offering:		194,356,700 shares (including 191,559 shares being processed for issuance in connection with employee stock grants under our 2016 Incentive Stock Plan (the “2016 Incentive Plan”)).
Shares Outstanding Immediately after this Offering		Shares.
Common stock outstanding after this offering		205,643,381 shares (or 207,336,383 shares if the underwriters’ option to purchase additional shares is exercised in full).
Use of Proceeds		We estimate the net proceeds to us from this Offering, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, will be approximately $ million.
Use of proceeds:		We estimate the net proceeds to us from this offering, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, will be approximately $45.8 million (or $52.8 million if the underwriters’ option to purchase additional shares is exercised in full). We intend to use the net proceeds for working capital and general corporate purposes, which include, but are not limited to expansion of our manufacturing capacity through the installation of additional machinery and equipment, bulk ordering of components for use in manufacturing of our systems and related devices, conducting global clinical trials to meet various regulatory requirements, lease of additional office and manufacturing space, augmenting our working capital and establishing regional marketing offices. See “Use of Proceeds” for more information.
		We intend to use the net proceeds for working capital and general corporate purposes, which include, but are not limited to expansion of our manufacturing capacity through the installation of additional machinery and equipment, bulk ordering of components for use in manufacturing of our final products, conducting global clinical trials to meet various regulatory requirements, and establishing regional marketing offices. See “Use of Proceeds” for more information.
Nasdaq symbol for our common stock		Our common stock is currently listed for trading on Nasdaq under the symbol “SSII.”
Current Market for our Shares		Our common stock is currently quoted on the OTCPink under the symbol “SSII.” However, the trading market for our common stock is sporadic and extremely limited.
Risk Factors		An investment in our securities involves a high degree of risk and could result in a loss of your entire investment. Prior to making an investment decision, you should carefully consider all of the information in this prospectus and, in particular, you should evaluate the risk factors set forth under the caption “Risk Factors” beginning on page 8.
Proposed Nasdaq Capital Market Trading Symbol and Listing		We have applied to list our common stock on the Nasdaq Capital Market under the symbols “SSII.” No assurance can be given that such listings will be approved or that a liquid trading market will develop for our common stock.
Underwriters’ Warrants		We will issue to Freedom Capital Markets (“Freedom”), as the representative of the underwriters, upon closing of this Offering, warrants entitling the underwriters or their designees to purchase up to 5% of the aggregate number of Shares that we issue in this Offering. The underwriters’ warrants will be exercisable for a five-year period, commencing six months following the effective date of the registration statement of which this prospectus forms a part at an exercise price per Share equal to 110% of the public offering price of the Shares offered hereby. See “Underwriting.”
Lock-Up		In connection with this offering, we, our directors, executive officers, and certain stockholders will enter into lock-up agreements with the underwriters. Pursuant to the terms of the lock-up agreements, we, our directors, executive officers, and certain stockholders will not offer for sale, issue, sell, contract to sell, pledge or otherwise dispose of any of our common stock or securities convertible into common stock for a period of 180 days commencing on the closing date of this offering. See “Underwriting.”
Risk Factors		You should read the “Risk Factors” section of this prospectus for a discussion of certain factors to consider carefully before deciding to purchase any of our securities.

~~Outstanding~~The number of shares outstanding immediately following this offering ~~Shares~~is based on 194,356,700 shares issued and outstanding as of the date of this prospectus (including 191,559 shares being processed for issuance in connection with employee stock grants under the 2016 Incentive Plan), and excludes, as of that date, the following:

~~The number~~● the 7,578,181 shares of ~~Shares~~our ~~outstanding~~common ~~immediately~~stock ~~following~~reserved ~~this~~for ~~Offering~~issuance isunder ~~based~~outstanding onoptions ~~170,711,881~~under ~~Shares~~the ~~issued~~2016 ~~and~~Incentive ~~outstanding~~Plan aswith ofa ~~December 31,~~weighted-average ~~2023~~exercise price of $4.97 ~~The~~per ~~number~~share; ● the 1,884,107 shares of ~~Shares~~common tostock beissuable upon the vesting of outstanding ~~immediately~~restricted ~~following~~stock ~~this~~grants ~~Offering~~under ~~does~~the ~~not~~2016 ~~take~~Incentive ~~into~~Plan; ~~account~~and ● the ~~number~~500,000 shares of ~~Shares outstanding~~our ascommon stock issuable upon exercise of ~~the~~outstanding ~~date~~warrants asat an exercise price of ~~December~~$8.89 ~~31,~~per ~~2023:~~share.

●Unless ~~the~~otherwise 7indicated,~~496,026~~ ~~shares~~all ofinformation ~~our~~in this ~~common~~prospectus stock reserved for issuance under presently outstanding options or unvested stock awards issued under our 2016 Incentive Stock Plan (the “Incentive Plan”) with a weighted-average exercise price of $5.14 per share; ● the 8,831,005 shares of our common stock reserved for future issuance under the Incentive Plan; and ● the shares that may be issued upon exercise of the underwriters’ warrants.assumes:

~~Unless otherwise~~● ~~indicated,~~no ~~all~~exercise ~~information~~of inthe ~~this~~Representative ~~prospectus~~Warrants; ~~assumes~~● no exercise of the outstanding options orand ~~the underwriters’~~ warrants, ; and ● no exercise by the underwriters of their option to purchase up to ~~additional shares~~ of1,693,002 ~~our~~additional ~~common stock~~shares.

Summary Financial Information

The summary consolidated statements of operations data for each of the years ended December 31, ~~2022~~2024 and December 31, ~~2021~~2023 and the summary consolidated balance sheet data as of December 31, ~~2022~~2024 have been derived from our audited consolidated financial statements and notes thereto included elsewhere in this prospectus.

The summary consolidated statements of operations data for the nine months ended September 30, ~~2023~~2025 and September 30, ~~2022~~2024 and the summary consolidated balance sheet data as of September 30, ~~2023~~2025, have been derived from our unaudited consolidated financial statements and notes thereto included elsewhere in this prospectus. The unaudited consolidated financial statements were prepared on the same basis as our audited financial statements. In our opinion, such financial statements include all adjustments, consisting only of normal recurring adjustments that we consider necessary for a fair presentation of the financial information set forth in those statements.

You should read this information together with the consolidated financial statements and related notes and other information under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this prospectus.

Statement of Operations	For the Nine Months Ended September 30, ~~2023~~2025			For the Nine Months Ended September 30, ~~2022~~2024			For the Year Ended December 31, ~~2022~~2024			For the Year Ended December 31, ~~2021~~2023
	(unaudited)			(unaudited)
Revenues	$	427,~~516~~950,~~458~~264		$	-12,533,335		$	-20,649,528		$	-5,875,314
Cost of Sales	$	3(14,~~621~~783,~~375~~062	)	$	-(8,049,960	)	$	-(12,197,162	)	$	-(5,149,786	)
Research and Development	$	-		$	-		$	72,959		$	1,000
Operating and Interest Expenses	$	(20,622,422	)	$	(21,711,181	)	$	(27,603,563	)	$	(21,603,820	)
Other Selling, General and Interest Expenses	$	5,717,588		$	1,040,525		$	2,140,053		$	1,483,313
Net Loss	$	(9,656,008	)	$	(17,227,806	)	$	(19,151,197	)	$	(20,878,292	)
Net Loss	$	4,822,406		$	1,040,525		$	2,213,012		$	1,484,313
Net Loss per share, basic and diluted	$	(0.05	)	$	(0.10	)	$	(0.11	)	$	(0.14	)
Net Loss per share, basic and diluted	$	-		$	-		$	0.5		$	0.5
Weighted-average shares outstanding- basic		188,720,115			170,750,183			170,847,444			144,866,674
Weighed-average shares outstanding, basic and diluted		114,855,607			38,471,501			40,878,824			28.480.973
Weighted-average shares outstanding- diluted		197,979,738			181,779,811			181,203,673			152,069,825

Balance Sheet Data	As of September 30, ~~2023~~2025		As of December 31, ~~2022~~2024
	(unaudited)
Cash	$	65,~~596~~681,~~224~~657	$	1466,~~351,364~~500
Total Assets	$	2469,~~058~~577,~~996~~027	$	442,~~371~~385,~~441~~213
Total Liabilities	$	829,~~296~~927,~~341~~721	$	428,~~051~~928,~~229~~110
Total Stockholders’ Equity / (Deficiency)	$	15,762,655	$	320,213
Total Stockholders’ Equity	$	39,649,306	$	13,457,103
Total Liabilities and Stockholders’ Equity (Deficit)	$	24,058,996	$	4,371,441

RISK FACTORS

An investment in our securities involves a number of very significant risks. You should carefully consider the following risk factors in conjunction with the other information contained in this prospectus before purchasing our securities. The risks discussed in this prospectus could adversely affect our business, operating results, prospects and financial condition. This could cause the value of our securities to decline and/or cause you to lose part or all of your investment. The risks and uncertainties described below are not the only ones we face but do represent those risks and uncertainties that we believe are material to us. Additional risks and uncertainties not presently known to us or that, as of the date of this prospectus, we deem immaterial may also harm our business. Some statements in this prospectus, including statements in the following risk factors, constitute forward-looking statements. Please refer to the section entitled “Special Note Regarding Forward-Looking Statements.”

Risks Related to Our Business

We only commercially launched ~~our~~the ~~Ssi~~SSi Mantra ~~Surgical Robotic System~~ in the second half of 2022 and, accordingly, our revenues have been limited to date. Accordingly, we have a limited operating history, we have not yet demonstrated our ability to generate revenue on a consistent basis, and we may not be able to operate on a profitable basis. As a result, it is difficult to evaluate our performance and to forecast our future operating results. Our prospects must be considered in light of the risks, uncertainties, expenses and difficulties frequently encountered by an early-stage revenue company in a highly competitive healthcare industry. We cannot provide any assurance that we will be successful in addressing the risks which we may encounter, and our failure to do so could have a material adverse effect on our business, prospects, financial condition and results of operations.

We have incurred losses since our inception and expect to continue to incur operating losses and negative cash flow for the foreseeable future. For the years ended December 31, ~~2022~~ 2024 and December 31, ~~2021, we~~2023 ~~had~~and ~~net~~the ~~losses~~nine ofmonths ~~$2.2~~ended ~~million~~September ~~and $1.5 million~~30, ~~respectively,~~2025 and ~~for the nine months ended~~ September 30, ~~2023~~2024, we had net losses of $419.~~8million~~15 million. $20.88 million, $9.66 million and $17.23 million, respectively. As of December 31, 2024 and September 30, ~~2023~~2025, we had an accumulated deficit of $2143.0966 million and $53.32 million, respectively. We anticipate that our losses will continue to increase from current levels because we expect to incur additional costs and expenses related to expanding our business, including additional manufacturing costs, sales, marketing and distribution costs, employee related costs, capital expenditures and the costs of complying with government regulations, sales force, manufacturing, distribution and training. To become and remain profitable, we must succeed in continuing to market our ~~Ssi~~SSi Mantra system and generate significant revenue from the sale thereof. We can provide no assurance as to when, or if, we can achieve profitability and, even if we achieve profitability, we may not be able to sustain profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. A decline in the value of our common stock could also cause you to lose all or part of your investment. These factors raise substantial doubt about our ability to continue as a going concern.

We ~~may~~ will require significant additional financing to expand marketing of ~~our~~the SSi Mantra ~~system~~, obtain regulatory approvals in the ~~United States~~U.S., the EU and other countries where we wish to market our ~~products~~systems and related devices, and develop and commercialize enhancements to ~~our~~the ~~surgical~~SSi ~~robotic system~~Mantra, as well as other related products. A failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our marketing and product development activities.

We believe that we will continue to expend substantial resources for the foreseeable future on expanded marketing of our SSi Mantra system, obtain regulatory approvals in the ~~United States~~U.S., the EU and other countries where we wish to market our ~~products~~systems and related devices, and develop and commercialize enhancements to our surgical robotic system, asand ~~well as other~~ related ~~products~~devices.

Our future capital requirements depend on many factors, including:

● the cost, time and success of expanded marketing efforts of our SSi Mantra system; ● obtaining regulatory approval of our SSi Mantra ~~Surgical~~system ~~Robotic System~~ in the U.S., the EU and other countries where we wish to market our ~~products~~systems and related devices;

10● the scope, progress, results and costs of research and development of enhancements to our SSi Mantra system and any future systems and related devices we may seek to develop; ● the cost of commercialization activities of any enhanced or future products which we may develop and seek to commercialize; ● our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements, if we choose to utilize such arrangements in connection with the commercialization of future systems and related devices; ● the number and characteristics of any future products we may develop; ● any product liability or other lawsuits related to our products or commenced against us; ● the expenses needed to attract and retain skilled personnel; ● the costs associated with being a public company; and ● the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims or other intellectual property rights, including litigation costs and the outcome of such litigation.

●Additional ~~the~~funds ~~scope, progress, results and costs of research and development of enhancements to our SSi Mantra system and any future products we~~ may ~~seek~~not tobe ~~develop;~~available ●when ~~the cost of commercialization activities of any enhanced or future products which~~ we need ~~may develop and seek to commercialize; ● our ability to establish and maintain strategic collaborations~~them, ~~licensing~~on ~~or other arrangements and the financial~~ terms ofthat ~~such~~are ~~agreements,~~acceptable ~~if we choose~~ to ~~utilize~~us ~~such~~or ~~arrangements~~at inall. ~~connection~~If ~~with~~adequate ~~the~~funds ~~commercialization~~are ofnot ~~future~~available ~~products; ● the number and characteristics of any future products we may develop; ● any product liability or other lawsuits related~~ to ~~our products or commenced against~~ us; ●on ~~the expenses needed to attract and retain skilled personnel; ● the costs associated with being~~ a ~~public~~timely ~~company; and ● the costs involved in preparing~~basis, ~~filing,~~we ~~prosecuting,~~may ~~maintaining,~~be ~~defending and enforcing patent claims or other intellectual property rights, including litigation costs and the outcome of such litigation.~~required to:

Additional funds may not be available when we need them, on terms that are acceptable to us, or at all. If adequate funds are not available to us on a timely basis, we may be required to:

	●	delay, limit, reduce or terminate sales and marketing activities for our SSi Mantra system, and other products; or

	●	delay, limit, reduce or terminate our research and development activities.

~~If our~~You ~~SSi~~should ~~Mantra~~exercise ~~Surgical~~caution ~~Robotic~~in ~~System~~relying ~~and~~on the ~~other~~estimated ~~products~~financial doand ~~not~~operating ~~achieve~~results ~~market~~set ~~acceptance,~~forth wein ~~will~~this ~~not be able to generate the revenue necessary to support our business~~prospectus.

~~We believe~~The ~~that~~estimated ~~our~~financial ~~SSi~~and ~~Mantra~~operating ~~Surgical~~results set ~~Robotic~~forth ~~System~~in ~~offers~~“Prospectus anSummary ~~important~~– ~~alternative~~Recent toDevelopment” ~~existing~~above ~~systems~~are ~~due to its advanced technology~~preliminary, ~~significantly~~ ~~lower~~unaudited ~~cost~~ and ~~ease~~subject ofto ~~training~~ completion, and ~~affords~~may ~~the~~change ~~opportunity~~as toa ~~bring~~result ~~the benefits~~ of ~~robotic~~management’s ~~surgery~~continued ~~to greater numbers of patients around the world~~review. ~~Achieving~~Such ~~physician~~preliminary ~~and~~results ~~patient~~are ~~acceptance~~subject ~~of our system will be crucial~~ to ~~our~~the ~~success. If~~finalization ~~our~~of ~~products~~quarter-end ~~fail~~financial toand ~~achieve~~accounting ~~market~~procedures ~~acceptance, customers will not purchase our products~~ and ~~we will not be able to generate~~ the ~~revenue~~completion ~~necessary to support our business. We believe that physicians’ acceptance~~ of the ~~benefits~~audit of ~~procedures performed using~~ our ~~system~~financial ~~will be~~statements ~~essential~~ for ~~acceptance~~the oftwelve ~~our~~months ~~system~~ended byDecember ~~patients~~31, 2025. In ~~addition,~~As wea ~~are~~result, ~~initially~~investors ~~focusing~~should onexercise ~~markets~~caution ~~with~~in arelying ~~low~~on ~~penetration of~~this ~~robotic~~information ~~surgery where hospitals~~ and ~~physicians~~should ~~may~~not bedraw ~~reluctant~~any toinferences ~~adopt~~from athis ~~new system because of perceived liability risks~~information. ~~If the~~ ~~SSi~~This ~~Mantra~~preliminary isfinancial ~~not~~information ~~accepted~~should ~~by the market and~~ not ~~competitive~~be ~~with~~viewed ~~other~~as ~~systems,~~a wesubstitute ~~may~~for ~~not~~full befinancial ~~able~~statements toprepared ~~generate~~in ~~the~~accordance ~~revenue necessary~~with toGAAP ~~support~~and ~~our~~reviewed ~~business~~by ~~and~~ our ~~business,~~independent ~~prospects,~~registered ~~financial~~public ~~condition~~accounting ~~and results of operations will be materially adversely affected~~firm.

Substantially all of our operating assets are pledged to secure our bank overdraft facility from HDFC Bank in India and in the event of a default under the credit facility, the lender would be entitled to foreclose on its lien which would effectively terminate our operations and business.

We are subject to various risks related to the current bank overdraft facility with HDFC Bank and any future debt we may use to finance our operations. The bank overdraft facility which our Indian subsidiary uses to fund its operations in part poses various risks including:

●

that it requires us to dedicate a portion of our financial resources to the payment of interest and principal, reducing money available to fund working capital, capital expenditures, product development and other general corporate purposes;

●

increases our vulnerability to adverse changes in general economic, industry and market conditions;

●

subjects us to restrictive covenants; and

●

limits flexibility in planning for, or reacting to, changes in our business and industry in which we compete.

A breach of any of the covenants in the agreements governing our existing or future indebtedness could result in an event of default, which, if not cured or waived, could trigger acceleration of our indebtedness which could result in a material adverse effect on our business, financial condition and results of operations.

Moreover, substantially all of our operating assets, which are held by SSI-India and located in India, are pledged to secure our bank overdraft facility from HDFC Bank and will likely be used to secure future indebtedness. In the event of a default under the bank overdraft facility or any subsequent indebtedness, the lender would be entitled to foreclose on its lien, which would effectively terminate our operations and business.

If our SSi Mantra system and related devices do not achieve market acceptance in India and abroad, we will not be able to generate the revenue necessary to support our business.

We believe that our SSi Mantra system offers an important alternative to existing systems due to its advanced technology, significantly lower cost and ease of training and affords the opportunity to bring the benefits of robotic surgery to greater numbers of patients around the world. Achieving physician and patient acceptance of our systems will be crucial to our success. If our systems and related devices fail to achieve market acceptance, customers will not purchase our products and we will not be able to generate the revenue necessary to support our business. We believe that physicians’ acceptance of the benefits of procedures performed using our system and related devices will be essential for acceptance of our system by patients. In addition, we are initially focusing on markets with a low penetration of robotic surgery where hospitals and physicians may be reluctant to adopt a new system because of perceived liability risks. If the SSi Mantra is not accepted by the market in India and abroad, and not competitive with other systems, we may not be able to generate the revenue necessary to support our business and our business, prospects, financial condition and results of operations will be materially adversely affected.

We may encounter resistance from customers to the effort required to be trained to use the SSi Mantra and other problems or delays with respect to training that could result in lost revenue.

We anticipate that there will be a learning process involved for users of our SSi Mantra system to become proficient in its use. Broad use of our system will require training. Market acceptance could be delayed by the time required to complete this training. Even if we are able to overcome market resistance, we may not be able to rapidly train users in numbers sufficient to generate adequate demand for our system.

11 The SSi Mantra and our related devices and operations have not been approved for marketing in the U.S. or the EU, and are and will be subject to extensive and rigorous government regulation by the CDSCO in India, by the FDA in the U.S. and by similar agencies in the EU and in many other countries where we plan to market our systems and related devices. If we do not obtain and maintain the necessary international regulatory approvals or certifications, we will not be able to sell our systems and related devices in other countries.

The SSi Mantra and our ~~other~~related ~~products~~devices and operations have not been approved for marketing in the ~~United~~U.S. ~~States~~ or the EU, and are and will be subject to extensive ~~and~~ rigorous government regulation ~~in India~~ by the CDSCO in India, by the FDA in the ~~United~~U.S. ~~States,~~ and by similar agencies in the EU and in many other countries or regions where we plan to market ~~our products. In particular, complying with FDA regulations is a complex process,~~ ~~and~~ our ~~failure~~systems ~~to obtain any necessary approvals could subject us to significant delay in marketing our products in the U.S.~~ and ~~could have~~related ~~a material adverse effect on the Company~~devices.

~~The SSi~~In ~~Mantra~~India, our systems and ~~our~~related ~~other~~devices ~~products~~are primarily ~~and~~regulated ~~operations~~under ~~have~~the ~~not~~Indian ~~been~~Medical ~~approved~~Device ~~for~~Rules, ~~marketing~~2017, inas amended by the ~~United~~Medical ~~States~~Device or(Amendment) Rules, 2020 (as amended, the EU“IMDR”), ~~and~~promulgated ~~are~~ and ~~will be~~administered ~~subject~~by tothe ~~extensive~~CDSCO. ~~rigorous~~These ~~government~~rules ~~regulation~~cover invarious ~~India~~aspects byof ~~the~~medical ~~CDSCO~~device related regulations, byincluding ~~the~~classification, ~~FDA~~registration, inmanufacturing ~~the~~and ~~United~~import, ~~States~~labeling, sales and bypost-market ~~similar~~requirements. ~~agencies~~Similar to rules in the EU, ~~and~~they ~~many~~mandate ~~other~~that ~~countries~~devices orare ~~regions~~safe ~~where~~and weperform ~~plan~~their tointended ~~market our products~~function.

In India, our products are primarily regulated under the Indian Medical Device Rules, 2017, as amended by the Medical Device (Amendment) Rules, 2020 (as amended, the “IMDR”), promulgated and administered by the CDSCO. These rules cover various aspects of medical device related regulations, including classification, registration, manufacturing and import, labeling, sales, and post-market requirements. Similar to rules in the EU, they mandate that devices are safe and perform their intended function

Based on intended use of the device, the risks associated with the device and other parameters referred to in the IMDR, the Central Licensing Authority of India classifies Medical Devices into four risk classes: (i) A (low risk); (ii) B (low moderate risk); (iii) C (moderate high risk); and (iv) D (high risk).

The CDSCO has divided the device classifications into 24 panels, whereas our surgical robotic system is classified as a Class B device pertaining to operating room procedures.

Our products and operations will be subject to extensive and rigorous regulation in the United States by the FDA and by similar agencies in the EU and many other countries or regions in which we may market our products. Unless an exemption applies, each medical device that we intend to market in the U.S. must first receive either “510(k) clearance” or “Premarket approval” (“PMA”) from the FDA pursuant to the Federal Food, Drug, and Cosmetic Act (the “FFDCA”). The FDA’s 510(k) clearance process usually takes from four to twelve months, but it can last longer. The process of Obtaining PMA approval is much more costly, lengthy and uncertain. It generally takes from one to three years or even longer.10

Our systems and related devices and operations will be subject to extensive and rigorous regulation in the U.S. by the FDA and by similar agencies in the EU and many other countries or regions in which we may market our systems and related devices. Unless an exemption applies, each medical device that we intend to market in the U.S. must first receive either “510(k) clearance” or “Premarket approval” (“PMA”) from the FDA pursuant to the Federal Food, Drug, and Cosmetic Act (the “FFDCA”). The FDA’s 510(k) clearance process usually takes from four to twelve months, but it can last longer. On December 5, 2025, we submitted a 510(k) premarket notification to the FDA for the SSi Mantra ~~Surgical~~for ~~Robotic~~multiple ~~System~~specialty procedure types, including: general, urological, colorectal, gynecological, and cardiac surgery. We believe that the 510(k) regulatory pathway offers potential speed and cost advantages. The FDA has stated that its goal is to complete reviews of 510(k) submissions within 90 days of receipt. However, time to approval could be ~~fail~~longer due to ~~receive~~factors ~~regulatory~~such as the 15-day acceptance review, the submission of additional information, and a submitter’s response time. We have engaged RQM+, a leading MedTech-focused CRO, to assist with the 510(k) submission. If approved by the FDA, the SSi Mantra would be cleared to market in the U.S. Submission of a 510(k) premarket notification request does not guarantee FDA approval. We have also submitted our technical files to Szutest, an EU Notified Body for ~~many~~the ~~reasons~~CE certification, ~~including~~which if obtained will allow us to market the ~~following:~~SSi Mantra in the EU. We believe that we will be able to secure FDA approval and EU certification in 2026. However, there can be no assurance as to when or if we will secure such regulatory approvals. The process of obtaining PMA approval is much more costly, lengthy and uncertain. It generally takes from one to three years or even longer.

Our SSi Mantra system could fail to receive regulatory approval for many reasons, including the following:

	●	we may be unable to successfully complete any clinical trials which we are required to conduct;

	●	we may be unable to demonstrate to the satisfaction of the FDA or other regulatory authorities that our surgical robotic system is safe;

	●	the FDA or other regulatory authorities may disagree with the design or implementation of any clinical trials we are required to conduct;

	●	the results of clinical trials that we do undertake may not meet the level of statistical significance required by the FDA or other regulatory authorities for approval;

	●	the FDA or other regulatory authorities may disagree with our interpretation of data from any preclinical studies or clinical trials we are required to conduct;

	●	a decision by the FDA, other regulatory authorities or us to suspend or terminate a clinical trial at any time;

	●	the data collected from clinical trials of the SSi Mantra system may be inconclusive or may not be sufficient to obtain regulatory approval in the U.S. or elsewhere; and

	●	our manufacturers of supplies needed for manufacturing the SSi Mantra may fail to satisfy FDA or other regulatory requirements and may not pass inspections that may be required by FDA or other regulatory authorities;

We may encounter substantial delays in our regulatory approvals. We cannot guarantee that any preclinical testing or clinical trials which we are required to conduct, will be conducted as planned or completed on schedule, if at all. Delays can be costly and could negatively affect our ability to complete any preclinical or clinical trials that we are required to conduct for our medical robotic system. If we are not able to successfully complete any such preclinical or clinical trials in a timely and cost-effective manner, we will not be able to obtain regulatory approval and/or will not be able to commercialize our medical robotic systems, which would have an adverse effect on our business.

12To be able to market and sell our systems and related devices in other countries, we must obtain regulatory approvals and comply with the regulations of those countries. These regulations, including the requirements for approvals, and the time required for regulatory review vary from country to country. Obtaining and maintaining foreign regulatory approvals is expensive, and we cannot be certain that we will receive regulatory approvals in any foreign country in which we plan to market the SSi Mantra. If we fail to obtain regulatory approval in any foreign country in which we plan to market our systems and related devices, our ability to generate revenue will be harmed.

~~To be~~We ~~able~~currently tohave ~~market~~ISO ~~and~~13485 ~~sell~~(quality ~~our~~management system) ~~products~~approval, inCDSCO ~~other~~approval ~~countries~~for the manufacture, wesale ~~must~~and ~~obtain~~distribution ~~regulatory~~of ~~approvals~~our systems and ~~comply~~related ~~with~~devices ~~the~~and ~~regulations~~a oflicense ~~those~~to export ~~countries.~~our ~~These~~systems ~~regulations,~~and ~~including~~related ~~the~~devices ~~requirements~~from ~~for~~India. These approvals, ~~and~~allow ~~the~~us ~~time~~to ~~required~~market ~~for~~our ~~regulatory~~systems ~~review~~and ~~vary~~related ~~from~~devices ~~country to~~in ~~country.~~India ~~Obtaining~~and in 50 non-FDA and ~~maintaining~~non-CE ~~foreign~~(EU) ~~regulatory~~countries ~~approvals~~without isfurther ~~expensive,~~regulatory approval and wein ~~cannot~~an beadditional ~~certain~~79 countries that werequire ~~will~~only ~~receive~~minimal ~~regulatory~~registration. ~~approvals~~We inhave ~~any~~received ~~foreign~~regulatory ~~country~~approval into ~~which~~market weand ~~plan~~sell toour ~~market~~systems ~~the~~and ~~SSi~~related ~~Mantra~~devices ~~Robotic~~in ~~Surgical~~Colombia, ~~our~~Ecuador, ~~medical~~Guatemala, ~~robotic~~Indonesia, ~~systems.~~Kenya, Oman, IfPhilippines, weSri ~~fail~~Lanka, ~~to obtain~~Ukraine ~~regulatory~~and ~~approval~~the inUnited ~~any~~Arab ~~foreign~~Emirates, ~~country~~and inhave initiated the regulatory approval process, which weif ~~plan~~successful will allow us to market our ~~products,~~systems ~~our~~and ~~ability~~related todevices ~~generate~~in ~~revenue~~more ~~will~~than be50 ~~harmed~~countries within approximately one year.

We currently have ISO 13485 (quality management system) approval, CDSCO approval for the manufacture, sell and distribution of our products and a license to export our products from India. These approvals allow us to market our products in in India and in fifty (50) non-FDA and non CE (EU) countries without further regulatory approval and in an additional seventy-nine (79) countries require only minimal registration We have received regulatory approval to market and sell our products in the United Arab Emirates and Guatemala and have initiated the regulatory approval process, which if successful will allow us to market our products in more than fifty (50) countries within approximately one year. 11

We have also initiated the process to secure regulatory approvals from the FDA and the EU. However, there can be no assurance as to when we will secure any of the foregoing regulatory approvals, if at all.

If we do not obtain and maintain the necessary international regulatory approvals or certifications, we will not be able to sell our systems and related devices in other countries.

Even if we obtain regulatory approval, we will be subject to ongoing post-market regulatory scrutiny.

Because our medical robotic systems, if approved, will be commercially distributed, numerous post-market regulatory requirements apply, particularly in the ~~United States~~U.S. We will be required to timely file various reports with the supervising agencies, including reporting to the FDA if our surgical robotic system has caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur. If these reports are not filed in a timely manner, regulators may impose sanctions and sales may suffer, and we may be subject to product liability or regulatory enforcement actions, all of which could harm our business.

If we initiate a correction or removal to reduce a ~~risk~~posed to health ~~posed~~risk, we would be required to submit a publicly available report of correction and removal to the FDA and in many cases, similar reports to other regulatory agencies. This report could be classified by the FDA as a product recall which could lead to increased scrutiny by the FDA, other international regulatory agencies and our customers regarding the quality and safety of our ~~products~~systems and related devices. Furthermore, the submission of these reports has been and could be used by competitors against us in competitive situations and cause customers to delay purchase decisions or cancel orders, ~~and~~which would harm our reputation.

In the ~~United States~~U.S., the FDA and the Federal Trade Commission (the “FTC”) also regulate the advertising and promotion of our surgical robotic system to ensure that the claims we make are consistent with our regulatory approvals, that there are adequate and reasonable data to substantiate ~~the~~our claims and that our promotional labeling and advertising is neither false nor misleading in any respect. If the FDA or FTC determines that any of our advertising or promotional claims are misleading, ~~not~~unsubstantiated ~~substantiated~~ or ~~not permissible~~impermissible, we may be subject to enforcement actions, including warning letters, and we may be required to revise our promotional claims and make other corrections or restitutions.

The CDSCO, the FDA and many foreign regulatory authorities have broad enforcement powers. Our failure to comply with applicable regulatory requirements could result in enforcement ~~action~~actions by such agencies, which may include any of the following sanctions:

● adverse publicity, warning letters, fines, injunctions, consent decrees and civil penalties; ● repair, replacement, refunds, recall or seizure of our ~~products~~systems and related devices; ● operating restrictions, partial suspension or total shutdown of production; or ● criminal prosecution.

We will be subject to inspection and marketing surveillance by the CDSCO, the FDA and various foreign agencies, to determine our compliance with regulatory requirements. If an agency finds that we have failed to comply, it can institute a wide variety of enforcement actions, ranging from a regulatory letter to a public warning letter to more severe civil and criminal sanctions, including the seizure of our ~~products~~systems and related devices and equipment or ban on the import or export of our ~~medical~~surgical robotic systems. Our failure to comply with applicable requirements could lead to an enforcement action that may have an adverse effect on our business, prospects, financial condition and results of operations.

1312

If defects are discovered in our surgical robotic ~~surgical~~ system and ~~other~~related ~~products~~devices, we may incur additional unforeseen costs stemming from physicians, hospitals and other potential customers possibly not purchasing our ~~products~~systems and related devices and our reputation may suffer. This would have a material ~~adverse~~ adverse effect on our business.

Our SSi Mantra ~~Surgical~~system ~~Robotic System~~ and ~~other~~related ~~products~~devices incorporate mechanical parts, electrical components, optical components and computer software, any of which can contain errors or failures, especially when first introduced. In addition, new ~~products~~systems and related devices or enhancements to them may contain undetected errors or performance problems that, despite testing, are discovered only after commercial shipment. Because our ~~products~~systems ~~will~~and berelated ~~designed~~devices towill be ~~used~~ designed for ~~performing~~use in complex surgical procedures, we expect that our customers will have an increased sensitivity to such defects. We cannot assure that, ~~once developed and marketed,~~ our medical robotic systems and related devices will not experience component aging, errors or performance problems. If we experience flaws or performance problems, any of the following could occur:

	●	delays in product shipments;

	●	loss of revenue;

	●	delay in market acceptance;

	●	diversion of our resources;

	●	damage to our reputation;

	●	product recalls;

	●	regulatory actions;

	●	increased service or warranty costs; or

	●	product liability claims.

The use of our surgical robotic systems exposes ~~could~~us ~~result~~to insignificant product liability and negligence ~~claims~~risks, ~~that~~and ~~could~~our insurance coverage may be ~~expensive,~~inadequate ~~divert~~or ~~management’s~~unavailable; we may ~~attention~~be ~~and~~unable ~~harm~~to obtain or expand coverage as our business grows.

Our ~~business~~systems ~~will~~and related devices expose us to significant ~~risks~~ risks of product liability and negligence claims. ~~The~~inherent ~~medical~~in ~~device~~the ~~industry~~design, ~~has~~manufacture, ~~historically~~testing, ~~been~~labeling, ~~litigious~~training, marketing and wesale of medical devices. We will face financial exposure to product liability claims if the use of our ~~products~~systems ~~were~~and torelated ~~cause~~devices ~~injury~~causes or ~~death. There~~ is ~~also~~alleged ~~the~~to ~~possibility~~cause ~~that~~injury ~~defects in the design~~ or ~~manufacture~~death, ofincluding ~~the~~claims ~~SSi~~alleging ~~Mantra~~design or ~~its~~manufacturing ~~components~~defects, ~~might~~failure ~~necessitate a product recall. Any weaknesses in training and services associated with our surgical robotic system may also be subject~~ to ~~product~~warn ~~liability~~or ~~lawsuits. Although~~provide weadequate ~~maintain product liability insurance~~instructions, ~~the~~negligence ~~coverage~~in ~~limits~~design ofor ~~these policies may not be adequate to cover future claims. A product liability claim~~manufacturing, ~~regardless~~inadequate disclosure of ~~its merit or eventual outcome~~risks, ~~could result in significant legal defense costs. A product liability~~ or ~~negligence~~misuse ~~claim~~and oroff ~~any~~label ~~product~~use ~~recalls could~~by ~~also~~third ~~harm~~party ~~our reputation or result in a decline in revenues~~users. ~~Furthermore,~~ ifThere ~~a patient~~ is ~~harmed by a surgical procedure in~~also ~~which~~ the ~~SSi~~possibility ~~Mantra~~that isdefects ~~used, even~~ in the ~~absence~~design ~~of any alleged system malfunction~~ or ~~defect,~~manufacture weof ~~can~~the beSSi ~~exposed~~Mantra ~~to negligence claims based on alleged inadequacies in our training of physicians~~ or ~~our~~its ~~training~~components ofmight ~~our~~necessitate ~~personnel.~~a Aproduct ~~negligence claim~~recall, ~~regardless of its merit~~field orcorrective ~~eventual outcome~~action, ~~could~~safety ~~result~~alert inor ~~significant~~other ~~legal~~remedial ~~defense costs. Legal actions also divert management’s attention from our business~~action, ~~resulting~~which incould aincrease ~~material~~the ~~adverse~~likelihood ~~effect~~and oncost ~~our~~of ~~business,~~claims ~~prospects,~~and ~~financial condition or results of operations~~investigations.

Any weaknesses in user training, proctoring, servicing or support associated with our surgical robotic system, including reliance on newly hired personnel, independent distributors or contractors in new markets, may also subject us to product liability or negligence lawsuits. We may face liability even where an adverse event is attributable to user error, preexisting patient conditions, off label use or third party component failures supplied by others. Any such claims, regardless of merit or eventual outcome, could be costly to defend, divert management’s attention, damage our reputation, lead to adverse publicity and impair our ability to market our products, and could result in significant monetary damages or injunctive relief.

Although we currently maintain product liability insurance, our insurance coverage may be inadequate or unavailable to cover all losses. Our policies contain limits, deductibles, self-insured retentions and exclusions (which may include, for example, punitive damages or certain categories of claims), and therefore may not cover all types or amounts of liabilities. As we develop and launch new products with new features or enter additional geographic markets, we expect that we will need to increase, broaden or otherwise modify our insurance coverage. However, we may be unable to obtain additional or replacement insurance on commercially reasonable terms or at all, and any available coverage may not be sufficient to protect us against all potential losses. Insurance premiums are volatile and may increase substantially, and insurers may reduce or eliminate available coverages, impose broader exclusions or require higher retentions. In addition, one or more successful claims in excess of our coverage limits, or claims falling within policy exclusions or retentions, could require us to pay substantial amounts out of pocket, which would have a material adverse effect on our business, financial condition and results of operations. In addition, any product liability claims brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing continuing coverage, harm our reputation in the industry, significantly increase our expenses and reduce product sales.

A product liability or negligence claim, recall or safety notice, with or without merit, could result in significant legal defense costs and other expenses, and could harm our reputation, reduce demand for our products and result in a decline in revenues. Legal actions also divert management’s attention from our business and could have a material adverse effect on our business, prospects, financial condition and results of operations.

We may encounter manufacturing problems or delays that could result in lost revenue.

Manufacturing the SSi Mantra and ~~our~~related ~~other~~devices ~~products~~ is a complex process. If demand for our ~~products~~systems and related devices grows, we may encounter difficulties in scaling -up production, including~~, among others~~:

	●	problems involving production yields;

	●	quality control and assurance;

	●	component supply shortages;

	●	import or export restrictions on components, materials or technology;

	●	shortages of qualified personnel; and

	●	compliance with state, federal and foreign regulations.

If demand for our ~~products~~systems and related devices exceeds our manufacturing capacity, we could develop a substantial backlog of customer orders. If we are unable to ~~maintain~~obtain larger-scale manufacturing capabilities, our ability to generate revenues will be limited and our reputation in the marketplace could be damaged.

We could be subject to significant, uninsured losses, which may have a material adverse impact on our business, financial condition, or results of operations.

For certain risks, we do not maintain insurance coverage due to cost and/or availability. For example, we ~~self-insure our product liability risks, and we~~ indemnify our directors and officers for third-party claims and do not carry insurance to cover that indemnity or the related underlying potential losses. Also, we do not carry, among other types of coverage, keyman or loss of profit insurance. In addition, in the future, we may not continue to maintain certain existing insurance coverage or adequate levels of coverage. Premiums for many types of insurance have increased significantly in recent years and, depending on market conditions and our circumstances, certain types of insurance, such as directors’ and officers’ insurance, may not be available in the future on acceptable terms or at all. Because we retain some portion of our insurable risks and, in some cases, we are entirely self-insured, unforeseen or catastrophic losses in excess of insurance coverage could require us to pay substantial amounts, which may have a material adverse impact on our business, financial condition, or results of operations.

We rely heavily on the consistent supply of components from overseas suppliers for our manufacturing operations.

We use several electric, electronic and mechanical components to manufacture our final products and a significant portion of these components are sourced from suppliers located outside of India. If any of these suppliers face disruptions in their operations or if any restrictions are placed on imports of these components into India, it could have an adverse impact on our manufacturing capabilities, and cause us to not be able to deliver against orders on a timely basis which could impact our ability to generate revenues.

Reliance on sole- and single-sourced suppliers and our ability to purchase at acceptable prices a sufficient supply of materials could harm our ability to meet product demand in a timely manner or within budget.

We currently do not use any sole -source component suppliers ~~supplier~~ and we believe that various alternative sources of supply are available. Notwithstanding the foregoing, there can be no assurance that in the event of a supply disruption, we will be able to obtain an alternative source of supply at commercially reasonable cost or that any supply disruption will not have a material adverse impact on our business.

We need to expand our sales and marketing capabilities and clinical and technical support team and the failure to do so could impair our ability to achieve profitability.

As we market and sell our ~~products~~systems and related devices outside of India, we need to expand our sales and marketing capabilities. We also need to expand our clinical and technical support team, who will support our sales and marketing organization by providing training, clinical and technical support and other services to our customers before and during the surgery. We will face significant challenges and risks in developing our sales and marketing organization, including~~, among others~~:

● our ability to recruit, train and retain adequate numbers of qualified sales and marketing and clinical and technical support personnel; ● the ability of sales personnel to obtain access to leading surgeons and persuade adequate numbers of hospitals to purchase our products; ● costs associated with hiring, maintaining and expanding a sales and marketing organization; and ● government scrutiny with respect to promotional activities in the healthcare industry.

1514

	●	the ability of sales personnel to obtain access to leading surgeons and persuade adequate numbers of hospitals to purchase our systems and related devices;

	●	costs associated with hiring, maintaining and expanding a sales and marketing organization; and

	●	government scrutiny with respect to promotional activities in the healthcare industry.

If we are unable to successfully expand our sales and marketing organization and clinical and technical support team, we may be unable to generate revenue and may not become profitable and our customer relationships may be harmed, which would adversely impact our business, prospects, financial condition or results of operations.

A number of companies manufacture and market or are developing and planning to market various robotic systems that are designed to be used in performing various surgical procedures. Many of these companies have significantly greater experience, longer operating histories and greater financial resources than ~~does~~we ~~the Company~~do.

We believe that the primary competitive factors in the market we address will be procedural capability, cost of operations, efficacy, ease of use, quality, reliability, and effective sales support, training and service. If we cannot compete effectively, our business, prospects, financial conditions or results may be significantly harmed.

If we lose our key personnel or are unable to attract and retain additional personnel, our ability to compete will be harmed.

We are highly dependent on the principal members of our management, scientific and marketing teams, including our Chief Executive Officer, President, Chief Financial Officer and Chief Operating Officer – Americas. Our product development plans depend, in part, on our ability to attract and retain engineers with experience in mechanics, electronics, software development and associated skills and ~~experience~~ experienced individuals to expand our marketing and sales efforts. Attracting and retaining qualified personnel is and will remain critical to our success, and competition for qualified personnel is intense. We may not be able to attract and retain personnel on acceptable terms given constraints on the labor market, the competition for such personnel among technology and healthcare companies and universities, both in India and abroad. The loss of any of these persons or our inability to attract and retain qualified personnel could harm our business and our ability to compete.

We are party to employment ~~agreements~~and consulting agreements with our executive officers, but we do not currently have key man insurance in place for such persons.

We are subject to a variety of risks due to the substantial portions of our operations which are conducted in India.

Substantially all of our development, manufacturing, marketing and distribution activities are conducted at our facility in New Delhi, India. In addition, substantially all of our revenues to date from sales of our SSi Mantra and ~~other~~related ~~products~~devices have been from sales to customers in India. Our India operations are, and will continue to be, subject to a number of risks including:

●

the failure to obtain or maintain the same degree of protection against infringement of our intellectual property rights due to differing intellectual property protection laws in India from those in the U.S.;

● Indian regulatory requirements that are subject to change and that could impact our ability to manufacture and sell our ~~products~~systems and related devices;

● changes in tariffs, trade barriers, and regulatory requirements, particularly in light of the aggressive tariff position being taken by the Trump administration;

● local or national regulations in India that make it difficult or impractical to market or use our ~~products~~systems and related devices;

~~● regulations imposed by the Reserve Bank of India, including those related to capital funding, pledging of assets, repatriation of funds and payment of dividends to U.S. corporations;~~15

●

regulations imposed by the Reserve Bank of India (“RBI”), including those related to capital funding, pledging of assets, repatriation of funds and payment of dividends to U.S. corporations;

●

India’s relations with the governments of the other countries in which we operate;

●

the inability or regulatory limitations on our ability to export goods out of India;

●

the risks associated with foreign currency exchange rate fluctuations;

●

different labor relations laws and employee rights;

●

anti-corruption laws and other local laws prohibiting corrupt payments to governmental officials;

●

economic weakness, including inflation, political instability and war; and

● business interruptions due to natural disasters, outbreak of disease, climate change, and other events beyond our control.

~~If hospitals~~Our ~~are~~international ~~unable~~operations toexpose ~~obtain~~us ~~coverage and reimbursement for procedures using our products, if reimbursement is insufficient~~ to ~~cover~~ ~~the~~various ~~costs~~risks ofwhich ~~purchasing~~individually ~~our products,~~ or ifin ~~limitations are imposed by governments on~~ the ~~amount~~aggregate ~~hospitals~~could ~~can~~materially ~~charge~~adversely ~~for~~affect ~~certain procedures, we may be unable to generate sufficient sales to support~~ our business.

~~In the~~Our ~~United~~international ~~States,~~operations ~~hospitals~~expose ~~generally~~us ~~bill for the services performed with products such as ours~~ to various ~~third-party payors, such~~ ~~as Medicare~~risks, ~~Medicaid,~~including ~~other~~delays ~~government~~or ~~programs,~~failures ~~and~~in ~~private~~obtaining ~~insurance~~or ~~plans.~~maintaining Ifregulatory ~~hospitals~~approvals, doreliance ~~not~~on ~~obtain sufficient reimbursement from~~ third-party ~~payors for procedures performed with our products~~distributors, orforeign ~~if government and private payors’ policies do not cover surgical~~currency ~~procedures~~exchange ~~performed~~rate ~~using our products~~fluctuations, wetrade ~~may not be able to generate the revenues necessary to support our business. In addition~~restrictions, to ~~the~~changes ~~extent~~in ~~that~~healthcare ~~there~~regulations isor areimbursement ~~shift from an inpatient setting to outpatient settings~~policies, ~~we may experience pricing pressure~~ and apolitical, ~~reduction~~economic, inor ~~the~~public ~~number~~health ofinstability ~~procedures performed. Our success~~ in ~~markets~~foreign ~~outside~~jurisdictions. ~~the~~These ~~United~~risks ~~States~~may ~~also~~increase ~~depends on the eligibility of~~ our ~~products for~~operating ~~coverage~~costs, ~~and~~disrupt ~~reimbursement~~supply ~~through~~chains, ~~government-sponsored~~delay ~~healthcare payment systems and third-party payors. Reimbursement practices~~market ~~vary~~entry ~~significantly~~or byexpansion, ~~country.~~or ~~Many~~reduce ~~markets~~demand ~~outside the United States have government-managed healthcare systems that control reimbursement~~ for ~~new~~our products ~~and procedures~~. ~~Other~~Any ~~foreign markets have both private insurance systems and government-managed systems that control reimbursement for new products and procedures. Market acceptance~~ of ~~our~~these ~~products~~factors, ~~may~~individually ~~depend~~or onin the ~~availability~~aggregate, ~~and~~could ~~level~~materially ofand ~~coverage~~adversely ~~and~~affect ~~reimbursement~~our inbusiness, afinancial ~~country within a particular time. In addition~~condition, ~~healthcare~~results ~~cost containment efforts similar to those in the United States are prevalent in many~~ of ~~the other countries in which we sell~~operations, and ~~intend~~future ~~to sell, our products, and these efforts are expected to continue~~prospects.

~~Risks Related~~It may be difficult for you to ~~Our~~enforce ~~Intellectual~~any judgment ~~Property~~obtained in the U.S. against us, our directors or executive officers or our affiliates.

IfMany of our directors and executive officers reside wein India. A substantial portion of our assets and the assets of many of these persons are also located outside of the U.S. As a result, you may be unable to ~~protect~~effect ~~the~~service ~~intellectual~~of ~~property~~process ~~for~~upon ~~our~~us ~~products~~outside ~~from~~of ~~use~~India byor ~~third~~upon ~~parties~~such persons outside their jurisdiction of residence. In addition, ~~our~~you ~~ability~~may be unable to ~~compete~~enforce against us in courts outside of India, or against these persons outside the ~~market~~jurisdiction ~~will~~of betheir ~~harmed~~residence, judgments obtained in courts of the U.S., including judgments predicated solely upon the federal securities laws of the U.S.

~~Our commercial~~We ~~success~~have ~~will~~been ~~depend~~advised inby ~~part~~our onIndian ~~patents~~counsel that the U.S. Weand ~~have~~India ~~filed~~do ~~and~~not ~~plan~~currently onhave ~~obtaining~~a ~~additional~~treaty ~~patent~~providing for reciprocal recognition and enforcement of judgments, other ~~intellectual~~than ~~property~~arbitration ~~protection~~awards, in civil and commercial matters. Therefore, a final judgment for the ~~technologies~~payment ~~developed~~of ~~and~~money torendered beby ~~developed~~any ~~for~~federal ~~our~~or ~~products~~state court in the U.S. on civil liability, ~~and~~whether or not predicated solely upon the federal securities laws of the U.S., would not be enforceable in India. However, the party in whose favor such final judgment is rendered may bring a new suit in a competent court in India based on ~~successfully~~a final ~~defending~~judgment ~~our~~that ~~patents~~has ~~and~~been obtained in the U.S. The suit must be brought in India within three years from the date of the judgment in the same manner as any other ~~intellectual~~suit filed to enforce a civil liability in India. It is possible that a court in India may not award damages ~~property~~on ~~against~~the ~~third~~same basis as a foreign court if an action is brought in India. Furthermore, it is unlikely that an Indian court would enforce a foreign judgment if it viewed the amount of damages awarded as excessive or inconsistent with Indian practice. A party ~~challenges~~seeking to enforce a foreign judgment in India is required to obtain approval from the RBI under the Foreign Exchange Management Act, 1999, to execute such a judgment or to repatriate any amount recovered.

~~We may~~If ~~incur~~hospitals ~~substantial~~are ~~costs~~unable into ~~obtaining~~obtain ~~patents~~ coverage and, ifreimbursement ~~necessary,~~for ~~defending~~procedures using our ~~proprietary~~systems ~~rights.~~and ~~The~~related ~~patent positions of medical device companies~~devices, ~~including~~if ~~ours,~~reimbursement ~~can~~is beinsufficient ~~highly~~to ~~uncertain~~cover ~~and~~the ~~involve~~costs ~~complex~~of ~~and~~purchasing our ~~evolving~~systems ~~legal~~ and ~~factual~~related ~~questions.~~devices Weor ~~cannot~~if ~~assure you~~limitations ~~that~~are weimposed ~~will~~by ~~obtain~~governments ~~the~~on ~~patent protection we seek or that~~ the ~~protection~~amount wehospitals ~~receive~~can ~~will~~charge befor ~~found~~certain ~~valid and enforceable if challenged.~~procedures, ~~We also cannot assure you that~~ we ~~will~~may be ~~able~~unable to ~~develop~~generate ~~additional~~sufficient ~~patentable~~sales ~~proprietary technologies. If we fail~~ to ~~obtain~~support ~~adequate protection of~~ our ~~intellectual property, or if any protection we obtain is reduced or eliminated, others could use our intellectual property without compensating us, resulting in harm to our~~ business. We may also determine that it is in our best interests to voluntarily challenge a third party’s products or patents in litigation or administrative proceedings, including patent interferences or reexaminations. In addition, the laws of certain foreign countries do not protect intellectual property rights to the same extent as do the laws of the United States.

In the U.S., hospitals generally bill for the services performed with products such as ours to various third-party payors, such as Medicare, Medicaid, other government programs and private insurance plans. If hospitals do not obtain sufficient reimbursement from third-party payors for procedures performed with our systems and related devices, or if government and private payors’ policies do not cover surgical procedures performed using our systems and related devices, we may not be able to generate the revenues necessary to support our business. In addition, to the extent that there is a shift from an inpatient setting to outpatient settings, we may experience pricing pressure and a reduction in the number of procedures performed. Our success in markets outside the U.S. also depends on the eligibility of our systems and related devices for coverage and reimbursement through government-sponsored healthcare payment systems and third-party payors. Reimbursement practices vary significantly by country. Many markets outside the U.S. have government-managed healthcare systems that control reimbursement for new products and procedures. Other foreign markets have both private insurance systems and government-managed systems that control reimbursement for new products and procedures. Market acceptance of our systems and related devices may depend on the availability and level of coverage and reimbursement in a country within a particular time. In addition, healthcare cost containment efforts similar to those in the U.S. are prevalent in many of the other countries in which we sell, and intend to sell, our systems and related devices, and these efforts are expected to continue.

Tariff policies could hamper our ability to import our surgical robotic systems and related devices and otherwise market our surgical robotic systems and related devices in the U.S.

As a result of the 2024 U.S. Presidential Election, Donald J. Trump was elected President. Mr. Trump has sought to impose tariffs, at times upward of 100%, and has threatened to impose additional tariffs, on goods imported from various countries. We do not currently sell our surgical robotic systems and related devices into the U.S. as we are currently not approved to market our surgical robotic systems and related devices in the U.S. However, in the event that we obtain such approvals we may be subject to tariffs on goods imported from India unless our surgical robotic systems and related devices qualify for an applicable exemption. To the extent our surgical robotic systems and related devices are subject to tariffs and our potential U.S. customers determine the costs of our devices and systems are too high, we may be forced to suspend, reduce the scope of or permanently abandon the implementation of our plans with respect to the U.S. market, which could have material and adverse effects on our plans and strategic initiatives.

Our business is subject to complex and evolving laws and regulations regarding data privacy, data protection, artificial intelligence, and responsible use of data.

There are numerous laws and regulations that require us to protect the personal data we generate, collect, share, and process on behalf of ourself and/or our customers. In addition to U.S. federal and state privacy laws, there are various comprehensive privacy laws across the globe that we are or may become subject to and that impact our business whether related to customers, employees, products, clinical trials, recruitment, or product research and development. We may be subject to significant consequences, including penalties, fines, restrictions on processing personal information, and/or reputational harm for a data breach or failure to comply with such legal requirements.

For example, if we market in the EU, the European Union General Data Protection Regulation 2016/679 and applicable national supplementing laws (collectively, the “GDPR”) requires controllers and processors of data relating to an identifiable living individual or “personal data” to adhere to certain key principles whenever accessing or processing personal data. The EU Data Protection Authorities have been active in their commitment to enforcing the GDPR. The European Data Protection Board, as well as individual member states, continues to refine requirements under the GDPR resulting in increased obligations to demonstrate compliance through policies, procedures, training, transfer impact assessments, privacy notices, and audits. Among other requirements, the GDPR regulates transfers of personal data subject to the GDPR to third countries that have not been found to provide adequate protection to such personal data, including the U.S., and the efficacy and longevity of current transfer mechanisms between the European Economic Area (“EEA”) and the U.S. remains uncertain. The GDPR provides that EEA member states may, in some circumstances, make their own laws that are more restrictive or prescriptive than GDPR, such as has occurred in France and Germany. Failure to comply with the requirements of the GDPR and the applicable EEA member state laws may result in significant fines, regulatory investigations, reputational damage, orders to cease/change data processing activities, enforcement notices, assessment notices (for a compulsory audit), and/or civil claims (including class actions). Compliance with data protection obligations imposed by the GDPR and EEA member state laws may be onerous and if we market to the EEA it could adversely affect our business, financial condition, or results of operations.

We are subject to applicable privacy laws in India and other foreign jurisdictions in which we market and sell the SSi Mantra.

If we market to the U.S., the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and regulations implemented thereunder, (“HIPAA”), imposes privacy, security, and breach notification obligations on covered entities and their business associates to ensure the confidentiality, integrity, and availability of individually identifiable health information. Entities that are found to be in violation of HIPAA, as a result of a breach of unsecured protected health information, a complaint about privacy practices, or an audit by the U.S. Department of Health and Human Services (“HHS”), may be subject to significant civil, criminal, and administrative fines and penalties and/or additional reporting and oversight obligations if they are required to enter into a resolution agreement and corrective action plan with HHS through settlement agreements.

Further, in the U.S., when HIPAA does not apply, according to the FTC, violating consumers’ privacy rights or failing to take appropriate steps to keep consumers’ personal information secure may constitute unfair and/or deceptive acts or practices in violation of Section 5(a) of the FTC Act. The FTC has the authority to initiate enforcement actions against entities that make deceptive statements about privacy and data sharing in privacy policies, fail to limit third-party use of personal health information, fail to implement policies to protect personal health information, or engage in other unfair practices that harm customers or that may violate Section 5(a) of the FTC Act. The FTC expects a company’s data security measures to be reasonable and appropriate in proportion to the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Additionally, federal and state consumer protection laws are increasingly being applied by the FTC and states’ attorneys general to regulate the collection, use, storage, and disclosure of personal information, through websites or otherwise, and to regulate the presentation of website content.

At the state level, multiple states have comprehensive consumer privacy laws enacted. Notably, the California Consumer Privacy Act, as amended by the California Privacy Rights Act (“CCPA”) gives California residents expanded rights to access, correct, and delete their personal information, opt out of certain personal information sharing, and receive detailed information about how their personal information is used. The CCPA allows for significant fines by the California attorney general as well as a private right of action from individuals in relation to certain security breaches. Similar laws have passed in other states and are continuing to be proposed at the state and federal level, reflecting the continuing trend toward more stringent privacy legislation in the U.S. These developments are increasing our compliance obligations and risk, including risks of regulatory fines, litigation, and associated reputational harm.

~~In addition~~Any ~~to patents~~failure, weor ~~may~~perceived ~~rely on a combination of trade secrets~~failure, ~~copyright~~by ~~and~~us ~~trademark~~to ~~laws, nondisclosure agreements and other~~comply ~~contractual~~with ~~provisions~~or ~~and~~make ~~technical~~effective ~~security~~modifications ~~measures~~ to ~~protect~~ our ~~intellectual~~policies ~~property~~or ~~rights.~~to ~~Nevertheless,~~comply ~~these~~with ~~measures~~any ~~may not~~federal, bestate, ~~adequate~~or tointernational ~~safeguard~~privacy, ~~the~~data-retention, ~~technology~~or data-protection-related ~~underlying~~laws, ~~our~~regulations, ~~products.~~orders, Ifor ~~these~~industry ~~measures~~self-regulatory doprinciples ~~not~~could ~~protect~~result ~~our~~in ~~rights~~proceedings ~~adequately,~~or ~~third~~actions ~~parties~~against ~~could~~us ~~use~~by ~~our~~governmental ~~technology,~~entities ~~and~~or ~~our~~others, ~~ability~~a toloss ~~compete~~of incustomer ~~the~~confidence, ~~market~~damage ~~would~~to beour ~~reduced.~~brand Inand ~~addition~~reputation, ~~employees,~~and ~~consultants~~a ~~and~~loss ~~others~~of ~~who~~customers, any ~~participate~~of inwhich ~~developing~~could ~~our~~have ~~products~~an ~~may~~adverse ~~breach~~effect ~~their~~on ~~agreements~~our ~~with~~business. usIn ~~regarding~~addition, ~~our~~various ~~intellectual~~federal, ~~property~~state, and weforeign ~~may~~legislative ~~not~~or ~~have~~regulatory ~~adequate~~bodies ~~remedies~~may ~~for~~enact ~~the~~new ~~breach.~~or Weadditional ~~also~~laws ~~may~~and ~~not~~regulations beconcerning ~~able~~privacy, todata-retention, ~~effectively~~and ~~protect~~data-protection ~~our~~issues, ~~intellectual~~including ~~property~~laws ~~rights~~or ~~in some foreign countries. We~~regulations ~~also~~mandating ~~realize~~disclosure ~~that~~to ~~our~~domestic ~~trade~~or ~~secrets~~international ~~may~~law ~~become~~enforcement ~~known~~bodies, ~~through~~which ~~other~~could ~~means~~adversely ~~not~~impact ~~currently~~our ~~foreseen~~business byor ~~us. Notwithstanding~~ our ~~efforts to~~reputation ~~protect~~with ~~our~~customers. ~~intellectual~~For ~~property~~example, ~~our~~some ~~competitors~~countries ~~may~~have ~~independently~~adopted ~~develop~~laws ~~similar~~mandating orthat ~~alternative~~some ~~technologies~~personal orinformation ~~products~~regarding ~~that~~customers ~~are~~in their country ~~equal~~be ormaintained ~~superior~~solely toin ~~our~~their ~~technology~~country. ~~and~~Having ~~products~~to ~~without~~maintain ~~infringing~~local ~~any~~data ofcenters ~~our~~and ~~intellectual~~redesign ~~property~~products, ~~rights~~services, orand ~~may~~business ~~design~~operations to ~~around~~limit ~~our proprietary~~personal ~~technologies,~~information ~~which~~processing ~~would~~to ~~harm~~within ~~our~~individual ~~ability~~countries tocould ~~compete~~increase inour ~~the~~operating ~~market~~costs significantly.

~~Moreover,~~ The European Strategy for Data includes a ~~portion~~collection of laws focused on ensuring fundamental principles (including doing business in an ethical way, respecting fundamental rights of ~~our~~individuals, not ~~intellectual~~exploiting ~~property~~individuals, ~~has~~and ~~been~~transparency ~~assigned~~in collection and use of data) are promoted and adhered to usin ~~from~~support ~~one~~of orinnovation ~~more~~for ~~third~~the benefit ~~parties~~of the community. ~~While~~In weparticular, ~~have~~the ~~conducted~~AI ~~diligence~~Act, ~~with~~European Health Data Space, and Data Act and Data Governance Acts regulate personal ~~respect~~and tonon-personal ~~such~~data ~~intellectual~~as ~~property,~~well ~~because~~as weartificial ~~did~~intelligence. ~~not~~These ~~participate~~laws are meant to be read and interpreted together (and in concert with the ~~development~~GDPR), orensuring ~~prosecution~~that ofinnovation ~~such~~respects ~~intellectual~~individuals’ ~~property, we~~fundamental ~~cannot~~rights ~~guarantee~~and that ~~our~~businesses ~~diligence~~act ~~efforts~~with ~~identified~~integrity. The Data Act and~~/or~~ ~~remedied~~European ~~all~~Health ~~issues~~Data ~~related~~Space Act provide individual and organizational users of certain systems and devices the right to ~~such~~access ~~intellectual~~a ~~property~~broad range of information not previously available and include, ~~including potential~~in ~~ownership~~some ~~errors~~cases, ~~potential~~rights ~~errors~~to ~~during~~secondary ~~prosecution~~uses of such ~~intellectual~~data. ~~property,~~These ~~and~~obligations ~~potential~~may be ~~encumbrances~~interpreted in ways that ~~could limit~~require us to modify our ~~ability~~business practices and products to ~~enforce~~maintain ~~such~~compliance, ~~intellectual~~potentially ~~property~~increasing ~~rights~~costs and operational complexity.

~~Others may~~Moreover, ~~assert~~some ~~that~~of the AI features of our products involve, ~~infringe~~or onmay ~~their~~involve, ~~intellectual~~the ~~property~~processing ~~rights~~of personal data and may be subject to laws, policies, legal obligations, and codes of conduct related to privacy and data protection, each of which may ~~cause~~be interpreted in ways that may affect the way in which we engage with machine learning and require us to ~~engage~~make inchanges ~~costly~~to ~~disputes~~our business practices and, ifproducts to comply with such obligations. Our use of AI technologies wemay ~~are~~involve ~~not~~the ~~successful~~storage inand ~~defending~~transmission ~~ourselves~~of confidential or sensitive information, ~~could~~including ~~also~~personal ~~require~~information usof employees, customers, and others, as well as protected health information of clients’ patients. In addition, due to ~~pay~~the ~~substantial~~sensitive ~~damages~~nature of the information, the ~~prohibiting~~security usfeatures ~~from~~of ~~selling~~our computers and systems, network, and communications systems infrastructure are critical to the success of our ~~products~~business.

~~There may be U.S. and foreign patents which are issued to third parties that relate to our products.~~ We dooperate ~~not~~in ~~know~~a ~~whether~~highly ~~any~~competitive ~~of these patents,~~global ~~if challenged, would be held valid, enforceable and infringed. The~~ medical device ~~industry~~and ~~has~~surgical ~~been~~robotics market characterized by ~~extensive~~rapid ~~litigation and~~technological ~~administrative proceedings regarding patents and other intellectual property rights~~change, ~~and~~pricing ~~companies have employed such actions to gain a competitive advantage. Our competitors~~pressure, ~~many of which have substantially greater resources~~ and ~~have made substantial investments in patent portfolios and competing technologies, may have applied for or obtained, or may in~~ the ~~future~~presence apply for or obtain, patents or other intellectual property that will prevent, limit or otherwise interfere with our ability to make, use, sell and/or export our products, services or to use our technologies or product names. As the number of competitors in our market grows and the number of patents issued in this area increases, the possibility of patent infringement claims against us may increase. Moreover, individuals and groups that are nonwell-~~practicing entities, commonly referred to as “patent trolls,” purchase patents and other intellectual property~~capitalized ~~assets~~competitors ~~for~~with ~~the~~greater ~~purpose of making claims of infringement in order to extract settlements. Additionally~~financial, ~~our products include components that we purchase from suppliers and may include design components that are outside of our direct control. If third parties in any patent action are successful~~regulatory, ~~our potential patent portfolio may be damaged~~manufacturing, ~~we may have to pay substantial damages, including treble damages,~~ and wecommercial ~~may be required to stop selling our products or obtain a license which, if available at all, may require us to pay substantial royalties. We cannot be certain that we will have the financial~~ resources or the substantive arguments to defend our patents from infringement or claims of invalidity or unenforceability, or to defend against allegations of infringement of third-party patents. Some of our competitors may be able to sustain the costs of litigation or administrative proceedings more effectively than we ~~can because of greater financial resources and more mature and developed intellectual property portfolios~~have. ~~In addition, any public announcements related to litigation or administrative proceedings initiated by us, or initiated or threatened against us, could cause our stock price to decline.~~

~~Even if~~Our wecompetitors ~~believe~~may ~~third-party~~have ~~intellectual~~established ~~property~~brand ~~claims are without merit~~recognition, ~~there is no assurance that a court would find in our favor,~~ ~~including~~larger oninstalled ~~questions of infringement~~bases, ~~validity,~~longer ~~enforceability,~~operating ~~or priority of patents. The strength of our defenses will depend on the patents asserted~~histories, ~~the interpretation of these patents,~~ and ~~our~~broader ~~ability~~customer ~~to invalidate the asserted patents. A court of competent jurisdiction could hold that these third-party patents are valid~~relationships, ~~enforceable, and infringed,~~ which ~~could~~may ~~materially~~enable ~~and~~them ~~adversely~~to ~~affect~~respond ~~our~~more ~~ability~~effectively to ~~commercialize~~market ~~any~~changes ~~products~~ or ~~technology~~engage wein ~~may~~aggressive ~~develop~~pricing, ~~and~~bundling, ~~any other products~~ or ~~technologies~~promotional ~~covered by the asserted third-party patents~~strategies. InAs ~~order~~a ~~to successfully challenge the validity of any such U.S. patent in federal court~~result, we ~~would~~may ~~need~~experience toreduced ~~overcome a presumption~~demand offor ~~validity.~~our Asproducts, ~~this~~longer ~~burden~~sales iscycles, apricing ~~high~~pressure, ~~one~~or ~~requiring~~loss ~~us to present clear and convincing evidence as to the invalidity~~ of ~~any~~market ~~such U.S. patent claim~~share, ~~there~~any ~~is no assurance that a court~~ of ~~competent~~which ~~jurisdiction~~could ~~would~~materially ~~invalidate~~and ~~the~~adversely ~~claims~~affect our ~~of any such U.S. patent. Conversely~~business, ~~the~~ ~~patent~~results ~~owner need only prove infringement by a preponderance~~ of ~~the evidence~~operations, ~~which~~and isfinancial ~~a lower burden of proof~~condition.

Risks Related to Our Intellectual Property

If we are unable to protect the intellectual property for our systems and related devices from use by third parties, our ability to compete in the market will be harmed.

Our commercial success will depend in part on patents. We have filed and plan on obtaining additional patents and other intellectual property protection for the technologies developed and to be developed for our systems and related devices, and on successfully defending our patents and other intellectual property against third party challenges.

We may incur substantial costs in obtaining patents and, if necessary, defending our proprietary rights. The patent positions of medical device companies, including ours, can be highly uncertain and involve complex and evolving legal and factual questions. We cannot assure you that we will obtain the patent protection we seek or that the protection we receive will be found valid and enforceable if challenged. We also cannot assure you that we will be able to develop additional patentable proprietary technologies. If we fail to obtain adequate protection of our intellectual property, or if any protection we obtain is reduced or eliminated, others could use our intellectual property without compensating us, resulting in harm to our business. We may also determine that it is in our best interests to voluntarily challenge a third party’s products or patents in litigation or administrative proceedings, including patent interferences or reexaminations. In addition, the laws of certain foreign countries do not protect intellectual property rights to the same extent as do the laws of the U.S.

In addition to patents, we may rely on a combination of trade secrets, copyright and trademark laws, nondisclosure agreements and other contractual provisions and technical security measures to protect our intellectual property rights. Nevertheless, these measures may not be adequate to safeguard the technology underlying our systems and related devices. If these measures do not protect our rights adequately, third parties could use our technology, and our ability to compete in the market would be reduced. In addition, employees, consultants and others who participate in developing our systems and related devices may breach their agreements with us regarding our intellectual property, and we may not have adequate remedies for the breach. We also may not be able to effectively protect our intellectual property rights in some foreign countries. We also realize that our trade secrets may become known through other means not currently foreseen by us. Notwithstanding our efforts to protect our intellectual property, our competitors may independently develop similar or alternative technologies or products that are equal or superior to our technology and products without infringing any of our intellectual property rights, or may design around our proprietary technologies, which would harm our ability to compete in the market.

Moreover, a portion of our intellectual property has been assigned to us from one or more third parties. While we have conducted diligence with respect to such intellectual property, because we did not participate in the development or prosecution of such intellectual property, we cannot guarantee that our diligence efforts identified and/or remedied all issues related to such intellectual property, including potential ownership errors, potential errors during prosecution of such intellectual property and potential encumbrances that could limit our ability to enforce such intellectual property rights.

There may be U.S. and foreign patents which are issued to third parties that relate to our systems and related devices. We do not know whether any of these patents, if challenged, would be held valid, enforceable and infringed. The medical device industry has been characterized by extensive litigation and administrative proceedings regarding patents and other intellectual property rights, and companies have employed such actions to gain a competitive advantage. Our competitors, many of which have substantially greater resources and have made substantial investments in patent portfolios and competing technologies, may have applied for or obtained, or may in the future apply for or obtain, patents or other intellectual property that will prevent, limit or otherwise interfere with our ability to make, use, sell and/or export our systems and related devices, services or use of our technologies or product names. As the number of competitors in our market grows and the number of patents issued in this area increases, the possibility of patent infringement claims against us may increase. Moreover, individuals and groups that are non-practicing entities, commonly referred to as “patent trolls,” purchase patents and other intellectual property assets for the purpose of making claims of infringement in order to extract settlements. Additionally, our systems and related devices include components that we purchase from suppliers and may include design components that are outside of our direct control. If third parties in any patent action are successful, our potential patent portfolio may be damaged, we may have to pay substantial damages, including treble damages, and we may be required to stop selling our systems and related devices or obtain a license which, if available at all, may require us to pay substantial royalties. We cannot be certain that we will have the financial resources or the substantive arguments to defend our patents from infringement or claims of invalidity or unenforceability, or to defend against allegations of infringement of third-party patents. Some of our competitors may be able to sustain the costs of litigation or administrative proceedings more effectively than we can because of greater financial resources and more mature and developed intellectual property portfolios. In addition, any public announcements related to litigation or administrative proceedings initiated by us, or initiated or threatened against us, could cause our stock price to decline.

Even if we believe third-party intellectual property claims are without merit, there is no assurance that a court would find in our favor, including on questions of infringement, validity, enforceability or priority of patents. The strength of our defenses will depend on the patents asserted, the interpretation of these patents, and our ability to invalidate the asserted patents. A court of competent jurisdiction could hold that these third-party patents are valid, enforceable, and infringed, which could materially and adversely affect our ability to commercialize any systems and related devices or technology we may develop and any other products or technologies covered by the asserted third-party patents. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. Conversely, the patent owner need only prove infringement by a preponderance of the evidence, which is a lower burden of proof.

We may be forced to litigate to enforce or defend our intellectual property rights.

We may be forced to litigate to enforce or defend our intellectual property rights against infringement by competitors, and to protect our trade secrets against unauthorized use. In so doing, we may place our intellectual property at risk of being invalidated, unenforceable, or limited or narrowed in scope and may no longer be used to prevent the manufacture and sale of competitive products. Further, an adverse result in any litigation or other proceedings before government agencies such as the ~~United~~U.S. ~~States~~ Patent and Trademark Office (the “USPTO”) and comparable foreign patent authorities may place pending applications at risk of non-issuance. Further, interference proceedings, derivation proceedings, entitlement proceedings, ex parte reexamination, inter partes reexamination, inter partes review, post-grant review, and opposition proceedings provoked by third parties or brought by the USPTO or any foreign patent authority may be used to challenge inventorship, ownership, claim scope, or validity of our patent applications. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential and proprietary information could be compromised by disclosure during this type of litigation.

Intellectual property disputes could cause us to spend substantial resources and distract our personnel from their normal responsibilities.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and/or management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the market price of our shares. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of litigation proceedings more effectively than we can because of their greater financial resources and personnel. In addition, the uncertainties associated with litigation could have a material adverse effect on our ability to raise the funds necessary to conduct our clinical trials, continue our internal research programs, in-license needed technology or enter into strategic collaborations that would help us bring our technologies to market. Additionally, we may be obligated to indemnify our customers or business partners in connection with litigation and to obtain licenses or refund subscription fees, which could further exhaust our resources. As a result, uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

The rights and measures we rely on to protect the intellectual property underlying our ~~products~~systems and related devices may not be adequate to prevent third parties from using our technology, which could harm our ability to compete in the market.

In addition to patents, we rely on a combination of trade secret, copyright and trademark laws, nondisclosure agreements and other contractual provisions and technical security measures to protect our intellectual property rights. Nevertheless, these measures may not be adequate to safeguard the technology underlying our systems ~~products~~and related devices. If they do not protect our rights adequately, third parties could use our technology, and our ability to compete in the market would be reduced. In addition, employees, consultants and others who participate in developing our ~~products~~systems and related devices may breach their agreements with us regarding our intellectual property, and we may not have adequate remedies for the breach. We also may not be able to effectively protect our intellectual property rights in some foreign countries. For a variety of reasons, we we may decide not to file for patent, copyright or trademark protection outside the ~~United States~~U.S. We also realize that our trade secrets may become known through other means not currently foreseen by us. Notwithstanding our efforts to protect our intellectual property, our competitors may independently develop similar or alternative technologies or products that are equal or superior to our technology and ~~products~~systems and related devices without infringing any of our intellectual property rights or may design around our proprietary technologies.

19Obtaining and maintaining patent protections depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.

~~Obtaining~~ The USPTO and ~~maintaining~~various ~~patent~~foreign ~~protection~~governmental ~~depend~~patent agencies onrequire compliance with ~~various~~a number of procedural, ~~document submission~~documentary, fee payment, examination and other deadlines or requirements during ~~imposed~~the patent application process. In addition, periodic maintenance fees on issued patents often must be paid to the USPTO and foreign patent agencies over the lifetime of the patent. While an unintentional lapse can in many cases be cured by ~~governmental~~payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or ~~agencies~~patent application, ~~and~~resulting ~~our~~in partial or complete loss of patent ~~protection~~rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to monitor and attend to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If we fail to maintain the patents and patent applications covering our systems and related devices, we may not be ~~reduced~~able to stop a competitor from marketing products that are the same as or ~~eliminated~~similar ~~for~~to ~~noncompliance~~our ~~with~~systems ~~these~~and ~~requirements~~related devices, which would have a material adverse effect on our business.

~~The USPTO~~Additionally, ~~and various foreign governmental~~ patent ~~agencies~~offices ~~require~~in ~~compliance~~certain ~~with a number of procedural, documentary, fee payment, examination,~~jurisdictions ~~and~~including ~~other deadlines or requirements during~~ the ~~patent~~USPTO ~~application~~impose ~~process.~~a Induty ~~addition,~~to ~~periodic~~disclose ~~maintenance~~information ~~fees~~known onto ~~issued patents often must~~ be ~~paid~~material to ~~the~~patentability ~~USPTO~~during ~~and foreign patent agencies over~~ the ~~lifetime~~application process of ~~the~~a patent. ~~While an unintentional lapse can in many cases~~ beFailure ~~cured~~to bydisclose ~~payment~~such ofinformation amay ~~late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can~~ result in ~~abandonment or lapse of~~ the patent orbeing ~~patent~~found ~~application,~~invalid ~~resulting in partial~~ or ~~complete loss of patent rights in the relevant jurisdiction~~unenforceable. ~~Noncompliance~~If ~~events~~one ~~that could result in abandonment~~ or ~~lapse~~more of aour ~~patent~~patents ~~or patent application include, but~~ are invalidated ~~not~~or ~~limited~~found to, ~~failure~~be tounenforceable ~~monitor~~due ~~and attend~~ to ~~official~~our ~~actions~~failure ~~within~~to ~~prescribed~~disclose ~~time~~such ~~limits~~information, ~~non-payment~~we ofcould ~~fees~~lose ~~and~~certain ~~failure to~~market ~~properly~~exclusivity ~~legalize~~afforded by ~~and~~those ~~submit formal documents. If we fail to maintain the~~ patents and ~~patent~~potential ~~applications~~competitors ~~covering~~could ~~our~~more ~~products,~~easily ~~we may~~bring ~~not~~products ~~be able~~ to ~~stop~~the amarket ~~competitor from marketing products~~ that ~~are~~directly ~~the~~compete ~~same~~with asour orsystems ~~similar~~and ~~to our products~~related devices, which ~~would~~could have a material adverse effect on our business and financial condition.

Additionally, patent offices in certain jurisdictions including the USPTO impose a duty to disclose information known to be material to patentability during the application process of a patent. Failure to disclose such information may result in the patent being found invalid or unenforceable. If one or more of our patents are invalidated or found to be unenforceable due to our failure to disclose such information, we could lose certain market exclusivity afforded by those patents and potential competitors could more easily bring products to the market that directly compete with our products, which could have a material adverse effect on our business and financial condition.21

We may be subject to claims by third parties claiming ownership of what we regard as our own intellectual property.

In addition, while it is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we cannot be certain ~~that~~in wethe ~~have~~future ~~executed~~that such agreements ~~with~~have been executed by all parties who may have contributed to our intellectual property. Our and their assignment agreements may not be self-executing or may be breached and we may not have an adequate remedy for such breach. Furthermore, local laws in the jurisdictions in which we operate may place restrictions on our ability to obtain assignments or the assignment of intellectual property rights in our agreements with employees, consultants and advisors may not be sufficient, or the assignment agreements may be breached. We may be forced to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of what we regard as our intellectual property. Our former employees or consultants and any other partners or collaborators who have access to our proprietary know-how, information or technology, may assert an ownership right in our patents, patent applications or other intellectual property. If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel which could have a material adverse effect on our competitive business position and prospects. Such intellectual property rights could be awarded to a third party, and we could be required to obtain a license from such third party to commercialize our technology or ~~products~~systems and related devices, which may not be available on commercially reasonable terms or at all. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to management.

We may be unsuccessful in licensing or acquiring intellectual property rights from third parties that may be necessary to develop, manufacture and/or commercialize our current and/or future ~~products~~systems and related devices or services.

A third party may hold intellectual property rights, including patent rights, that are important or necessary to the development, manufacture and/or commercialization of our current and/or future products or services, in which case we would be need to acquire or obtain a license to such intellectual property rights from such third party. A third party that perceives us to be a competitor may be unwilling to assign or license its intellectual property rights to us. In addition, the licensing or acquisition of third-party intellectual property rights is a competitive area, and other companies may also pursue similar strategies to license or acquire such third party’s intellectual property rights. Some of these companies may be established and may have a competitive advantage over us due to their size, capital resources and greater development, manufacture and commercialization capabilities. We also may be unable to license or acquire third -party intellectual property rights on commercially reasonable terms that would allow us to make an appropriate return on our investment, or at all, or we may be unable to obtain any such license or acquisition at all. If we are unable to successfully obtain rights to necessary third-party intellectual property rights, we may not be able to develop, manufacture or commercialize our current and/or future ~~products~~systems and related devices or services, which could have a material adverse effect on our business, financial condition and results of operations.

Our products rely on licenses from third parties, and if we lose access to these technologies, our revenues could decline.

We rely on technology that we license from others, including technology that is integral to our products. We have entered into a license agreement with Energid Technologies Corporation (“Energid”). This agreement may be terminated for breach, including the failure to make required payments under the agreement. If this agreement is terminated, we may be unable to reacquire the necessary license on satisfactory terms, or at all. The loss or failure to maintain this license could prevent or delay further development or commercialization of our products.

Risks Related to Our Status as a Public Company

We are subject to the periodic reporting requirements of the ~~Securities~~ Exchange Act ~~of 1934~~ that require us to incur audit fees and legal fees in connection with the preparation of such reports. These additional costs could reduce or eliminate our ability to earn a profit.

We are, ~~and following the consummation of this Offering, we will be,~~ required to file periodic reports with the SEC pursuant to the ~~Securities~~ Exchange Act ~~of 1934 (the “Exchange Act”)~~ and the rules and regulations promulgated thereunder. In order to comply with these requirements, our independent registered public accounting firm must review our financial statements on a quarterly basis and audit our financial statements on an annual basis. Moreover, our legal counsel must review and assist in the preparation of such reports. The incurrence of such costs is an expense to our operations and thus ~~have~~has a negative effect on our ability to meet our overhead requirements and earn a profit. If we cannot provide reliable financial reports or prevent fraud, our business and operating results could be harmed, investors could lose confidence in our reported financial information, and the trading price of our common stock, ~~if a sustained trading market ever develops,~~ could drop significantly.

~~Our internal controls may be inadequate, which could cause our financial reporting to be unreliable and lead to misinformation being disseminated to the public.~~22

~~Section 404~~Our ~~of the Sarbanes-Oxley Act requires the~~ management ofhas ~~public~~reported ~~companies~~that toour ~~conduct an annual review and evaluation of their internal~~disclosure controls and toprocedures ~~obtain~~and anour ~~attestation report from their registered public accounting firm regarding the effectiveness of~~ internal ~~controls. However,~~control soover ~~long~~financial asreporting wewere ~~qualify~~not ~~as an emerging growth company~~effective, wewhich ~~will~~could because ~~exempt~~our ~~from~~financial ~~the auditors’ attestation requirement under~~reporting ~~Section~~to ~~404~~be ofunreliable ~~the~~and ~~Sarbanes-Oxley~~lead ~~Act.~~to Wemisinformation ~~would~~being nodisseminated ~~longer~~to ~~qualify as an emerging growth company at such time as described in~~ the ~~risk factor below~~public.

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. As defined in Rule 13a-15(f) under the Exchange Act, internal control over financial reporting is a process designed by, or under the supervision of, the principal executive and principal financial officer and effected by the board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:

●

pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets;

●

provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of our Company are being made only in accordance with authorizations of our management and/or directors; and

●

provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.

In our periodic reports under the Exchange Act, we are required to include a report of management on the effectiveness of our internal control over financial reporting. Currently, management has reported that our disclosure controls and procedures and our internal control over financial reporting, were not effective as of December 31, 2024, March 31, 2025, June 30, 2025 and September 30, 2025 at the reasonable assurance level in that:

● We dofailed ~~not~~to ~~have~~design ~~written~~adequate ~~documentation~~controls ofand ~~our~~procedures ~~internal~~to ~~control~~provide ~~policies~~reasonable ~~and~~assurance ~~procedures~~that U.S. ~~Written~~GAAP ~~documentation~~was ofbeing ~~key~~properly ~~internal~~applied ~~controls~~to ~~over~~the ~~financial~~matters ~~reporting~~resulting isinto athe ~~requirement~~restatement of ~~Section~~our ~~404~~quarterly offinancial ~~the~~statements, ~~Sarbanes-Oxley~~including ~~Act.~~recognition ~~Management~~of ~~evaluated~~revenue ~~the~~in ~~impact~~case of ~~our~~deferred ~~failure~~payment tosales, ~~have~~recognition ~~written~~of ~~documentation~~right of ~~our~~use ~~internal~~of ~~controls~~certain assets and ~~procedures~~lease onliabilities ~~our~~and ~~assessment~~functional ofand ~~our~~other ~~disclosure~~classifications, ~~controls~~also ~~and~~leading ~~procedures~~to ~~and~~certain ~~has~~accounting ~~concluded~~errors ~~that~~as described in details in the ~~control~~restatement ~~deficiency~~notes ~~that~~as ~~resulted~~included ~~represented~~in athe ~~material~~respective ~~weakness~~amended quarterly financial statements.

21● We do not have written documentation of our internal control policies and procedures. Written documentation of key internal controls over financial reporting is a requirement of Section 404 of the Sarbanes-Oxley Act.

● We do not have sufficient segregation of duties within accounting functions, which is a basic internal control. Due to our size and nature, segregation of all conflicting duties may not always be possible and may not be economically feasible. However, to the extent possible, the initiation of transactions, the custody of assets and the recording of transactions should be performed by separate individuals. Management evaluated the impact of our failure to have segregation of duties on our assessment of our disclosure controls and procedures and has concluded that the control deficiency that resulted represented a material weakness.

~~Following completion~~Remediation of this Offering, we intend to address these weaknesses by expanding our internal accounting and financial staff and implementing written internal control policies and procedures. We may have to incur significant time and expense to do so.Plan

~~To maintain~~The ~~the~~Company ~~effectiveness~~has ofbeen ~~our~~addressing ~~disclosure controls~~ and ~~procedures and our internal control over financial reporting, we expect that~~remediating wethese ~~will~~material ~~need~~weaknesses towith ~~continue~~the ~~enhancing~~support ~~existing,~~ and ~~implement~~assistance ~~new,~~of ~~financial~~the ~~reporting~~accounting and ~~management~~financial ~~systems,~~staff ~~procedures~~employed ~~and~~by ~~controls to manage~~ our ~~business~~Indian ~~effectively~~operating ~~and~~subsidiary. We ~~support~~have ~~our~~enhanced ~~growth in~~ the ~~future.~~review ~~The~~ process offor ~~evaluating~~significant ~~our~~transactions ~~internal~~to ~~control~~ensure ~~over~~proper ~~financial~~accounting ~~reporting requires~~treatment anunder ~~investment~~applicable ofguidelines ~~substantial time~~ and ~~resources, including by our Chief Financial Officer and other members of our senior management.~~ ~~The~~have ~~determination~~engaged ~~and~~the ~~any~~external ~~remedial~~experts ~~actions~~to ~~required~~provide ~~could~~guidance ~~divert internal resources and take a significant amount of time and effort~~ to ~~complete~~the ~~and~~Company ~~could~~staff ~~result~~ in ~~us incurring additional costs that we did not anticipate, including~~ the ~~hiring~~areas of ~~outside consultants. During the evaluation and testing process, if we identify one or more additional material weaknesses in our internal control over~~ financial reporting, ~~we will be unable to assert that our~~ internal controls, ~~are effective. If we are unable to assert that our internal control~~and ~~over~~enterprise ~~financial~~risk ~~reporting~~management isand ~~effective,~~assist weit ~~could lose investor confidence~~ in the ~~accuracy~~application ~~and completeness~~ of ~~our~~accounting ~~financial~~principles ~~reports,~~to ~~which could~~complex ~~cause~~transactions. ~~the~~This ~~price~~external ofexpert ~~our~~group is ~~securities to decline. We could~~ also ~~become~~helping ~~subject to investigations by~~ the ~~stock~~Company ~~exchange~~in onstrengthening ~~which~~its ~~our securities~~existing ~~are~~internal ~~listed~~controls, ~~the~~policies ~~SEC,~~and orStandard ~~other~~Operating ~~regulatory~~Procedures ~~authorities,~~(“SOPs”) in ~~which~~all ~~could~~of ~~require~~our ~~additional~~major ~~financial~~functional ~~and management resources~~areas.

In addition, we have also engaged the services of external experts in the field of designing, development and implementation of a comprehensive cloud-based Enterprise Resource Planning (“ERP”) system. The ERP implementation process involves a detailed process study of each of our business functions and engagement with their respective process owners, identifying their linkages with other business functions and designing report formats, data sourcing and customizing the ERP system and training of the respective teams to meet the business data flow and reporting requirements of each business function. Rollout of this new cloud-based ERP system which is designed to integrate all business functions within the accounting and financial department, will help us to further address the abovementioned weaknesses.

There can be no assurance that our remediation efforts will effectively remedy the identified weaknesses or that additional material weakness in our internal control over financial reporting will be identified in the future. If we are unable to assert that our internal control over financial reporting is effective, we could lose investor confidence in the accuracy and completeness of our financial reports, which could cause the price of our securities to decline. We could also become subject to investigation by Nasdaq, the SEC, or other regulatory authorities, which would require additional financial and management resources and attention.

As a smaller reporting company, we are subject to scaled disclosure requirements that may make it more challenging for investors to analyze our results of operations and financial prospects.

Currently, we are a “smaller reporting company,” as defined by Rule 12b-2 of the Exchange Act. As a “smaller reporting company,” we are able to provide simplified executive compensation disclosures in our filings and have certain other decreased disclosure obligations in our filings with the SEC, including being required to provide only two years of audited financial statements in annual reports. Consequently, it may be more challenging for investors to analyze our results of operations and financial prospects.

Furthermore, we are a non-accelerated filer as defined by Rule 12b-2 of the Exchange Act, and, as such, are not required to provide an auditor attestation of management’s assessment of internal control over financial reporting, which is generally required for SEC reporting companies under Section 404(b) of the Sarbanes-Oxley Act. Because we are not required to, and have not, had our auditors provide an attestation of our management’s assessment of internal control over financial reporting, a material weakness in internal controls may remain undetected for a longer period.

The Jobs Act has reduced the information that we are required to disclose.

Under the Jobs Act, the information that we will be required to disclose has been reduced in a number of ways.

As a company with less than $1.235 billion in revenues during our last fiscal year, we qualify as an “emerging growth company,” as defined in the Jobs Act (an “EGC”). We will retain that status until the earliest of (a) the last day of the fiscal year which we have total annual gross revenues of $1.235 billion (as indexed for inflation in the manner set forth in the Jobs Act) or more; (b) the last day of the fiscal year following the fifth (5th) anniversary of the date of the first sale of our common stock pursuant to an effective registration statement under the Securities Act of 1933, as amended (the “Securities Act”); (c) the date on which we have, during the previous three-year (3-year) period, issued more than $1.0 billion in non-convertible debt; or (d) the date on which we are deemed to be a “large accelerated filer,” as defined in Rule 12b-2 under the Exchange Act or any successor thereto which would generally occur upon our attaining a public float of at least $700 million.

As an EGC, we are relieved from the following:

● We are excluded from Section 404(b) of Sarbanes-Oxley Act, which otherwise would have our auditors to attest to and report on our internal control over financial reporting. The JOBS Act also amended Section 103(a)(3) of Sarbanes-Oxley to provide that (i) any new rules that may be adopted by the Public Company Accounting Oversight Board (the “PCAOB”) requiring mandatory audit firm rotation or changes to the auditor’s report to include auditor discussion and analysis (each of which is currently under consideration by the PCAOB) shall not apply to an audit of an EGC; and (ii) any other future rules adopted by the PCAOB will not apply to our audits unless the SEC determines otherwise.

● The Jobs Act amended Section 7(a) of the Securities Act to provide that we need not present more than two years of audited financial statements in an initial public offering registration statement and in any other registration statement, need not present selected financial data pursuant to Item 301 of Regulation S-K for any period prior to the earliest audited period presented in connection with such initial public offering. In addition, we are not required to comply with any new or revised financial accounting standard until such date as a private company (i.e., a company that is not an “issuer” as defined by Section 2(a) of the Sarbanes-Oxley Act) is required to comply with such new or revised accounting standard. Corresponding changes have been made to the Exchange Act, which relates to periodic reporting requirements, which would be applicable if we were required to comply with them.

● As long as the Company is an EGC we may comply with Item 402 of Regulation S-K, which requires extensive quantitative and qualitative disclosure regarding executive compensation, by disclosing the more limited information required of a “smaller reporting company.”

● The Jobs Act will also exempt us from the following additional compensation-related disclosure provisions that were imposed on U.S. public companies pursuant to the Dodd-Frank Act: (i) the advisory vote on executive compensation required by Section 14A(a) of the Exchange Act; (ii) the requirements of Section 14A(b) of the Exchange Act relating to stockholder advisory votes on “golden parachute” compensation; (iii) the requirements of Section 14(i) of the Exchange Act as to disclosure relating to the relationship between executive compensation and our financial performance; and (iv) the requirement of Section 953(b)(1) of the Dodd-Frank Act, which requires disclosure as to the relationship between the compensation of our chief executive officer and median employee pay.

Risks Related to Our Common Stock

~~An active~~Our ~~trading~~Chairman ~~market~~and ~~does~~Chief ~~not~~Executive ~~exist~~Officer, who is our principal and ~~may~~controlling ~~not~~shareholder, ~~develop~~holds ~~for~~approximately ~~our~~58.35% ~~common~~of ~~stock~~the ~~and~~combined ~~you~~voting ~~may~~power ~~not~~of bethe ~~able~~Company, which gives him the ability to ~~sell~~control ~~your~~our ~~Shares~~business atand may limit or ~~above the~~eliminate ~~offering~~minority ~~price~~shareholders’ ~~per~~ability ~~Share~~to influence corporate affairs.

~~Our~~As of the date of this prospectus, Dr. Sudhir Srivastava, Chairman and Chief Executive Officer, beneficially owns approximately 58.35% of our issued and outstanding common stock. isIn addition, ~~currently~~he ~~quoted~~beneficially onowns all of our Series A Preferred Shares, which vote together with the ~~OTCPink~~common stock as a single class and afford ~~under~~the holder 51% of the ~~symbol~~total ~~“SSII.”~~voting ~~However~~power of the Company, regardless of the ~~trading~~number ~~market~~of ~~for~~shares ~~our~~of common stock isoutstanding. ~~sporadic~~The ~~and~~Series ~~extremely~~A Preferred ~~limited.~~Shares ~~Moreover~~are not convertible into common stock, however the Series A Preferred Shares are automatically redeemed by the Company ~~until~~for nominal consideration at such time as the ~~review~~holder owns less than 50% of the ~~Form~~shares ~~15c2-11~~issued ~~which~~to ~~has~~it. ~~been~~Together, ~~filed~~Dr. ~~with~~Srivastava ~~FINRA~~holds onapproximately 58.35% ~~our~~of ~~behalf~~the total voting power of the Company and therefore is ~~completed~~our principal and ~~cleared~~controlling ~~(as~~shareholder, toand ~~which~~following nothis ~~assurance~~offering ~~can~~will be ~~given),~~able ~~our~~to ~~common~~determine ~~stock~~the isoutcome ~~not~~of ~~eligible~~all ~~for~~matters ~~proprietary~~requiring ~~broker-dealer~~shareholder ~~quotations~~approval. ~~and~~For ~~may~~example, ~~only~~Dr. Srivastava will be ~~bought~~able to control the election of directors, amendment of our organizational documents or ~~sold~~approval inof ~~unsolicited customer~~any ~~orders~~merger, sale of assets or other major corporate transactions. This ~~further~~may ~~limits~~prevent ~~the~~or ~~trading~~discourage ~~market~~unsolicited acquisition proposals, offers for our common stock or consummation of other corporate matters that you may believe are in your best interest as one of our shareholders.

~~We have~~Although applied to list our Shares on the Nasdaq Capital Market under the symbol “SSII.” There can be no assurance that we will be successful in listing our common stock on the Nasdaq Capital Market. Even if our common stock is listed on the Nasdaq Capital Marketeligible, we ~~cannot~~have ~~predict~~elected ~~the~~not ~~extent~~ to ~~which~~take advantage ~~investor~~of ~~interest~~Nasdaq’s incontrolled ~~our~~company ~~Company~~governance ~~will~~exemptions ~~lead~~applicable to the ~~development~~composition of ~~any~~its ~~active~~board ~~trading~~of ~~market in our common stock or how liquid the market for our common stock might become. If a market does not develop or is not sustained~~directors, ~~it may be difficult for you to sell your Shares at the time you wish to sell them~~compensation, ~~at a price that is attractive to you, or at all. You~~ ~~may~~nominating ~~not~~and becorporate ~~able~~governance ~~to sell your Shares at or above the offering price per Share~~committees.

~~The market price and trading volume of our common stocks may be volatile and may be affected by economic conditions beyond our control.~~24

Our common stock was only recently listed for trading on Nasdaq and accordingly, there can be no assurance that an active liquid market for our common stock will develop and be sustained. If such a market does not develop or is not sustained, you may not be able to sell your shares at or above the offering price per share.

Our common stock is currently listed for trading on Nasdaq under the symbol “SSII.” However, such listing only became effective on April 25, 2025, and accordingly, there can be no assurance that an active liquid market for our common stock will develop and be sustained. If such a market does not develop or is not sustained, it may be difficult for you to sell your shares at the time you wish to sell them, at a price that is attractive to you, or at all. You may not be able to sell your shares at or above the offering price per Share.

The market price and trading volume of our common stock may be volatile and may be affected by economic conditions beyond our control.

The market price of our common stock is likely to be volatile. Some specific factors that could negatively affect the price of our common stock or result in fluctuations in its price and trading volume include:

● regulatory actions with respect to our SSi Mantra ~~Surgical~~system ~~Robotic System~~ or our competitors’ products;

●

actual or anticipated fluctuations in our quarterly operating results or those of our competitors;

●

publication of research reports by securities analysts about us or our competitors in the industry;

●

our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market;

●

issuances by us of debt or equity securities;

● litigation involving the Company, including ~~stockholder~~shareholder litigation;, investigations or audits by regulators into the operations of SSi; or proceedings initiated by our competitors or customers;

●

strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy;

● the passage of legislation or other regulatory developments affecting us or our industry; and fluctuations in the valuation of companies perceived by investors to be comparable to us;

●

trading volume of our common stock;

● sales or perceived potential sales of our common stock by our directors, senior management or our ~~stockholders~~shareholders in the future;

●

short selling or other market manipulation activities;

●

announcement or expectation of additional financing efforts;

●

terrorist acts, acts of war or periods of widespread civil unrest;

●

natural disasters, pandemics and other calamities;

●

changes in market conditions for medical device stocks; and

● conditions in the U.S. financial markets, the fluctuations in tariff policies under the Trump administration or changes in general economic conditions.

If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our common stock, the price and trading volume of our common stock could decline.

The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about us or our business. We do not currently have and may never obtain research coverage by securities and industry analysts. If no or few securities or industry analysts commence coverage of us, the trading price for our common stock could be negatively impacted. In the event we obtain securities or industry analyst coverage, if any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model, our intellectual property or our stock performance, or if our operating results fail to meet the expectations of analysts, the price of our common stock would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause the price or trading volume of our common stock to decline.

The ability of our Charman and Chief Executive Officer, who is also our principal and controlling stockholder, to control our business may limit or eliminate minority stockholders’ ability to influence corporate affairs.

As of December 31, 2023, Dr. Sudhir Srivastava, Chairman and Chief Executive Officer, beneficially owns approximately 68.9% of our common stock. In addition, he beneficially owns all the outstanding shares of our Series A Non-Convertible Preferred Stock (the “Series A Preferred Shares”), which affords the holder 51% of the total voting power of the Company. The Series A Preferred Shares are automatically redeemed by the Company for nominal consideration at such time as the holder owns less than 50% of the shares issued to it in connection with the CardioVentures Merger. Therefore, Dr. Srivastava is the principal and controlling stockholder of the Company and will be able to determine the outcome requiring stockholder approval. For example, Dr. Srivastava will be able to control elections of directors, amendment of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may believe are in your best interest as one of our stockholders.

Although eligible, the Company does not intend to take advantage of Nasdaq’s controlled company governance exemptions applicable to the composition of its board of directors, compensation, nominating and corporate governance committees.

We do not expect to pay cash dividends in the foreseeable future.

We have never paid cash dividends on our common stock. We do not expect to pay cash dividends on our common stock at any time in the foreseeable future. The future payment of dividends directly depends upon our future earnings, capital requirements, financial requirements and other factors that our board of directors will consider. Since we do not anticipate paying cash dividends on our common stock, return on your investment, if any, will depend solely on an increase, if any, in the market value of our common stock. Under its bank overdraft facility with HDFC Bank, SSI–India is prohibited from declaring and paying dividends, which effectively makes us, as a parent holding company, unable to declare and pay dividends as well.

Our board of directors has the authority, without ~~stockholder~~shareholder approval, to issue preferred stock with terms that may not be beneficial to holders of our common stock.

Our Amended and Restated Articles of Incorporation allows us to issue shares of preferred stock without any vote or further action by our ~~stockholders~~ shareholders. Our board of directors has the authority to fix and determine the relative rights and preferences of preferred stock. As a result, our board of directors could authorize the issuance of a series of preferred stock that would grant to holders the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders of common stock and the right to the redemption of the shares, together with a premium, prior to the redemption of our common stock.

Our Amended and Restated Articles of Incorporation, Bylaws, employment agreements with our executive officers and appointment agreements with our directors, provide for indemnification of directors and officers at our expense and limit their liability that may result in a major cost to us and hurt the interests of our ~~stockholders~~ shareholders because corporate resources may be expended for the benefit of executive officers and/or directors.

Our Amended and Restated Articles of Incorporation, Bylaws, employment agreements with our executive officers and appointment agreements with our directors, provide for the indemnification of officers and directors. We have been advised that, in the opinion of the SEC, indemnification for liabilities arising under federal securities laws is against public policy as expressed in the Securities Act, and is, therefore, unenforceable.

Raising additional funds through debt or equity financing could be dilutive or restrictive and may cause the market price of our securities to decline.

We expect to raise some or all of the funds we need to develop, manufacture and market our ~~products~~systems and related devices by selling our securities, ~~including~~ including but not limited to sales of our common stock, in private or public offerings. To the extent that we raise additional capital ~~through~~ through the sale of equity or convertible debt securities, your ownership interest may be substantially diluted, and the terms of these ~~securities~~ securities may include liquidation or other preferences that adversely affect your rights as a ~~stockholder~~shareholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take certain actions, such as incurring debt, making ~~capital~~ capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic collaborations or partnerships, or or marketing, distribution or licensing arrangements with third parties, we may be required to limit valuable rights to our intellectual property, technologies, product candidates or future revenue streams, or grant licenses or other rights on terms that are not favorable to us. Furthermore, any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates.

Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.

Sales of a substantial number of shares of our common stock in the public market or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional ~~equity~~ securities. We are unable to predict the effect that sales may have on the prevailing market price of our common stock.

25The anti-takeover provisions of our charter documents and Florida law could affect shareholders.

Certain provisions of our Amended and Restated Articles of Incorporation and Bylaws may have anti-takeover effects and may delay, defer or prevent a takeover attempt of the Company. In addition, Florida has enacted legislation that may deter or hinder takeovers of Florida corporations. The Florida Control Share Act generally provides that shares acquired in excess of certain specified thresholds will not have any voting rights unless such voting rights are approved by a majority of the corporation’s disinterested shareholders. The Florida Affiliated Transactions Act generally requires supermajority approval by disinterested shareholders of certain specified transactions between a public corporation and holders of more than 10% of the outstanding voting shares of the corporation or their affiliates.

Our failure to meet Nasdaq’s continued listing requirements could result in a delisting of our common stock.

If we fail to satisfy the continued listing requirements of Nasdaq, such as the corporate governance requirements or the minimum closing bid price requirement, Nasdaq may take steps to delist our common stock. Such a delisting would have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement, or prevent future non-compliance with the listing requirements of Nasdaq. The delisting of our common stock could significantly impair our ability to raise capital and the value of your investment.

Risks Related to this Offering

Resales of our common stock being offered in this Offering in the public market may cause the market price of our common stock to fall.

Sales of a substantial number of shares of our common stock, including the ~~Shares~~shares being offered in this ~~Offering~~offering, in the public market could occur at any time. These resales could have the effect of depressing the market price for our common stock.

As of ~~December~~the ~~31,~~date ~~2023~~of this prospectus, we had ~~approximately 170~~194,~~711~~356,~~811~~700 shares of common stock outstanding (including 191,559 shares being processed for issuance in connection with employee stock grants under the 2016 Incentive Plan), substantially all of which may be resold in the public market, subject to certain exceptions for affiliated ~~stockholders~~shareholders. If our existing ~~stockholders~~shareholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after the expiration of applicable legal restrictions on resale and the lock-up agreements, the trading price of our stock could decline.

Our management will have broad discretion over the use of the net proceeds from this ~~Offering~~offering, you may not agree with how we use the proceeds, and the proceeds may not be invested successfully.

Our management will have broad discretion as to the use of the net proceeds from this ~~Offering~~offering and could use them for purposes other than those contemplated at the time of commencement of this ~~Offering~~offering. Accordingly, you will be relying on the judgment of our management with regard to the use of these net proceeds, and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used appropriately. It is possible that, pending their use, we may invest the net proceeds in a way that does not yield a favorable, or any, return for our Company.

You will experience immediate and substantial dilution in the book value per ~~Share~~share you purchase.

The initial public offering price per ~~Share~~share is substantially higher than the net tangible book value per share of our common stock. Therefore, if you purchase ~~Shares~~shares in this ~~Offering~~offering, you will pay an effective price per ~~Share~~share you acquire that substantially exceeds our net tangible book value per share of common stock after this ~~Offering~~offering. Accordingly, you will experience immediate dilution of $ 4.02 per ~~Share~~share, representing the difference between our as adjusted net tangible book value per share of common stock after giving effect to this ~~Offering~~offering and the initial public offering price per ~~Share~~share. In addition, if options to acquire common stock previously issued under our 2016 ~~Stock~~ Incentive Plan ~~(the “Incentive Plan”)~~ are exercised at prices below the offering price, you will experience further dilution. See “Dilution” for a more detailed discussion of the ~~dilution~~ dilution you may incur in connection with this ~~Offering~~offering.

~~The offering price per Share in this Offering is not an indication of the fair value of our common stock.~~27

~~In determining~~If ~~the~~you ~~offering~~purchase ~~price per Share in the Offering,~~ our ~~board~~securities ~~of directors considered a number of factors, including, but not limited to, our need to raise capital~~ in ~~the near term to continue and expand our operations, the current and historical trading prices of our common stock, a price that would increase the likelihood of participation in~~ this ~~Offering and the cost and availability of capital from other sources. No valuation consultant or investment banker has opined upon the fairness or adequacy of the~~ offering ~~price per Share.~~, ~~You~~you ~~should~~may ~~not~~experience ~~consider~~future ~~the~~dilution ~~offering price per Share~~ as ana ~~indication~~result of ~~the~~future ~~value~~equity ofofferings ~~our Company~~ or ~~our~~other ~~common~~equity ~~stock~~issuances.

~~The anti-takeover~~We ~~provisions~~will likely offer and issue additional shares of our ~~charter~~common ~~documents~~stock or ~~and~~other ~~Florida~~equity ~~law~~or ~~could~~convertible ~~affect~~debt securities in order to raise additional capital. Future equity offerings or other equity issuances may be at a price per share that is equal to or greater than the price per share paid by investors in this offering. Future investors in such offerings may have rights superior to existing shareholders, and the price per share at which we sell additional shares of common stock or other equity or convertible debt securities in future transactions may be at a higher or lower price per share than the price per share in this offering.

~~Certain provisions~~A ofsubstantial ~~our~~number ~~amended~~of ~~and~~shares ~~restated articles~~ of ~~incorporation and bylaws may have anti-takeover effects and may delay, defer or prevent~~common astock ~~takeover attempt of the Company. In addition, Florida has enacted legislation that~~ may ~~deter~~be orsold ~~hinder takeovers of Florida corporations. The Florida Control Share Act generally provides that shares acquired~~ in ~~excess of certain specified thresholds will not have any voting rights unless such voting rights are approved by a majority of~~ the ~~corporation’s~~market ~~disinterested~~following ~~shareholders.~~this ~~The~~offering, ~~Florida~~which ~~Affiliated Transactions~~may ~~Act~~depress ~~generally requires supermajority approval by disinterested shareholders of certain specified transactions between a public corporation and holders of more than 10% of~~ the ~~outstanding~~market ~~voting~~price ~~shares~~for ofour ~~the~~common ~~corporation or their affiliates~~stock.

26The securities offered hereby will be freely tradable without restriction or further registration under the Securities Act of 1933, as amended (the “Securities Act”). Sales of a substantial number of shares of our common stock in the public market following this offering, or the perception that such sales could occur, could cause the market price of our common stock to decline.

The offering price per share in this offering is not an indication of the fair value of our common stock.

In determining the offering price per share in this offering, our board of directors considered a number of factors, including, but not limited to, our need to raise capital in the near term to continue and expand our operations, the current and historical trading prices of our common stock, a price that would increase the likelihood of participation in this offering and the cost and availability of capital from other sources. No valuation consultant or investment banker has opined upon the fairness or adequacy of the offering price per Share. You should not consider the offering price per share as an indication of the value of our Company or our common stock.

FINRA sales practice requirements may limit a shareholder’s ability to buy and sell our securities.

Effective June 30, 2020, the SEC implemented Regulation Best Interest requiring that “A broker, dealer, or a natural person who is an associated person of a broker or dealer, when making a recommendation of any securities transaction or investment strategy involving securities (including account recommendations) to a retail customer, shall act in the best interest of the retail customer at the time the recommendation is made, without placing the financial or other interest of the broker, dealer, or natural person who is an associated person of a broker or dealer making the recommendation ahead of the interest of the retail customer.” This is a significantly higher standard for broker-dealers to recommend securities to retail customers than before under FINRA “suitability” rules. FINRA suitability rules do still apply to institutional investors and require that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending securities to their customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information, and for retail customers determine that the investment is in the customer’s “best interest” and meet other SEC requirements. Both SEC Regulation Best Interest and FINRA’s suitability requirements may make it more difficult for broker-dealers to recommend that their customers buy speculative, low-priced securities. They may affect investing in our common stock, which may have the effect of reducing the level of trading activity in our securities. As a result, fewer broker-dealers may be willing to make a market in our common stock, reducing a shareholder’s ability to resell our common stock.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains certain statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Any and all statements contained in this prospectus that are not statements of historical fact may be deemed forward-looking statements. Terms such as “may,” “might,” “would,” “should,” “could,” “project,” “estimate,” “pro-forma,” “predict,” “potential,” “strategy,” “anticipate,” “attempt,” “develop,” “plan,” “help,” “believe,” “continue,” “intend,” “expect,” “future” and terms of similar import (including the negative of any of the foregoing) may be intended to identify forward-looking statements. However, not all forward-looking statements may contain one or more of these identifying terms. Those statements appear in this prospectus, ~~and~~ and include statements regarding the intent, belief or current expectations of our Company and management that are subject to known and ~~unknown~~ unknown risks, uncertainties and assumptions and other factors that could cause actual results and the timing of certain events to differ ~~materially~~ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such ~~differences~~ differences include, but are not limited to, those discussed in “Risk Factors” above.

Forward-looking statements in this prospectus may include, without limitation, statements regarding:

(i) the plans and objectives of management for future operations, including plans or objectives relating to the development of our ~~medical~~surgical robotic systems,

(ii) the timing or likelihood of regulatory filing, approvals and required licenses for our ~~medical~~surgical robotic systems;

(iii)

our ability to adequately protect our intellectual property rights and enforce such rights to avoid violation of the intellectual property rights of others;

(iv) the timing, costs and other aspects of the commercial launch of our ~~medical~~surgical robotic systems;

(v) our estimates regarding the market opportunity, clinical utility, potential advantages and market acceptance of our ~~medical~~surgical robotic systems;

(vi)

the impact of government laws and regulations;

(vii) the potential effect U.S. tariff policies may have on our ability to ~~recruit~~import ~~and~~our ~~retain~~surgical ~~qualified~~robotic ~~research~~systems and ~~development~~related ~~personnel~~devices into the U.S., once approval to market has been obtained;

(viii) ~~difficulties~~our inability ~~maintaining~~to ~~commercial~~recruit ~~scale~~and ~~manufacturing~~retain ~~capacity~~qualified ~~and~~research ~~capability~~ and ~~our~~development ~~ability to generate growth~~personnel;

(ix) ~~uncertainty~~difficulties in ~~industry~~maintaining ~~demand~~commercial scale manufacturing capacity and capability and our ability to generate growth;

(x) ~~general~~uncertainty ~~economic conditions and market conditions~~ in ~~our~~ industry demand;

(xi) ~~future~~general ~~sales~~economic ofconditions ~~large~~and ~~blocks~~market ofconditions ~~our~~in ~~securities, which may adversely impact~~ our ~~share price~~industry;

(xii) ~~the~~future ~~depth~~sales of ~~the~~large ~~trading~~blocks ~~market~~of in our securities, which may adversely impact our share price;

(xiii) athe ~~projection~~depth of ~~income~~the ~~(including~~trading ~~income/loss),~~market ~~earnings~~in ~~(including~~our ~~earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items~~securities; ~~and~~

(xiv) ~~our~~a ~~future~~projection ~~financial~~of ~~performance,~~income (including ~~any~~income/loss), ~~such~~earnings ~~statement~~(including ~~contained~~earnings/loss) inper ashare, ~~discussion~~capital ~~and~~expenditures, ~~analysis~~dividends, ofcapital ~~financial~~structure ~~condition by management~~ or inother ~~the~~financial ~~results~~items; ~~of operations included pursuant to the rules~~ and ~~regulations of the SEC.~~

~~These statements~~(xv) ~~are~~our ~~not~~future ~~guarantees~~financial ofperformance, ~~future~~including ~~performance~~any such statement contained in a discussion and ~~are~~analysis ~~subject~~of tofinancial ~~numerous~~condition ~~risks,~~by ~~uncertainties,~~management ~~and~~or ~~assumptions~~in ~~that~~the ~~are~~results ~~difficult~~ of operations included pursuant to ~~predict~~the rules and regulations of the SEC.

~~Because forward-looking~~These statements are ~~inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should~~ not ~~rely~~guarantees ~~upon forward-looking statements as predictions~~ of future ~~events. The events and circumstances reflected in the forward-looking~~ ~~statements~~performance ~~may not be achieved or occur~~ and ~~actual~~are ~~results~~subject ~~could~~to ~~differ~~numerous ~~materially from those projected in the forward-looking statements. Except as required by applicable law~~risks, ~~including~~uncertainties ~~the securities laws of the United States~~ and ~~the~~assumptions ~~rules~~that ~~and~~are ~~regulations~~difficult ~~of the SEC, we do not assume any obligation~~ to ~~update any forward-looking statement~~predict. ~~We disclaim any intention or obligation to update or revise any forward-looking statement contained herein, whether as a result of new information, future events or otherwise.~~

27Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely upon forward-looking statements as predictions of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, including the securities laws of the U.S. and the rules and regulations of the SEC, we do not assume any obligation to update any forward-looking statement. We disclaim any intention or obligation to update or revise any forward-looking statement contained herein, whether as a result of new information, future events or otherwise. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date the statement is made, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.

USE OF PROCEEDS

We estimate that our net proceeds from this ~~Offering~~offering will be approximately $ 45.8 million, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. If the underwriters exercise their option to purchase additional ~~Shares~~shares in full, we estimate that the net proceeds will be approximately $ 52.8 million, after ~~deducting~~ deducting the underwriting discounts and commissions and estimated offering expenses payable by us. WeThe ~~intend~~table tobelow ~~use~~depicts ~~the~~how ~~net~~we ~~proceeds of this Offering~~plan ~~for working capital and general corporate purposes, which include, but are not limited~~ to ~~expansion~~utilize ~~of our manufacturing capacity through~~ the ~~installation~~proceeds of ~~additional~~this ~~machinery and equipment~~offering, ~~bulk~~after ~~ordering~~deducting ofestimated ~~components~~offering ~~for~~expenses ~~use~~payable inby ~~manufacturing of our final products, conducting global clinical trials to meet various regulatory requirements, and establishing regional marketing offices.~~us:

~~The expected~~We ~~use~~intend ofto use the net proceeds ~~from~~of this ~~Offering~~offering ~~represents~~for ~~our~~expansion ~~intentions based upon~~ of our ~~current~~manufacturing ~~plans~~capacity ~~and~~through ~~business conditions, which could change in~~ the ~~future~~installation asof ~~our~~additional ~~plans~~machinery and ~~business~~equipment, ~~conditions~~bulk ~~evolve.~~ordering ~~The amounts and timing~~ of ~~our~~components ~~actual~~for ~~expenditures~~use ~~depend~~in ~~on numerous~~manufacturing ~~factors, including the progress~~ of our ~~development~~systems ~~efforts~~ and ~~any~~related ~~unforeseen~~devices, ~~cash~~conducting ~~needs~~clinical ~~are~~trials ~~difficult~~ to ~~predict.~~meet Asvarious aregulatory ~~result~~requirements, welease ~~cannot currently specify in more detail the percentage~~ of ~~the~~additional ~~net~~office ~~proceeds~~and manufacturing ~~that~~space, weestablishing ~~may~~regional ~~use~~marketing ~~for each of the listed purposes. Accordingly~~offices, ~~we will~~and ~~have~~working ~~broad~~capital ~~discretion in the use of the net proceeds from this Offering~~ and ~~could~~other ~~spend~~general ~~the~~corporate ~~proceeds in ways that do not improve our results of operations or enhance the value of our common stock~~purposes.

The expected use of the net proceeds from this offering represents our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve. The amounts and timing of our actual expenditures depend on numerous factors, including the progress of our development efforts and any unforeseen cash needs are difficult to predict. As a result, we cannot currently specify in more detail the percentage of the net proceeds that we may use for each of the listed purposes. Accordingly, we will have broad discretion in the use of the net proceeds from this offering and could spend the proceeds in ways that do not improve our results of operations or enhance the value of our common stock.

Pending the use of the proceeds from this offering, we intend to invest the net proceeds in short-term, interest-bearing, investment-grade securities, certificates of deposit or government securities.

We believe that the net proceeds from this offering, together with our existing cash and cash equivalents and revenues that we anticipate generating from sales of our robotic surgery systems, will be sufficient to fund our operations ~~through~~for ~~2027~~a period of not less than 24 months from the closing of this offering. We have based this estimate on on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

2830

DIVIDEND POLICY

We have not paid any dividends on our common stock since inception , and we currently expect that, in the foreseeable future, all earnings (if any) will be retained for the development of our business and no dividends will be declared or paid. Any future dividends will be subject to the discretion of our board of directors and will depend upon, among other things, our earnings (if any), operating results, financial condition and capital requirements, general business conditions and other pertinent facts. Under its bank overdraft facility with HDFC Bank, SSI–India is prohibited from declaring and paying dividends, which effectively makes us, as a parent holding company, unable to declare and pay dividends as well.

CAPITALIZATION

The following table sets forth our cash and cash equivalents and capitalization as of September 30, ~~2023~~2025:

●

on an actual basis; and

● on an as adjusted basis after giving effect to ~~reflect~~our ~~the~~issuance and sale of $11,286,681 ~~million~~shares inof ~~Shares~~our bycommon usstock in ~~this~~the ~~Offering~~offering, ~~after~~at ~~deducting~~an ~~estimated~~assumed ~~Offering~~public ~~expenses~~offering ~~payable~~price byof us$4.43 ~~The~~per asshare, ~~adjusted~~the ~~basis~~closing ~~assumes~~price noper ~~exercise~~share of ~~the~~our ~~overallotment~~common ~~option~~stock byon ~~the~~Nasdaq ~~underwriters~~on January 28, 2026, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

You should read this table in conjunction with our historical financial statements and related notes and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and our consolidated financial statements and related notes appearing elsewhere in this prospectus.

	As of September 30, 2023
	As of September 30, 2025
	Actual			As Adjusted
Cash and cash equivalents	$	65,~~596~~681,~~224~~657		$	51,506,657
Debt: Bank Overdraft	$	610,~~118~~069,~~214~~783		$	10,069,783
Stockholders’ equity (deficit):
Shareholders’ equity (deficit):
Common stock, $0.0001 par value per share; authorized 250,000,000 shares; 53,887,738 shares issued and outstanding, actual; 169,117,202 shares issued and outstanding, as adjusted;	$	16,911		$
Common stock, $0.0001 par value per share; authorized 250,000,000 shares; 193,592,410 shares issued and outstanding, actual and as adjusted;	$	19,358		$	20,487
Preferred stock, $0.0001 par value per share; authorized 5,000,000 shares of Series A Non-Convertible Preferred Stock, issued and outstanding actual and as adjusted
Preferred stock, $0.0001 par value per share; authorized 5,000,000 shares; 1,000 shares of Series A Non-Convertible Preferred Stock, issued and outstanding actual and as adjusted		1			1
Additional paid-in capital		3693,~~194~~353,~~435~~412			139,177,280
Accumulated deficit		(2153,~~085~~318,~~962~~557	)		(53,318,557	)
Accumulated other comprehensive income (loss)		~~637~~(1,~~271~~304,825	)		(1,304,825	)
Total stockholders’ equity (deficit)		15,762,655
Total shareholders’ equity (deficit)		38,749,389			84,574,386
Total liabilities and stockholders’ equity (deficit)	$	24,058,996
Total Capitalization	$	48,819,172		$	94,644,169
Total Capitalization	$	21,880,869

The number of shares of common stock issued and outstanding actual and as adjusted in the table above is based on 193,592,410 shares of our common stock outstanding as of September 30, 2025 and excludes, as of such date, the following:

● the 7,~~496~~578,~~026~~181 shares of our common stock reserved for issuance under ~~presently~~ outstanding options ~~or unvested stock awards issued~~ under our 2016 Incentive Plan with a weighted-average exercise price of $ 54.1497 per share; ● the 1,607,332 shares of common stock issuable upon the vesting of outstanding restricted stock grants under the 2016 Incentive Plan; and ● the 500,000 shares of our common stock issuable upon exercise of outstanding warrants at an exercise price of $8.89 per share.

●Each $1.00 increase or decrease in the 8assumed public offering price of $4.43 per share,~~831,005~~ ~~shares~~the closing price per share of our common stock ~~reserved~~on ~~for~~Nasdaq ~~future~~on ~~issuance~~January ~~under~~28, 2026, would increase or decrease, respectively, the ~~Incentive~~amount ~~Plan;~~of cash and cash equivalents, additional paid-in capital, total shareholders’ equity and total capitalization by $10.5 million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

●We may also increase or decrease the number of shares ~~that~~we ~~may~~are beoffering. An ~~issued~~increase ~~upon~~or ~~exercise~~decrease of 500,000 in the ~~underwriters~~number of shares we are offering would increase or decrease, respectively, the amount of cash and cash equivalents, stockholders’ ~~warrants~~equity and total capitalization by approximately $2.1 million, assuming the assumed public offering price per share remains the same, and after deducting underwriting discounts and commissions. The pro forma information is illustrative only, and we will adjust this information based on the actual public offering price and other terms of this offering determined at pricing.

If the underwriters’ option to purchase additional shares is exercised in full, our as adjusted cash and cash equivalents, total shareholders’ equity, and total capitalization as of September 30, 2025 would be $58.5 million, $91.55 million and $101.6 million, respectively.

DILUTION

If you invest in our Shares, your interest will be diluted to the extent of the difference between the public offering price per Share that you pay and the pro forma as adjusted net tangible book value per share of our common stock after this Offering. Net tangible book value per share is determined by dividing our total tangible assets less our total liabilities by the number of shares of common stock outstanding. Our historical net tangible book value as of September 30, 2023 was $15,762,655 or $0.09 per share, based on 169,117,202 shares of common stock outstanding as of September 30, 2023.

Net tangible book value dilution per share represents the difference between the price per Share paid by new investors who purchase Shares from us in this Offering and the pro forma net tangible book value per share of common stock immediately after completion of this Offering. As of September 30, 2023, after giving effect to our sale of the $ of Shares in this Offering and after deducting estimated Offering expenses payable by us, our pro forma as adjusted net tangible book value would have been $ or $ per Share. This represents an immediate increase in pro forma net tangible book value of $ per share of common stock to existing stockholders, and an immediate dilution in pro forma net tangible book value of $ per share of common stock to new investors purchasing Shares in this Offering. The table below illustrates this per Share dilution as of September 30, 2023.

	Before Offering		After Offering
Public offering price per Share	$		$
Net tangible book value per Share as of September 30, 2023	$	0.09
Increase in pro forma net tangible book value per Share attributable to new investors participating in this Offering	$		$
Pro forma as adjusted net tangible book value per Share after this Offering			$
Dilution of pro forma net tangible book value per Share to new investors			$

If the underwriters exercise their option to purchase additional Shares in full, the adjusted net tangible book value per share of our common stock after giving effect to this Offering would be approximately $ per share of common stock and the dilution in adjusted net tangible book value per share to investors in this Offering would be approximately $ per share of common stock.

The following table sets forth, on an as adjusted basis as of September 30, 2023, the number of shares of common stock purchased or to be purchased from us, the total consideration paid or to be paid and the average price per share of common stock paid or to be paid by existing holders of common stock and by new investors, at a public offering price of $ per Share, and before deducting estimated Offering expenses that payable by us.

	SHARES PURCHASED					TOTAL CONSIDERATION				AVERAGE PRICE PER
	NUMBER		PERCENT			AMOUNT	PERCENT			SHARE
Existing stockholders		169,117,002			%	$			%	$
New investors					%				%
Total				100	%	$		100	%	$

The foregoing discussion and tables are based on the number of shares of common stock outstanding as of September 30, 2023, but excludes:

● the 7,496,026 shares of our common stock reserved for issuance under presently outstanding options or unvested stock awards issued under the Incentive Plan with a weighted-average exercise price of $5.14 per share;

● the 8,831,005 shares of our common stock reserved for future issuance under the Incentive Plan; and

● the shares that may be issued upon exercise of the underwriters’ warrants.

DILUTION

If you invest in our common stock in this offering, your interest will be immediately diluted to the extent of the difference between the public offering price per share and the as adjusted net tangible book value per share of our common stock after this offering. Net tangible book value per share represents our total tangible assets less total liabilities, divided by the number of shares of our common stock outstanding.

As of September 30, 2025, our net tangible book value was $39.65 million, or $0.20 per share of common stock, based on 193,592,410 shares of common stock outstanding as of September 30, 2025.

After giving effect to the sale of 11,286,681 shares of our common stock at an assumed public offering price of $4.43 per share, the closing price per share of our common stock on Nasdaq on January 28, 2026, and after deducting the underwriters discount and commissions and estimated offering expenses payable by us, our as adjusted net tangible book value as of September 30, 2025 would have been approximately $0.41 per share of common stock. This represents an immediate increase in net tangible book value of approximately $0.21 per share of common stock to our existing common stockholders and an immediate dilution in as adjusted net tangible book value of approximately $4.02 per share of common stock to purchasers of common stock in this offering. We determine dilution per share to investors participating in this offering by subtracting the as adjusted net tangible book value per share after giving effect to this offering from the assumed public offering price per share paid by investors participating in this offering.

The following table illustrates this per share dilution to the new investors purchasing shares in this offering:

Assumed public offering price per share			$	4.43
Historical net tangible book value per share as of September 30, 2025	$	0.20
Increase in net tangible book value per share attributable to investors purchasing in this offering	$	0.21
As adjusted net tangible book value per share as of September 30, 2025 after this offering			$	0.41
Dilution per share to investors purchasing in this offering			$	4.02

If the underwriters exercise their option to purchase additional shares in full, the adjusted net tangible book value per share of our common stock after giving effect to this offering would be approximately $0.44 per share of common stock and the dilution in adjusted net tangible book value per share to investors in this offering would be approximately $3.99 per share of common stock.

Each $1.00 increase or decrease in the assumed public offering price of $4.43 per share of common stock (the closing price per share of our common stock on Nasdaq on January 28, 2026) would increase or decrease the as adjusted net tangible book value per share by $0.05 per share and the dilution per share to investors participating in this offering by $0.95 per share, assuming that the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the underwriters discount and commissions and estimated offering expenses payable by us.

We may also increase or decrease the number of shares of common stock that we are offering. A 500,000 share increase in the number of shares offered by us, as set forth on the cover page of this prospectus, would increase the as adjusted net tangible book value per share by approximately $0.01 and decrease the dilution per share to new investors participating in this offering by approximately $0.01, based on an assumed public offering price of $4.43 per share (the closing price of our common stock on Nasdaq on January 28, 2026), and after deducting the underwriters discount and commissions and estimated offering expenses payable by us. Similarly, a 500,000 share decrease in the number of shares offered by us, as set forth on the cover page of this prospectus, would decrease the as adjusted net tangible book value per share by approximately $0.01 and increase the dilution per share to new investors participating in this offering by approximately $0.01, based on an assumed public offering price of $4.43 per share, the closing price of our common stock on Nasdaq on January 28, 2026, and after deducting the underwriters discount and commissions and estimated offering expenses payable by us.

The foregoing discussion and tables are based on 193,592,410 shares of common stock outstanding as of September 30, 2025, and excludes as of such date, the following:

	●	the 7,578,181 shares of our common stock reserved for issuance under presently outstanding options under our 2016 Incentive Plan with a weighted-average exercise price of $4.97 per share;

	●	the 1,607,332 shares of common stock issuable upon the vesting of outstanding restricted stock grants under the 2016 Incentive Plan; and

	●	the 500,000 shares of our common stock issuable upon exercise of outstanding warrants at an exercise price of $8.89 per share.

To the extent that any outstanding options are exercised, new options or other equity awards are issued under our 2016 Incentive Plan, or we issue additional shares in the future, there will be further dilution to new investors participating in this offering.

The information discussed above is illustrative only and will change based on the actual public offering price, the actual number of shares that we offer in this offering, and other terms of this offering determined at pricing.

BUSINESS

Overview

We are a commercial-stage surgical robotics company focused on transforming patient lives by democratizing access to advanced surgical robotics technologies. We design, ~~develop,~~ manufacture and market an advanced, next-generation and affordable surgical robotic ~~systems~~system ~~including~~called the SSi Mantra, ~~Surgical~~intended ~~Robotic~~for ~~System~~use ~~and~~in ~~its~~urology, ~~associated~~general, gynecology, ~~instruments~~colorectal, gastroenterology, head and ~~accessories~~neck, thoracic and cardiac surgeries. ~~Our~~While ~~vision~~surgical isrobotic tosystems ~~create~~have ~~new~~gained acceptance globally in the past two decades for providing greater efficiency, ~~technologically~~better ~~advanced~~clinical ~~systems~~outcomes ~~that~~and ~~will~~reducing ~~surpass~~healthcare ~~existing~~costs, ~~surgical~~access ~~robotic~~ to such systems remains largely limited to ~~provide~~developed ~~cost~~countries ~~effective~~such ~~surgical~~as ~~solutions~~the U.S., the EU and Japan. With the SSi Mantra, we are breaking down barriers and accelerating access to ~~benefit~~surgical ~~greater~~robotics ~~numbers~~technologies ofin ~~patients~~underserved ~~around~~regions of the world.

~~Robotic surgical~~Led ~~procedures~~and ~~have~~developed ~~achieved~~by ~~acceptance~~Dr. ~~globally~~Sudhir ~~over~~Srivastava, ~~the~~our founder, ~~past~~Chairman ~~two~~and ~~decades~~Chief ~~because~~Executive ~~they~~Officer ~~generally~~with ~~offer~~ a ~~faster~~visionary ~~recovery~~team ~~period~~of engineers, ~~result~~ insurgeons ~~less~~and ~~post-operative~~industry ~~pain~~veterans, ~~and~~the ~~discomfort,~~SSi ~~provide~~Mantra ~~for~~includes several ~~greater~~innovative ~~precision,~~features ~~reduce~~to address shortcomings of the ~~risk~~current generation of ~~infection,~~robotic ~~result~~surgery insystems. ~~minimal~~The ~~blood loss~~SSi ~~and~~Mantra ~~permit~~marks the ~~use~~ realization of ~~smaller incisions~~Dr. ~~However,~~Srivastava’s ~~the~~vision ~~global~~to ~~market~~develop ~~penetration~~and ~~for~~commercialize a surgical robotic ~~systems~~system ~~has~~which inwould ~~large~~facilitate ~~part~~making ~~been~~robotic surgery ~~limited~~affordable and accessible to ~~developed~~a ~~countries~~global ~~due~~population. toWe commenced development of the ~~high~~SSi ~~costs~~Mantra in 2014, received regulatory approval by the CDSCO India’s equivalent of the U.S. FDA, for its sale and ~~steep~~use ~~learning~~in ~~curve~~India and commercially launched sales in late 2022. We also received ISO 13485 (quality management system) approval for the ~~existing~~SSi ~~systems~~Mantra in November 2021. The latest generation SSi Mantra 3 was ~~specifically~~introduced ~~developed~~in ~~from~~India ~~the~~with ~~ground~~telesurgery upand totele-proctoring ~~address~~capabilities ~~these~~along ~~issues~~with byadvanced ~~providing~~energy aninstrumentation. ~~advanced~~The SSi Mantra 3 received CDSCO approval in November 2024 and has been clinically validated for safety, ~~affordable~~efficacy and ~~accessible~~effectiveness ~~surgical~~for ~~robotic~~its ~~system~~intended use to perform robotically assisted surgeries.

We commenced development of the Ssi Mantra in 2014, received regulatory approval for its sale and use in India and commercially launched sales in August 2022. The Ssi Mantra has been clinically validated for more than fifty different types of surgical procedures. As of December 31, ~~2023~~2025, we have installed ~~twenty three~~ 168 systems, of which ~~twenty~~154 ~~one~~ are located in India, ~~one~~and in14 ~~Dubai~~at ~~and~~overseas ~~one~~locations. atIncluding ~~the~~our ~~Johns~~strong ~~Hopkins~~foundational ~~Hospital~~market inof ~~Baltimore~~India, ~~Maryland~~the ~~for~~SSi ~~clinical~~Mantra ~~training~~installed ~~and~~base ~~ongoing~~currently ~~research~~spans ~~and~~10 ~~development~~countries. ~~The~~We ~~systems~~are ~~installed~~currently infocusing ~~India~~our ~~have~~efforts ~~been~~on ~~used~~marketing toour ~~perform more~~latest ~~than seven hundred surgical procedures, including cardiovascular, thoracic, head and neck, gynecological, urological, cancer and~~generation ~~general surgeries. The~~ SSi Mantra ~~Surgical~~3 ~~Robotic~~in ~~System~~international ~~has~~markets ~~been~~and ~~granted~~anticipate ~~regulatory~~receiving ~~approval~~EU ~~in India~~ and ~~Guatemala~~U.S. Weregulatory ~~have~~approvals ~~initiated the process~~ to ~~obtain~~market ~~regulatory approvals~~ in ~~the~~those ~~United~~regions ~~States from the Food and Drug Administration (the “FDA”) and~~ in the ~~European Union. We have filed a pre-submission application with the FDA requesting feedback on the SSi Mantra Surgical Robotic~~first ~~System.~~half ~~We received an acknowledgement~~ of ~~this pre-submission filing (#Q240119) from the Center for Devices and Radiological Health (CDRH) on January 17~~2026, ~~2024 and we have a feedback meeting scheduled with the FDA on April 02~~however, ~~2024.~~there ~~We have also been in discussions with an EU Notified body for the CE certification.. There~~ can be no assurance as to when or if we will secure such regulatory approvals~~, if at all~~. Our ISO 13485 (quality management system) approval, CDSCO approval for the manufacture, sale and distribution of our products, and Indian export license allow us to market our products in fifty non-FDA and non-EU countries without further regulatory approvals. An additional seventy-nine countries require only minimal registration.

Our commercially installed SSi Mantra systems have been used to perform more than 7,800 surgical procedures including approximately 400 cardiac robotic surgeries across 153 hospitals as of December 31, 2025. The SSi Mantra has been clinically validated for safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries in more than 100 different types of surgical procedures without any device-related adverse events. These procedures have spanned across the following nine surgical specialties:

Type of Surgical Procedure	No. of Procedures performed as of December 31, 2025		% of total procedures
General Surgery		3,409		43.2	%
Urology		2,004		25.4	%
Gynecology		1,247		15.8	%
Colorectal		444		5.6	%
Cardiac		390		4.9	%
Gastroenterology		217		2.8	%
Head and Neck		93		1.2	%
Thoracic		73		0.9	%
Plastic/Reconstructive		8		0.1	%
Total		*7,885		100	%

Includes: 121 pediatric surgeries, 120 telesurgeries and 232 surgeries outside of India

In December 2024, we became the first and only company in India to receive the CDSCO regulatory approval for use of a robotic surgical system in the performance of Telesurgery and Tele-proctoring procedures. Since receiving such approvals, we have performed more than 120 telesurgeries using our SSi Mantra as of December 31, 2025, including a robotic cardiac surgery over a distance of more than 5,000 miles.

In addition to India, the SSi Mantra has also been granted regulatory approval in Colombia, Ecuador, Guatemala, Indonesia, Kenya, Oman, Philippines, Sri Lanka, Ukraine, and the United Arab Emirates.

On December 5, 2025, we submitted a 510(k) premarket notification to the FDA for the SSi Mantra for multiple specialty procedure types, including: general, urological, colorectal, gynecological, and cardiac surgery. We believe that the 510(k) regulatory pathway offers potential speed and cost advantages. The FDA has stated that its goal is to complete reviews of 510(k) submissions within 90 days of receipt. However, time to approval could be longer due to factors such as the 15-day acceptance review, the submission of additional information, and a submitter’s response time. We have engaged RQM+, a leading MedTech-focused CRO, to assist with the 510(k) submission. If approved by the FDA, the SSi Mantra would be cleared to market in the U.S. Submission of a 510(k) premarket notification request does not guarantee FDA approval. We have also submitted our technical files to Szutest, an EU Notified Body for the CE certification, which if obtained will allow us to market the SSi Mantra in the EU. We believe that we will be able to secure FDA approval and EU certification in 2026. However, there can be no assurance as to when or if we will secure such regulatory approvals.

We generate revenues from the sale of the SSi Mantra. We offer our SSi Mantra through three selling models: (i) outright purchase, where revenue is realized upfront; (ii) purchase on a deferred or installment payment basis; and (iii) purchase on a pay-per-procedure basis, where revenue is recognized over time. We also earn recurring revenue from the sales of instruments, accessories and services. We sell our systems and related devices directly to customers as well as through distributors.

We believe the SSi Mantra improves patient experience, reduces variabilities and disruption and lowers per-procedure costs. We believe that the SSi Mantra benefits patients, physicians and hospitals by providing access to an advanced and optimized robotic system.

Our Founder, Chairman and Chief Executive Officer

Dr. Sudhir P. Srivastava, M.D., is the founder, Chairman and Chief Executive Officer of SSi. Dr. Srivastava is an internationally recognized robotic cardiothoracic surgeon with more than four decades of clinical, academic, and leadership experience in minimally invasive and robotic surgery across multiple global healthcare systems. Dr. Srivastava completed advanced surgical training in North America and held senior clinical and academic leadership roles in the U.S., including serving as Director of Robotic Cardiac Surgery at the University of Chicago. He was an early adopter and clinical innovator in robotic cardiac surgery and played a significant role in the development and clinical validation of minimally invasive and robotic techniques during the early adoption of surgical robotics in the U.S.

Over the course of his clinical career, Dr. Srivastava has performed more than 1,500 robotic cardiothoracic surgical procedures, including a substantial number of totally endoscopic coronary artery bypass (“TECAB”) procedures. At the time these procedures were performed, this experience represented one of the largest single-surgeon case volumes globally. In addition to his clinical practice, Dr. Srivastava has trained and proctored more than 1,000 surgical teams worldwide and has contributed to surgeon education, procedural standardization, and technology adoption in robotic surgery.

In 2011, Dr. Srivastava founded SSi with the objective of developing advanced surgical robotic technology designed to expand access to minimally invasive surgery in cost-constrained healthcare environments. As founder, Chairman and CEO, he has led our clinical vision, product strategy, and early-stage technology development, working closely with engineering, regulatory, and clinical teams.

Under his leadership, we developed the SSi Mantra system, a modular, multi-specialty platform that was clinically validated in 2021 and commercially launched in 2022. The system was designed to support a broad range of soft-tissue surgical procedures, including cardiac surgery, and to address economic and operational barriers that have historically limited the adoption of robotic surgery in certain markets.

Dr. Srivastava has also overseen the development and demonstration of advanced digital surgery capabilities, including remote surgery and tele-mentoring applications utilizing the SSi Mantra platform. These demonstrations illustrate the potential of robotic and digital technologies to support remote clinical collaboration and surgeon training.

Dr. Srivastava has received multiple international recognitions for his contributions to minimally invasive and robotic cardiac surgery and for his role in advancing surgical innovation and education. As Chairman and Chief Executive Officer, Dr. Srivastava continues to play a key role in shaping our long-term strategy, clinical direction, and innovation roadmap.

Products

The SSi Mantra

The SSi Mantra ~~Surgical Robotic System~~ is designed to enable surgeons to perform a wide range of surgical procedures including cardiovascular, thoracic, head and neck, gynecological, urological, cancer and general surgeries. The SSi Mantra has been clinically validated for safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries in more than ~~fifty~~100 different types of surgical procedures in India without any device related adverse events. To As of the date, of this prospectus, surgeons have performed ~~more~~over ~~than~~7,800 ~~seven hundred~~ surgical procedures in a wide array of fields using the SSi Mantra, including many complex surgeries. The SSi Mantra offers the entire operating room staff three-dimensional, high definition (“~~3DHD~~3D 4K”) vision, and gives the surgeon a magnified view up to ten times magnification. Our system uses specialized instrumentation, including a miniaturized surgical camera (endoscope) and wristed instruments (for example, scissors, scalpels and forceps) that are designed to help with the precise dissection and reconstruction of anatomical structures within the body. We are currently focusing our efforts on marketing our SSi Mantra 3 in international markets.

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The SSi Mantra 3 is comprised of the following components:

Surgeon Console. The SSi Mantra ~~allows~~3 allows surgeons to operate while comfortably seated at an ergonomic open-faced console. Surgeons use a special pair of passive 3D glasses to view a ~~3DHD~~3D 4K image of the surgical field on a 32-inch 3D 4K resolution monitor with up to ten (10) times magnification, resulting in significantly enhanced vision for the surgeon. The surgeon also has a second large 23-inch 2D touch monitor for system controls and digital imaging and communications in medicine (“DICOM”) applications. The surgeon’s fingers grasp extremely precise ergonomic lightweight magnetic hand controls, with the surgeon’s hands naturally positioned relative to his or her eyes, thereby minimizing strain during the surgeon’s movements. Using electronic hardware, software, algorithms and mechanics, our technology translates the surgeon’s hand movements into precise and corresponding real-time movements of the SSi Mantra instruments positioned through surgical ports going inside of the patient. When using the SSi Mantra 3, the surgeon is able to sit in an ergonomic position and can see both the specific positioning of his or her hands and feet, thereby reducing the learning curve and maintaining comfortable ~~ergonomics~~ ergonomics during the surgical procedure. The SSi Mantra is also equipped with a head-tracking camera safety feature that detects when the surgeon looks away from the 3D 4K monitor to help prevent inadvertent instrument movement. In addition, the SSi Mantra’s robotic arms hold the camera and instruments steady, offering greater stability for surgeons and operating room staff.

Patient-Side Robotic Arm Carts. The robotic arm carts are modular in design with robotic arms mounted on individual carts, each with a maximum height of 7.2 feet. The modular design offers the flexibility of cart and robotic arm positioning to provide better placement in relation to the procedure and avoid collisions. Further, there is the option of using three, four or five robotic arm configurations based on the users’ preference and specific surgical procedures. Each robotic arm cart includes stability via parking locks, freedom of patient docking and advanced touch-screen controls. Each robotic arm cart has a built-in auto-leveling feature which allows each individual arm cart to be perfectly horizontally level with respect to uneven floor surfaces that may be present in an operating room.

Vision Cart. The vision cart provides an additional 32-inch 3D 4K resolution monitor, identical to the surgeon’s console, for the operating room staff. While wearing the 3D glasses, the entire operating team can view what the surgeon sees with the same depth perception. This ability also helps in reducing the entire team’s learning curve and translates into a safer and more efficient exchange of instruments and introduction of supplies required in surgery. The vision cart also houses the control system for the articulating endoscope and camera and pre-operative guidance software. It has uninterruptible power supply battery backup,; universal safety features and incorporates an ~~Omni~~the ~~3DHD~~SSi Mantra multimedia recording and streaming platform.

Tele-Proctoring/Tele-Mentoring Capabilities. The SSi Mantra has a built-in live streaming platform, which provides for remote mentoring and proctoring, thereby resulting in efficient and cost-effective teaching and training capabilities.

Instruments and Accessories

We offer a comprehensive suite of stapling, energy and core instrumentation for our surgical systems, under the brand name of SSi Mudra.

Mudra Technology. The technology employed in our instruments is designed to transform the surgeon’s natural hand movements outside of the body into corresponding controlled movements inside the patient’s body, just as would be available to the surgeon in open surgery. With our technology, a surgeon can also use “motion scaling,” a feature that translates, for example, a three-centimeter hand movement outside the patient’s body into a one-centimeter instrument movement in the surgical field inside the patient’s body. Motion scaling is designed to allow precision and control for delicate tasks. In addition, the advanced software technology of the robotic system filters and eliminates any tremors that may be present in a surgeon’s hands.

Mudra Endo-surgical Instruments. ~~Most~~Over of40 ~~the more than 30~~ instruments that we manufacture ~~incorporate~~have ~~Mudra~~endo ~~technology~~wrist technology with ~~wristed~~7 ~~joints~~degrees of freedom for natural dexterity and tips customized for various surgical procedures. Mudra instruments are offered in an ~~8mm~~8.6 mm diameter. We recently completed the development of five new 5-millimeter surgical instruments for clinical use across multiple specialties, including pediatric, cardiac, and head and neck surgery, among other procedures involving smaller anatomical structures. Various Mudra instrument tips include forceps, scissors, electrocautery tools, scalpels and other surgical tools that are familiar to the surgeon from open surgery and conventional minimally invasive surgery (“MIS”). We have also developed and made available aover ~~variety~~20 of cardiac surgery specific instruments. A variety of instruments may be selected and used interchangeably during surgery. All instruments are sterilizable at the hospital, and ~~all~~most ~~are~~have ~~reusable for~~ a ~~defined~~minimum ~~number~~reusable lifecycle of ~~procedures~~10 uses.. A programmed memory chip inside each instrument performs several functions that help determine how the SSi Mantra and our instruments work together. In addition, the chip generally will not allow the instrument to be used for more than the prescribed number of procedures to help ensure that its performance meets specifications during each procedure.

Accessory Products. We sell various accessory products, which are used in conjunction with the SSi Mantra as surgical procedures are performed. Accessory products include sterile drapes used to help ensure a sterile field during surgery, vision products—such as replacement 3D stereo endoscopes, cannulas for the instruments and camera and special seals to prevent leakage of carbon dioxide gas used during a procedure.

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Tele proctoring and Telesurgery. We are the first surgical robotic company to have received a regulatory approval from CDSCO for both tele proctoring and telesurgery. Following the demonstration of our telesurgery capabilities at the SMRSC 2024, a global conference organized by the Company, we began our clinical trials that were conducted to validate this novel approach towards remote surgery. We first conducted two animal trials at a leading laparoscopy hospital in Delhi NCR region located five kilometers away from our telesurgery lab facility. Thereafter, we performed a simple robotic gall bladder removal (Cholecystectomy) to demonstrate safety and efficacy of our SSi Mantra system, when utilized in a remote setting. After this trial, SSi commenced clinical trials wherein six complex urology, oncology and gynecology procedures were performed at Rajiv Gandhi Cancer Institute at a distance of approximately 35 kilometers. We have successfully performed five robotic cardiac telesurgeries between our telesurgery lab in Gurugram and at a hospital in Jaipur located at a distance of approximately 286 kilometers, marking the world’s first accomplishment in the field of robotic cardiac surgery. In March 2025, we used the SSi Mantra 3 to perform robotic cardiac telesurgery over a 2,000 kilometer distance between SSi’s headquarters in Gurugram, and the Aster CMI Hospital in Bengaluru. In July 2025, we successfully completed the world’s first inter-continental robotic cardiac telesurgery on July 19, 2025, from Strasbourg, France to Indore, India, a distance of over 4,000 miles, using the SSi Mantra and the world’s first robotic bariatric telesurgery over a distance of 560 miles from Gurugram, India to Indore, India using the SSi Mantra. In September 2025, we announced the successful completion of the first robotic telesurgery performed from our MantraM bus mobile robotic telesurgery unit and the successful completion of the world’s first pediatric pyeloplasty telesurgery utilizing our SSi Mantra from our headquarters in Gurugram, India to a 16-month-old patient in Hyderabad, India nearly 1,000 miles away. As of the date of this prospectus, more than 120 telesurgeries have been performed, at distances of up to 6,000 miles, utilizing the SSi Mantra.

Instruments under Development

We also have a number of additional sophisticated instruments currently under development. These include:

NADI – Automated Coronary Anastomotic Connector. This instrument is a micro stapling device intended to join two arteries together in cardiac bypass procedures. We intend to offer the instrument in both robotic surgery and manual versions. The manual version is for use by cardiac surgeons who do not have a robotic system and can be utilized in an open or minimally invasive procedure.

SSi Multi-Fire Clip Applier. The SSi Multi-Fire Clip Applier is a cartridge-based clip applicator being developed to be utilized for the hemostasis of blood vessels. Use of such a device is a requirement during many surgical procedures. Currently, the clip applicators traditionally used in surgical procedures require withdrawal of the instrument after each clip is placed resulting in a time-consuming process. By providing a cartridge with multiple clips we believe the SSi Multi-Fire Clip Applier will allow for greater efficiency and time savings during surgical procedures.

SSi ~~Ultrasonic~~Robotic ~~Surgical Device~~Stapler. ~~The~~We ~~harmonic~~are in the process ~~scalpel~~of isfinalizing athe ~~surgical~~design ~~instrument~~and ~~being~~manufacturing ~~designed~~of toour ~~simultaneously~~SSI ~~cut~~Robotic Stapler that would have broad applications in General Surgery, Thoracic Surgery and ~~cauterize~~Oncology ~~tissue~~Surgery. ~~Ultrasonic~~Once ~~energy~~development isof ~~used~~the inSSi Robotic Stapler has been completed, SSI will be the ~~harmonic scalpel~~second ~~where~~company ~~ultrasonic~~globally ~~energy~~with isa ~~converted~~robotic tostapler ~~mechanical~~compatible ~~energy~~with atits ~~the~~robotic ~~active~~surgical ~~blade~~platform.

SSi Maya ~~– XR Pre-Operative Simulator~~. SSi Maya is aan ~~Mixed~~enabling ~~Reality~~digital platform ~~(XR)~~that ~~software~~compliments ~~application, being crafted to transform~~ the ~~educational~~SSI ~~paradigm~~Mantra ~~for~~system ~~surgeons~~ and enhances surgical ~~assistants.~~ ~~SSi~~capabilities ~~Maya~~with isMixed ~~specifically~~Reality ~~being~~(XR) ~~designed to train~~ and ~~educate~~AI ~~users~~enabled ontechnologies including the ~~intricacies of the SSi Mantra Surgical Robotic System. We intend SSi Maya to offer immersive and innovative pre-operative training.~~following:

● SSi ~~Holographic~~ ~~Anatomy~~Guru. ~~This~~SSi ~~product~~Guru is ana ~~advanced~~virtual ~~augmented~~tele ~~reality~~illustration ~~tool~~feature ~~being~~used ~~developed~~ for ~~the~~tele ~~purpose~~mentoring ofwith ~~visualizing~~the ~~anatomies, providing~~help ~~comprehensive~~of ~~patient~~a ~~education,~~portable ~~and~~3D ~~offering~~surgery ~~guidance for surgical procedures. This application will potentially present patients with three-dimensional DICOM data~~viewer, ~~enabling~~XR ~~them~~headset ~~to better understand~~ and ~~engage~~interactive ~~with~~virtual ~~their own health information~~screens.

● SSi ~~Yog~~XR –Cognitive ~~Tele~~Skill ~~Proctor~~Simulator. SSi ~~Yog introduces~~XR aCognitive ~~pioneering~~Skill ~~solution~~Simulator ~~for~~is ~~tele-proctoring.~~an Itextended isreality ~~designed~~(XR) ~~for~~software ~~remote~~platform ~~surgical~~developed ~~proctoring.~~to ~~This~~train ~~software~~and ~~seamlessly~~educate ~~integrates mixed~~surgeons ~~reality~~and ~~with~~surgical assistants in the application of the SSi Mantra. ~~Surgical~~The ~~Robotic~~system ~~System,~~combines ~~offering~~a ~~healthcare~~console-based ~~professionals~~interface ~~and~~with ~~surgeons~~VR-driven ~~unprecedented~~instructional ~~access~~modules tothat ~~real-time guidance~~provide ~~over~~instrument ~~long~~tracking ~~distances~~overlays and guided procedural workflows. ~~Notably,~~This ~~the~~integrated ~~application~~learning environment is ~~platform-agnostic~~designed to strengthen cognitive understanding, reinforce muscle memory, and ~~caters~~improve tomotor ~~both~~skills ~~open~~through repetitive, ~~laparoscopic~~structured practice, supporting immersive and ~~robotic~~innovative ~~surgeries~~pre-operative training. The simulator incorporates SSi’s AR Smart Glasses 3D Visualization System, ~~making~~ itdelivering ~~versatile~~3D ~~enough~~HD to1080p ~~address~~imaging ~~diverse~~with ~~surgical~~adjustable ~~scenarios~~interpupillary distance, direct endoscope video input, advanced signal processing, and IMU-based head tracking.

SSi ~~Chitrasa~~Holographic –Anatomy. ~~Advanced~~SSi ~~DICOM Viewer.~~Holographic ~~SSi~~Anatomy ~~Chitrasa~~ is ~~being~~an ~~designed~~advanced toaugmented ~~empower~~reality ~~robotic~~tool ~~surgeons~~being ~~with~~developed ~~unparalleled~~for ~~DICOM~~the ~~visualization~~purpose ~~capabilities.~~of Itvisualizing ~~includes~~anatomies, aproviding ~~state-of-the-art~~comprehensive patient AIeducation, ~~enabled~~and ~~application~~offering ~~viewer~~guidance ~~which~~for issurgical ~~seamlessly~~procedures. ~~integrated with the~~ SSi ~~Mantra~~Holographic ~~Surgical~~Anatomy ~~Robotic~~is ~~System~~being designed to ~~provide~~present ~~surgeons~~patients with ~~comprehensive~~three-dimensional ~~tools~~DICOM todata, ~~enhance~~enabling ~~their~~them ~~surgical~~to ~~confidence~~better understand and ~~precision~~engage inwith ~~the~~their ~~operating~~own ~~room~~health information.

SSi ~~Mixed~~ ~~Reality~~Chitrasa ~~Headset. The SSi Mixed Reality headset is a medical~~-~~grade~~ ~~device~~Advanced ~~that~~DICOM weViewer. ~~hope will revolutionize intraoperative experiences by seamlessly interfacing with the~~ SSi ~~Mantra~~Chitrasa ~~Surgical Robotic System. This device~~ is being designed to ~~offer~~empower robotic surgeons anwith ~~immersive 3D~~DICOM ~~endoscopic feed~~ visualization, ~~while~~capabilities. ~~interactable~~It ~~augmented~~includes ~~objects~~a ~~provide real~~state-~~time~~of-the-art ~~patient~~AI ~~vitals~~enabled ~~and~~application ~~data~~viewer ~~for~~which ~~enhanced~~is ~~surgical~~seamlessly ~~precision. The~~integrated ~~potentially~~with ~~seamless~~the ~~collaboration~~SSi ~~between~~Mantra to ~~these~~provide ~~technologies~~surgeons ~~creates~~with a comprehensive ~~surgical~~tools ~~platform,~~to ~~setting~~enhance atheir ~~new~~surgical ~~standard~~confidence ~~for intraoperative medical advancements~~ and ~~pushing~~precision in the ~~boundaries~~operating ~~of surgical excellence~~room. ~~Some salient features include:~~

●SSi ~~Peripheral~~Mixed Reality Headset. The SSi Mixed Reality Headset is a light-weight set of glasses with a magnified 3D view aimed at improving surgeons’ intraoperative experience by seamlessly interfacing with the SSi Mantra. This device is being designed to offer surgeons an immersive 3D endoscopic feed visualization, while interactable augmented objects provide real-time patient vitals and data for enhanced surgical precision. The collaboration between the SSi Mixed Reality Headset and SSi Mantra technologies will create a comprehensive surgical platform, setting a new standard for intraoperative medical advancements and pushing the boundaries of surgical excellence. Features include:

● ~~1080p~~Peripheral ~~resolution 3DHD vision~~view;

● ~~32-inch~~1080p ~~image~~resolution ~~projection~~3DHD ~~which allows for one meter depth perception~~vision;

● ~~Two~~32-inch ~~separate~~image ~~left~~projection ~~and~~which ~~right~~allows ~~eye~~for ~~video~~one ~~signals~~meter ~~projected~~depth ~~through an optical engine onto an opaque micro-LED screen~~perception;

● ~~Natural~~Two ~~reconstruction~~separate ofleft ~~the~~and 3Dright ~~image~~eye byvideo ~~the~~signals ~~human~~projected ~~brain~~through an optical engine onto an opaque micro-LED screen; and

34● Natural reconstruction of the 3D image by the human brain.

SSi MantraM. In March 2025, we unveiled our Mobile Tele-Surgical Unit, the “SSi MantraM” which is designed to offer access to remote robotically assisted surgical procedures, to geographic areas, which have only limited access to that level of healthcare.

SSi Mantra Tele Surgeon Console (TSC). The SSi Mantra Tele Surgeon Console (TSC) is a compact, self-contained telesurgery workstation designed to enable safe and effective remote surgical operation in environments with limited space. The TSC integrates a compact ergonomic chair with inbuilt electronics, magnetic sensor-based control systems, lightweight 3D viewing glasses, and a magnified three-dimensional view of the surgical field, while its portable, space-efficient design allows deployment in physician offices and other locations with small physical footprints.is a compact, self-contained telesurgery workstation designed to enable safe and effective remote surgical operation in environments with limited space. The TSC integrates a compact ergonomic chair with inbuilt electronics, magnetic sensor-based control systems, lightweight 3D viewing glasses, and a magnified three-dimensional view of the surgical field, while its portable, space-efficient design allows deployment in physician offices and other locations with small physical footprints.

Unlike conventional consoles where the surgeon sits opposing a stationary unit, the TSC features a “surgeon-within-the-console” design, integrating the surgeon directly into the station and offering extensive ergonomic adjustments, including foot pedal retraction and extension, console height adjustment, and fully configurable armrests, along with comprehensive back and neck support to maintain optimal posture and minimize fatigue during prolonged procedures. In October 2025, the first telesurgery using the TSC was successfully performed by Dr. Sudhir Srivastava from his residence in New Delhi, India, demonstrating the system’s portability, ergonomic effectiveness, and feasibility for remote surgical applications.

5mm Surgical Instruments. We recently completed the development of five new 5-millimeter surgical instruments for clinical use across multiple specialties, including pediatric, cardiac, and head and neck surgery, among other procedures involving smaller anatomical structures.

Services

General. We have a network of field service engineers in India and maintain relationships with various distributors around the globe. This infrastructure of service and support specialists offers a full complement of services for our customers, including installation, repair, maintenance, 24/7 technical support and proactive system health monitoring.

Our comprehensive support and program assistance helps ensure customers and care teams maximize program performance and protect their investment.

Readiness and Maintenance Support. Readiness support is operational support to ensure smooth onboarding and the adoption of new systems and technology. Maintenance support helps to maximize operational efficiency and reduce unplanned equipment downtime. It includes services care plans, support teams, monitoring, software upgrades and updates, as well as a customer portal. The service care plan portfolio offers flexible service plans to ensure reliability of the systems and instruments and help optimize the robotics program. ~~The~~Our support team consisting of expert field service, remote technical support and customer care agents assist customers to resolve and prevent any technology issues that could inhibit optimal utilization of our SSi Mantra system. Software upgrades and updates enable the latest product innovations, enhancements and reliability improvements.

Peer Review Papers

The following peer review papers have been published with respect to the SSi Mantra and our technology:

In a peer review paper entitled, “Initial experience of SSI Mantra robot-assisted transabdominal pre-peritoneal repair of primary ventral hernias” by Magan Mehrotra and Chukka Gautam Kumar published on July 30, 2024 in the Journal of Minimal Access Surgery, the authors describe their initial experience with robot-assisted transabdominal pre-peritoneal (rTAPP) repair of small- and medium-sized primary midline ventral hernias using the SSi Mantra.

In a peer review paper entitled, “Robotic uro-oncology applications of SSI Mantra robot” by Sudhir K. Rawal, Ashish Khanna, Amitabh Singh, Sarbartha K. Pratihar, Ishan Malla, Mujahid Ali, Vivek Vasudeo, Kaushik Jaganthan, Bhuvan Kumar, and Nikhil Saurabh published on April 19, 2024 in the Asian Journal of Urology, the authors report on their preliminary clinical experience with the SSi Mantra.

In a peer review paper entitled, “Safety and Efficacy of Robotic Hysterectomy Using the SSI Mantra Robotic System” by Gajbhiye et al. published in 2025 in the Cureus Journal of Medical Science, the authors evaluate the safety, feasibility, and peri-operative outcomes of robotic hysterectomy performed using the SSi Mantra.

In a peer review paper entitled, “Feasibility of One Anastomosis Gastric Bypass Using the SSI Mantra Robotic Platform” by Magan Mehrotra, Chukka Gautam Kumar and Nikhil Mehrotra published on September 16, 2024 in the Journal of Bariatric Surgery, the authors describe the first robotic one anastomosis gastric bypass (OAGB) performed using the SSI Mantra in a patient with severe obesity.

In a peer review paper entitled, “Real-world performance of the SSI Mantra™ robotic system: a multicentric multi-specialty study evaluating its safety and surgical applications” by Somashekhar S.P. (a director of the Company and member of our medical advisory board), Medha Sugara, Kushal Agrawal, Sudhir Kumar Rawal, Amitabh Singh, Magan Mehrotra, Raj Gajbhiye, Chandramohan Vaddi, Srikarthik Voleti, Leena Mehrotra, Ganesh Gorthi, Manjiri Somashekhar, and Nitin Kumar Rajput on December 23, 2025 in the Journal of Robotic Surgery, the authors evaluate the real-world safety, feasibility, and learning curves of the SSI Mantra across India.

Macro Healthcare Trends

Advances in surgical technology are making next-generation robotic systems increasingly versatile across a broad spectrum of procedures, at a time when demographic shifts, including an aging global population, are driving higher demand for surgical interventions and the disease burden from chronic and lifestyle-related conditions continues to rise. These trends are further compounded by workforce challenges, as healthcare systems face shortages of trained professionals, which robotic and digital technologies help address by reducing labor intensity per care episode. From an economic perspective, such systems improve value for both providers and payers through greater efficiency and optimized resource utilization. They also deliver meaningful patient benefits, including reduced surgical trauma, shorter recovery times, and improved clinical outcomes, while offering surgeons significant benefits through enhanced ergonomics, precision, and reduced fatigue. In addition, hospitals benefit from increased revenue potential, lower complication rates, shorter lengths of stay, and overall improved operational efficiency.

Increasing demand for healthcare: The increasing demand for healthcare in emerging markets such as India is driven by population growth and a growing middle class, rising per capita incomes, growing health insurance penetration and changing lifestyles.

These trends are increasingly resulting in patients demanding specialized, higher quality products and services that deliver better clinical outcomes, improved efficiency and an overall superior healthcare experience. According to the New Indian Express, India’s healthcare industry is expected to grow from $638 billion in 2025 to $1.5 trillion by 2030. This growth is supported by favorable demographics, with India continuing to benefit from a large working-age population. The proportion of the Indian population in the working age-group (15–64 years of age) is expected to reach 68.9% by 2030, with a median age of 28.4 years, according to www.dristiias.com. This demographic represents a sizeable consumer base with rising purchasing power and we believe is willing to spend on high-quality healthcare services.. Together, these factors create strong long-term demand fundamentals for advanced healthcare solutions and specialized medical technologies in India.

Growing adoption of technology: India has a large and growing unmet need for advanced surgical care. The country has an extensive healthcare delivery network with tens of thousands of hospitals (including public, private and multi-speciality institutions) performing a very high volume of procedures each year. According to recent industry data, over 30 million surgeries are performed annually in India across various specialties, reflecting the sheer scale of surgical demand in the country, while robotic surgery adoption remains a small but rapidly growing segment of this total surgical volume.

Although precise consolidated national figures on total robotic surgeries in India varies, recent reports indicate that India recorded more than 10,000 robotic assisted procedures in 2024 and industry associations estimate that up to 60,000 robotic-assisted surgeries are now performed annually by over 1,500 trained surgeons spanning general surgery, urology, oncology, gynaecology, cardiology, and other specialties. Recent market intelligence also shows that India has over 950 trained robotic surgeons and more than 180 installed robotic surgical systems across government and private hospitals, with growth expected to accelerate as more systems and training capacity come online.

Significant unmet need: Despite this growth, surgical robotic procedures represent only a small fraction of total surgical volumes in India nationwide, highlighting a significant unmet need for surgical robotic platforms that are affordable, accessible, and supported with strong aftermarket service networks across urban and non-urban centers. The established prevalence of laparoscopic surgery in India has created a large base of laparoscopic surgeons, many of whom are well-positioned to adopt surgical robotic systems as they seek technologies that can facilitate the transition from traditional laparoscopy to robot-assisted surgery, improve precision, reduce recovery times, and expand the scope of minimally invasive procedures.

Increasing health insurance penetration: Health insurance coverage is a critical determinant of access to and demand for healthcare services in India. Insurance penetration has expanded steadily over the last decade, primarily driven by public schemes and growing private insurance adoption. As of 2025, government-backed schemes led by Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (PM-JAY) have issued over 420 million health cards, making it the world’s largest public health insurance program. When combined with state government schemes and private insurance, a significant share of the population has some form of financial health protection, although household-level surveys indicate that coverage is not yet universal and remains uneven across income groups and states.

India has also made progress in reducing the financial burden on patients. Out-of-pocket expenditure (“OOPE”), which exceeded 60% of total health spending in 2014-2015, declined to approximately 39.4% in 2021-2022. This improvement reflects increased public health spending, wider insurance penetration, and expanded access to empanelled hospitals. Key enablers of this transformation include the National Health Mission, Ayushman Bharat, and the continued growth of medical value travel.

Medical value travel: India has emerged as one of the world’s leading destinations for medical value travel, attracting patients from Asia, Africa, the Middle East, and other markets. According to Mordor Intelligence, the Indian medical tourism market estimated at approximately $12.32 billion in 2026, is projected to grow to $22.1 billion by 2031, at a CAGR of 12.42% during the forecast period (2026-2031), supported by a strong pipeline of complex surgical procedures. Medical tourism has become an important growth driver for surgical volumes, including advanced minimally invasive and robotic procedures. Key factors underpinning this growth include significantly lower treatment costs compared to developed markets, availability of highly skilled doctors, advanced infrastructure in private hospitals, English language proficiency, and improving ease of travel. The Government of India has actively supported this segment through policy initiatives such as e-Medical visas, multiple-entry visas, and extended stay provisions for patients and caregivers.

Favorable regulatory environment: India’s healthcare sector continues to benefit from a supportive and evolving regulatory environment. Public health expenditure has increased steadily, with government policy reiterating a long-term target of raising public health spending toward 2.5% of GDP. The government has also committed substantial investments in healthcare and medical infrastructure over the past decade, alongside structural reforms under the Aatma Nirbhar Bharat Abhiyaan. To strengthen domestic manufacturing, the government introduced the Production-Linked Incentive (PLI) Scheme for Medical Devices, the Scheme for Promotion of Medical Device Parks, and is progressing toward PLI 2.0, including support for in-vitro diagnostics. These initiatives offer capital incentives, infrastructure support, and scale advantages, positioning India as an increasingly attractive hub for medical technology manufacturing and innovation.

Our Strategy

Our initial strategy is to focus on underserved markets, such as India, where market penetration for surgical robotic systems has in large part been limited because of the high costs of and steep learning curve for existing systems. After validating the SSi Mantra ~~Surgical Robotic System~~ in these markets, ~~which~~ we ~~believe we are currently accomplishing, we~~ intend to leverage ~~its~~our advanced technology, ~~significantly~~ significantly lower cost ~~(approximately one-third of the cost of existing systems)~~ and ease of training to move into other markets, such as the ~~United States~~U.S. and Europe. Key elements of this strategy include:

Focus on underserved markets. India, where our operations are based and where we have commercially launched the SSi Mantra, has a population of approximately 1.4 billion people, supported ~~and~~by an extensive network of roughly 70,000 hospitals. providing ~~However,~~diverse ~~only~~care ~~about~~across ~~0.1%~~urban ofand ~~global~~rural ~~robotic~~regions. ~~surgical~~Compared to ~~procedures~~the ~~are~~United ~~performed in~~States, ~~India.~~which Ashas aapproximately 6,000 ~~comparison~~hospitals, ~~there~~India’s ~~are~~healthcare ~~only~~infrastructure ~~approximately~~is ~~6,120~~far ~~hospitals~~larger in ~~the~~scale ~~U.S.~~but still Bydeveloping ~~offering~~in ~~our~~ advanced, ~~cost-effective~~surgical ~~SSi~~capabilities. ~~Mantra Surgical~~Despite ~~Robotic~~this ~~System~~scale, wethe ~~believe~~adoption ~~that~~of werobotic ~~can~~surgery ~~significantly~~in ~~penetrate~~India ~~the~~remains ~~Indian~~relatively ~~market,~~low. As asof ~~well~~2024, asIndia ~~other~~accounted ~~underserved~~for ~~markets~~approximately 6% inof the Asia,-Pacific robotic surgical systems market and reported over ~~Africa~~10,000 ~~Europe~~robotic-assisted surgeries in 2024 alone, ~~Central~~with over ~~and~~180 ~~South~~installed ~~America~~systems and ~~elsewhere~~more than 950 trained robotic surgeons supporting growth in major specialty centers.

~~Focus on~~Given ~~key~~this ~~institutions. Our marketing efforts are focused on large multi~~under-~~specialty~~penetration—surgical ~~care~~robotic procedures ~~hospitals~~comprise ~~where~~only a ~~majority~~small fraction of ~~complex~~overall surgical ~~procedures~~ ~~are~~volumes ~~performed.~~in ~~Following~~India ~~the~~despite ~~initial~~millions ~~placement~~of atannual aoperations. ~~given~~We ~~hospital,~~believe wethere is ~~intend~~significant toopportunity ~~expand~~for ~~the~~affordable, ~~number~~high-performance ofsystems ~~physicians~~like ~~who use~~ the SSi Mantra ~~Surgical~~to ~~Robotic~~expand ~~System~~access in underserved domestic markets and ~~work~~globally ~~with~~across Asia, ~~the~~Africa, ~~hospitals~~Europe, Central and ~~their~~South ~~surgeons~~America, toand ~~promote~~other ~~patient~~regions. ~~education~~The assurgical torobotics ~~the benefits and~~market ~~cost~~in ~~effectiveness~~India ofis ~~our~~projected ~~system.~~to Wegrow ~~believe~~robustly ~~that~~over ~~these~~the ~~efforts~~coming ~~will~~decade, ~~not~~driven ~~only~~by ~~result~~increasing indemand ~~both~~for ~~increased~~minimally ~~usage~~invasive ~~and~~procedures, ~~additional~~rising ~~sales of~~chronic ~~instruments~~disease prevalence, and ~~systems~~broader atcapability ~~hospitals~~adoption ~~that~~in ~~purchase~~tertiary ~~the~~care ~~system~~centers, ~~but~~yet ~~also~~accessibility ~~increased~~outside ~~demand~~of ~~from~~premier ~~competing~~institutions ~~hospitals, surgeons and other~~remains ~~physicians~~limited.

Focus on ~~Leading~~key ~~Surgeons~~institutions. toOur ~~Drive~~marketing efforts ~~Rapid~~are ~~and~~focused ~~Broad~~on ~~Adoption.~~large Wemulti-specialty ~~place~~care ~~significant~~hospitals ~~emphasis~~where onmost ~~marketing~~complex ~~the~~surgical ~~SSi~~procedures ~~Mantra~~are toperformed. ~~leading~~Following ~~surgeons~~the initial ~~who~~placement ~~are~~at ~~considered~~a togiven behospital, ~~the~~we ~~“thought~~intend ~~leaders”~~to inexpand ~~their~~the ~~institutions~~number ~~and~~of ~~fields.~~physicians Inwho ~~this~~use ~~regard,~~the weSSi ~~have~~Mantra ~~established~~and ~~both an~~work ~~Indian~~with ~~Medical~~the ~~Advisory~~hospitals ~~Board~~ and antheir surgeons ~~International~~to ~~Advisory~~promote ~~Board~~patient ~~consisting~~education ofas ~~leading~~to ~~surgeons~~the inbenefits ~~their~~and ~~respective~~cost ~~fields~~effectiveness of our system. We believe that ~~the~~these ~~participation~~efforts ofwill ~~these~~not only ~~surgeons~~result in ~~our~~both ~~product~~increased ~~development~~usage and ~~their~~additional ~~use~~sales of ~~the~~instruments ~~SSi~~and ~~Mantra~~systems ~~will~~at ~~generate~~hospitals ~~confidence~~that inpurchase ~~many other~~the ~~surgeons~~system, tobut ~~utilize~~also ~~the~~increased demand ~~system~~from ~~for~~competing ~~all~~hospitals, ~~types~~surgeons ofand ~~surgical~~other ~~procedures~~physicians.

~~Continued Development~~Focus on Leading Surgeons to Drive Rapid and Broad ~~Marketing~~Adoption. We ~~intend~~place significant emphasis on marketing the SSi Mantra to ~~continue~~leading ~~developing~~surgeons ~~and~~who ~~enhancing~~are ~~our~~“thought ~~technology~~leaders” in ~~and~~their ~~products~~institutions and tofields. ~~communicate~~In ~~the~~this ~~benefits~~ regard, we have established both an Indian Medical Advisory Board and ~~advantages~~an International Advisory Board consisting of ~~the~~leading ~~SSi~~surgeons ~~Mantra~~in ~~System~~their ~~(lower~~respective ~~cost,~~fields. ~~ease~~We ofbelieve ~~training~~that ~~and~~the ~~improved~~participation ~~patient~~of ~~outcomes)~~these surgeons in ~~India~~our product development and their use of the ~~other~~SSi ~~markets~~Mantra ~~we plan~~will generate confidence in many other surgeons to ~~enter~~utilize the system for all types of surgical procedures.

Evaluation, Familiarization and Training Agreements with Major Medical Facilities. We have and intend to continue entering into agreements with major medical facilities to install the SSi Mantra Surgical Robotic System for evaluation, familiarization and training purposes. As of December 31, 2023, we have entered into such agreements with approximately four hospital networks in India and with Johns Hopkins University in Baltimore, Maryland.39

35Continued Development and Marketing. We intend to continue developing and enhancing our technology and products and to communicate the benefits and advantages of the SSi Mantra (lower cost, ease of training and improved patient outcomes) in India and the other markets we plan to enter.

Evaluation, Familiarization and Training Agreements with Major Medical Facilities. We have and intend to continue entering into agreements with major medical facilities to install the SSi Mantra for evaluation, familiarization and training purposes. As of the date of this prospectus, we had entered into such agreements with approximately ten hospital networks in India and with Johns Hopkins University in Baltimore, Maryland.

National and International Medical Conferences. We have and intend to continue to participate in International and National Conferences hosted by nationally accredited and internationally acclaimed bodies to help both raise awareness about the SSi Mantra platform and provide surgeons with the opportunity to view our SSi Mantra system. Our first Global SMRSC (SSi Mantra Robotic Surgery Conference) that was hosted in January 2024, was attended by over 700 national and international faculty and our second Global SMRSC that was hosted in March 2025, was attended by over 1,400 participants and displayed the increased capabilities of the SSi Mantra 3, including the performance of telesurgery and the introduction of our mobile robotic surgical system. At both conferences, key opinion leaders from India and abroad were given a platform to discuss their experience with the SSi Mantra and foster discussions regarding the global potential of our cost-effective surgical robotic system.

Clinical Applications

The SSi Mantra has been clinically validated infor safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries in more than ~~fifty~~one hundred different types of surgical procedures in India without any device related adverse events. As of December 31, ~~2023~~2025, we have installed ~~twenty~~168 ~~one~~ systems, of which 154 are located in India, and 14 at overseas locations which have been used to perform more than ~~seven~~7,800 ~~hundred~~surgical procedures (compared to 2,759 cumulative surgical procedures as of December 31, 2024), including cardiovascular, thoracic, head and neck, gynecological, urological, cancer and general surgeries. We maintain productive collaborations with leading surgeons to explore and develop new techniques and applications for robotic-assisted surgery with the SSi Mantra. We primarily focus our development efforts on those procedures in which we believe our products bring the highest patient value, surgeon value and hospital value. Representative surgical applications are described below.

Cardiovascular Surgery

Internal Mammary Artery Dissection. In a coronary artery bypass graft procedure used in cardiac surgery, a blocked coronary artery is bypassed with a graft. When available, an artery from the chest called the internal mammary artery is dissected from its natural position and grafted into place to perform ~~the~~ the bypass. Because the internal mammary artery is located inferior to the anterior surface of the chest, dissection of the vessel is ~~challenging~~ challenging using existing surgical instruments through the three- to five-inch incision commonly used in a non-robotic coronary artery bypass graft procedure. Our products have multiple joints that emulate the surgeon’s shoulders and elbows, allowing exact positioning of the instruments inside the patient’s chest. In addition, our Mudra instrument joints isare designed to permit the surgeon to reach ~~behind~~ behind the tissues for easier dissection of the internal mammary artery. Thus, we believe that the internal mammary artery can be dissected ~~with~~ with greater ease and precision using the SSi Mantra ~~Surgical Robotic System~~.

Totally Endoscopic Coronary Artery Bypass Surgery (TECAB). Coronary artery bypass graft surgery demands that the surgeon delicately dissect and precisely suture very small structures, which are less than two millimeters in diameter, under significant magnification. These procedures are difficult when performed in open surgery. They are even more difficult when performed using a limited incision approach and can be challenging to perform when the heart is beating. As a result, this procedure is typically done as open surgery by stopping the heart and using a heart/lung bypass machine. The technology employed by the SSi Mantra is designed to allow surgeons to perform scaled instrument movements that can be even more precise than the movements used in open surgery, thus enabling precise suturing of single and multiple coronary vessels on a stopped or beating heart.

Mitral and Aortic Valve Repair/Replacement. Valve repair and replacement surgeries are challenging even when using open surgical techniques. Significant exposure of the surgical field is essential to the identification and precise manipulation of valves and other structures inside the heart and is key to successful surgical outcomes with minimal complications. Motion scaling allows a surgeon using the SSi Mantra to maneuver instruments inside the patient even more precisely than is possible in open surgery. The SSi Mantra has enabled heart valve repairs to be performed through small ports in a manner that could not have been accomplished with open surgery.

Thoracic Surgery

Conventional approaches to surgical procedures in the thorax include both open and video-assisted thoracoscopic approaches. Procedures performed via these methods include pulmonary wedge resection, pulmonary lobectomy, thymectomy, mediastinal mass excision and esophagectomy.

Head and Neck Surgery

Transoral Surgery. Head and neck cancers are typically treated by either surgical resection or chemo-radiation, or a combination of both. Surgical resection performed by an open approach may require a “jaw-splitting” mandibulotomy. This procedure, while effective in treating cancer, is potentially ~~traumatic~~ traumatic and disfiguring to the patient. Less invasive approaches via the mouth (transoral surgery) are challenged by line-of-sight ~~limitations~~ limitations dictated by conventional endoscopic tools. Chemo-radiation as a primary therapy ~~does~~allows ~~allow~~ patients to avoid traumatic surgical ~~incisions;~~ incisions however, ~~the~~medical literature suggests that this modality diminishes patients’ ability to speak and swallow normally. Robotically assisted transoral surgery allows ~~them~~surgeons to operate on tumors occurring in the oropharynx (i.e., tonsil and base of tongue) and larynx via the mouth and to overcome some of the line-of-sight limitations of conventional transoral surgery.

Gynecologic Surgery

Hysterectomy. Removal of the uterus is is one of the most commonly performed surgeries in gynecology and is performed for a variety of underlying benign and cancerous conditions. ~~Hysterectomies~~ Hysterectomies can be performed using open surgery or minimally invasive techniques, which include vaginal, laparoscopic, and robotic-assisted approaches. We believe that robotic-assisted surgery with the SSi Mantra provides patients with the opportunity to receive a minimally invasive treatment as an alternative to an open hysterectomy.

~~Sacrocolpopexy~~Sacro colpopexy. The abdominal (open) ~~sacrocolpopexy~~Sacro colpopexy is ~~one~~a type of ~~the~~operation ~~operations~~ performed to treat vaginal vault prolapse. ~~Sacrocolpopexy~~Sacro colpopexy involves suturing a synthetic mesh that connects ~~and~~ and supports the vagina to the sacrum (tailbone). A ~~sacrocolpopexy~~Sacro colpopexy can be performed using a conventional laparoscopic technique; however, it is often difficult and cumbersome to perform. Robotic assisted surgical capabilities enable a larger number of these procedures to be performed through a minimally invasive technique, conferring the benefits of ~~minimally~~MIS ~~invasive surgery~~ to a broader range of ~~sacrocolpopexy~~ Sacro colpopexy patients.

Urologic Surgery

Prostatectomy. Radical prostatectomy is the removal of the prostate gland and accompanying lymph nodes in patients diagnosed with clinically localized prostate cancer. The standard approach to the removal of the prostate ~~was~~is via an open surgical procedure. The conventional laparoscopic approach is ~~an option, but it is~~ difficult and poses challenges to even the most skilled urologist. The SSi Mantra will enable a larger number of surgeons to ~~convert~~ transition from ~~using an~~ open surgical techniques ~~technique~~ to a minimally invasive robotic surgical technique.

Partial Nephrectomy. Partial nephrectomy is the removal of a small portion of a kidney (typically, an area of the kidney containing a tumor). Partial nephrectomies are most commonly performed in patients diagnosed with clinically localized renal cancer. Excluding robotic-assisted surgery, there are three common surgical approaches to performing partial nephrectomies: open surgical technique, laparoscopy, and hand-assisted laparoscopy, which is a hybrid of ~~the~~ open surgery and laparoscopic techniques. Robotic assisted surgical capabilities may enable a large number of these procedures to be performed through a minimally invasive technique, conferring the benefits of ~~minimally~~MIS ~~invasive surgery~~ to a broader range of partial nephrectomy patients.

Radical Nephrectomy. A radical nephrectomy is a surgery to remove the entire kidney, typically done to treat kidney cancers and occasionally or other reasons. In some instances, the adrenal gland, and lymph nodes may be removed as well.41

~~Cystectomy~~Radical Nephrectomy. ~~Robotic-assisted~~Radical ~~cystectomy~~nephrectomy is a ~~minimally invasive bladder~~ surgery ~~with~~to remove the ~~same~~entire ~~cancer removal success as open surgery. During a robotic cystectomy~~kidney, ~~robotically trained~~typically ~~urology~~done ~~surgeons~~to ~~remove~~treat ~~the~~kidney ~~bladder~~cancers and ~~redirect~~occasionally ~~the~~or ~~urinary~~other ~~tract using a surgical robot~~reasons. AIn ~~robotic~~some ~~cystectomy is performed~~instances, ~~through a series of small keyhole-sized incisions across~~ the ~~abdomen,~~adrenal ~~which~~gland ~~is less painful, heals faster,~~ and ~~produces~~lymph ~~significantly less~~nodes ~~surface~~may ~~scarring~~be ~~than~~removed ~~the~~as ~~larger incision associated with open surgery~~well.

Cystectomy. Robotic-assisted cystectomy is a minimally invasive bladder surgery with the same cancer removal success as open surgery. During robotic cystectomy, robotically trained urology surgeons remove the bladder and redirect the urinary tract using a surgical robot. A robotic cystectomy is performed through a series of small keyhole-sized incisions across the abdomen, which is less painful, heals faster, and produces significantly less surface scarring than the larger incision associated with open surgery.

General Surgery

Hernia Repair. A hernia occurs when an organ or other tissue squeezes through a weak spot in a surrounding muscle or connective tissue. During a hernia repair surgery, the ~~weakened~~ weakened tissue is secured, and defects are repaired. Common types of hernias are ventral and inguinal. Ventral, or abdominal hernia, may occur through a scar after surgery in the abdomen. Inguinal hernia is a bulge in the groin and is more common in men.

Colorectal Surgery. These procedures typically involve benign or cancerous conditions of the lower digestive system, in particular the rectum or colon. Common procedures in this area include hemicolectomy, ~~sigmoidectomy~~sigmoidoscopy, low anterior resection and abdominoperineal resection.

Cholecystectomy. Cholecystectomy, or the surgical removal of the gall bladder, is a commonly performed general surgery procedure. Cholecystectomy is the primary method for the treatment of gallstones and other gall bladder diseases. Most cholecystectomies are performed using multi-port MIS techniques, ~~although~~ although some surgeons choose to perform ~~cholecystectomy~~cholecystectomies using manual single-port instrumentation.

The Global Robotic Surgery Market

General

~~The~~According ~~global~~to ~~surgical~~Markets ~~robotics~~and ~~market~~Markets ~~was~~research, ~~valued~~the atglobal ~~$8.78~~surgical ~~billion~~robots inmarket ~~2023, and~~ is projected to reach $3727.514 billion by ~~2032,~~2030 ~~growing~~from at$11.98 abillion ~~compound~~in ~~annual~~2024, ~~growth~~at ~~rate~~a (“CAGR”) of 1914.97% ~~from~~during ~~2023~~the forecast ~~to 2032~~period.1 Surgical robots offer significant advantages in ~~minimally~~MIS ~~invasive surgery~~ by enabling exceptionally precise manipulation of surgical instruments within constrained operation spaces, surpassing human capabilities. Robotic surgery is a procedure which involves a minimally invasive spectrum and represents an evolution in practice across numerous medical disciplines. Surgical robotics technology is used across various medical specialties, enabling surgeons to perform complex procedures through small incisions, resulting in reduced patient trauma, shorter recovery times, and enhanced patient outcomes.

1 https://www.expertmarketresearch.com/reports/surgical-robotics-market

Market Dynamics

Increase in demand and acceptance of laparoscopic or ~~minimally invasive surgery (“~~MIS”) due to the benefits to patients and surgeons, such as better screening, greater precision, shorter hospitalization, reduced pain and discomfort has fueled the growth in the global surgical robotics market. In addition, the surge in the number of gynecological, neurological and urological diseases is a primary factor driving the surgical robotics market growth.

In addition, surgical robotics enable minimally invasive procedures, which involve smaller incisions, reduced trauma to surrounding tissues, and quicker recovery times. Patients are increasingly seeking procedures that result in less pain and shorter hospital stays, and surgical robots fulfill these demands and the rise in adoption of minimally invasive procedures has fueled market growth.

Many surgical robotic systems incorporate advanced visualization technologies, such as high-definition 3D imaging and augmented reality. These technologies grant surgeons a clearer view of the surgical site, enhancing their ability to visualize complex anatomical structures and perform intricate tasks. The growth of the surgical robotics market is expected to be driven by the availability of improved healthcare infrastructure, increase in unmet healthcare needs, rise in prevalence of chronic diseases, and surge in demand for advanced surgical robotics products.

Furthermore, the increase in need for automation in the healthcare industry and the shifting trend towards advanced robotic surgeries fuels market growth. Moreover, untapped economies such as Brazil, India, China and other developing economies create a lucrative surgical robotics market opportunity.

The demand for surgical robotics is not only ~~limited~~ limited to developed countries such as the U.S. but is also being witnessed in the developing countries, such as China, and India, which ~~fuel~~ fuel the growth of the market. Factors such as the rise in the number of surgeries drive the adoption of robotic technologies across ~~different~~ different specialties, contributing to the robust growth of the surgical robotics market. For instance, according to the National Center for Biotechnology and Information (NCBI), in 2022, around 1,918,030 new cancer cases are projected to occur in the United States. In light of this projection, the number of cancer surgeries performed by the subspecialty of robotic oncology surgeons is also expected to increase drastically as well.

Furthermore, as the global population ages, we ~~expected~~expect that there will be a greater need for surgical interventions to address age-related health conditions which boosts market growth. Surgical robots assist surgeons in handling the complexities of these procedures, allowing for safer and more effective outcomes in elderly patients. Moreover, initially limited to specific procedures, robotic technologies are now being adapted for a broader spectrum of surgeries across various medical fields, including cardiac, neurology, urology, gynecology, and more. This versatility attracts hospitals and clinics ~~aiming~~to aim to offer comprehensive robotic surgical services which is expected to drive the market growth.

High initial costs associated with acquiring ~~and~~ and implementing robotic systems, including infrastructure and training, pose a financial challenge for many healthcare facilities which ~~may~~ may impede market growth. Regulatory complexities and concerns regarding patient safety, as well as the need for rigorous clinical validation of robotic procedures, slow down the adoption process. In addition, the intricate nature of surgical robotics necessitates specialized training for surgeons, potentially leading to a shortage of skilled professionals. These factors collectively ~~hinder~~have ~~the~~hindered ~~rapid~~ expansion of the surgical robotics market.

Segmental Overview

The surgical robotics industry is segmented into ~~component~~components, surgery type, and region. By component, the market is categorized into systems, accessories, and services. OnBased ~~the~~on ~~basis of~~ surgery type, the market is segregated into gynecology surgery, urology surgery, neurosurgery, orthopedic surgery, general surgery, and ~~other~~ other surgeries. Region wise, the market is analyzed across North America, Europe, Asia-Pacific, ~~and~~ Latin America, the Middle East and Africa (“LAMEA”).

By Component

With a consistently expanding installed base of of surgical robotic systems globally (i.e., Colombia, Ecuador, India, Indonesia, Iraq, Nepal, Oman, Philippines and the United Arab Emirates) and increasing utilization thereof, the accessories and services segment dominated the global surgical robotics market in 2022 and is expected to remain dominant throughout the forecast period, due to a ~~further~~ rise in the number of surgical robotics procedures performed with precision, accuracy, and improved patient outcomes, coupled with the increased adoption of surgical robotics technology. However, the systems segment is expected to register the highest CAGR during the forecast period, owing to a rise in technological advancements and an increase in demand for advanced robotic surgical systems.

By Surgery Type

The general surgery segment dominated the global surgical robotics market share in ~~2022~~2023 and is anticipated to continue this trend during the forecast period. This is attributed to versatility and effectiveness of surgical robotics in a wide range of general surgery procedures, increase in patient demand for minimally invasive surgeries, and ongoing advancements in technology.

By Region

The surgical robotics market size is analyzed across North America, Europe, Asia-Pacific, and LAMEA. North America accounted for a major share of the surgical robotics industry in ~~2022~~2024 in terms of the number of surgical robotic systems installed and is expected to maintain its dominance during the forecast period. In In addition, the presence of well-established healthcare infrastructure, high purchasing power, and rise in adoption rate of advanced ~~surgical~~ surgical robotics products are expected to drive the market growth. Furthermore, product ~~launch~~launches, collaborations, and acquisitions adopted by the key players in this region help to boost the growth of the market.

Asia-Pacific is expected to grow at the highest rate during the surgical robotics market forecast period. The market growth in this region is attributable to the growing industrial infrastructure, the rise in prevalence of chronic diseases, such as cancer and cardiovascular conditions which has driven the need for sophisticated surgical interventions, which surgical robotic systems can provide. Moreover, the increase in awareness and acceptance of minimally invasive procedures among patients in the Asia-Pacific region along with the benefits offered by surgical robotics further propels the market growth in this region.

India

Within the Asia-Pacific region, India stands out as the fastest-growing large economy and a critical growth engine for advanced healthcare technologies, including surgical robotics. Rising incomes, rapid urbanisation, demographic shifts, and a significant unmet need for high-quality tertiary care position India as a pivotal driver of regional healthcare expansion.

India’s healthcare sector has expanded rapidly over the past decade, growing from approximately $110 billion in 2016 to about $372 billion in 2023. Over the longer term, industry and policy projections indicate India’s healthcare market could approach $1.5 trillion by 2030, supported by sustained demand and structural reforms.

Healthcare spending in India, while increasing, remains below global averages. Over the next five years, healthcare spending as a percentage of GDP is expected to trend upward toward 5%, though it may still remain below many OECD and emerging-market peers.

According to Niti Aayog, it is estimated that 70% of the Indian population is covered under public or voluntary private health insurance. while the remaining 30% (approximately 400 million people) remain uninsured.. The India health insurance market in terms of gross written premiums was estimated at $15.06 billion in 2024 and is projected to grow at a CAGR of 20.9% from 2025 to 2030.

Despite strong growth, India continues to face structural gaps in healthcare infrastructure. The doctor-to-population ratio has improved to roughly 1:811, yet regional disparities persist, particularly in non-urban areas. These gaps are driving both public and private investment in hospital capacity, medical colleges, and advanced care facilities.

In 2026, hospital revenue growth of 16–18% is projected, supported by higher insurance-funded procedures, medical value travel, and increasing adoption of advanced technologies.

India’s healthcare ecosystem in 2025 was characterised by rapid market expansion, rising insurance penetration, declining out-of-pocket spending, and accelerating investment in infrastructure and technology. While capacity constraints remain, these structural trends strongly support the long-term growth of advanced healthcare solutions, including surgical robotics, positioning India as a central pillar of healthcare growth in the Asia-Pacific region.

Sales, Marketing and Customer Support

Sales Model

We provide our ~~products~~systems ~~through~~and related devices through a direct sales organization in India and, outside of India, through an expanding distributor network that, as of December 31, ~~2023~~2025, ~~includes distributors~~included distributors in Colombia, Ecuador, Guatemala, Indonesia, the Philippines, the United Arab Emirates, ~~and~~CIS ~~ten~~Countries, ~~other~~the ~~countries~~Baltic Region, Greece, Cyprus, Sri Lanka, Bangladesh, Nepal, Oman, Iraq, the West Indies, Mauritius, Madagascar, Seychelles, and Australia.

WeOur direct sales organization is composed of a capital sales team of ten individuals, who are ~~further~~responsible ~~expanding~~for selling systems, and a clinical support team of thirty individuals, which is responsible for supporting the systems used in procedures performed at our ~~domestic~~hospital ~~Indian~~accounts. Our hospital accounts include both individual hospitals and ~~foreign~~healthcare ~~distribution~~facilities ~~capabilities~~as ~~through~~well ~~the~~as ~~establishment~~hospitals and healthcare facilities that are part of ~~strategic~~an ~~partnerships~~integrated chain. InThe ~~December~~initial ~~2023,~~system sale weinto ~~entered~~an ~~into~~account is a ~~memorandum~~major capital equipment purchase by our customers and typically has a lengthy sales cycle that can be affected ofby ~~understanding~~evaluation ~~with~~periods, ~~Surgical~~macroeconomic ~~Lab~~factors, ~~Ltd.~~capital spending prioritization, athe ~~Cairo-based~~timing ~~medical~~of ~~device~~budgeting ~~distributor~~cycles and competitive bidding processes. Capital sales activities include educating surgeons, tophysicians ~~provide~~and ~~accessibility~~other ~~our~~hospital ~~SSi~~staff ~~Mantra~~across ~~Surgical Robotic~~multiple ~~System~~specialties ~~for~~on the benefits ~~entire~~of ~~African~~robotic-assisted ~~continent.~~surgery Inwith ~~January~~the ~~2024~~SSi Mantra, wetotal ~~reached~~treatment ancosts ~~agreement~~and inthe ~~principle~~clinical ~~for~~applications athat ~~strategic~~our ~~partnership~~technology ~~with~~enables. ~~India’s~~We ~~leading~~also ~~medical~~train ~~equipment~~our ~~supplier,~~sales ~~Medikabazaar,~~organization to ~~facilitate~~educate ~~sales~~hospital ofmanagement on the ~~SSi~~potential ~~Mantra~~benefits ~~Surgical~~of ~~Robotic~~adopting ~~System~~our tosystem, ~~hospitals~~including the clinical ~~and~~benefits ~~medical~~of ~~facilities~~robotic-assisted ~~across~~surgery ~~India~~with the SSi Mantra, such as improved patient outcomes.

Our direct sales organization is composed of a capital sales team of six individuals, which is responsible for selling systems, and a clinical support team of twenty individuals, which is responsible for supporting the systems used in procedures performed at our hospital accounts. Our hospital accounts include both individual hospitals and healthcare facilities as well as hospitals and healthcare facilities that are part of an integrated chain. The initial system sale into an account is a major capital equipment purchase by our customers and typically has a lengthy sales cycle that can be affected by evaluation periods, macroeconomic factors, capital spending prioritization, the timing of budgeting cycles and competitive bidding processes. Capital sales activities include educating surgeons, physicians and other hospital staff across multiple specialties on the benefits of robotic-assisted surgery with the SSi Mantra, total treatment costs and the clinical applications that our technology enables. We also train our sales organization to educate hospital management on the potential benefits of adopting our system, including the clinical benefits of robotic-assisted surgery with the SSi Mantra, such as improved patient outcomes.

Our clinical sales team works onsite at hospitals, interacting with surgeons and physicians, operating room staff and hospital administrators to develop and sustain successful robotic-assisted surgery. They assist the hospital in identifying surgeons or physicians who have an interest in robotic-assisted surgery and the potential benefits provided by the SSi Mantra. Our clinical sales team provides current clinical information on robotic-assisted surgery and new product applications to the hospital teams.

~~We offer our SSi Mantra through three selling models— outright purchase, purchase on a deferred or installment payment basis, and purchase on a pay per procedure basis.~~44

41We offer our SSi Mantra through three selling models— outright purchase, purchase on a deferred or installment payment basis, and purchase on a pay-per-procedure basis.

In cases where the systems are installed on a pay-per-procedure basis, the Company earns revenue share which is a mix of fixed and variable components. Variable components consist of revenue share which is agreed based on the number and type of procedures performed by the customer, while the fixed component involves an agreed amount which the customer is obliged to pay over the lease term. Accordingly, the fixed component is recognized on a straight-line basis as lease income. Since title for the system is not getting transferred to the customer, the cost relating to those systems is capitalized under property, plant and equipment and accordingly depreciation is charged over its period of useful life.

Our customers place orders to replenish their supplies of instruments and accessories on a regular basis. New direct customers who purchase a system typically place an initial stocking order of instruments and accessories soon after they receive their system.

To date, substantially all of our sales have ~~been~~ been in India, with one ~~initial~~ sale each in the United Arab Emirates, ~~where~~Ecuador, ~~the~~Iraq ~~SSi~~and ~~Mantra~~Nepal, ~~system~~and istwo ~~being~~sales ~~utilized~~in ~~for~~Colombia, ~~surgical~~Indonesia ~~team~~and ~~training prior to~~ the ~~commencement of clinical procedures~~Philippines.

Training and Customer Support

We also provide training for surgeons, physicians and staff on the operation and use of the ~~SSI~~SSi Mantra using a variety of training approaches. These include didactic modules training, hands on training, dry runs with the surgeons and their entire team, in-person proctored initial cases, on-site support for additional cases and remote proctoring support for complex cases. With respect to the sale of surgical robotic systems, training is provided at the time of delivery to the end customer, however the effort involved is considered negligible.

We have a network of field service and technical support engineers in India and are establishing relationships with various distributors around the globe where we intend to market and sell the SSi Mantra. This infrastructure of service and support specialists, along with advanced service tools and solutions, offers a full complement of services for our customers, including installation, repair, maintenance, 24/7 technical support and proactive system health monitoring.

Research and Development

We focus our research and development efforts on enhancing and improving our products and services with a view to fulfilling our vision that the benefits of advanced robotic surgery should be cost-effective and available to everyone. Through ingenuity and intelligent technology, we believe that we can expand the potential of physicians to heal without constraints due to both cost and accessibility of these technologies. We employ engineering and research and development staff ~~to focus on delivering future innovations~~ and ~~sustaining~~currently ~~improvements~~have ~~that~~a ~~advance our mission. In certain instances, we complement our~~ research and development ~~effort~~team ~~through~~of ~~collaborations~~73 ~~with~~employees ~~other~~to ~~companies~~focus oron ~~organizations~~delivering ~~such~~future asinnovations ~~our arrangement~~and ~~with~~sustaining ~~Johns~~improvements ~~Hopkins~~that ~~University~~advance our mission.

Manufacturing

Our systems and instruments are manufactured by by our employees at our 51approximately 75,~~100~~000 square-foot facility in ~~Gurgaon~~Gurugram, Delhi NCR, India. Our facility currently operates with a production capacity of 20 systems per month across multiple shifts. The manufacturing of our products is a complex operation involving a number of separate processes and components.

We purchase both custom and off-the-shelf components from a large number of suppliers from both within India and overseas and subject them to stringent quality specifications, inspections, and processes. Some of the components necessary for the assembly of our products are currently provided to us by sole-sourced suppliers (the only recognized supply source available to us) or single-sourced suppliers (the only approved supply source for us among other sources). We believe, however, that alternative suppliers are available if it should become necessary, although no assurance can be given that we could secure such alternative sources of supply, if required, on commercially reasonable terms or without undue operational disruption.

We purchase the majority of our components and major assemblies through purchase orders rather than long-term supply agreements and generally do not maintain large volumes of finished goods relative to our anticipated demand.

ASubject ~~portion~~to ofreceipt ~~the net proceeds~~ of ~~this~~necessary ~~Offering~~financing, we ~~will~~plan ~~be used~~ to expand our in-house manufacturing capacity in order to meet anticipated increases in demand and to reduce our reliance on third-party suppliers.

Competition

We face competition in the forms of existing ~~open~~ open surgery, conventional MIS, drug therapies, radiation treatment and other emerging diagnostic and interventional surgical approaches. ~~Our~~ Our success depends on continued clinical and technical innovation, quality and reliability, as well as educating hospitals, surgeons ~~and~~ and patients on the demonstrated results associated with robotic-assisted medical procedures using ~~our~~the SSi Mantra ~~Surgical Robotic System~~ and its efficacy and cost-effectiveness relative to other techniques.

42We compete with a number of U.S. and foreign companies that have developed and currently manufacture and market products in the field of robotic-assisted medical procedures, including but not limited to: Intuitive Surgical, Inc.; Asensus Surgical, Inc.; avateramedical GmbH; CMR Surgical Ltd.; Johnson & Johnson; Medicaroid Corporation; Medrobotics Corporation; Medtronic plc; meerecompany Inc.; Olympus Corporation; Samsung Electronics Co., Ltd.; Shandong Weigao Group Medical Polymer Company Ltd.; Shanghai Microport Medbot (Group) Co., Ltd.; and Titan Medical Inc. Most, if not all of these companies have longer operating histories and greater financial resources than SSi. In addition, other companies with substantial experience in industrial robotics could potentially expand into the field of medical robotics and become competitors.

We compete with a number of U.S. and foreign companies that have developed and currently manufacture and market products in the field of robotic-assisted medical procedures, including but not limited to: Intuitive Surgical, Inc.; Asensus Surgical, Inc.; avateramedical GmbH; CMR Surgical Ltd.; Johnson & Johnson; Medicaroid Corporation; Medrobotics Corporation; Medtronic plc; meerecompany Inc.; Olympus Corporation; Samsung Electronics Co., Ltd; Shandong Weigao Group Medical Polymer Company Ltd.; Shanghai Microport Medbot (Group) Co., Ltd.; and Titan Medical Inc. Most, if not all of these companies have longer operating histories and greater financial resources than SSi. In addition, other companies with substantial experience in industrial robotics could potentially expand into the field of medical robotics and become competitors.

Our failure to compete effectively with these existing and potential competitors could adversely affect our results of operations, business and prospects.

Intellectual Property

We place considerable importance on obtaining and maintaining patent, copyright, and trademark protection for our technologies, products and processes.

We generally rely upon a combination of intellectual property laws, confidentiality procedures and contractual provisions to protect our proprietary technology. For example, we have patents and trademarks, both registered and unregistered, that provide distinctive identification of our products in the marketplace.

As of ~~December~~the ~~31,~~date ~~2023~~of this prospectus, our intellectual ~~property~~ property portfolio consists of ~~fifty-eight~~6 ~~filed~~granted utility patents and ~~twenty-seven~~74 ~~granted~~pending utility ~~patents~~patent applications, and 8 PCT international WIPO applications as follows:

Country

Utility Patent(s)

Granted

Pending

Granted

Total

Country

No. of Patents

Earliest Expiration

Latest Expiration

No. of Patents

Earliest Expiration

Latest Expiration

Product

India

Europe

February 8, 2043

December 1, 2043

MANTRA

WIPO

Europe

June 9, 2043

MAYA

USA

India

January 28, 2042

March 11, 2044

March 3, 2042

July 1, 2045

MANTRA

Europe

India

March 31, 2043

November 10, 2043

MANTRA & MAYA

South Korea

India

June 10, 2042

July 27, 2043

MAYA

Japan

India

October 5, 2041

August 23, 2045

MUDRA

China

USA

January 28, 2043

December 27, 2044

MANTRA

Singapore, Hong Kong, and Taiwan

USA

July 15, 2044

MANTRA & MAYA

Total Utility Patents

USA

June 9, 2043

MAYA

USA

November 4, 2042

MUDRA

Japan

November 1, 2043

December 27, 2044

MANTRA

Japan

July 15, 2044

MANTRA & MAYA

Korea

November 9, 2043

December 27, 2044

MANTRA

Korea

July 15, 2044

MANTRA & MAYA

Singapore

September 19, 2044

December 27, 2044

MANTRA

Singapore

July 15, 2044

MANTRA & MAYA

Australia

October 20, 2043

December 27, 2044

MANTRA

Australia

July 15, 2044

MANTRA & MAYA

Israel

September 19, 2044

December 27, 2044

MANTRA

Israel

July 15, 2044

MANTRA & MAYA

BRAZIL

February 8, 2043

December 27, 2044

MANTRA

BRAZIL

July 15, 2044

MANTRA & MAYA

INDONESIA

October 20, 2043

November 9, 2043

MANTRA

INDONESIA

June 9, 2043

MAYA

Total

~~Further, our intellectual property portfolio also consists of eleven pending design patents and thirty-two granted design patents as follows:~~46

Country	Design Patent(s)
	Pending		Granted		Total
India		11		23		34
Europe		--		01		01
South Korea		--		01		01
Japan		--		01		01
China		--		06		06
Total Design Patents		11		32		43

Further, our intellectual property portfolio also consists of 8 PCT international WIPO applications as follows:

In addition, we have filed forty-two applications for trademark registrations in India of which twenty-two have been granted. We have also filed two copyright applications , both of which have been granted.

Granted

Pending

Country

No. of
Patents

Earliest
Expiration

Latest
Expiration

No. of
Patents

Earliest
Expiration

Latest
Expiration

Product

WIPO

August 18, 2026

December 29, 2026

MANTRA

WIPO

February 27, 2026

MAYA

WIPO

October 31, 2025

June 10, 2026

MANTRA & MAYA

Total

WeFurther, ~~intend~~our tointellectual ~~apply~~property ~~for~~portfolio ~~additional~~also consists of 31 granted design patents inand ~~various~~3 ~~jurisdictions.~~pending design patent applications as follows:

Notwithstanding the foregoing, we cannot be certain as to the scope of protection that the patents granted will afford our technology and products, nor can we be certain that any pending or future patent applications will be granted. Furthermore, if any protection we obtain is reduced or eliminated, others could use our intellectual property without compensating us, resulting in harm to our business. In addition, others may assert that our products infringe on their intellectual property rights, which may cause us to engage in costly disputes and, if we are not successful in defending ourselves, could also cause us to pay substantial damages and prohibit us from selling our products.

Granted

Pending

Country

No. of
Patents

Earliest
Expiration

Latest
Expiration

No. of
Patents

Earliest
Expiration

Latest
Expiration

Product

India

January 31, 2033

September 27, 2034

December 20, 2033

MANTRA

India

August 29, 2033

January 20, 2035

October 25, 2034

March 17, 2035

MUDRA

Total

In addition, we have filed 96 applications for trademark registrations in India of which 44 have been registered. Further, we have filed 21 applications for trademark registrations through both Madrid and direct foreign filings of which 9 have been registered.

We have also filed two copyright applications, both of which have been granted.

We intend to apply for additional utility patents, designs and trademarks in various jurisdictions.

Notwithstanding the foregoing, we cannot be certain as to the scope of protection that the patents granted will afford our technology and systems and related devices, nor can we be certain that any pending or future patent applications will be granted. Furthermore, if any protection we obtain is reduced or eliminated, others could use our intellectual property without compensating us, resulting in harm to our business. In addition, others may assert that our systems and related devices infringe on their intellectual property rights, which may cause us to engage in costly disputes and, if we are not successful in defending ourselves, could also cause us to pay substantial damages and prohibit us from selling our systems and related devices.

None of our patents and patent applications are licensed to or from third parties.

Government Regulation

General

Our ~~products~~systems and ~~operations~~related devices and operations are subject to regulation in India by the ~~Central Drugs Standard Control Organization (the “~~CDSCO”), by the FDA in the U.S. and by similar agencies in other countries and regions in which we market or plan to market our products. In addition, our products must meet the requirements of a large and growing body of international standards, which govern the design, manufacture, materials content and sourcing, testing, certification, packaging, installation, use and disposal of our ~~products~~systems and related devices. We must continually keep abreast of these regulations, standards and requirements and integrate our compliance into the development and regulatory documentation for our ~~products~~systems and related devices. Failure to meet these standards could limit our ability to market our ~~products~~systems and related devices in those regions that require compliance with such standards. Examples of standards to which we are subject include ISO 13485, an internationally recognized quality management system for the design, development and manufacture of medical devices.

ISO 13485 Quality Management System

ISO 13485 is an internationally recognized quality management system for the design, development and manufacture of medical devices. It sets out the requirements for a quality management system specific to the medical device industry. This standard is designed to be used by manufacturers ~~and end-users~~ throughout the life cycle of a medical device. We are required to meet this standard to register our ~~products~~systems and related devices for sale globally and are subject to rigorous annual reassessment and audit procedures.

Our Company has developed ana Harmonized ISO 13485 QMS system in line with EN ISO 13485 and 21 CFR 820, for compliance with U.S. and EU quality management systems requirements.

We received ISO 13485 certifications in 2021,. During the course of 2024, we conducted a recertification audit from EU Notified Body for EN ISO 13485 and ~~have~~ISO ~~successfully~~13485 ~~completed~~and ~~two~~we ~~surveillance~~received ~~audits~~the certification in Q4 of 2024.

India Regulation

In the past. Medical devices in India had been mostly unregulated ~~for~~, ~~a long time~~ but that has changed in recent years, with the adoption of rules and regulations designed to improve and enhance patient safety. Our ~~products~~systems and related devices are primarily regulated under the ~~Indian Medical Device Rules, 2017, as amended by the Medical Device (Amendment) Rules, 2020 (as amended, the “~~IMDR”) promulgated and administered by the CDSCO. These rules cover various aspects of medical device related regulations, including classification, registration, manufacturing and import, labeling, sales, and post-market requirements. Similar to rules in the EU, ~~they~~these regulations mandate that devices ~~are~~be safe and perform their intended function.

Based on intended use of the device, the risks associated with the device and other parameters referred to in the IMDR, the Central Licensing Authority of India classifies Medical Devices into four risk classes: A (low risk); B (low moderate risk); C (moderate high risk); and D (high risk).

The CDSCO has further divided the device classifications into 24 panels, where our surgical robotic system is classified as a Class B device pertaining to operating room procedures. This license has been updated to Class C to be in line with the international classification System.

We currently have CDSCO approval for the manufacture, sale and distribution of our ~~products~~systems and related devices under Class C including the Telesurgery approvals and a license to export our systems ~~products~~and related devices from India.

In December 2024 we became the first company in India to receive CDSCO regulatory approval for telesurgery and tele proctoring capabilities of a surgical robotic system.

U.S. Regulation

Our ~~products~~systems and related devices will be subject to regulation as medical devices in the ~~United~~U.S. ~~States~~ under the ~~Federal Food, Drug, and Cosmetic Act (“~~FFDCA”), as implemented and enforced by the FDA. The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, installation, recordkeeping, complaint and adverse event reporting, clearance, approval, certification, promotion, marketing, export, import, distribution and service of medical devices in the U.S. to ensure that medical devices distributed domestically are safe and effective for their intended uses.

We ~~have~~ filed a pre-submission application with the U.S. FDA, requesting feedback on the SSi Mantra. ~~Surgical~~We ~~Robotic~~had ~~System~~a feedback meeting with the FDA on April 2, 2024. The pre-submission meeting (Reference number Q240119) was organized with the FDA to seek interactive feedback from the FDA regarding the regulatory strategy, biocompatibility assessment, reprocessing validation, and weclinical ~~received~~data. ~~acknowledgment~~While ofFDA acknowledged that certain similarities exist between the ~~filing~~SSi onMantra and ~~January~~the 17proposed predicate device(s), ~~2024~~the recommendation was to proceed with a de novo review instead of the 510(k) route.

Under the ~~FFDCA~~FDA’s regulatory scheme, medical devices are classified into one of three classes—Class I, Class II or Class III—, depending on the degree of risk associated with each medical device and the extent of control needed to ensure safety and effectiveness. We believe that our current SSi Mantra ~~Surgical Robotic System and~~system ~~other~~and ~~products~~related devices will be classified as Class II medical devices.

44The de novo classification process under the FFDCA provides a pathway for certain new types of devices to obtain marketing authorization as class I or class II devices, rather than remaining automatically designated as a class III device, which would require premarket approval.

Class II medical devices are those that are subject to general controls, and most require premarket demonstration of adherence to certain performance standards, as specified by the FDA, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These special controls can include performance standards, post-market surveillance, patient registries and FDA guidance documents.

~~Manufacturers~~Based ofon ~~most~~further ~~Class~~discussions IIwith ~~devices~~the ~~are~~FDA, ~~required~~in toAugust ~~submit~~2025, to the ~~FDA~~company pivoted from filing a ~~premarket~~de ~~notification~~novo ~~under~~request ~~Section~~for the SSi Mantra to pursuing the 510(k) ofregulatory ~~the~~pathway ~~FFDCA~~which ~~requesting~~offers potential ~~authorization~~speed toand ~~commercially~~cost ~~distribute~~advantages ~~the~~We successfully completed a human factors validation study for our SSi Mantra system at Johns ~~device.~~Hopkins ~~The~~Hospital ~~FDA’s~~in ~~authorization~~September to2025. ~~commercially~~On ~~distribute~~December a5, ~~device~~2025, ~~subject~~we tosubmitted a 510(k) premarket notification isto ~~generally~~the ~~known as~~FDA ~~510(k)~~for ~~clearance.~~the ~~Our~~SSi ~~current~~Mantra ~~products~~surgical robotic ~~are~~system ~~expected~~for tomultiple bespecialty ~~subject~~procedure totypes, ~~premarket~~including: ~~notification~~general, urological, colorectal, gynecological, and ~~clearance~~cardiac ~~under~~surgery. We ~~section~~have engaged RQM+, a leading MedTech-focused CRO, to assist with the 510(k) ofsubmission. If approved by the FDA, the SSi Mantra would be cleared to market in the ~~FFDCA~~U.S. ToSubmission ~~obtain~~of a 510(k) ~~clearance,~~premarket notification request does not guarantee FDA approval. We believe that we ~~must~~will ~~submit~~be able to ~~the~~secure FDA acertification ~~premarket~~in ~~notification~~2026. ~~submission~~However, ~~demonstrating~~there ~~that~~can ~~the~~be ~~proposed device~~no isassurance ~~“substantially~~as ~~equivalent”~~ to awhen ~~legally~~or ~~marketed~~if ~~predicate~~we ~~device~~will secure such regulatory approval.

The FDA may require additional information, including clinical data, to make a determination regarding substantial equivalence. In addition, the FDA collects user fees for certain medical device submissions and annual fees for medical device establishments.48

IfThe ~~the~~ FDA ~~agrees~~generally ~~that~~reviews ~~the~~a ~~device~~510(k) ispremarket ~~substantially~~notification ~~equivalent~~submission towithin a90 ~~predicate~~calendar ~~device,~~days itof ~~will~~receipt; ~~grant~~however, ~~clearance~~in topractice, ~~commercially~~review ~~market~~timelines ~~the~~may ~~device~~extend inif ~~the~~additional ~~U.S.~~information ~~The~~is ~~FDA has a statutory ninety-day~~requested. ~~(90-day)~~During ~~period~~the toreview, ~~respond~~the toFDA amay ~~510(k)~~issue ~~submission;~~requests ~~however,~~for asadditional adata ~~practical~~or ~~matter,~~clarification ~~clearance~~to ~~often~~determine ~~takes~~whether ~~longer.~~the ~~The~~subject ~~FDA~~device ~~may~~is ~~require~~substantially ~~further~~equivalent ~~information, including clinical data,~~ to ~~make~~ a ~~determination~~legally ~~regarding~~marketed ~~substantial~~predicate ~~equivalence~~device. If the FDA determines that the device, ~~or its intended use,~~ is not “substantially equivalent” (NSE) to a predicate device, the ~~device~~product may be ~~designated~~considered as a ~~Class III~~novel device. ~~The~~that ~~device~~does ~~sponsor~~not ~~must~~qualify ~~proceed~~for ~~with and fulfill~~ the ~~requirements of the more rigorous requirements of the premarket approval~~ 510(~~“PMA”~~k) ~~process~~pathway. orIn ~~can~~such ~~request~~cases, ~~a risk-based classification determination for~~ the ~~device~~sponsor inmay ~~accordance with~~ pursue the de novo classification ~~pathway,~~process ~~which~~for ~~is a route~~ low-to-moderate-risk ~~market~~devices ~~for~~or, ~~novel~~if ~~medical~~the ~~devices~~device ~~that~~presents ~~are~~a ~~low~~higher ~~to moderate~~ risk, ~~and~~proceed ~~are~~with ~~not substantially equivalent to~~ a ~~predicate~~PMA ~~device~~application.

The PMA process is more demanding ~~than~~and ~~the 510(k)~~requires ~~premarket~~a ~~notification~~full ~~process~~evaluation of clinical trial data and extensive documentation. In a PMA application, the manufacturer must demonstrate that the device is safe and effective, and the PMA application must be supported by extensive data, including data from preclinical studies and human clinical trials. The FDA, by statute and regulation, has 180 days to review a PMA application, although the review more often occurs over a significantly longer period of time and can take up to several years. In approving a PMA application or clearing a ~~510(k)~~de ~~submission~~novo classification request under Class II, the FDA may also require ~~some~~ additional manufacturing controls, design control activities and approvals, as well as specific post-market surveillance requirements when necessary to protect the public health or to provide additional safety and effectiveness data for the device. In such cases, the manufacturer might be required to follow certain patient groups for a number of years and make periodic reports to the FDA on the clinical status of those patients.

Clinical trials are almost always required to support a PMA and are sometimes required to support a ~~510(k)~~de ~~submission~~novo classification request. All clinical investigations designed to determine the safety and effectiveness of a medical device must be conducted in accordance with the FDA’s investigational device exemption (“IDE”) regulations, which govern investigational device labeling, prohibit the promotion of the investigational device and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. Regardless of the degree of risk presented by the medical device, clinical studies must be approved by, and conducted under the oversight of, an Institutional Review Board (“IRB”) for each clinical site. During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, trial monitoring, selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping and prohibitions on the promotion of ~~investigational~~investigation devices or on making safety or effectiveness claims for them. The clinical investigators in the clinical study are also subject to the FDA’s regulations and must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control the disposition of the investigational device and comply with all reporting and recordkeeping requirements. Additionally, after a trial begins, we, the FDA, or the IRB could suspend or terminate a clinical trial at any time for various reasons, including a belief that the risks to ~~study~~ studying subjects outweigh the anticipated benefits.

After a device receives ~~510(k)~~premarket ~~clearance~~authorization from the FDA, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification in its intended use, will require a new 510(k) clearance or, depending on the modification, PMA approval or de novo classification. ~~The~~ The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k), de novo classification or a a PMA in the first instance, but the FDA can review any such decision and disagree with athe manufacturer’s determination. If the ~~FDA~~ FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified device until 510(k) marketing clearance, approval of a PMA or issuance of a de novo classification. Also, in these circumstances, the manufacturer may be subject to significant regulatory fines or penalties.

45In addition, the FDA may place significant limitations upon the intended use of our systems and related devices as a condition of granting marketing authorization. Moreover, after a device is placed on the market, numerous FDA and other regulatory requirements continue to apply. These requirements include establishment registration and device listing with the FDA; compliance with medical device reporting regulations, which require that manufacturers report to the FDA if their device has caused or contributed, or may have caused or contributed, to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur; compliance with corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FFDCA that may present a risk to health; the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device. In addition, the FDA and the Federal Trade Commission also regulate the advertising and promotion of our systems and related devices to ensure that any claims we make are consistent with our regulatory clearances, that there is scientific data to substantiate the claims and that our advertising is neither false nor misleading. In general, we may not promote or advertise our systems and related devices for uses not within the scope of our intended use statement in our clearances or make unsupported safety and effectiveness claims.

In addition, the FDA may place significant limitations upon the intended use of our products as a condition of granting marketing authorization. Moreover, after a device is placed on the market, numerous FDA and other regulatory requirements continue to apply. These requirements include establishment registration and device listing with the FDA; compliance with medical device reporting regulations, which require that manufacturers report to the FDA if their device caused or contributed, or may have caused or contributed, to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur; compliance with corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FFDCA that may present a risk to health; the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device. In addition, the FDA and the Federal Trade Commission also regulate the advertising and promotion of our products to ensure that the claims we make are consistent with our regulatory clearances, that there is scientific data to substantiate the claims and that our advertising is neither false nor misleading. In general, we may not promote or advertise our products for uses not within the scope of our intended use statement in our clearances or make unsupported safety and effectiveness claims.49

In ~~the U.S.~~addition, ~~our manufacturing processes will be required to comply with~~ the ~~Quality~~FDA ~~System~~collects ~~Regulation~~user ~~(“QSR”).~~fees ~~The QSR covers, among other things, the methods used in, and the facilities and controls used~~ for, ~~the design, testing, controlling, documenting, manufacture, packaging, labeling, storage,~~certain ~~installation and servicing of all~~ medical ~~devices~~device ~~intended~~submissions ~~for human use. The QSR also requires maintenance of extensive records, which demonstrate compliance with the FDA regulations, the manufacturer’s own procedures, specifications~~ and ~~testing,~~annual asfees ~~well as distribution and post-market experience. Compliance with the QSR is necessary~~ for amedical ~~manufacturer~~device ~~to be able to continue to market cleared or approved product offerings in the U~~establishments.S. A company’s facilities, records and manufacturing processes are subject to periodic scheduled or unscheduled inspections by the FDA. Failure to maintain compliance with applicable QSR requirements could result in the shut-down of, or restrictions on, manufacturing operations and the recall or seizure of marketed products. If the FDA determines that a manufacturer has failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:

In the U.S., our manufacturing processes will be required to comply with the Quality System Regulation (“QSR”). The QSR covers, among other things, the methods used in, and the facilities and controls used for, the design, testing, controlling, documenting, manufacture, packaging, labeling, storage, installation and servicing of all medical devices intended for human use. The QSR also requires maintenance of extensive records, which demonstrate compliance with the FDA regulations, the manufacturer’s own procedures, specifications and testing, as well as distribution and post-market experience. Compliance with the QSR is necessary for a manufacturer to be able to continue to market cleared or approved product offerings in the U.S. A company’s facilities, records and manufacturing processes are subject to periodically scheduled or unscheduled inspections by the FDA. Failure to maintain compliance with applicable QSR requirements could result in the shutdown of, or restrictions on, manufacturing operations and the recall or seizure of marketed products. If the FDA determines that a manufacturer has failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:

●

warning letters, untitled letters, fines, injunctions, consent decrees, administrative penalties, and civil or criminal penalties;

● recalls, withdrawals, or administrative detention or seizure of our ~~products~~systems and related devices;

●

operating restrictions or partial suspension or total shutdown of production;

● refusing or delaying requests for 510(k) marketing clearance or PMA approvals of new ~~products~~ or modified ~~products~~systems or devices;

●

withdrawing 510(k) clearances or PMA approvals that have already been granted;

● refusal to grant export approvals for our ~~products~~systems and related devices; or

●

criminal prosecution.

In addition, the discovery of previously unknown problems with any marketed ~~products~~systems and related devices, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.

Products manufactured outside of the U.S. by or for us are subject to U.S. Customs and FDA inspection upon entry into the U.S. We must demonstrate compliance of such products with U.S. regulations and carefully document the eventual distribution or re-exportation of such products. Failure to comply with all applicable regulations could prevent us from having access to products or components critical to the manufacture of finished products and lead to shortages and delays.

European Union Regulation

In the ~~European Union (the “~~EU”), all medical devices placed on the EU market must meet the essential requirements (“Essential Requirements”), including the requirement that a medical device must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients or the safety and health of users and others. In addition, the device must achieve the performance intended by the manufacturer and be designed, manufactured and packaged in a suitable manner.

All medical devices are currently regulated by Regulation (EU) No 2017/745 (the “EU Medical Devices Regulation” or the “MDR”), which became effective on May 26, 2021 and replaced the former regulatory framework set forth in Council Directive 93/42/EEC (the “MDD”).

We have submitted our technical file to Szutest, an EU Notified body for CE certification, which if approved will allow us to market the SSi Mantra in the EU. We expect to receive a scheduled audit in the second quarter of 2025 and CE marking by the end of 2025. Szutest may require us to perform additional clinical trials, which if required will be conducted under the guidance of EU MDR regulation. There can be no assurance that we will receive CE certification.

The MDR was adopted with the aim of ensuring better protection of public health and patient safety. The MDR establishes a uniform, transparent, predictable and sustainable regulatory framework across the EU for medical devices and ensures a high level of safety and health while supporting innovation. Unlike directives, regulations are directly applicable in EU member states without the need for member states to implement them into national law. This aims to increase harmonization across the EU member states.

The MDR requires that, before placing a device on the market, other than a custom-made device, manufacturers (as well as other economic operators, such as authorized representatives and importers) must register by submitting identification information to the EUDAMED electronic system, which is in the process of being implemented. The information to be submitted by manufacturers (and authorized representatives) also includes the name, address and contact details of the person or persons responsible for regulatory compliance. The MDR also requires that, before placing a device on the market, other than a custom-made device, manufacturers must assign a unique identifier to the device and provide it along with other core data to the unique device identifier (“UDI”) database.

All manufacturers placing medical devices on ~~the~~ the market in the EU must comply with the EU medical device vigilance system. Under this system, serious incidents and Field Safety Corrective Actions (“FSCAs”) must be reported to the relevant authorities of EU member states. These reports are to be submitted through EUDAMED (once fully functional) and aim to ensure that, in addition to reporting to the relevant authorities of the EU member states, other actors, such as the economic operators in the supply chain, will also be informed. Until EUDAMED is fully functional, the corresponding provisions of the MDD continue to apply. Manufacturers are required to take FSCAs, which are defined as any corrective ~~action~~ action for technical or medical reasons to prevent or reduce athe risk of a serious incident associated with the use of a medical device ~~that~~ that is made available on the market.

The advertising and promotion of medical devices is subject to some general principles set forth in EU legislation. According to the MDR, only devices that are ~~CE (~~Conformité Européene (“CE”) marked may be marketed and advertised in the EU in accordance with their intended purpose. Directive 2006/114/EC ~~concerning~~ concerning misleading and comparative advertising and Directive 2005/29/EC on unfair commercial practices, while not specific to the advertising of medical devices, also apply to the advertising thereof and contain general rules, such as, for example, requiring that advertisements are evidenced, balanced and not misleading. Specific requirements are defined at a national level. EU member states’ laws related to the advertising and promotion of medical devices, which vary between jurisdictions, may limit or restrict the advertising and promotion of products to the general public and may impose limitations on promotional activities with healthcare professionals.

47Many EU member states have adopted specific anti-gift statutes that further limit commercial practices for medical devices, in particular vis-à-vis healthcare professionals and organizations. Additionally, there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities and many EU member states have adopted national “Sunshine Acts,” which impose reporting and transparency requirements (often on an annual basis), similar to the requirements in the U.S., on medical device manufacturers. Certain EU member states also mandate implementation of commercial compliance programs.

Many EU member states have adopted specific anti-gift statutes that further limit commercial practices for medical devices, in particular vis-à-vis healthcare professionals and organizations. Additionally, there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities and many EU member states have adopted national “Sunshine Acts,” which impose reporting and transparency requirements (often on an annual basis), similar to the requirements in the United States, on medical device manufacturers. Certain EU member states also mandate implementation of commercial compliance programs.

In the EU, regulatory authorities have the power to carry out announced and, if necessary, unannounced inspections of companies, as well as of suppliers and/or sub-contractors and, where necessary, the facilities of professional users. Failure to comply with the applicable regulatory requirements could require time and resources to respond to the regulatory authorities’ observations and to implement corrective and preventive actions, as appropriate. Regulatory authorities have broad compliance and enforcement powers and, if such issues cannot be resolved to their satisfaction, can take a variety of actions, including untitled or warning letters, fines, consent decrees, injunctions, or civil or criminal penalties.

The aforementioned EU rules are generally applicable in the ~~European Economic Area (“~~EEA”), which consists of the twenty-seven EU member states, as well as Iceland, Liechtenstein and Norway.

Other countries

Regulations in other countries, including the requirements for approvals, certification or clearance and the time required for regulatory review, vary from country to country. Certain countries, such as South Korea, Brazil, Australia and Canada, have their own regulatory agencies. These countries typically require regulatory approvals and compliance with extensive safety and quality system regulations included in the Medical Device Single Audit Program that we will be required to comply with on an ongoing basis. ~~Failure~~We tohave ~~obtain~~partnered ~~regulatory~~with ~~approval~~a inMDSAP-Recognized ~~any~~Auditing ~~foreign~~Organization, ~~country~~TUV-SUD ~~in which we plan~~ to ~~market our products or failure to comply with any regulation in any foreign country in which we market our products may negatively~~obtain ~~impact~~MDSAP ~~our ability to generate revenue and harm our business~~certification.

InFailure addition, local regulations may apply, which govern the use of our products and which could have an adverse effect on our product utilization if they are unfavorable. All such regulations are revised from time to ~~time~~obtain ~~and,~~regulatory inapproval ~~general, are increasing~~ in ~~complexity~~any ~~and~~foreign country in ~~the~~which ~~scope~~we ~~and~~plan ~~degree~~to ofmarket ~~documentation~~our ~~and~~systems ~~testing required. There can be no assurance that the outcomes from such documentation~~ and ~~testing~~related ~~will~~devices ~~be acceptable to any particular regulatory agency~~ or ~~will~~failure ~~continue~~ to becomply ~~acceptable~~with ~~over~~any ~~time.~~regulation ~~There~~in ~~are~~any ~~further~~foreign ~~regulations~~country ~~governing the importation, marketing, sale, distribution,~~in ~~use,~~which ~~and~~we ~~service~~market asour ~~well~~systems ~~as the removal~~ and ~~disposal~~related ~~of medical~~ devices inmay ~~the~~negatively ~~regions~~impact inon ~~which we operate and market~~ our ~~products.~~ability ~~Failure~~ to ~~comply~~generate ~~with~~revenue ~~any of these regulations could result in sanctions or fines~~ and ~~could~~harm ~~prevent us from marketing~~ our ~~products in these regions~~business.

~~Our ISO~~In ~~13485~~addition, ~~(quality~~local ~~management~~regulations ~~system)~~may ~~approval~~apply, ~~CDSCO~~which govern ~~approval~~the ~~for~~use ~~the~~of ~~manufacture,~~our ~~sale~~systems and ~~distribution~~related ofdevices, and which could have an adverse effect on our ~~products,~~product ~~and~~utilization ~~Indian~~if they are unfavorable. ~~export~~All ~~license~~such ~~allow~~regulations usare torevised ~~market~~from ~~our~~time ~~products~~to time and, in ~~fifty~~general, ~~(50)~~are ~~non-FDA~~increasing in complexity and ~~non~~in CEthe ~~(EU)~~scope ~~countries~~and ~~without~~degree ~~further~~of ~~regulatory~~documentation ~~approvals~~ and intesting anrequired. ~~additional~~There ~~seventy-nine~~can ~~(79)~~be ~~countries~~no ~~require~~assurance ~~only~~that ~~minimal~~the ~~registration.~~outcomes Wefrom ~~have~~such ~~received~~documentation ~~regulatory~~and ~~approval~~testing will be acceptable to any particular ~~market~~regulatory ~~and~~agency ~~sell~~or ~~our~~will ~~products~~continue into be acceptable over time. There are further regulations governing the ~~United~~importation, ~~Arab~~marketing, ~~Emirates~~sale, distribution, use, and ~~Guatemala~~service ~~and~~as ~~have~~well ~~initiated~~as the ~~regulatory~~removal ~~approval~~and ~~process,~~disposal ~~which~~of ifmedical ~~successful, will~~devices ~~allow~~in usthe toregions in which we operate and market our systems ~~products~~and inrelated ~~more~~devices. ~~than~~Failure ~~fifty~~to ~~(50)~~comply ~~countries~~with ~~within~~any ~~approximately~~of ~~one~~these ~~year.~~regulations ~~However,~~could ~~there~~result ~~can~~in besanctions ~~no assurance~~or asfines toand ~~when~~could weprevent ~~will~~us ~~secure~~from marketing ~~any~~our ~~such~~systems ~~regulatory~~and ~~approvals,~~related ifdevices atin ~~all~~these regions.

Our ISO 13485 (quality management system) approval, CDSCO approval for the manufacture, sale and distribution of our systems and related devices and our Indian export license allows us to market our systems and related devices in fifty (50) non-FDA and non-CE (EU) countries without further regulatory approvals and in an additional seventy-nine (79) countries which require only minimal registration. We have received regulatory approval to market and sell our systems and related devices in Colombia, Ecuador, Guatemala, Indonesia, Kenya, Oman, Philippines, Sri Lanka, Ukraine, and the United Arab Emirates and have initiated the regulatory approval process, in many other countries, which if successful, will allow us to market our systems and related devices in more than fifty (50) countries within approximately one year. However, there can be no assurance as to when or if we will secure any such regulatory approvals.

Data Privacy and Security Laws

Numerous state, federal, and foreign laws, regulations, and standards govern the collection, use, access to, confidentiality, and security of health-related and other personal information and could apply now or in the future to our operations or the operations of our partners. In the U.S., numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws and consumer protection laws and regulations govern the collection, use, disclosure, and protection of health-related and other personal information. In addition, certain foreign laws govern the privacy and security of personal data, including health-related data. Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.

We collect, process, share, disclose, transfer, and otherwise use data, some of which contains personal information about identifiable individuals including, but not limited to, our employees, clinical trial participants, partners, and vendors. Therefore, if we commence marketing our ~~products~~systems inand related devices in the U.S., the EU and other countries, we will be subject to U.S. (federal, state and local) and international laws and regulations, including those in the EEA regarding data privacy and security and our use of such data.

4852

If we market our products in the EU, we will be be subject to the ~~European Union General Data Protection Regulation 2016/679 and applicable national supplementing laws (collectively, the “~~GDPR”). The GDPR imposes comprehensive data privacy compliance obligations in relation to our collection, processing, sharing, disclosure, transfer and other use of data relating to an identifiable living individual or “personal data,” including a principle of accountability and the obligation to demonstrate compliance through policies, procedures, training, and audits.

The GDPR also regulates cross-border transfers of personal data out of the EEA. Recent legal developments in Europe have created complexity and uncertainty regarding such transfers, in particular in relation to transfers to the ~~United States~~U.S.

Cybersecurity

In the normal course of business, we may collect and store personal information and other sensitive information, including proprietary and confidential business information, trade secrets, intellectual property, patient information, sensitive third-party information and employee information. To protect this information, our existing cybersecurity policies require continuous monitoring and detection programs, network security precautions, encryption of critical data and in-depth security assessments of vendors. We maintain various protections designed to safeguard against cyberattacks, including firewalls and virus detection software. We have established and regularly test our disaster recovery plan, and we protect against business interruption by backing up our major systems. In addition, we periodically scan our environment for any vulnerabilities, perform penetration testing and engage third parties to assess the effectiveness of our data security practices.

Cybersecurity Governance

We are in the process of implementing a cybersecurity governance and risk management framework. We consider cybersecurity risk as part of our overall enterprise risk management and are developing policies, procedures, and controls to identify, assess, and manage cybersecurity and information technology risks.

Our management team, including IT leadership, is responsible for overseeing cybersecurity risk management and for implementing our cybersecurity program. Management provides updates to senior leadership on cybersecurity matters, including the status of implementation efforts and any identified cybersecurity risks or incidents.

We monitor cybersecurity risks on an ongoing basis and intend to establish regular internal reporting processes as our cybersecurity program matures. Management may also engage external cybersecurity consultants and service providers to support the implementation, monitoring, and improvement of cybersecurity controls.

As part of our ongoing implementation efforts, we plan to obtain relevant cybersecurity and information security certifications and to enhance our capabilities to prevent, detect, mitigate, and respond to cybersecurity incidents. However, our cybersecurity program is still under development, and there can be no assurance that these measures will be fully implemented in a timely manner or will be effective in preventing all cybersecurity incidents.

Employees

As of December 31, ~~2023~~2025, we had ~~214~~476 employees, ~~121~~203 of whom were engaged in manufacturing ~~and service~~, 30123 in marketing, sales, clinical support and ~~sales~~field service, 1077 in research and development, 22 12in sourcing, 4 in ~~Quality~~quality control and 41 47 in administration. Most of our employees are based at our facility in Gurgaon, Delhi NCR, India. We generally consider our relationship with our employees to be good.

Facilities

We lease approximately 5175,~~100~~000 square feet in ~~Gurgaon~~Gurugram, Delhi NCR, India, which serves as our headquarters as well as our manufacturing facility. The facility, spread over ~~two~~three floors, is leased pursuant to a nine-year lease expiring in March 2030 for ~~one~~the third floor, ~~and~~ another ~~four~~nine-year lease expiring in May 2032 for the ~~other~~ground floor and another six-year lease expiring in July 2030 for the first floor. ~~Both~~ All the leases are further renewable under similar mutually agreed terms. Following completion of this ~~Offering~~offering, using the proceeds therefrom, we expect to lease additional space or build our own facility to increase our additional manufacturing capacity in anticipation of increased sales volumes. ~~We intend to use a portion of the net proceeds from this Offering in that regard.~~

Legal Proceedings

~~Currently~~In ~~there~~2014, ~~are~~Avra noSurgical ~~legal~~Robotics, ~~proceedings~~Inc., ~~pending~~a Delaware orcorporation ~~threatened~~(“Avra ~~against~~Surgical”), usof which Barry F. ~~However~~ Cohen, ~~from~~our ~~time~~Chief toOperating ~~time,~~Officer we– ~~may~~Americas ~~become~~and ~~involved~~a indirector, was ~~various~~Chief ~~lawsuits~~Executive Officer, a director and a principal shareholder, had a dispute with Quinn Emmanuel Urquhart & Sullivan LLP (“Quinn Emmanuel”) over legal ~~proceedings~~fees allegedly due to Quinn Emmanuel. Avra Surgical, which ~~arise~~was seeking to develop a robotic surgery system using certain technology developed in ~~the~~Germany ~~ordinary~~by ~~course~~then ofhad ~~business~~ceased operations. ~~Litigation~~ isThese ~~subject~~events occurred prior to ~~inherent~~our ~~uncertainties~~formation as Avra Medical Robotics, Inc. Other than the facts that both Avra Surgical and anwe ~~adverse~~shared ~~result~~the inAvra ~~any~~name ~~such~~and ~~matter~~that ~~may~~Mr. Cohen was an officer, director and ~~harm~~principal ~~our~~shareholder ~~business~~of both companies, there was no relationship between the two companies.

49On May 26, 2020, Quinn Emmanuel filed a petition in the Supreme Court of the State of New York, New York County against Avra Surgical, the Company (then known as Avra Medical Robotics, Inc.), Barry F. Cohen, Jared B. Stamell, an attorney affiliated with Avra Surgical, and various individuals who at that time were or had been affiliated with Avra Surgical and or us (collectively, “Respondents”). The petition sought to recover the legal fees from the Respondents on the basis that they were “alter egos” of Avra Surgical.

~~Management’s Discussion and Analysis of Financial Condition and Results of Operations~~53

~~The~~As ~~following~~we ~~discussion~~and ofMr. ~~our~~Cohen ~~financial condition~~never ~~and~~received ~~results~~notice of ~~operations should be read in conjunction with our financial statements and related notes included elsewhere~~the infiling ~~this~~of ~~prospectus.~~the ~~This~~petition ~~discussion~~or ~~contains~~of ~~certain~~subsequent ~~forward-looking~~proceedings ~~statements~~(although ~~that~~Quinn ~~involve~~Emmanuel ~~risk~~filed ~~and~~affidavits ~~uncertainties.~~with ~~Our~~the ~~actual~~court ~~results may~~stating ~~differ materially from those discussed below. Factors~~ that ~~could~~they ~~cause~~had ~~or contribute to such differences include, but are not limited~~been ~~to,~~duly ~~those identified below and those set forth under the section titled “Risk Factors~~served),~~” and~~ ~~other~~neither ~~documents~~ we ~~file~~nor ~~with the SEC~~Mr. ~~Historical~~Cohen ~~results~~entered ~~are~~an ~~not~~appearance ~~necessarily~~in ~~indicative~~the ~~of future results~~matter.

In early 2024, we learned from a third party that in November 2020, the court had rendered a decision holding that we and Messrs. Cohen and Stamell were “alter egos” of Avra Surgical and therefore were liable for payment of the Quinn Emmanuel legal fees. In addition, we also learned that in December 2023, the court ordered the entry of a judgment against Avra Surgical, us and Messrs. Cohen and Stamell in the amount of $296,000 plus interest from November 2020.

In 2023, Mr. Stamell appealed the judgement against him on the basis that Quinn Emmanuel had not presented any evidence to support the finding that Mr. Stamell was an alter ego of Avra Surgical or that Avra Surgical had transferred any assets to us. The Appellate Division, First Department ruled in favor of Mr. Stamell and in December 2024 entered an order vacating the judgment against him.

As a result of the foregoing, in April 2025, Quinn Emmanuel moved to sever Mr. Stamell from the case and for judgement to be reentered against Avra Surgical, Mr. Cohen and us. That motion was granted on July 22, 2025. In addition, in June 2025, Quinn Emmanuel moved on an ex parte basis to authorize service on Mr. Cohen and us by email to Mr. Cohen’s email or text to his cell phone. In connection therewith, Quinn Emmanuel alleged that Mr. Cohen and we had made efforts to evade service. That motion was granted on July 1, 2025. Quinn Emmanuel entered a revised judgment against Avra Surgical, Mr. Cohen and us on November 13, 2025. We are not aware of any efforts Quinn Emmanuel has undertaken to enforce the judgment since that time.

Notwithstanding the foregoing, Mr. Cohen and us have entered into an indemnification agreement, pursuant to which Mr. Cohen has agreed to fully indemnify us for any damages and costs (including legal fees) we incur in connection with the action.

In April 2024, an ex-shareholder of Otto Pvt Ltd., an indirect wholly owned Bahamian subsidiary of SSi (“Otto”) commenced litigation in the Bahamas, seeking legal confirmation that it holds 9,000 shares (approximately a 9% interest) in Otto. The litigation, in which Otto is one of the defendants, relates to a purported transaction in 2021, at which time Dr. Sudhir Srivastava, our Chairman, Chief Executive Officer and principal shareholder, was the sole shareholder of Otto. The plaintiff in the litigation alleges that at that time, it acquired the 9,000 Otto shares from Dr. Srivastava. However, as the plaintiff failed to pay the agreed upon consideration for the shares, in July 2022, the shareholding was cancelled. Dr. Srivastava along with Otto, has recently filed an action in the Bahamas to confirm the cancellation of the shares and reconfirm their ownership and both actions are pending in the Bahamian courts. The Bahamian court has issued an interim order to maintain the status quo as it stands today with respect to the 9,000 Otto shares at the center of the dispute, as well as Otto’s shareholdings in SSI-India, our Indian operating subsidiary and SSI-India’s assets during the pendency of the litigation. Based on legal opinions obtained from counsel, we believe that there will be a favorable outcome in this case.

Notwithstanding the foregoing, we have entered into an Indemnification Agreement with Dr. Srivastava on October 12, 2024, pursuant to which Dr. Srivastava has agreed to fully indemnify us for any claims, damages and costs (including legal fees) which we incur in connection with this litigation or in relation to any of his ventures prior to consummation of our acquisition by merger of CardioVentures, Inc. in April 2023.

Other than the foregoing, there are no legal proceedings currently pending or threatened against us. However, from time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in any such matter may harm our business.

Management’s Discussion and Analysis of

Financial Condition and Results of Operations

The following discussion of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes included elsewhere in this prospectus. This discussion contains certain forward-looking statements that involve risk and uncertainties. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those set forth under the section titled “Risk Factors,” and other documents we file with the SEC. Historical results are not necessarily indicative of future results.

Results of Operations

Introduction

The Company is engaged in the business of developing, manufacturing, and selling a surgical robotic system under our proprietary brand “~~SSI~~SSi Mantra,” together with ~~allied~~related accessories and a wide range of surgical instruments capable of supporting cardiac and a variety of other surgical procedures under our proprietary brand “SSi Mudra”. Having commenced commercial sales of our surgical robotic system in the second half of 2022, the year 2023 was our first full year of commercial sales ~~of our surgical robotic system~~ and ~~its~~during ~~allied~~the ~~instruments~~year ~~and accessories. Accordingly~~2024, ~~the~~we ~~operating~~further ~~results~~consolidated ~~detailed~~our ~~below~~installed ~~largely~~base ~~reflect~~of ~~the~~SSi ~~impact~~Mantra ofin ~~the~~various ~~consummation~~parts of ~~the~~India ~~CardioVentures~~and ~~Merger~~also inexpanded ~~April~~our ~~2023,~~presence ~~when~~in ~~compared with operating results for~~ the ~~corresponding period~~global ~~in 2022~~markets.

Our financial performance is largely driven by increasing awareness of the benefits of robotically assisted surgery, reduced learning curves for robotic surgeons and the affordability and accessibility of ~~this~~surgical ~~treatment~~robotic technology. Our financial performance is also dependent on our obtaining regulatory approvals in various regulated markets where we have plans to sell our products. Robotically assisted surgeries are increasingly being recognized as as an approved treatment modality from an insurance coverage perspective.

Our manufacturing operations being based in India derive significant operating cost advantages in terms of availability of quality and cost-effective fabrication/3D printing solutions, electronic/electrical/mechanical components, outsourced services and skilled manpower. All these factors help us in having lower costs of production which eventually helps us make our surgical robotic system cost effective and relatively affordable.

AsDuring ofthe three-month period ended September 30, ~~2023~~2025, we ~~had~~ sold 28 surgical robotic systems, compared to a total of 55 ~~twelve surgical robotic~~ systems ~~and~~sold during the nine-month ~~months~~ period ~~ending~~ended ~~Sept~~ September 30, ~~2023~~2025, weand 47 ~~sold nine~~ systems. Insold ~~addition~~during tothe ~~this,~~year weended ~~also~~2024. ~~installed~~In ~~one system in each of two hospitals~~addition, ~~belonging~~during tothe ~~a well~~three-~~known~~month ~~group~~period ofended ~~hospitals~~September in30, ~~India~~2025, we installed one system on a pay-per-use basis. and one Assystem ~~these systems~~ on a ~~pay-per-use basis~~demonstration were installed towards the latter part of the nine month period ending September 2023, there was no revenue recognized from these two installations as not many procedures had been performed as of the end of the periodbasis.

Results of Operations

~~Nine months ended September 30, 2023, as compared to Nine months ended September 30, 2022~~Introduction

~~Revenues.~~The Wefinancial ~~had~~statements ~~revenues~~appearing ofelsewhere ~~$4.5 million~~in ~~for~~this ~~the~~prospectus ~~nine~~have ~~months~~been ~~ended~~prepared ~~September~~assuming ~~30,~~that ~~2023~~we ~~(comprising~~will ofcontinue ~~$4.4~~as ~~million~~a ofgoing ~~system sales revenue and $0~~concern.1 ~~million~~We ofare ~~warranty~~still ~~sales), as~~in ~~compared~~our toinitial $0years ~~for~~of ~~the nine months ended September 30, 2022. This increase in~~ revenue ~~was~~generation by ~~due~~way toof the sale of ~~nine~~our ~~surgical~~product ~~robotic systems~~and ~~during~~have ~~this~~not ~~nine-month~~yet ~~period~~established ~~ended~~consistent ~~September~~operational ~~30,~~revenue ~~2023~~cash ~~whereas~~flows ~~there~~to ~~were~~meet noall ~~sales~~our infixed ~~the~~operating costs ~~corresponding~~and ~~period~~hence ~~the~~may ~~prior~~continue ~~year. Due~~ to ~~application~~incur oflosses ~~ASC606,~~for assome ~~of September 30, 2023, the sum of $1~~time.3 ~~million~~These ~~stands~~conditions ~~transferred~~raise tosubstantial ~~unrealized~~doubt ~~deferred~~about ~~revenue~~our ~~and due~~ability to ~~this~~continue ~~adjustment, the revenues, and gross and net profitability for the nine-month) period ended September 30, 2023 is reflected~~as ~~less~~a togoing ~~the extent of this unrealized deferred revenue~~concern.

5055

~~Salaries,~~The ~~Payroll~~following ~~and~~tables ~~Compensation~~provide ~~Expense. We~~selected ~~had salary, payroll and stock compensation expenses of $3.8 million and $0.82 million during the nine months ended September 30,~~financial ~~2023~~data ~~and September 30, 2022, respectively. This includes compensation~~ for ~~the~~us ~~management~~as staff and stock-based compensation expenses related to the Company’s Incentive Plan. The increase in Salaries, Payroll and Compensation Expense was due to increased labor requirements to support our increased commercial operations which were non-existent in the corresponding period of ~~the prior year.~~:

~~General~~Balance ~~and~~Sheet ~~Administrative Expenses.~~Data We incurred $1.6 million and $0.33 million in general and administrative expenses during the nine months ended September 30, 2023, and September 30, 2022, respectively. General and administrative expenses include marketing expenses, and travel expenses, legal and other professional expenses related to the Company’s filings as a public company with the SEC. The increase in General and Administrative Expenses resulted from the commencement of full commercial operations leading to increased marketing operations, business related travel expenses, compliance and related legal costs.

Other Income/Expenses. We incurred $0.18 million in other expenses/income for the nine months ended September 2023, as compared to $0.11 million in other income during the nine months ended September 30, 2022. Other expenses consisted of interest expense related to bank overdraft.

	September 30, 2025		December 31, 2024
Cash		5,681,657		466,500
Restricted cash**		6,357,590		6,157,035
Total Assets		69,577,027		42,385,213
Total Liabilities		29,927,721		28,928,110
Total liabilities and stockholders’ equity		69,577,027		42,385,213

~~Net~~** ~~Loss. We~~Represents ~~incurred~~Fixed aDeposits ~~net~~held ~~loss of~~by ~~$4.8~~bank ~~million for the nine months ended September 30, 2023,~~ as ~~compared~~security ~~to a net loss of $1.0 million~~ for ~~the~~bank ~~nine~~facilities ~~months~~and ~~ended~~certain ~~September 30,~~performance ~~2022~~guarantees.

~~Year~~To ~~ended~~date, ~~December~~we ~~31,~~have mainly relied on debt and equity ~~2022~~raised in private offerings to finance our operations. We plan to raise additional capital through further private or public offerings of its securities. However, asif ~~compared~~we are unable to ~~year~~do ~~ended~~so ~~December~~and 31if we experience a shortfall in operating capital, ~~2021~~we could be faced with having to limit our expansion plans, research and development and marketing activities.

~~Revenues. We~~Three ~~had~~months noended ~~revenues~~September ~~during the~~30, ~~years~~2025, ~~ended~~as ~~December~~compared ~~31,~~to ~~2022~~the ~~and~~three months ~~December~~ended 31September 30, ~~2021.~~2024

Research and Development Expenses: Research and development expenses during the year ended December 31, 2022 were $72,959 as compared to $1,000 for the year ended December 31, 2021. Research and development expenses reflect continuing development work on the Company’s prototype robotic system at its facilities at UCF’s incubator in Orlando, Florida.

	For the three months ended
	September 30, 2025			September 30, 2024
Total Revenue		12,829,349			4,386,516
Cost of revenue		(6,664,413	)		(2,069,109	)
Gross profit		6,164,936			2,317,407
Research & development expense		786,319			442,839
Stock compensation expense		2,095,163			2,451,355
Depreciation and amortization expense		297,173			119,502
Selling, general and administrative expense		4,821,552			2,508,479
Loss from operations		(1,835,271	)		(3,204,768	)
Other income (expenses)		(35,634	)		(40,715	)
Income tax expense		1,847,059			-
Net loss		(3,717,964	)		(3,245,483	)

~~Compensation~~Total ~~Expense~~Revenue. WeFor ~~had~~the ~~compensation~~three months ended ~~expenses~~September 30, 2025, we had revenues of $~~1.1~~12,829,349 ~~million~~(comprised ~~and~~of $~~947~~11,~~237~~705,375 ~~during~~of ~~year~~system ~~ended~~sales, ~~2022~~$854,440 of instrument sales, $244,399 of warranty sales and ~~2021~~lease income $25,135), ~~respectively.~~as ~~This~~compared ~~includes~~to ~~compensation~~$4,386,516 (comprised of $3,969,805 of system sales, $337,580 of instrument sales $58,547 of warranty sales and lease income $20,584) for the ~~management~~three ~~staff~~months ended September 30, 2024. The increase in revenue was primarily due to an increase in the number of SSi Mantra 3 surgical robotic systems and ~~stock-based~~instruments ~~compensation~~during ~~expense~~the ~~related~~three months ended September 30, 2025, as compared to the ~~Incentive~~three ~~Plan~~months ended September 30, 2024.

~~General~~Gross ~~and Administrative Expenses~~profit. ~~We incurred~~For ~~$1.2~~the ~~million~~three inmonths ~~general~~ended September ~~and~~30, ~~administrative~~2025, ~~expenses~~we ~~during~~had ~~the~~gross ~~year~~profit ~~ended~~of ~~December 31~~$6, ~~2022~~164,936, as compared to $~~458~~2,~~801~~317,407 for the ~~year~~ three months ended ~~December~~September 3130, ~~2021~~2024. ~~General~~The ~~and~~increase in ~~administrative~~gross ~~expenses~~profit ~~include~~margin ~~legal~~was on account of decreases in raw material prices and ~~other~~improvements ~~professional~~in ~~expenses~~manufacturing ~~related~~processes towhich ~~the~~resulted ~~Company’s~~in ~~filings~~less asconsumption aof ~~public~~raw ~~company~~material ~~with~~from the ~~SEC~~2024 quarter to the 2025 quarter.

~~Other Income (Expenses). We have earned $234,594 during the year ended 2022 as compared to $118 during 2021. The increase in other income is primarily the result of origination fees on notes.~~56

~~Net~~Research ~~Loss.~~and Wedevelopment ~~incurred~~expense. aResearch and ~~net~~development ~~loss~~expenses ofwere $~~2.2 million~~786,319 for ~~2022~~the three months ended September 30, 2025, as compared to a$442,839 ~~net~~for ~~loss~~the three months ended September 30, 2024. Research and development expense primarily consists of salaries paid to engineers, amounting to $~~1.48~~691,273 ~~million~~and $333,625 for ~~2021~~the three months ended September 30, 2025 and 2024, respectively. The increase in ~~net~~research ~~loss~~and ~~from~~development ~~2022~~expenses compared to ~~2021~~the prior isperiod was primarily adue ~~result of~~to the ~~increase~~nature inof ~~consulting~~activities ~~fees,~~undertaken. ~~payroll~~Our ~~expenses,~~research and ~~compensation~~development ~~expenses~~efforts were focused on routine product enhancements, which involved relatively lower expenditure.

Stock compensation expense. We had stock compensation expenses of $2,095,163 and $2,451,355 during the three months ended September 30, 2025 and 2024, respectively. The substantial decrease in the stock compensation expense was primarily due to reversal of expenses relating to resigned employees during the three months ending September 30, 2025.

Depreciation and amortization expense. We had depreciation and amortization expense of $297,173 for three months ended September 30, 2025, as compared to $119,502 for three months ended September 30, 2024. The depreciation and amortization expenses primarily consist of depreciation on fixed assets.

Selling, general and administrative expense. We incurred $4,821,552 in selling, general and administrative (“SG&A”) expense during the three months ended September 30, 2025, as compared to $2,508,479 for the three months ended September 30, 2024.

Our SG&A expense is comprised of expenses relating to salaries and benefits, retirement benefits as well as costs related to recruitment, other compensation expenses of sales and marketing and client management personnel, sales commission, travel and brand building, client events and conferences, training and retention of senior management and other support personnel in enabling functions, telecommunications, utilities, travel and other miscellaneous administrative costs. SG&A expense also includes acquisition-related costs, legal and professional fees (which represent the costs of third party legal, tax, accounting, immigration and other advisors), investment in product development, digital technology, advanced automation and robotics, and costs related to grants of our equity awards to members of our board of directors. The increase in SG&A expense compared to the previous period is primarily due to higher legal and underwriting fees and expenses incurred for business events held during the current period, which were not present in the previous period.

Other income/expenses, net. We incurred other expenses of $35,634 for the three months ended September 30, 2025, as compared to $40,715 of other expenses during the three months ended September 30, 2024. The decrease in interest income by $65,899 related to fixed deposits which was offset by increase in interest expense by $70,980 related to interest on bank overdraft facility and convertible notes.

Income tax expense. For the three months ended September 30, 2025 our income tax expense increased by $1,847,059 as compared to nil during the three months period ended September 30, 2024, primarily due to the recognition of income tax expense in our Indian operations for the first time. Historically, our Indian subsidiary had incurred tax losses and was not subject to current income tax. However, during the current period, the Indian operations generated sufficient taxable profits, resulting in the recognition of current tax expense.

Net Loss. We incurred net loss of $3,717,964 for the three months ended September 30, 2025, as compared to a net loss of $3,245,483 for the three months ended September 30, 2024. The decrease in net loss from September 30, 2024 to September 30, 2025 was primarily the result of increases in gross profit by $3,847,529 and reduction in stock compensation expense by $356,192 offset by increases in SG&A expense by $2,313,073 and income tax expense of $1,847,059.

Nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024

	For the nine months ended
	September 30, 2025			September 30, 2024
Total Revenue		27,950,264			12,533,335
Cost of revenue		(14,783,062	)		(8,049,960	)
Gross profit		13,167,202			4,483,375
Research & development expense		2,295,014			1,729,834
Stock compensation expense		6,104,670			12,003,897
Depreciation and amortization expense		766,416			290,079
Selling, general and administrative expense		11,460,139			7,596,841
Loss from operations		(7,459,037	)		(17,137,276	)
Other income (expenses)		3,817			(90,530	)
Income tax expense		2,200,788			-
Net loss		(9,656,008	)		(17,227,806	)

Total Revenue. We had revenues of $27,950,265 (comprised of $24,988,895 of system sales, $2,339,478 of instrument sales, $560,262 of warranty sales and lease income of $61,629), for the nine months ended September 30, 2025, compared to $12,533,335 (comprising $11,722,762 of system sales and $660,216 of instrument sales, $96,749 of warranty sales and lease income of $53,608) for the nine months ended September 30, 2024. The increase in revenue was primarily due to sale of increased number of surgical robotic systems and instruments in the September 2025 period, as compared to the September 2024 period.

Gross profit. We had gross profit of $13,167,202 for the nine months ended September 30, 2025, as compared to $4,483,375 for the nine months ended September 30, 2024. The increase in gross profit margin was on account of decreases in raw material prices and improvements in manufacturing processes which resulted in less consumption of raw material from the 2024 quarter to the 2025 quarter.

Research and development expense. Research and development expenses were $2,295,014 during the nine months ended September 30, 2025 as compared to $1,729,834 for the nine months ended September 30, 2024. Research and development expense primarily consists of salaries paid to engineers, of $1,102,778 and $954,621 for the nine months ended September 30, 2025 and September 30, 2024, respectively. The increase in research and development expenses as compared to the prior period was in line with our continued focus on improving the design and technological capabilities of its existing SSi Mantra system and further expanding its product offerings through the previous quarter.

Stock compensation expense. We had stock compensation expense of $6,104,670 and $12,003,897 during nine months ended September 30, 2025 and September 30, 2024, respectively. The substantial decrease in the stock compensation expense was primarily due to reversal of expenses relating to resigned employees during the current period.

Depreciation and amortization expense. We had depreciation and amortization expense of $766,416 for the nine months ended September 30, 2025, as compared to $290,079 for the nine months ended September 30, 2024. The depreciation and amortization expenses primarily consisted of depreciation on fixed assets.

Selling, general and administrative expense. We incurred $11,460,139 in SG&A expenses during the nine months ended September 30, 2025, as compared to $7,596,841 for the nine months ended in September 30, 2024.

Our SG&A expense was comprised of expense relating to salaries and benefits, retirement benefits as well as costs related to recruitment, other compensation expenses of sales and marketing and client management personnel, sales commission, travel and brand building, client events and conferences, training and retention of senior management and other support personnel in enabling functions, telecommunications, utilities, travel and other miscellaneous administrative costs. SG&A expense also includes acquisition-related costs, legal and professional fees (which represent the costs of third party legal, tax, accounting, immigration and other advisors), investment in product development, digital technology, advanced automation and robotics, and costs related to grants of our equity awards to members of our board of directors. The increase in SG&A expenses compared to the previous period was primarily due to higher legal and underwriting fees, increased expenses associated with our uplisting to Nasdaq, and expenses incurred for business events held during the current period, which were not present in the previous period.

Other income/expenses. We earned other income of $3,817 for the nine months ended September 30, 2025, as compared to $90,530 of other expenses during the nine months ended September 30, 2024. The increase in interest income by $187,407 relating to fixed deposits which was offset by increase in interest expense by $93,060 related to interest on bank overdraft facility and convertible notes.

Income tax expense. For the nine months ended September 30, 2025 our income tax expense increased by $2,200,788 as compared to nil during the nine months ended September 30, 2024, primarily due to the recognition of income tax expense in our Indian operations for the first time. Historically, our Indian subsidiary had incurred tax losses and was not subject to current income tax. However, during the current period, the Indian operations generated sufficient taxable profits, resulting in the recognition of current tax expense.

Net Loss. We incurred a net loss of $9,656,008 for the nine months ended September 30, 2025, as compared to a net loss of $17,227,806 for the nine months ended September 30, 2024. The decrease in net loss from the nine months ended September 30, 2024, to the nine months ended September 30, 2025 was primarily the result of the increase in gross profit by $8,683,827, decrease in stock compensation expense by $5,899,227 offset by increase in SG&A expense of $3,863,298 and income tax expense of $2,200,788.

Year ended December 31, 2024, as compared to year ended December 31, 2023

The following table provides selected financial data about us at December 31, 2024, and December 31, 2023:

Balance Sheet Data

	As of		As of
	December 31,		December 31,
	2024		2023
Cash		466,500		2,022,276
Restricted Cash**		6,157,035		5,065,569
Total Assets		42,385,213		31,515,994
Total Liabilities		28,928,110		11,797,916
Total Shareholders’ Equity		13,457,103		19,718,078

**	Represents Fixed Deposits held by the bank as security for bank facilities and certain performance guarantees.

To date, we have mainly relied on debt and equity raised in private offerings to finance its operations. We plan to raise additional capital through further private or public offerings. However, if we are unable to do so and if we experience a shortfall in operating capital, we could be faced with having to limit our expansion plans, research and development and marketing activities.

	For the year ended
Particulars	December 31, 2024			December 31, 2023
Total Revenue		20,649,528			5,875,314
Cost of revenue		(12,197,162	)		(5,149,786	)
Gross profit		8,452,366			725,528
Research & development expense		2,491,771			1,058,660
Stock compensation expense		14,342,784			9,723,492
Depreciation and amortization expense		436,005			152,738
Selling, general and administrative expense		10,157,768			10,064,622
Loss from operations		(18,975,962	)		(20,273,984	)
Other income (expenses)		(175,235	)		(604,308	)
Income tax expense		-			-
Net loss		(19,151,197	)		(20,878,292	)

Total Revenue. During the year ended December 31, 2024, we had revenues of $20,649,528 (comprising $19,457,767 of system sales, $942,548 of instrument sales and $177,518 of warranty sales and $71,695 of Lease income), compared to revenues of $5,875,314 (comprising $5,225,777 of system sales, $647,766 of instrument sales and $1,771 of warranty sales) during the year ended December 31, 2023.The increase in revenue was primarily due to sale of increased number of surgical robotic systems and instruments in the year ended December 31, 2024 as compared to the year ended December 31, 2023.

Research and Development Expenses. Research and Development expenses during the year ended December 31, 2024, were $2,491,771, as compared to $1,058,660 for the year ended December 31, 2023. The increase in the Research and Development expenses as compared to the previous year was in line with our continued focus on improving the design and technological capabilities of its existing SSi Mantra system and further expanding its product offerings.

Stock Compensation Expense. We had stock compensation expenses of $14,342,784 and $9,723,492 during the years ended December 31, 2024, and December 31, 2023 respectively. The substantial increase in the stock compensation expense in 2024 was primarily the result of the award of a second tranche of stock grants to employees of ours and our subsidiaries and the issuance of stock awards and stock options to executive officers of ours and our subsidiaries in November 2024 under our Incentive Stock Plan, in recognition of their efforts in our operational growth.

Depreciation and amortization expenses. We had depreciation and amortization expense of $436,005 for the year ended December 31,2024, as compared to $152,738 in the year ended December 31, 2023. The depreciation and amortization expenses primarily consisted of depreciation on fixed assets.

Selling, General and Administrative expenses. We incurred $10,157,768 in selling, general and administrative expenses during the year ended December 31, 2024, as compared to $10,064,622 for the year ended December 31, 2023.

Our Selling, General and Administrative expenses (“SG&A”) comprise of expenses relating to salaries and benefits, retirement benefits as well as costs related to recruitment, other compensation expenses of sales and marketing and client management personnel, sales commission, travel and brand building, client events and conferences, training and retention of senior management and other support personnel in enabling functions, telecommunications, utilities, travel and other miscellaneous administrative costs. SG&A expenses also include acquisition-related costs, legal and professional fees (which represent the costs of third party legal, tax, accounting, immigration and other advisors), investment in product development, digital technology, advanced automation and robotics, related to grant of our equity awards to members of our board of directors. We expect our SG&A costs to increase as we continue to strengthen our support and enabling functions and invest in leadership development, performance management and training programs. The increase in selling, general and administrative expenses resulted from the increased headcount and an increase in the scale of our commercial operations during 2024 as compared to the year ended December 31, 2023.

Other Income (Expenses). We have incurred $175,235 in interest expenses (net) during the year ended December 31, 2024, as compared to an interest expense (net) of $604,308 during the year ended December 31, 2023. The decrease in interest expense (net) from 2023 to 2024 was due to an increase in interest income on fixed deposits with HDFC bank in India and interest income recognized during the year related to deferred payment sales.

Net Loss. We incurred a net loss of $19,151,197 for the year ended December 31, 2024, as compared to a net loss of $20,878,292 for the year ended December 31, 2023. The decrease in net loss from 2023 to 2024 was primarily due to an increase in gross profit of $7,726,838, offset by an increase in stock compensation expense of $4,619,292 and a decrease in interest expense (net) of $175,235 from $604,308 respectively.

Liquidity and Capital Resources

ToWe ~~date~~expect weto ~~have~~require ~~funded~~substantial ~~our~~funds ~~operations~~for ~~primarily~~scaling ~~through~~up ~~the~~our ~~sale of equity and equity-linked securities~~operations, ~~revenues~~incurring ~~from~~capital ~~the~~expenditure ~~sale~~to ofhave our ~~surgical~~own ~~robotic~~in-house ~~systems~~machining and ~~working~~tooling ~~capital~~capacity ~~bank overdraft.~~and ~~Through~~to ~~September~~continue ~~30,~~to ~~2023,~~finance ~~we raised an aggregate of $17.87 million of gross proceeds from the sale of~~ our ~~securities and~~ ~~$1.29~~research ~~million from working capital bank overdraft. As of September 30, 2023, we had cash~~ and ~~cash~~development ~~equivalents~~work ofin ~~$ 6.6 million. Our net loss was $4.8 million, $2.21 million and $1.48 million for~~ the ~~nine~~field ~~months~~of ~~ended~~surgical ~~September 30, 2023 and the years ended December 31, 2022 and 2021, respectively~~robotics. ~~Since our inception, we have incurred losses and negative cash flows from operations and expect these conditions to continue for the foreseeable future.~~

~~The~~Effective ~~Company~~February ~~expects~~14, 2024, we sold $2,450,000 in principal amount of 7% Convertible One-Year Promissory Notes (the “Bridge Notes”) to ~~require~~five ~~substantial~~investors ~~funds~~in a private ~~for~~transaction, ~~scaling~~one upof ~~its~~whom ~~operations~~was Sushruta, the Bahamian holding company of Dr. Sudhir Srivastava, our founder, Chairman, Chief Executive Officer and controlling shareholder, who subscribed for ~~incurring~~a ~~capital~~$1,000,000 ~~expenditure~~Bridge toNote. ~~have~~Interest ~~its~~on ~~own~~the ~~in-house~~Bridge ~~machining~~Notes accrued at the rate of 7% per annum and ~~tooling~~was ~~capacity~~payable together with the principal amount upon maturity, towhich ~~expand~~was ~~its~~one year from issuance. The Bridge Notes were convertible ~~business~~at ~~globally~~the ~~and~~option toof ~~continue~~the noteholders, at any time prior to ~~finance~~maturity ~~its~~into ~~research~~shares ~~and~~of ~~development~~our ~~work~~common instock ~~the~~at ~~field~~a conversion price of ~~surgical~~$4.45 ~~robotics~~per share. Sushruta’s Bridge Note, together with accrued interest thereon, was repaid upon maturity in February 2025.

51In April 2024, we raised $2,000,000 from Sushruta by the issuance of two One-Year 7% Promissory Notes (the “7% Notes”) of $1,000,000 each, to meet certain working capital requirements. In July 2024, we raised $500,000 from Sushruta by the issuance of an additional 7% Note to finance its ongoing working capital requirements. In October and November 2024, we raised $500,000 from Sushruta by issuance of 7% Notes to finance its ongoing working capital requirements. All of the 7% Notes are payable in full together with accrued interest, after 12 months from their respective date of issuance. All of the 7% Notes were repaid in full together with accrued interest thereon, upon maturity in February 2025.

~~Cash~~Dr. ~~Flows~~Sudhir ~~used~~Srivastava, through Sushruta, provided us with $2,000,000 in ~~Operating~~financing ~~Activities~~on December 4, 2024, $5,000,000 in financing on January 3, 2025, $10,000,000 in financing on January 20, 2025, $5,000,000 in financing on January 30, 2025 and $8,000,000 in financing on March 19, 2025.

~~During~~Each ~~the~~tranche ~~nine~~of ~~months~~financing ~~ended~~provided ~~September~~by ~~30,~~Dr. ~~2023,~~Srivastava ~~net~~was ~~cash~~evidenced ~~used~~ by ~~operating~~a ~~activities~~one-year ~~was~~convertible ~~$13,831,054~~promissory ~~resulting~~note ~~from~~(collectively, ~~our~~the ~~net~~“One-Year ~~loss~~Notes”). ofThe ~~$4,822,406~~One-Year ~~partially~~Notes ~~offset~~bore interest byat ~~non-cash~~the ~~charges~~ rate of ~~$1,587,581~~seven ~~primarily~~percent ~~driven~~(7%) byper ~~depreciation~~annum, ~~stock~~which ~~compensation~~accrued ~~expense~~ and ~~translation~~was ~~adjustment.~~due ~~During~~at ~~the~~maturity. ~~nine~~The ~~months~~One-Year ~~ended~~Notes ~~September 30,~~were ~~2023,~~convertible weat ~~also~~the option ~~had~~of ~~cash~~the ~~used~~holder ininto ~~net~~shares ~~operating~~of ~~assets~~our ~~and~~common ~~liabilities,~~stock toat ~~the~~a ~~extent~~conversion price of $101.38 per share,~~596,231~~ ~~primarily~~subject ~~driven~~to byadjustment ~~increases~~for instock splits, ~~prepaid~~stock ~~expenses~~dividends and ~~other~~similar ~~current~~recapitalization ~~assets~~events. toAs ~~the~~of ~~extent~~September of30, 2025, all $1230,~~723~~000,~~129~~000 ~~including~~in ~~the~~principal ~~fixed~~amount ~~deposits~~of ~~provided~~One-Year ~~to bank to secure the working~~Notes, ~~capital~~together ~~facilities~~with ~~thereagainst~~$164,548 ~~and~~in aninterest ~~increase~~thereon, inwere ~~accounts~~converted ~~payable~~by ~~and~~Sushruta ~~accrued~~into ~~expenses~~21,858,368 toshares ~~the~~of ~~extent~~our ofcommon ~~$2,126,898~~stock.

During the nine months ended September 30, 2022, net cash used by operating activities was $303,711, resulting from our net loss of $1,040,525, partially offset by non-cash expenses of $819,732. During the same period, we also had cash invested in our operating assets and liabilities of $89,782 primarily due to decreases in accounts payable and contract liabilities.61

While we have been successful in raising funds to meet our working capital needs to date, and we believe that we will be successful in obtaining the necessary financing to fund our operations going forward, we do not have any committed sources of funding and there are no assurances that we will be able to secure additional funding if and when needed. The condensed consolidated financial statements included in this prospectus have been prepared assuming that we will continue as a going concern. If we cannot obtain financing, then we may be forced to further curtail our operations or consider other strategic alternatives. Even if we are successful in raising the additional financing, there is no assurance regarding the terms of any additional investment and any such investment or other strategic alternative would likely substantially dilute our current shareholders. These factors raise a substantial doubt about our ability to continue as a going concern.

	For the nine months ended
	September 30, 2025			September 30, 2024
Net cash provided by operating activities:
Net loss		(9,656,008	)		(17,227,806	)
Non-cash adjustments		7,431,442			13,528,234
Change in operating assets and liabilities		(14,798,851	)		(2,541,697	)
Net cash used in operating activities		(17,023,417	)		(6,241,269	)
Net cash used in investing activities		(1,944,527	)		(536,337	)
Net cash provided by financing activities		24,793,391			6,014,946
Net change in cash		5,825,447			(762,660	)
Effect of exchange rate on cash		(409,735	)		(172,923	)
Cash at beginning of year		6,623,535			7,087,845
Cash at end of year		12,039,247			6,152,262

Cash Flows from Operating Activities

During the nine months ended September 30, 2025, net cash used in operating activities was $17,023,417 resulting from our net loss of $9,656,008 partially offset by non-cash charges of $7,431,442 primarily driven by depreciation charges, operating lease expense, Interest expense (net), Interest and other income, net, credit loss reserve, advisory share expense and other stock compensation expense. We had cash used in our operating assets and liabilities of $17,023,417 primarily driven by an increase in inventory, prepaid and other assets and accounts receivables offset by an increase in deferred revenue, accounts payable, accrued expenses, prepaids and other noncurrent assets, operating lease expense and other liabilities.

During the nine months ended September 30, 2024, net cash used in operating activities was $6,241,269 resulting from our net loss of $17,227,806 partially offset by non-cash charges of $13,528,234 primarily driven by credit loss reserve, depreciation charges, operating lease expense, interest expense (net) and stock compensation expense. We had cash used in our operating assets and liabilities of $2,541,697 primarily driven by inventory, accounts payable, Receivables from / payables to related parties, deferred revenue, accrued expenses and other current liabilities, other noncurrent liabilities and prepaid expenses.

Cash Flows from Investing Activities

During the nine months ended September 30, ~~2023~~2025, we had net cash used in investing activities of $41,~~946~~944,~~786,~~527 ~~investment~~ in ~~$877,403 in~~ purchase of ~~equipment,~~property ~~as well as our loans~~ and ~~advances~~ ~~and long term receivables of $4,069,383~~equipment.

During the nine months ended September 30, ~~2022~~2024, we had nonet cash ~~flows~~used ~~from~~in investing activities ~~activity~~of $536,337 in purchase of property and equipment.

Cash Flows from Financing Activities

During the nine months ended September 30, ~~2023~~2025, we had net cash provided by ~~investing~~financing activities of $24,~~022~~793,~~701~~391, ~~including~~which ~~$6,118,214~~comprised inof proceeds ~~from~~of ~~bank~~$28,000,000 ~~overdraft~~from ~~including~~issuance ~~bank~~of convertible ~~overdraft~~notes ~~against~~to ~~fixed~~our ~~deposits,~~principal ~~$446,188~~shareholder inand ~~securities~~proceeds ~~offering,~~from ~~$12,360~~our inbank ~~repayment~~overdraft offacility ~~warrants,~~(net) by $222,~~980~~074,~~000~~877 inoffset ~~proceeds~~by ~~from~~repayment ~~notes~~of convertible ~~converted,~~notes ~~$50,000~~to inour ~~proceeds~~principal ~~from~~shareholder ~~options~~and ~~exercised,~~other asinvestors ~~well~~amounting asto ~~our recapitalization of~~ $4,~~594~~212,~~341~~637 and ~~repayment of notes to the extent of~~ $1,~~000~~068,~~000~~849 respectively.

During the nine months ended September 30, ~~2022~~2024, we ~~generated~~had net cash, provided by financing activities of $~~412~~6,~~080~~014,946, which comprised of $1,064,946 in proceeds from aour ~~private~~bank ~~securities~~overdraft ~~offering~~facility (net), $1,000,000 in proceeds from issuance of convertible notes to Sushruta, $ 1,450,000 proceeds from issuance of convertible notes to other investors and $2,500,000 in proceeds from issuance of promissory notes to Sushruta.

Critical Accounting Policies

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the ~~United~~U.S. ~~States~~ requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. ~~Significant estimates included deferred revenue, costs incurred related to deferred revenue, the useful lives of property and equipment and the useful lives of intangible assets.~~

~~Income~~We ~~Taxes~~consider the policies discussed below to be critical to an understanding of our consolidated financial statements, as their application places the most significant demands on management’s judgment regarding matters that are inherently uncertain at the time an estimate is made.

~~The~~These ~~Company~~policies ~~accounts for~~include ~~income~~fair ~~taxes~~value in accordance with the Financial Accounting Standards Board’s Accounting Standards Codification (“ASC”) 740, Accounting for Income Taxes, as clarified by ASC 740-10, Accounting for Uncertainty in Income Taxes. Under this method, deferred income taxes are determined based on the estimated future tax effects of ~~differences~~stock ~~between the financial statement and tax basis of~~options ~~assets~~ and ~~liabilities~~standalone ~~given~~selling ~~the~~price provisions of enacted tax laws. Deferred income tax provisions and benefits are based on changes to the assets or liabilities from year to year. In providing for deferred taxes, the Company considers tax regulations of the jurisdictions in ~~which~~case ~~the Company operates, estimates~~ of ~~future~~bundled ~~taxable~~revenue ~~income, and available tax planning strategies~~contracts. If tax regulations, operating results or the ability to implement tax-planning strategies vary, adjustments to the carrying value of deferred tax assets and liabilities may be required. Valuation allowances are recorded related to deferred tax assets based on the “more likely than not” criteria of ASC 740.

52These accounting policies, estimates and the associated risks are set out below. Future events may not develop exactly as forecasted and estimates routinely require adjustment.

ASC 740-10 requires that the Company recognize the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the “more-likely-than-not” threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the relevant tax authority.63

Stock Compensation Expense

Under the fair value recognition provisions of ASC Topic 718, Compensation-Stock Compensation, cost is measured at the grant date based on the fair value of the award and is amortized on a straight-line basis over the requisite service periods of the awards, which is generally the vesting period.

Determining the fair value of stock-based awards at the grant date requires significant judgment, including estimating the expected term over which the stock awards will be outstanding before they are exercised and the expected volatility of our stock.

As of September 30, 2025, we have issued two types of equity incentives:

Stock Options: These provide employees with the right, but not the obligation, to purchase shares of our stock at a specified price, within a defined period, as per the terms of the stock option agreement. Stock-based compensation expense associated with our 2016 Incentive Plan is measured at fair value using a Black-Scholes option-pricing model at commencement of each offering period and recognized over that offering period.

Stock Units (Restricted Stock Units, or RSUs): These do not require the employee to exercise any options. Each stock unit automatically converts into a specified number of shares upon vesting. We use last three months’ average share price of common stock on OTC (prior to April 24, 2025) or on Nasdaq (subsequent to April 24, 2025) as grant date fair value for RSUs.

Standalone Selling Price

Our system sale arrangements contain multiple products and services, including system, accessories, instruments and services. Other than services, we generally deliver all of the products upfront. Each of these products and services is a distinct performance obligation. System, instruments, accessories and services are also sold on a standalone basis. For multiple-element arrangements, revenue is allocated to each performance obligation based on its relative standalone selling price. Standalone selling prices are based on observable prices at which we separately sell the products or services. If a standalone selling price is not directly observable, then we estimate the standalone selling prices considering market conditions and entity-specific factors including, but not limited to, historical pricing data, features and functionality of the products and services and industry benchmark. We regularly review standalone selling prices and maintain internal controls over establishing and updating these estimates. Revenue that is allocated to the service obligation is deferred and recognized ratably over the service period upon expiration of first year of service which is free and included in the system sale arrangements.

Off-Balance Sheet Arrangements

There are no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that isare material to investors.

~~Recently Issued Accounting Pronouncements~~64

Compensation—Stock Compensation

In May 2017, the FASB issued ASU 2017-09, “Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting,” that provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. The new guidance became effective for the Company on January 1, 2018 and was applied on a prospective basis, as required. The adoption of this standard did not have an impact on the financial statements or the related disclosures.

Leases

In February 2016, the FASB issued ASU 2016-02, “Leases (Topic 842)” (“ASU 2016-02”). The FASB issued ASU 2016-02 to increase transparency and comparability among organizations recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. Under ASU 2016-02, lessors will account for leases using an approach that is substantially equivalent to existing GAAP for sales-type leases, direct financing leases and operating leases. Unlike current guidance, however, a lease with collectability uncertainties may be classified as a sales-type lease. If collectability of lease payments, plus any amount necessary to satisfy a lessee residual value guarantee, is not probable, lease payments received will be recognized as a deposit liability and the underlying assets will not be derecognized until collectability of the remaining amounts becomes probable. ASU 2016-02 is effective for interim and annual periods beginning after December 15, 2018, with early adoption permitted, and must be adopted using a modified retrospective transition. The Company did not adopt the standard effective January 1, 2019, utilizing the lessor practical expedient. On November 15, 2019, the FASB issued ASU 2019-10 which amended the effective dates for ASC 842, to give implementation relief. Under the FASB’s new framework, two “buckets” were defined, bucket 1 includes public companies that are SEC filers but excludes “Small Reporting Companies” (SRC’s). Bucket 2 includes all other entities, including SRC’s. Bucket 2 entities have to apply ASC 842 for fiscal years beginning after December 15, 2020, and interim periods within fiscal years beginning after December 15, 2021.

Directors, Executive Officers and Corporate Governance

Directors and Executive Officers

Our directors and executive officers and their respective ages and titles are as follows:

Name	Age	Position(s) and Office(s) Held
Sudhir Srivastava, M.D.	7578	Chairman, Chief Executive Officer and Director
Anup Kumar Sethi	58	Chief Financial Officer
Milan Rao	54	Global Chief Operating Officer and Chief Financial Officer
Vishwajyoti P. Srivastava, M.D.	4648	~~President,~~ Chief ~~Operating~~Executive Officer – ~~South~~ Asia Pacific and Director
Barry F. Cohen	8385	Chief Operating Officer – Americas and Director
Dr. Mylswamy Annadurai	6566	Director
Dr. S.P. Somashekhar	5052	Director
Dr. Frederic H Moll	73	Director
Tim Adams	56	Director

Set forth below is a brief description of the background and business experience of our directors and executive officers.

Sudhir Srivastava, M.D., joined the Company on April 14, 2023, as its Chairman, Chief Executive Officer and a director upon completion of the CardioVentures Merger. Dr. Srivastava founded ~~Sudhir Srivastava Innovations Pvt. Ltd. (“~~SSI-India”), our Indian operating subsidiary in 2019 and has served as its Chairman, Managing Director and Chief Executive Officer since that time. SSI-India was founded with the objective of launching the development of an advanced, affordable, and accessible surgical robotic system that would benefit greater numbers of patients around the world. Dr. Srivastava completed his medical degree in India in 1971 and moved to the ~~United~~U.S. ~~States~~ in 1972, where he underwent a residency in general surgery in St. Louis and further completed his training, including in cardiothoracic surgery, at the University of British Columbia Hospitals in Vancouver, Canada. He is double board certified by the American Board of Surgery and Thoracic Surgery. Dr. Srivastava, after moving to Texas to begin his practice in 1981, became heavily involved in advancing minimally invasive cardiac surgical approaches and robotic cardiac surgery procedures during his time in Texas. While in Texas, in 2002 Dr. Srivastava was the founding chairman of Alliance Hospital, which became one of the busiest robotic cardiac centers globally. In 2007, Dr. Srivastava joined the University of Chicago faculty and served as the Director of Robotic Cardiac Surgery to launch their program. In 2009, Dr. Srivastava moved to Atlanta, Georgia, and founded the International College of Robotic Surgery and launched the Robotic Revascularization Program at St. Joseph’s Hospital. While in the ~~United States~~U.S., he performed over 1,400 robotic cardiothoracic procedures and trained over 350 surgical teams from around the world. His passion and experience took him to various countries around the world, where he helped launch robotic cardiac surgery programs. Dr. Srivastava returned to India in 2011 to establish robotic surgery programs throughout the country during a time when robotic surgery was still nascent in India. He founded the International Centre for Robotic Surgery in Delhi, India, and trained surgeons in different specialties, introducing them to high-level robotic cardiac surgery procedures. Recognizing the high cost and limited access to robotic surgery in India, in 2012, Dr. Srivastava undertook the mission of developing an affordable system that would be technologically advanced, so that greater numbers of patients could benefit from robotic cardiac surgery in India and worldwide. His efforts led to the development of the SSi Mantra ~~Surgical Robotic System~~ by the SSi Companies Group, which was commercially introduced in August 2022. Dr. Srivastava is globally recognized as a pioneer and leader in robotic cardiac surgery and has received numerous awards worldwide for advancing the field.

~~Anup~~Milan ~~Kumar Sethi~~Rao, joined the Company onas ~~April~~Global Chief ~~14,~~Operating ~~2023~~Officer asand ~~its~~ Chief Financial Officer, ~~upon~~on ~~completion~~January of16, ~~the Cardio Ventures Merger~~2026. Mr. ~~Sethi~~Rao, has ~~served as~~more ~~Chief~~than ~~Financial~~three ~~Officer~~decades of ~~SSI~~executive leadership experience driving technology-~~India~~enabled ~~since~~transformation, ~~January~~operational ~~2023~~efficiency and ~~has~~growth ~~been~~at ~~associated~~leading ~~with~~global ~~SSI-India~~companies ~~since~~across ~~2018~~industries, including onthe ahealthcare ~~consulting~~sector. ~~basis~~From ~~as a~~June ~~financial~~2024 ~~advisor~~until joining the Company, Mr. ~~For~~Rao ~~over~~served ~~ten~~as ~~years~~Chief ~~prior~~Operating ~~thereto~~Officer and Chief Revenue Officer of Markets & Markets, hea ~~held~~global ~~senior~~consulting ~~management~~firm ~~positions~~based in ~~well-established~~New ~~healthcare~~York ~~companies~~City, inwhere he led global operations, sales, marketing and ~~India~~consulting, ~~including~~and ~~Fortis~~was responsible for global partnerships and ~~International~~the ~~Oncology~~firm’s inorganic growth initiatives. ~~With~~From ~~close~~September 2021 to ~~thirty~~December 2023, ~~years~~Mr. ofRao ~~overall~~served ~~experience~~as President and ~~having~~Global ~~worked~~Business inHead ~~India,~~of ~~China~~Smart Energy Water (“SEW”), a cloud-based SaaS company ~~South~~based ~~Africa,~~in California and ~~Nigeria~~New York, inconnecting ~~organizations~~consumers with energy and water providers worldwide. Following SEW’s acquisition of Choice ~~various~~Technologies, ~~sizes~~in ~~belonging~~2022 tohe aserved ~~diverse~~as ~~range~~Interim Chief Executive Officer of ~~industries~~Choice ~~like~~Technologies ~~automotive~~and ~~tires~~led ~~manufacturing~~its global integration with SEW, ~~textiles,~~expanding ~~digital~~platform ~~media~~capabilities ~~and~~in ~~healthcare~~artificial ~~delivery~~intelligence, ~~Mr.~~machine ~~Sethi~~learning isand ~~very~~data ~~well~~analytics ~~adapted~~and togrowing ~~building~~its ~~and~~customer ~~working~~base. ~~with~~From ~~multi-faceted~~August 2017 to August 2021, ~~multi-cultural teams.~~ Mr. ~~Sethi~~Rao ~~has~~was aPresident ~~FCMA~~at ~~qualification~~Wipro Limited (~~Fellow~~“Wipro”) ~~Member~~a ofTechnology ~~Institute~~Services ofcompany. ~~Cost~~He ~~Accountants~~also ofled ~~India)~~Wipro’s Technology & Transformation Office, anincluding ~~Associate~~innovation, ~~membership~~IP ~~of CPA~~and platforms, ~~Australia~~marketing, and arevenue ~~Certified~~operations, ~~Financial~~and ~~Planner~~launched ~~(CFP)~~a ~~certification~~digital-first, AI-led ~~from~~transformation ~~the~~program. ~~Financial~~From ~~Planning~~June ~~Standards~~2013 ~~Board~~to August 2017, ~~with~~Mr. ~~hands-on~~Rao ~~experience in~~served ~~leading~~as ~~teams~~President inand ~~the~~Chief ~~functional~~Executive ~~areas~~Officer of ~~corporate~~GE ~~finance~~Healthcare for India, ~~strategy~~South Asia, ~~accounting~~and emerging markets. Mr. Rao holds a BS in Computer Science and Engineering from IIT (BHU) Varanasi, ~~compliance~~where he was recognized as a Distinguished Alumnus, and ~~business~~an ~~development~~MBA in Finance from IIM Calcutta.

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Vishwajyoti P. Srivastava, M.D., joined the Company on April 14, 2023, as its President, Chief Operating Officer – South Asia and a director upon completion of the CardioVentures Merger. In May 2025 Dr. Srivastava was appointed to the position of Chief Executive Officer – Asia Pacific and served as the Company’s interim Chief Financial Officer from July 23, 2025 through September 24, 2025. Dr. Srivastava joined SSI - India as President and Chief Operating Officer for South Asia in November 2020. Prior to that, he served as President of OMNI 3DHD from January 2018 to November 2020, where he led the development of a secondary 3D Visualization System that was designed with the objective of giving 3D vision to the entire robotic surgical team. In 2015, Dr. Srivastava served as the COO of a Miami, Florida based health and wellness startup, Reshape Inc., that developed an online platform for healthy living initiatives. Dr. Srivastava was also instrumental in the creation of the International College of Robotic Surgery in Atlanta, Georgia, in 2009 as well as the International Centre for Robotic Surgery in New Delhi, India, in 2011. Dr. Srivastava has been deeply involved in the field of surgical robotics since 2008, covering the wide spectrum of clinical applications, teaching and training, tele-mentoring platforms, web-based surgeon didactic training modules, digital media and marketing. Dr. Srivastava graduated from Saint James School of Medicine in Anguilla, receiving his M.D. degree in August 2020. Dr. Srivastava also holds a B.A. in International Studies with a focus on South Asia from the University of Washington in Seattle that he received in ~~1999~~2000. Dr. Srivastava completed all his premedical requirements at Columbia University’s Post Baccalaureate Program in New York City, graduating in 2003. He is fluent in English, Hindi and French.

Barry F. Cohen co-founded the Company (then known as Avra Medical Robotics, Inc.) and served as its Chief Executive Officer and a director from February 4, 2015, until completion of CardioVentures Merger on April 14, 2023, when he assumed the position of Chief Operating Officer-Americas and continued as a director. Between 2006 and 2008, Mr. Cohen was a private investor and founded AVRA Surgical, Inc., a medical technology company. Prior to founding the Company, Mr. Cohen was a director of Dualis Med-Tech from 2012 to 2014 and was a director of AvraMiro GmbH from 2009 to 2014 and ~~Avra~~ Avra Surgical Robotics, Inc. since 2011, which is currently inactive. From approximately 1979 to 1983 he served as director of Synalloy Corp., a manufacturer of pipe, piping systems and specialty chemicals after which he was appointed to serve as President from 1984 to 1985. Mr. Cohen also served as Chairman of the Executive Board of Wolverine Technologies, Inc., a NYSE listed company from 1979 to 1983 and President of Barry F. Cohen & Co., an NASD member from 1983 to 1999. Mr. Cohen has over fifty years’ experience in managing private and public industrial companies, and forty-seven years’ experience as a securities executive.

Dr. Mylswamy Annadurai joined the Company as a director on July 30, 2023. Dr. Annadurai is a distinguished space scientist of international repute, who has been involved in the Indian space program for over forty years, approximately thirty-six of which (1982-2018) were spent in various positions with the Indian Space Research Organization (“ISRO”), most recently as Director of the ISRO Satellite Center from April 2015 to July 2018. During that period, he was responsible for overseeing the development, manufacture and launch of twenty-nine satellites. Prior thereto, he also served as Program Director of Indian Remote Sensing and Small Satellite Program at ISRO from 2011-2015, where among other matters, he was responsible for overseeing ISRO’s Mars Orbiter Mission and as Project Director of India’s firs lunar mission, Chandarayaan-1, from 2004-2010. From August 2018 until March 2022, Dr. Annadurai served as Chairman of the National Design and Research Forum and from October 2018 to March 2023, he served as Vice President of the ~~Tamilnadu~~Tamil Nadu State Council for Science and Technology. Since May 2019. Dr. Annadurai has been serving as Chairman of the Aerospace Committee of the Southern India Chamber of Commerce and Industries in Chennai and since March 2021, as a director of Moon Land Technologies Pvt. Ltd. Since February 2023, he is also serving as a Trustee Member of the India Trustee Board of the America-India Foundation. Dr. Annadurai has received numerous awards from the Indian government, ISRO, international space organizations, academic institutions and professional bodies and societies. Dr. Annadurai holds B.E. (ECE), M.E. (Applied Electronics) and Ph.D. degrees from Anna University.

Dr. S.P. Somashekhar joined the Company as a director on July 30, 2023. Dr. Somashekhar is a highly respected surgical oncologist and one of the first physicians to employ robotic surgery in India. Since January 2022, he has been affiliated with the Aster Group of Hospitals in India, where he serves as Global Director of the Aster International Institute of Oncology and Head of Department and Lead Consultant in Surgical and Gynecological Oncology and Robotic Surgery. He also serves as Chairman of the Medical Advisory Board for Aster DM Healthcare. For over twenty years prior to joining Aster, he was affiliated with Manipal Hospitals in Bengaluru, most recently as Head of Department of Surgical Oncology and Chairman of the Surgical Oncology Advisory Board. Dr. Somashekhar has served in a number of teaching positions, significant experience in conducting clinical studies, authored numerous medical papers and articles and received multiple awards in the medical field. He holds an M.B.B.S. degree from Mysuru University, an M.S. in General Surgery from the Sheth K.M. School of Postgraduate & Research in Ahmedabad, and an MCh in Oncosurgery from the Gujarat Cancer & Research Institute in Ahmedabad. He is also a Fellow of the Royal College of Surgeons (Edinburgh).

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Dr. Frederic H Moll joined the Company as a Director on August 20, 2024. Dr. Moll is a renowned physician and visionary entrepreneur whose pioneering work in medical robotics has shaped the field of MIS. He did his B.A. from the University of California at Berkeley, an M.D. from the University of Washington, and an M.S. in Business Management from Stanford University. He is a pioneer in Medical Robotics, particularly in MIS. Dr. Moll co-founded Intuitive Surgical in 1995, where he co-developed the da Vinci robotic-assisted surgery system, a global standard for MIS. He also founded Hansen Medical and Auris Health, creating advanced robotic technologies for vascular procedures and lung cancer diagnosis, respectively. His innovations have shaped the field of surgery, and he has served on the Boards of influential Healthcare Tech companies like Mako Surgical and RefleXion.

Tim Adams joined the Company as a Director on August 20, 2024. Mr. Adams served as President and CEO of Ascension Saint Thomas Health and Ministry Market Executive for Ascension Tennessee from January 2018 until January 2023, leading a network of nine inpatient facilities across Middle Tennessee. Prior to this, he was the Texas Region Chief Executive Officer at Tenet Healthcare, overseeing 26 hospitals and leading operational efforts for one of the company’s largest regions. Earlier in his career, Mr., Adams served as CEO of Cedar Park Regional Medical Center, a partner with Ascension’s Seton Healthcare Family, and held executive roles at Community Health Systems and IASIS Healthcare, overseeing multi-hospital operations in Texas and Florida. Beyond his professional commitments, he is also an active member of the healthcare community, serving on numerous boards, including the Tennessee Hospital Association, Nashville Health Care Council, and the United Way of Greater Nashville. He holds a Bachelor of Business Administration from Baylor University and an MBA from The University of Texas at El Paso. In January 2023, Tim transitioned to the role of Regional Operating Officer and Senior Vice President for Ascension, overseeing Ascension ministries in 10 states, including Tennessee.

Terms of Office

Our directors are appointed for a one-year term to hold office until the next annual meeting of our ~~stockholders~~shareholders and until a successor is appointed and qualified, or until their removal, resignation, or death. Executive officers serve at the pleasure of the board of directors.

Family Relationships

Dr. Sudhir Srivastava and Dr. Vishwajyoti P. ~~Srivastava~~ Srivastava are father and son. ~~There are no other familial relationships among our officers and directors.~~

~~Board~~There ~~Diversity~~are no other familial relationships among our officers and directors.

Our board presently consists of at least one “Diverse” board member as that term is defined under Rule 5605(f)(1) of the Nasdaq Listing Rules. Our policy regarding board composition is to select knowledgeable individuals who are committed to a diverse, equitable, and inclusive environment. To this end, and in accordance with the requirements of any national stock exchange on which our shares may trade in the future, and subject to any applicable phase-in period, the Company may at such time require the board to be comprised of at least two Diverse board members including at least one who self-identifies as female, and at least one who self-identifies as an underrepresented minority or LGBTQ+. Our priority is to select diverse board members who will further the interests of our stockholders through his or her established record of accomplishment, the ability to contribute positively to the collaborative culture among board members, knowledge of our business, and understanding of the competitive landscape in which we operate.

Board Committees and Independence

~~Subject~~The toCompany ~~and effective upon the effectiveness of the registration statement of which this prospectus forms a part, our board of directors~~ has ~~established~~constituted three standing committees: an audit committee, a compensation committee and a nominating and corporate governance committee. Each committee will consist of three independent directors. Our board of directors has determined that Dr. Annadurai and Dr. Somashekhar are “independent” within the meaning of the applicable rules and regulations of the SEC and the listing standards of the Nasdaq Stock Market. Prior to effectiveness of this registration statement of which this prospectus forms a part, the board of directors will be expanded to consist of a majority of independent directors.

InOur ~~addition~~board of directors has determined that Dr. Annadurai, atDr. ~~least~~Somashekhar ~~one~~and ofMr. ~~our~~Adams are currently “independent” within the meaning of the applicable rules and regulations ~~directors~~of ~~will~~the ~~need~~SEC toand ~~qualify~~the aslisting standards of the Nasdaq Stock Market. In addition, the board has determined that Mr. Adams is an “audit committee financial expert” as the term is defined by the applicable rules and regulations of the SEC and the Nasdaq Stock Market listing standards, based on his business and management experience. AtOur ~~the~~board ~~time of~~has ~~the~~also ~~listing~~determined ofthat ~~our~~at ~~common stock for trading on the Nasdaq Capital Market~~present, weDr. ~~will~~Moll beis ~~required~~not to“independent” because ~~certify~~his tobeneficial ~~the~~ownership ~~Nasdaq~~of ~~Stock Market, that~~ our ~~audit~~common ~~committee~~stock ~~has,~~exceeds ~~and~~10%. ~~will~~Dr. ~~continue~~Sudhir ~~to have~~Srivastava, atDr. ~~least~~Vishwajyoti ~~one~~P. ~~member~~Srivastava ~~who~~and ~~has~~Mr. ~~past~~Barry ~~employment experience in finance or accounting,~~F. ~~requisite~~Cohen ~~professional~~are ~~certification~~not inindependent ~~accounting,~~as orthey ~~other~~are ~~comparable~~officers ~~experience~~and oremployees ~~background~~of ~~that results in~~ the ~~individual’s financial sophistication~~Company.

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Members of the aforesaid Committee (s) are as follows:

Name of the Committee		Members of the Committee
Audit Committee		Mr. Tim Adams
		Dr. SP Somasekhar
		Dr. Mylswamy Annadurai

Compensation Committee		Mr. Tim Adams
		Dr. SP Somasekhar
		Mr. Barry F. Cohen

Nominating and Corporate Governance Committee		Mr. Tim Adams
		Dr. SP Somasekhar

Audit Committee

The audit committee assists our board of directors in its oversight of the Company’s accounting and financial reporting processes and the audits of the Company’s financial statements, including (a) the quality and integrity of the Company’s financial statements; (b) the Company’s compliance with legal and regulatory requirements; (c) the independent auditors’ qualifications and independence; and (d) the performance of our Company’s internal audit functions and independent auditors, as well as other matters which may come before it as directed by the board of directors. Further, the audit committee, to the extent it deems necessary or appropriate, among its several other responsibilities, shall:

●

be responsible for the appointment, compensation, retention, termination and oversight of the work of any independent auditor engaged for the purpose of preparing or issuing an audit report or performing other audit, review or attest services for the Company;

● discuss the annual audited financial statements and the quarterly unaudited financial statements with management and the independent ~~auditor~~auditors prior to their filing with the SEC in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q;

● review with the Company’s financial management on a periodic basis (a) ~~issues~~issue regarding accounting principles and financial statement presentations, including any significant changes in the Company’s selection or application of accounting principles; and (b) the effect of any regulatory and accounting initiatives, as well as off-balance sheet structures, on the financial statements of the Company;

●

monitor the Company’s policies for compliance with federal, state, local and foreign laws and regulations and the Company’s policies on corporate conduct;

● maintain open, continuing, and direct communication between the board of directors, the audit committee and our independent auditors; and

●

monitor our compliance with legal and regulatory requirements and shall have the authority to initiate any special investigations of conflicts of interest, and compliance with federal, state and local laws and regulations, including the Foreign Corrupt Practices Act, as may be warranted.

Compensation Committee

The compensation committee aids our board of directors in meeting its responsibilities relating to the compensation of the Company’s executive officers and to administer all incentive compensation plans and equity-based plans of the Company, including the plans under which Company securities may be acquired by directors, executive officers, employees and consultants. Further, the compensation committee, to the extent it deems necessary or appropriate, among its several other responsibilities, shall:

● review periodically the Company’s philosophy regarding executive compensation to (a) ensure the attraction and retention of corporate officers, (b) ensure the motivation of corporate officers to achieve the Company’s business objectives, and (c) align the interests of key management with the long-term interests of our ~~stockholders~~shareholders;

●

review and approve corporate goals and objectives relating to Chief Executive Officer compensation and other executive officers of SSi and its subsidiary companies;

●

make recommendations to the board of directors regarding compensation for non-employee directors, and review periodically non-employee director compensation in relation to other comparable companies and in light of such factors as the compensation committee may deem appropriate; and

●

review periodically reports from management regarding funding the Company’s pension, retirement, long-term disability and other management welfare and benefit plans.

Nominating and Corporate Governance Committee

The nominating and corporate governance committee ~~recommends~~shall recommend to the board of directors individuals qualified to serve as directors and on committees of the board of directors to advise the board of directors with respect to the board of directors composition, procedures and committees to develop and recommend to the ~~board~~ board of directors a set of corporate governance principles applicable to the Company; and to oversee the evaluation of our board of ~~directors~~ directors and management.

Further, the nominating and corporate governance committee, to the extent it deems necessary or appropriate, among its several other responsibilities shall:

● recommend to the board of directors and for approval by a majority of independent directors for election by ~~stockholders~~shareholders or appointment by the board of directors as the case may be, pursuant to our bylaws and consistent with the board of directors’ criteria for selecting new directors;

●

review the suitability for continued service as a director of each member of the board of directors when his or her term expires or when he or she has a significant change in status;

●

review annually the composition of the board of directors and to review periodically the size of the board of directors;

●

make recommendations on the frequency and structure of board of directors’ meetings or any other aspect of procedures of the board of directors;

●

make recommendations regarding the chairmanship and composition of standing committees and monitor their functions;

● review ~~annually~~annual committee assignments and chairmanships;

●

recommend the establishment of special committees as may be necessary or desirable from time to time; and

●

develop and review periodically corporate governance procedures and consider any other corporate governance issue.

Code of Ethics

We have adopted a Code of Ethics that applies to employees, including our principal executive officer, principal financial officer and/or ~~persons~~people performing similar functions.

Board of Directors Role in Risk Oversight

Members of the board of directors have periodic meetings with management and the Company’s independent auditors to perform risk oversight with respect to the Company’s internal control processes. The Company believes that the board’s role in risk oversight does not materially affect the leadership structure of the Company.

58Insider Trading Policies and Procedures

We have adopted insider trading policies and procedures governing the purchase, sale, and/or other dispositions of our securities by our directors, officers and employees, and the Company itself, that are reasonably designed to promote compliance with insider trading laws, rules and regulations, and any listing standards applicable to the Company.

Compensation Committee Interlocks and Insider Participation

None of our officers currently serves, or in the past year has served, as a member of the compensation committee of any entity that has one or more officers serving on our Board of Directors.

EXECUTIVE COMPENSATION

Summary Compensation Table

The table below summarizes all compensation awarded to, earned by, or paid to our Chief Executive Officer (our principal executive officer) and our two most highly compensated executive officers other than our chief Executive Officer (collectively, the “named executive officers”) for the years ended December 31, ~~2023~~2025, December 31, ~~2022~~2024 and December 31, ~~2021~~2023.

Name and Principal Position	Year		Salary ($)		Bonus ($)		Stock Awards (#)			Option Awards (#)			Option Awards ($)			Non-Equity Incentive Plan Compensation ($)		Nonqualified Deferred Compensation Earnings ($)		All Other Compensation ($)		Total ($)
Sudhir Srivastava, M.D. Chairman and Chief Executive Officer(1)		2023		600,000		0		0			2,536,776	(2)			(2)		0		0		205,992		805,992
Sudhir Srivastava, M.D.		2025		600,000		0		0			5,886,997	(2)		13,307,213	(2)		0		0		299,538		14,206,751
Anup Kumar Sethi Chief Financial Officer(3)		2023		167,197		0		845,592	(4)		0			0			0		0		578		167.775
Chairman and		2024		600,000		0		0			5,886,997			13,307,213			0		0		289,567		14,196,780
Vishwajyoti P. Srivastava, M.D. President and Chief Operating Officer – South Asia(5)		2023		200,000		0		0			845,592	(2)			(2)		0		0		9623		209,623
Chief Executive Officer(1)		2023		600,000		0		0			2,536,776			8,650,405			0		0		205,992		9,456,397
Barry F. Cohen		2023		128,000		0		0			845,592	(2)			(2)		0		0				128,000
Vishwajyoti P. Srivastava, M.D.		2025		266,668		0		0			845,592	(2)		2,883,468	(2)		0		0		54,333		3,204,469
Chief Operating Officer-Americas(6)		2022		292,700		0		206,00	(7)		540,000	(8)		358,429	(8)		0		0		0		651,129
Chief Executive		2024		200,000		0		0			845,592			2,883,468			0		0		12,164		3,095,632
		2021		0		0		0			0			0			0		0		0		0
Officer – Asia Pacific(3)		2023		200,000		0		0			845,592			2,883,468			0		0		9,623		3,093,091
Barry F. Cohen		2025		180,000		0		0			845,592	(2)		2,883,468	(2)		0		0		0		3,063,468
Chief Operating		2024		180,000		0		0			845,592			2,883,468			0		0		0		3,063,468
Officer-Americas(4)		2023		128,000		0		0			845,592			2,883,468			0		0		0		3,011, 468

(1) Sudhir ~~Srivastva~~Srivastava became our Chairman and Chief Executive Officer on April 14, 2023, upon completion of the ~~Cardio~~CardioVentures ~~Ventures~~ Merger.

(2) Represents an option to purchase common stock granted under our 2016 Incentive Plan. The option vests in five equal annual installments commencing upon the date of grant and expires five years from the date of grant.

(3) MrDr. ~~Sethi~~Vishwajyoti Srivastava became our President and Chief ~~Financial~~Operating Officer – South Asia on April 14, 2023, upon completion of the ~~Cardio~~CardioVentures ~~Ventures~~ Merger. In May 2025, he was appointed Chief Executive Officer – Asia Pacific.

(4) ~~Represents~~Barry aF. ~~grant~~Cohen ofserved ~~restricted~~as ~~shares~~our Chairman and Chief Executive Officer from founding of ~~our~~the ~~common~~Company ~~stock~~on ~~awarded~~February ~~under~~4, ~~our~~2015, ~~Incentive~~until ~~Plan.~~completion ~~The~~of ~~grant~~the ~~vests~~CardioVentures inMerger ~~five~~on ~~equal~~April ~~annual~~14, ~~installments~~2023, ~~commencing~~when ~~upon~~he stepped down from those positions and assumed the ~~date~~position of ~~grant~~Chief Operating Officer – Americas.

~~(5) Dr. Vishwajyoti Srivastava became our President and Chief Operating Officer – South Asia on April 14, 2023, upon completion of the CardioVentures Merger.~~71

(6) Barry F. Cohen served as our Chairman and Chief Executive Officer from founding of the Company on February 4, 2015 until completion of the Cardio Ventures Merger on April 14, 2023, when he stepped down from those positions and assumed the position of Chief Operating Officer – Americas.

(7) Represents a grant of restricted shares of our common stock awarded under our Incentive Plan, which vested in full on the date of grant.

(8) Represents option to purchase common stock granted under our Incentive Plan, which option vested in full on the date of grant.

Employment Agreements

The Company, ~~through Otto Pvt. Ltd., a wholly owned subsidiary,~~ is party to an employment ~~agreements~~agreement with ~~each of~~ Dr. Sudhir Srivastava~~, Anup Kumar Sethi and Dr. Vishwajyoti P. Srivastava.~~ ~~Dr. Sudhir Srivastava’s employment agreement is~~ for a ~~five-~~three year period expiring inon ~~November~~July ~~2024 and provides for an annual base salary of $600,000~~31. ~~Mr. Sethi’s employment agreement is for a five-year (5-year) period expiring in January 2028 and provides for an annual base salary of $175~~2027,~~000.~~ ~~Dr.~~which ~~Vishwajyoti P. Srivastava’s employment agreement is for a five-year period expiring in September 2026 and~~ provides for an annual base salary of $~~200~~600,000. ~~Each of the employment agreements contain customary confidentiality, assignment of proprietary rights, non-competition and non-solicitation provisions.~~

~~Through~~Dr. ~~December~~Vishwajyoti ~~2022,~~P. ~~the~~Srivastava ~~Company~~is ~~was~~ party to an employment agreement with ~~Barry~~the F.Company ~~Cohen, its then Chairman and Chief Executive Officer, which had a term~~ expiring on ~~June~~April 30, ~~2024~~ ~~and~~2030, ~~provided~~which provides for a base annual salary of $15300,000 ~~per month~~. The employment agreement also provided for reimbursement of other reasonable business expenses incurred by Mr. Cohen in the performance of his duties and contained confidentiality and non-competition provisions. In December 2022, in contemplation of completion of the CardioVentures Merger, the board cancelled the employment agreement with Mr. Cohen and in return paid him the balance of payments due per such agreement through the end of its term.

~~Upon~~The ~~completion of the CardioVentures Merger on April 14, 2023, the~~ Company ~~entered~~is ~~into~~party ato ~~new~~an employment agreement with ~~for~~Barry aF. ~~three-year~~Cohen ~~period~~ expiring in April 2026, which provides for an annual base salary of $180,000. The employment agreement also provides for reimbursement of other reasonable business expenses incurred by Mr. Cohen in the performance of his duties and contains customary confidentiality, assignment of proprietary rights, non-competition and non- solicitation provisions.

The Company and Mr. Rao entered into a one-year services agreement, effective January 16, 2026 (the “Services Agreement”), providing for monthly base compensation of $41,667. In addition, the Services Agreement provides for Mr. Rao to receive a stock grant under the Company’s 2016 Incentive Plan) in the amount of 120,000 shares of the Company’s common stock vesting in equal monthly installments of 10,000 shares, subject to continued engagement of Mr. Rao by the Company and the other terms and conditions of the 2016 Incentive Plan. In the event, the Services Agreement is terminated by the Company “Without Cause” (as defined in the Services Agreement) prior to the six month anniversary of the effective date of the Services Agreement, then Mr. Rao shall be entitled to receive, (i) payment of his base compensation through the six month anniversary of the effective date of the Services Agreement; and (ii) any unvested installment of the stock grant which would vest on or before the six month anniversary of the effective date shall vest in full as of the termination date. Any other unvested portion of his stock grant will terminate as of the termination date of the Services Agreement.

Each of the above agreements provides for reimbursement of reasonable business expenses incurred in the performance of the executive’s duties and contains customary confidentiality, assignment of proprietary rights, non-competition and non-solicitation provisions.

Outstanding Equity Awards at Fiscal Year-End Table

The table below summarizes all unexercised options, stock that has not vested, and equity incentive plan awards for each of our named executive officers outstanding as of December 31, ~~2023, the end of our last completed fiscal year~~2025.

	Number of Securities Underlying Unexercised Options Exercisable		Number of Securities Underlying Unexercised Options Unexercisable		~~Option Exercise Price~~	Option Exercise Price		~~Option Expiration Date~~	Option Expiration Date	Number of shares that have not vested	~~Number of shares that have not vested~~	Market value of shares of stock that have not vested**	Market value of shares of stock that have not vested**
Sudhir Srivastava, M.D.		~~507~~4,~~355~~872,286		21,~~029~~014,~~421~~710	$	~~5.00~~$	5.00		Nov 27, 2028
Anup Kumar Sethi					$						676,474		5,249,435
Vishwajyoti P. Srivastava		507,355		338,237		$	5.00		Nov 27, 2028
Vishwajyoti P. Srivastava		169,118		676,474	$	5.00			Nov 27, 2028
Barry F. Cohen		507,355		338,237		$	5.00		Nov 27, 2028
Barry F. Cohen		169,118		676,474		5.00			Nov 27, 2028
		75,000		75,000	$	10.00			Dec 1, 2024

* The volume weighted average exercise price per share for all options awarded is $ 5.14.

*	The volume weighted average exercise price per share for all options awarded is $5.00.

**	Based on the market price of $7.76 per share on the grant date

** Based on market price of $7.76 per share on the grant date72

The above are options to purchase common stock granted under our 2016 Incentive Plan. The options vest in five equal annual instalments commencing upon the date of grant and expire five years from the date of grant.

Compensation of Directors Table

The table below summarizes all compensation paid to our directors for the year ended December 31, ~~2023~~2025, our last completed fiscal year.

	~~DIRECTOR COMPENSATION~~		DIRECTOR COMPENSATION
Name	Fees Earned or paid in Cash ($)		Stock Awards~~(1)~~ ($)			Option Awards~~(2)~~ ($#)		~~Non-Equity~~Option ~~Incentive~~Awards(1) ~~Plan Compensation~~ ($)		Non-~~Qualified~~Equity ~~Deferred~~Incentive Plan Compensation ~~Earnings~~ ($)		~~All~~Non-Qualified ~~Other~~Deferred Compensation Earnings ($)		~~Total~~All Other Compensation ($)		Total ($)
Sudhir Srivastava, M.D.		600,000					25,~~536~~886,~~776~~997		013,307,213		0		~~205,992~~0		~~805~~299,~~992~~538		14,206,751
Vishwajyoti P. Srivastava, M.D.		~~200~~266,~~000~~668					845,592		02,883,468		0		~~9,623~~0		~~209~~54,~~623~~333		3,204,469
Barry F. Cohen		~~128~~180,000					845,592		02,883,468		0		0		~~128,000~~0		3,063,468
Dr. Mylswamy Annadurai		0					0		0		0		0		06,000		6,000
Dr. S.P. Somashekhar		0		~~116,348~~0	*		0		0		0		0		06,000		6,000
Tim Adams		0		0					0		0		0		8,819		8,819
Frederic H Moll		0		0					0		0		0		15,999		15,999

*(1) Represents athe ~~grant~~value of ~~restricted~~options ~~shares~~to ofpurchase ~~our~~ common stock ~~awarded~~granted under our 2016 Incentive Plan. The ~~grant~~option ~~has~~vests ~~fully~~in ~~vested~~five asequal annual instalments commencing upon the date of ~~December~~grant ~~31,~~and ~~2023~~expires five years from the date of grant.

(1) Represents a grant of restricted shares of our common stock awarded under our Incentive Plan. The option grant vests in five equal annual instalments commencing upon the date of grant.

(2) Represents an option to purchase common stock granted under our Incentive Plan. The option vests in five equal annual instalments commencing upon the date of grant and expires five years from the date of grant.

Narrative Disclosure to the Director Compensation Table

~~The~~We ~~Company~~compensate ~~has~~our ~~not established a formal compensation arrangement for its~~ non-employee directors ~~but anticipates that they will initially be compensated~~ with cash ~~periodic~~fees ~~grant~~ of ~~options under the 2016 Incentive Stock Plan~~$1,500 inper ~~the discretion of the board of directors~~meeting. Non-employee directors are also reimbursed for travel and lodging expenses in connection with their attendance at in-person meetings of the board. ~~When~~Following ~~the~~completion ~~Company~~of isthis ~~sufficiently capitalized~~offering, ~~the~~ ~~Company~~we ~~may~~intend ~~institute~~to ~~payment~~implement ofan ~~cash~~equity-based ~~directors’~~compensation ~~fees~~plan tofor our ~~its~~ non-employee directors in ~~amounts~~conjunction towith beour ~~determined at that time~~advisors.

2016 Incentive Stock Plan

Our 2016 Incentive ~~Stock~~ Plan ~~(the “Incentive Plan”)~~ provides for equity incentives to be granted to our employees, executive officers or directors or to key advisers or consultants. Equity incentives may be in the form of stock options with an exercise price not less than the fair market value of the underlying shares as determined pursuant to the ~~Incentive~~ 2016 Plan, restricted stock awards, other stock-based awards, or any combination of the foregoing. ~~The~~In ~~Incentive~~the absence of a compensation committee, the 2016 Plan iswas administered by the ~~compensation~~board ~~committee,~~of ordirectors. ~~alternatively~~However, ifwith ~~there~~the isrecent noconstitution of compensation committee, the ~~board~~Plan ofwill henceforth ~~directors.~~be 8administered by the compensation committee,~~831~~ 3,~~005~~000,000 shares of our common stock ~~are~~were ~~currently~~originally reserved for issuance pursuant to the exercise of awards under the ~~Incentive~~2016 Plan. ~~The~~In August 2019, our board of directors and our majority shareholders approved an increase in the number of shares so reserved ~~automatically~~under ~~adjusts~~the ~~upward~~2016 onPlan ~~January~~to 110,000,000 shares of ~~each~~our ~~year~~common stock. Our board of directors and majority shareholders in July 2022, soapproved ~~that~~a subsequent increase in the number of shares ~~covered~~ byof ~~the~~our ~~Incentive~~common ~~Stock~~stock reserved under the 2016 Plan isto ~~equal~~20,000,000 shares of common stock. Our board of directors and majority shareholders in October 2023 mandated to keep 10% of our issued and outstanding common shares ~~stock~~reserved under the 2016 Incentive Stock Plan. As of December 31, ~~2023~~2025, we have granted options to purchase 47,~~529~~578,~~838~~181 shares under the ~~Incentive~~2016 Plan, exercisable at ~~prices~~a ~~ranging~~weighted ~~from~~average price of $5.00 ~~to $7.13~~ per share and ~~awarded 4~~3,~~301~~554,~~167~~477 shares in ~~restricted~~ stock grants.

61The 2016 Incentive Plan (but not awards under the 2016 Incentive Plan) expires in accordance with its terms on February 1, 2026. We intend to implement a new equity incentive plan following the completion of this offering.

~~Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters~~73

~~The following table sets forth, as of the date~~Security ofOwnership ~~December 31, 2023, the beneficial ownership~~ of ~~our~~Certain ~~common~~Beneficial ~~stock~~Owners ~~by (i) each director~~ and ~~executive~~Management ~~officer; (ii) directors~~ and ~~executive officers~~Related Shareholder ~~as a group; (iii) each other five percent (5%) beneficial owner of our common stock.~~Matters

The ~~percentage~~following ~~ownership~~table ~~information~~sets ~~shown~~forth, ~~in the~~as ~~table~~of isthis ~~based upon 170~~prospectus,~~711,881~~ the ~~shares~~beneficial ownership of our common stock ~~outstanding~~by as(i) ofeach ~~December~~director ~~31,~~and ~~2023. Unless~~executive ~~otherwise~~officer; ~~stated,~~(ii) ~~the~~directors ~~address of~~and ~~the~~executive ~~persons~~officers ~~set~~as ~~forth~~a ingroup; (iii) ~~the~~each ~~table~~five ispercent ~~c/o~~(5%) ~~the~~beneficial ~~Company~~owner of our common stock.

The percentage ownership information shown in the table reflects beneficial ownership prior to and immediately after the completion of this offering and is based upon 194,356,700 shares of common stock outstanding as of the date of this prospectus (including 191,559 shares being processed for issuance in connection with employee stock grants under the 2016 Incentive Plan) and assumes there are 205,643,381 shares of our common stock outstanding as of the date immediately following the completion of this offering, assuming no exercise by the underwriters of their option to purchase additional shares of our common stock. Unless otherwise stated, the address of the persons set forth on the table is c/o the Company.

Beneficial ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to the securities. Except as otherwise indicated, each person or entity named in the table has sole voting and investment power with respect to all shares of our capital shown as beneficially owned, subject to applicable community property laws. In accordance with SEC rules, shares of our common stock which may be acquired upon exercise of stock options which are currently exercisable or which become exercisable within sixty (60) days of the date of this prospectus are deemed beneficially owned by the holders of such options and are deemed outstanding for the purpose of computing the percentage of ownership of such person, but are not treated as outstanding for the purpose of computing the percentage of ownership of any other person.

Names and addresses of beneficial owners	Number of shares of common stock		Percentage of class Before Offering (%)			Percentage of class After Offering (%)
	Number of shares of		Percentage of class (%)
Names and addresses of beneficial owners	common stock		Before			After
Directors and executive officers
Sudhir Srivastava, M.D.(1)		~~120~~116,~~128~~257,~~489~~301		7058.3735	%		55.23	%
Anup Sethi(4)		865,592		*
Milan Rao(2)		20,000		*			*
Vishwajyoti P. Srivastava, M.D.(2)		845,592		*
Vishwajyoti P. Srivastava, M.D.(3)		507,355		*			*
Barry F. Cohen(3)		9,422,546		5.52
Barry F. Cohen(4)		8,345,443		4.28	%		4.05	%
Dr. Mylswamy Annadurai		0-		-*			*
Dr. S.P. Somashekhar(5)		~~232~~341,~~696~~165		*			*
All directors and executive officers as a group (six persons)(6)		131,494,915		77.03
Tim Adams		5,031,902		2.59	%		2.45	%
5% or greater stockholders
Dr. Frederic H Moll		20,335,045		10.46	%		9.89	%
Dr. Frederic H. Moll		10,274,293		6.02
All directors and executive officers as a group (eight persons)(6)		150,838,211		76.13	%		72.03	%
4000 E. Denny Blaine Place Seattle, WA 98101
5% or greater shareholders
Manipal Global Health Services(7)		14,949,070		7.69	%		7.27	%
22, St. Georges Street, Port Louis 11302, Mauritius

Unless otherwise indicated, the address for all our directors and executive officers is, care of the Company, 404-405, 3rd Floor, iLabs Info Technology Centre, Udyog Vihar, Phase III, Gurugram, Haryana 122016, India.

*	Less than 1%.

(1) Includes (a) 117,559,713 shares held of record by Sushruta Pvt. Ltd. (“Sushruta”), a Bahamian holding company beneficially owned by Dr. Sudhir Srivastava; (b) 32,000 shares held by Sudhir Srivastava Innovations Pte. Ltd., a Singapore registered company beneficially owned by Dr Sudhir Srivastava; and (c) 2,536,776 shares issuable upon the exercise of vested stock options granted under our Incentive Plan. Sushruta also holds of record all 1,000 issued and outstanding Series A Preferred Shares, which entitle the holder to 51% of the total voting power of the Company.

(1)	Includes (a) 111,343,014 shares held of record by Sushruta, a Bahamian holding company beneficially owned by Dr. Sudhir Srivastava; (b) 32,000 shares held by Dr Sudhir Srivastava; and (c) 4,872,287 shares issuable upon the exercise of vested stock options granted under our 2016 Incentive Plan. Sushruta also holds all 1,000 issued and outstanding Series A Preferred Shares, which entitles the holder to 51% of the total voting power of the Company.

(2)	Represents a grant of 20,000 shares of our common stock awarded under our 2016 Incentive Plan which vest within sixty (60) days of the date of this prospectus.

(23) ~~Represents~~Includes ~~845~~507,~~592~~355 shares issuable upon the exercise of vested stock options granted under ~~our~~the 2016 Incentive Plan.

(34) Includes ~~920~~507,~~592~~355 shares issuable upon the exercise of vested stock options granted under the 2016 Incentive Plan.

(4)	Includes 676,474 stock awards which will be vesting over 4 years from the grant date.
(5)	Includes a grant of 116,348 restricted shares of our common stock awarded under our Incentive Plan. The grant has fully vested as of December 31, 2023.

(5)	Includes a grant of 166,348 fully vested restricted shares of our common stock awarded under our 2016 Incentive Plan and 58,469 shares of common stock held by his spouse Dr. Manjiri Somashekhar.

(6)	Includes the items in footnotes (1) – (5) above.

62(7) Dr. Ranjan R. Pai is the beneficial owner of the shares of common stock held of record by Manipal Global Health Services.

The people named above have full voting and investment power with respect to the shares indicated. Under the rules of the SEC, a person (or group of persons) is deemed to be a “beneficial owner” of a security if he or she, directly or indirectly, has or shares the power to vote or to direct the voting of such security, or the power to dispose of or to direct the disposition of such security. Accordingly, more than one person may be deemed to be a beneficial owner of the same security.

Certain Relationships and Related Transactions, and Director Independence

Related Party Transactions

On April 15, 2023, the Company executed a Convertible Promissory Note (the “Line of Credit Note”) with Sushruta, the Bahamian holding company owned by Dr. Sudhir Srivastava, our Chairman, Chief Executive Officer, and principal shareholder. Pursuant to the Line of Credit Note, ~~SPL~~Sushruta, ~~agreed,~~in toits discretion may make multiple advances to the Company, ~~in its discretion,~~ through December 31, 2023 (the “Maturity Date”), in an aggregate amount of up to to $20.0,000,000 ~~million~~ for working capital purposes. The advances under the Line of Credit Note ~~did~~do not bear interest and ~~were~~are due and payable on on or before the Maturity Date. ~~SPL~~Sushruta may, ~~had~~at ~~the~~its option, to convert the principal amount of any advance into shares of our common stock, at at a conversion price of $0.74 per ~~Share~~share. AsDuring ofthe ~~September~~year 27ended December 31, 2023, $16,980,000 in advances that were outstanding under the Line of Credit Note~~. On September 27~~, ~~2023,~~were ~~SPL~~converted ~~exercised~~into ~~its~~22,945,945 ~~option~~shares issued to ~~convert~~Sushruta at the ~~$16,980,000~~conversion inprice ~~advances~~of ~~that~~$0.74 ~~were~~per ~~outstanding~~share ~~under~~and ~~the~~as ~~Line~~ of ~~Credit~~ ~~Note~~December ~~into~~31, 222023,~~945,946~~ ~~shares~~there atwere ~~the~~no ~~conversion~~further ~~price~~advances ofconvertible ~~$0.74~~under ~~per~~the ~~Share~~Line of Credit Note.

~~Effective~~In ~~February~~September 142022, ~~2024~~November 2022, ~~the~~December ~~Company sold~~2022 ~~$1,000,000~~and inApril ~~principal~~2023, ~~amount of 7% Convertible One-Year Promissory Notes (~~the ~~“Bridge~~Company ~~Notes”)~~issued ~~to two investors in~~ a ~~private~~total ~~transaction, one~~ of ~~whom~~four ~~was~~convertible ~~Sushruta.~~redeemable ~~Interest~~notes onin the ~~Bridge~~aggregate ~~Notes~~principal ~~accrues~~amount ~~at the rate~~ of 7%$3,000,000 ~~per~~to ~~annum~~Dr. Frederic ~~and~~Moll. isOn ~~payable~~April ~~together with~~14, ~~the~~2023, ~~principal~~upon ~~amount~~completion onof the ~~maturity~~CardioVentures ~~date~~Merger, ~~which is one year from issuance~~Dr. AtFrederic ~~the~~Moll, ~~option~~a ofcurrent ~~the noteholder~~director, ~~the~~converted ~~Bridge Notes may~~$3,049,364 be(comprising ~~converted~~$3,000,000 atof ~~any~~principal ~~time~~and ~~prior~~$49,364 toin ~~maturity~~accrued ~~into~~interest) ~~Shares at a conversion price~~ of ~~$4.45,~~his ~~subject~~convertible tonotes ~~adjustment~~into ~~for stock splits~~3,767,933 ~~stock~~shares ~~dividends and~~of ~~similar~~our ~~recapitalization~~common ~~events~~stock.

~~The~~Effective ~~Company~~February ~~has~~14, 2024, the Company sold $2,450,000 ~~two~~in ~~surgical~~principal ~~robotic~~amount ~~systems to~~of ~~Aster~~7% ~~Hospitals~~Convertible ~~group~~One-Year Promissory Notes (~~one~~the “Bridge Notes”) to ~~Aster~~five ~~Hospitals~~investors ~~Dubai~~in a ~~and~~private ~~another~~transaction, toone ~~Aster~~of ~~CMI~~whom ~~hospital~~was Sushruta, ~~Bangalore~~who subscribed for a $1,000,000 ~~India).~~Bridge DrNote. SPInterest ~~Somashekhar,~~on athe ~~director~~Bridge Notes accrued at the rate of 7% per annum and was payable together with the ~~Company~~principal amount upon maturity, ~~holds~~which was one year from issuance. The Bridge Notes were convertible at the ~~positions~~option of ~~Chairman~~the -noteholders, ~~Medical~~at ~~Advisory~~any ~~Board,~~time ~~Aster~~prior DMto ~~Healthcare~~maturity -into ~~GCC~~shares &of ~~India~~our ~~and~~common ~~Global~~stock ~~Director~~at -a conversion ~~Aster~~price ~~International~~of ~~Institute~~$4.45 ofper ~~Oncology~~share. -Sushruta’s ~~GCC~~Bridge &Note, ~~India~~together with accrued interest thereon, was repaid upon maturity in February 2025.

DrIn ~~Sudhir~~April ~~Kumar Rawal~~2024, athe ~~director~~Company onraised ~~the~~$2,000,000 ~~board~~from Sushruta by the issuance of ~~SSI~~two ~~India~~7% Notes of $1,000,000 aeach, ~~subsidiary~~to ofmeet certain working capital requirements. In July 2024, the Company raised $500,000 ~~beneficially~~from ~~owns~~Sushruta ~~477,084~~by ~~restricted~~the ~~shares~~issuance of ~~our~~an ~~common~~additional ~~stock~~7% ~~awarded~~Note to ~~him~~finance ~~under~~its ~~the~~ongoing ~~Incentive~~working capital requirements. In October 2024, ~~Plan~~the ~~towards~~Company ~~his~~raised ~~medical~~$500,000 ~~advisory~~from ~~and~~Sushruta ~~proctorship~~by ~~services~~issuance ~~for~~of a ~~period~~7% ofNote ~~five~~to ~~years.~~finance ~~The~~its ~~grant~~ongoing ~~has~~working ~~fully~~capital ~~vested~~requirements. asAll of ~~December~~the ~~31,~~7% ~~2023~~Notes were repaid in full together with accrued interest thereon, upon maturity in February 2025.

WeDr. ~~have~~Sudhir ~~granted~~Srivastava, ~~stock~~through ~~options~~Sushruta, toprovided the ~~certain~~Company ofwith ~~our executive~~$2,000,000 ~~officers.~~in ~~See~~financing ~~“Executive~~on ~~Compensation — Outstanding~~December ~~Equity~~4, ~~Awards~~2024, at$5,000,000 ~~Year-End”~~in ~~above~~financing ~~for~~on January 3, 2025, $10,000,000 in financing on aJanuary ~~description~~20, of2025, ~~these~~$5,000,000 ~~stock~~in ~~options~~financing ~~outstanding~~on asJanuary of30, ~~December~~2025 31and $8,000,000 ~~2023~~in financing on March 17, 2025.

The financing provided by Dr. Srivastava was evidenced by the One-Year Notes. The One-Year Notes bore interest at the rate of seven percent (7%) per annum, which accrued and was due at maturity. The One-Year Notes were convertible at the option of the holder into shares of our common stock at a conversion price of $1.38 per share, subject to adjustment for stock splits, stock dividends and similar recapitalization events. As of March 31, 2025, all $30,000,000 in principal amount of One-Year Notes, together with $164,548 in interest thereon, were converted by Sushruta into 21,858,368 shares of our common stock.

We have issued stock options and stock awards to certain of our executive officers. See “Executive Compensation – Outstanding Equity Awards at Fiscal Year-End Table” above for a description of these stock options outstanding as of December 31, 2025.

Other than as described above, there has not been, nor is there any currently proposed, transactions or series of similar transactions to which we have been or will be a party.

Review, Approval and Ratification of Related Party Transactions

~~Prior~~It tois ~~the date of this prospectus, we had not adopted formal policies and procedures for the review, approval or ratification of transactions with~~ our ~~executive officers, directors and significant stockholders. However, upon effectiveness of the registration statement of which this prospectus forms a part, we will implement a formal~~ policy ~~whereby~~that our executive officers, directors, beneficial holders of more than 5% of our outstanding common stock and any entity affiliated with any of the foregoing persons, are not permitted to enter into a related party transaction with us without the prior consent of our audit committee, or other independent members of our board of directors, if it is inappropriate for our audit committee to review such transaction due to a conflict of interest.

Indemnification Agreements

We have entered into indemnification agreements with each of our directors and executive officers. The indemnification agreements, our amended and restated certificate of incorporation and our bylaws require us to indemnify our directors to the fullest extent permitted by Florida law.

Information related to the independence of our directors is provided under the section titled “Directors, Executive Officers and Corporate Governance.”

6375

DESCRIPTION OF CAPITAL STOCK

~~Our~~The ~~authorized~~following description of our capital stock is ~~consists~~not ofcomplete ~~250,000,000 shares~~and ofmay ~~common~~not ~~stock,~~contain ~~par~~all ~~value~~the ~~$0.0001~~information ~~(“shares”),~~you ~~and~~should ~~5,000,000~~consider ~~shares~~before ofinvesting ~~preferred~~in our capital stock,. ~~par~~See ~~value~~“Where You $0Can Find More Information.~~0001. As~~” ofFor ~~December~~a ~~31,~~complete ~~2023~~description, ~~170,711,881~~you ~~shares~~should ofrefer ~~common~~to ~~stock~~our amended and ~~1,000~~restated ~~shares~~certificate of ~~preferred~~incorporation and ~~stock~~amended and restated bylaws, ~~all~~copies of which are ~~designated~~included as ~~shares of~~exhibits ~~Series~~to ~~A Non-Convertible Preferred Stock (~~the ~~“Series~~registration Astatement ~~Preferred~~of ~~Shares”),~~which ~~are~~this ~~issued~~prospectus ~~and~~forms a ~~outstanding~~part.

Our authorized capital stock consists of 250,000,000 shares of common stock, par value $0.0001, and 5,000,000 shares of preferred stock, par value $0.0001. As of the date of this prospectus, 194,356,700 shares of common stock (including 191,559 shares being processed for issuance in connection with employee stock grants under the 2016 Incentive Plan) and 1,000 shares of Series A Preferred Shares, were issued and outstanding.

Common Stock

The shares of common stock presently outstanding are and the shares ~~of common stock~~ being offered and sold in ~~the~~this ~~Offering~~offering, when paid for and issued as provided for in this prospectus, will be fully paid and non-assessable. Each holder of common stock is entitled to one vote for each share owned on all matters voted upon by ~~stockholders~~shareholders, and a majority vote is required for all actions to be taken by ~~stockholders~~shareholders. In the event we liquidate, dissolve or wind-up our operations, the holders of the common stock are entitled to share equally and ratably in our assets, if any, remaining after the payment of all our debts and liabilities and the liquidation preference of any shares of preferred stock that may then be outstanding. The common stock has no preemptive rights, no cumulative voting rights, and no redemption, sinking fund, or conversion provisions.

Holders of common stock are entitled to receive dividends, if and when declared by the board of directors, out of funds legally available for such purpose, subject to the dividend and liquidation rights of any preferred stock that may then be outstanding.

Preferred Stock

General

Our board of directors has the authority, without further action by the ~~stockholders~~shareholders, to issue shares of preferred stock in one or more series and to fix the rights, preferences and the number of shares constituting any series or the designation of such series. While our Amended and Restated Articles of Incorporation and bylaws do not contain any provisions that may delay, defer or prevent a change in control, the issuance of preferred stock may have the effect of delaying or preventing a change in control or make removal of our management more difficult.

Series A Preferred Shares

The 1,000 issued and outstanding shares of preferred stock which are designated as the Series A Preferred Shares were issued to Sushruta, Dr. Sudhir Srivastava’s Bahamian holding company, in connection with the consummation of the April 14, 2023 CardioVentures Merger.

The Series A Preferred Shares vote together with shares of our common stock as a single class on all matters presented to a vote of ~~stockholders~~shareholders, except as required by law and entitle the holder to exercise 51% of the total combined voting power of the Company, without regard to the number of shares of common stock outstanding. The Series A Preferred Shares are not convertible into common stock, do not have any dividend rights and do have a nominal liquidation preference. The Series A Preferred Shares also have certain protective provisions, such as requiring the vote of a majority of Series A Preferred Shares to change or amend their rights, powers, privileges, limitations and restrictions. The Series A Preferred Shares are automatically redeemed by the Company for nominal consideration at such time as the holder owns less than 50% of the shares issued to it in connection with the CardioVentures Merger.

64Representative Warrants

We have agreed to issue to Roth Capital Partners LLC the Representative Warrants to purchase a number of our shares of common stock equal to an aggregate of 5% of the shares of common stock sold in this offering. See “Underwriting — Representative Warrants.”

Certain Florida Legislation

Florida has enacted legislation that may deter or frustrate takeovers of Florida corporations. The Florida Control Share Act generally provides that shares acquired in a “control share acquisition” will not possess any voting rights unless such voting rights are approved by a majority of the corporation’s disinterested ~~stockholders~~shareholders. A “control share acquisition” is an acquisition, directly or indirectly, by any person of ownership of, or the power to direct the exercise of voting power with respect to, issued and outstanding “control shares” of a publicly held Florida corporation. “Control shares” are shares, which except for the Florida Control Share Act, would have voting power that, when added to all other shares owned by a person or in respect to which such person may exercise or direct the exercise of voting power in the election of directors within any of the following ranges: (i) at least 20% but less than 33-1/3% of of all voting power; (ii) at least 33-1/3% but less than a majority of all voting power; or (iii) a majority or more of all voting power. The Florida Affiliated Transactions Act generally requires supermajority approval by disinterested ~~stockholders~~shareholders of certain specified ~~transactions~~ transactions between a public company and holders of more than 10% of the outstanding voting shares of the corporation (or their affiliates). ~~Florida~~ Florida law and the Company’s Amended and Restated Articles of Incorporation and Bylaws also authorize the Company to indemnify the Company’s Amended and Restated Articles of Incorporation and Florida law presently limit the personal liability of corporate directors for monetary damages , except where directors(i) breach their fiduciary duties; and (ii) such breach constitutes or includes certain violations of criminal law, a transaction from which the directors derived ~~and~~an improper personal benefit, certain unlawful distributions or certain other reckless, wanton or willful acts or misconduct.

Transfer Agent and Registrar

The Company has appointed VStock Transfer, LLC, 18 Lafayette Place, Woodmere, New York 11598 as transfer agent and registrar for its common stock. Shares of our common stock will be issued in uncertificated form only, except in limited circumstances.

Market Listing

Our common stock ~~trades~~is onlisted ~~the~~for ~~OTCPink~~trading ~~tier of over-the-counter market under the symbol “SSII.” We have applied to list our common stock~~ on ~~the~~ Nasdaq ~~Capital Market~~ under the symbol “SSII.” However, the trading market for our common stock is sporadic and extremely limited. No assurance can be given that such listing will be approved or that an active trading market will develop for the common stock.

6577

MATERIAL U.S. FEDERAL INCOME TAX CONSIDERATIONS ~~FOR HOLDERS OF OUR COMMON STOCK~~

The following discussion ~~describes~~is ~~the~~a ~~material~~summary of certain material U.S. federal income tax consequences of the ~~acquisition~~purchase, ownership and disposition of ~~our~~the shares of common stock ~~acquired~~issued inpursuant to this ~~Offering.~~offering, ~~This discussion~~but isdoes ~~based~~not onpurport ~~the~~to ~~current~~be ~~provisions~~a complete analysis of ~~the~~all ~~Internal~~potential ~~Revenue~~tax ~~Code~~effects. The effects of ~~1986~~other U.S. federal tax laws, such as ~~amended~~estate and gift tax laws, and any applicable state, local or foreign tax laws are not discussed. This discussion is based on the Internal Revenue Code of 1986, ~~existing~~as ~~and~~amended ~~proposed~~(the ~~U.S.~~ “Code”), Treasury ~~regulations~~Regulations promulgated thereunder, judicial decisions, and ~~administrative~~published rulings and ~~court~~administrative ~~decisions~~pronouncements of the U.S. Internal Revenue Service (the “IRS”) in effect as of the date ~~hereof,~~of ~~all~~this ofoffering. ~~which are~~These authorities may change or be subject to differing interpretations. Any such change ator ~~any~~differing interpretation ~~time,~~may ~~possibly~~be ~~with~~applied ~~retroactive~~retroactively ~~effect.~~in Noa ~~ruling~~manner ~~has~~that ~~been~~could oradversely ~~will~~affect bea ~~sought~~holder ~~from~~of the ~~Internal~~shares. ~~Revenue~~We ~~Service,~~have not sought and will ornot ~~IRS,~~seek ~~with~~any ~~respect~~rulings tofrom the IRS regarding the matters discussed below,. ~~and~~There ~~there~~ can be no assurance that the IRS or a court will not take a contrary position regarding the tax consequences of the ~~acquisition~~purchase, ownership orand disposition of ~~our~~the ~~common stock, or that any such contrary position would not be sustained by a court~~shares.

WeThis ~~assume~~discussion inis ~~this~~limited ~~discussion~~to holders that hold the shares of ~~our~~as ~~common~~a ~~stock~~“capital ~~will~~asset” bewithin ~~held~~the asmeaning ~~capital~~of ~~assets~~Section 1221 of the Code (generally, property held for investment). This discussion does not address all aspects of U.S. federal income ~~taxes,~~taxation ~~does~~that ~~not~~may ~~discuss~~be ~~the~~relevant ~~potential~~to ~~application~~a ofparticular ~~the~~holder ~~Medicare~~in ~~contribution~~light ~~tax~~of onthat holder’s ~~net~~individual ~~investment~~circumstances, ~~income~~nor ~~or the~~does it address any alternative minimum, Medicare contribution, estate or gift tax ~~and~~consequences, or ~~does~~any ~~not~~aspects ~~deal~~of ~~with~~U.S. state, local or ~~local~~non-U.S. taxes, or any other U.S. federal ~~gift~~tax ~~and~~laws. ~~estate~~This discussion also does not address consequences relevant to holders subject to special tax ~~laws~~rules, ~~except~~such as ~~specifically~~holders that own, or are deemed to own, more than 5% of our capital stock (except ~~provided~~to the extent specifically set forth below), ~~with~~corporations ~~respect~~that accumulate earnings to ~~non-~~avoid U.S. ~~holders~~federal income tax, tax-exempt organizations, governmental organizations, banks, financial institutions, investment funds, insurance companies, brokers, dealers or ~~any~~traders ~~non-~~in securities, commodities or currencies, regulated investment companies or real estate investment trusts, persons that have a “functional currency” other than the U.S. dollar, tax-qualified ~~consequences~~retirement ~~that~~plans, ~~may~~holders bewho ~~relevant~~hold or receive our securities pursuant to the exercise of employee stock options or otherwise as compensation, holders inholding ~~light~~our securities as part of ~~their~~a ~~particular~~hedge, straddle or other risk reduction strategy, ~~circumstances.~~conversion ~~This~~transaction ~~discussion~~or ~~also~~other ~~does~~integrated ~~not~~investment, ~~address~~holders deemed to sell our securities under the constructive sale provisions of the Code, holders subject to special tax accounting rules ~~applicable~~under toSection ~~particular~~451(b) ~~holders~~of the Code, ~~such~~controlled asforeign corporations, passive foreign investment companies and certain former U.S. citizens or long-term residents.

●If ~~financial~~a ~~institutions;~~partnership (or other entity or arrangement treated as a partnership for U.S. federal income tax purposes) holds the shares, the tax treatment of a partner in the partnership will depend on the status of the partner, the activities of the partnership and certain determinations made at the partner level. Accordingly, partnerships holding the shares and the partners in such partnerships should consult their tax advisors regarding the U.S. federal income tax consequences to them.

●THIS ~~brokers~~DISCUSSION orIS ~~dealers~~FOR inINFORMATION ~~securities~~PURPOSES ONLY orAND ~~currencies~~IS NOT INTENDED AS LEGAL OR TAX ADVICE. INVESTORS SHOULD CONSULT THEIR TAX ADVISORS WITH RESPECT TO THE APPLICATION OF THE U.S. FEDERAL INCOME TAX LAWS TO THEIR PARTICULAR SITUATIONS AS WELL AS ANY TAX CONSEQUENCES OF THE PURCHASE, orOWNERSHIP ~~traders~~AND inDISPOSITION ~~securities~~OF ~~that~~THE SECURITIES ~~elect~~ARISING toUNDER ~~use~~THE aU.S. ~~mark~~FEDERAL ESTATE OR GIFT TAX LAWS OR UNDER THE LAWS OF ANY STATE, LOCAL OR NON-~~to-market~~U.S. ~~method~~TAXING ofJURISDICTION OR ~~accounting~~UNDER ~~for~~ANY ~~their~~APPLICABLE ~~securities~~INCOME ~~holdings;~~TAX TREATY.

~~● tax-exempt organizations;~~78

● pension plans;

● regulated investment companies, real estate investment trusts;

● owners that hold our common stock as part of a straddle, hedge, conversion transaction, synthetic security or other integrated investment;

● insurance companies;

● persons that own, or are deemed to own, more than 5% of our capital stock (except to the extent specifically set forth below);

● entities or arrangements treated as partnerships for U.S. federal income tax purposes and other pass-through entities (and partners or other investors therein);

● controlled foreign corporations, passive foreign investment companies, or corporations that accumulate earnings to avoid U.S. federal income tax;

● persons subject to special tax accounting rules as a result of any item of gross income with respect to our common stock being taken into account in an applicable financial statement;

● persons deemed to sell our common stock under the constructive sale provisions of the Code; and

● certain U.S. expatriates and certain former citizens or long-term residents of the United States.

In addition, this discussion does not address the tax treatment of partnerships or other pass-through entities or persons who hold our common stock through partnerships or other entities which are pass-through entities for U.S. federal income tax purposes. A partner in a partnership or other pass-through entity that will hold our common stock should consult his, her or its own tax advisor regarding the tax consequences of the ownership and disposition of our common stock through a partnership or other pass-through entity, as applicable.

This discussion of U.S. federal income tax considerations is for general information purposes only and is not tax advice. Prospective investors should consult their own tax advisors regarding the U.S. federal, state, local and non-U.S. income and other tax considerations of acquiring, holding and disposing of our common stock.

For the purposes of this discussion, a “U.S. Holder” means a beneficial owner of our common stock that is, for U.S. federal income tax purposes: (a) an individual who is a citizen or resident of the United States; (b) a corporation (or other entity taxable as a corporation for U.S. federal income tax purposes), created or organized in or under the laws of the United States, any state thereof or the District of Columbia; (c) an estate the income of which is subject to U.S. federal income taxation regardless of its source; or (d) a trust if it (1) is subject to the primary supervision of a court within the United States and one or more U.S. persons (within the meaning of Section 7701(a)(30) of the Code) have the authority to control all substantial decisions of the trust or (2) has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person. A “Non-U.S. Holder” is, for U.S. federal income tax purposes, a beneficial owner of common stock that is not a U.S. Holder or an entity or arrangement treated as a partnership for U.S. federal income tax purposes.

Tax Considerations Applicable to U.S. Holders

The following is a summary of the U.S. federal income tax consequences that will apply to a U.S. holder (as defined below) of the shares.

Definition of a U.S. Holder

For purposes of this discussion, a “U.S. holder” is any beneficial owner of the shares that, for U.S. federal income tax purposes, is or is treated as any of the following:

	●	an individual who is a citizen or resident of the U.S.;

	●	a corporation or an entity treated as a corporation for U.S. federal income tax purposes, created or organized under the laws of the U.S., any state thereof, or the District of Columbia;

	●	an estate, the income of which is subject to U.S. federal income tax regardless of its source; or

	●	a trust that (1) is subject to the primary supervision of a U.S. court and the control of one or more U.S. persons (within the meaning of Section 7701(a)(30) of the Code), or (2) has made a valid election under applicable Treasury Regulations to be treated as a U.S. person for U.S. federal income tax purposes.

Distributions

As ~~discussed~~described ~~above,~~in wethe ~~currently~~section ~~anticipate~~entitled ~~that~~“Dividend ~~we will retain future earnings~~Policy,” ifwe ~~any, to finance the growth and development of our business and~~ do not currently intend to pay any cash dividends in ~~respect~~on of our ~~common~~capital stock in the foreseeable future. InHowever, ~~the~~if ~~event that~~ we do make distributions of cash or property on our common stock to(other athan ~~U.S.~~certain ~~Holder, those~~ distributions ~~generally~~of ~~will~~common ~~constitute~~stock ~~dividends~~or ~~for~~rights ~~U.S.~~to ~~tax~~acquire ~~purposes~~our stock), such distributions will constitute dividends to the extent paid out of our current or accumulated earnings and profits, (as determined for ~~under~~ U.S. federal income tax ~~principles)~~purposes. ~~Distributions~~Dividends inreceived ~~excess~~by ofa ~~our~~corporate ~~current~~U.S. ~~and~~holder ~~accumulated~~may ~~earnings and~~be ~~profits~~eligible ~~will~~for ~~constitute~~ a ~~return~~dividends ofreceived ~~capital~~deduction, subject ~~that~~to isapplicable ~~applied~~limitations ~~against~~(including ~~and~~holding ~~reduces,~~period ~~but~~requirements). ~~not~~With ~~below~~certain ~~zero~~exceptions, adividends received by certain non-corporate U.S. ~~Holder’s~~holders, ~~adjusted tax~~including ~~basis~~individuals, inare ~~our~~generally ~~common~~taxed ~~stock.~~at ~~Any~~the ~~remaining~~lower ~~excess~~applicable ~~will~~capital begains ~~treated~~rate asprovided ~~gain~~certain ~~realized~~holding onperiod ~~the~~and other ~~sale~~requirements orare ~~exchange~~satisfied. Distributions in excess of our ~~common~~current ~~stock~~and asaccumulated ~~described below~~earnings ~~under~~and ~~the~~profits ~~section~~will ~~titled~~constitute “—a ~~Disposition~~ return of ~~Our~~capital ~~Common~~and ~~Stock.”~~first ~~Under~~be ~~current~~applied ~~law,~~against ifand ~~certain~~reduce ~~requirements are met,~~ a ~~preferential~~ U.S. ~~federal~~holder’s ~~income~~adjusted tax ~~rate~~basis in its common stock, but not below zero. Any excess will ~~apply~~be totreated ~~any~~as ~~dividends~~capital ~~paid~~gain toand ~~the~~will ~~beneficial~~be ~~owner~~treated ofas ~~our~~described ~~common~~below ~~stock~~in ~~who is~~the ansection ~~individual~~relating ~~U.S.~~to ~~Holder~~the ~~and~~sale ~~meets~~or ~~certain~~disposition ~~holding~~of ~~period~~our common ~~requirements~~stock.

~~Distributions~~Sale ~~constituting dividends for U.S. federal income tax purposes that are made to U.S. Holders that are corporate stockholders may qualify for the dividends received deduction,~~ or ~~DRD,~~Other ~~which~~Taxable isDisposition ~~generally~~of ~~available to corporate stockholders. No assurance can be given that we will have sufficient earnings and profits~~Common ~~(as~~Stock determined for U.S. federal income tax purposes) to cause any distributions to be eligible for a DRD. In addition, a DRD is available only if certain holding periods and other taxable income requirements are satisfied.

~~Disposition~~Upon the sale, exchange or other taxable disposition of ~~Our~~the ~~Common~~common ~~Stock~~stock, a U.S. holder generally will recognize capital gain or loss equal to the difference between (a) the amount of cash and the fair market value of any property received upon the sale, exchange or other taxable disposition and (b) such U.S. holder’s adjusted tax basis in the common stock. Such capital gain or loss will be long- term capital gain or loss if the U.S. holder’s holding period in such common stock is more than one year at the time of the sale, exchange or other taxable disposition. Long-term capital gains recognized by certain non-corporate U.S. holders, including individuals, generally will be subject to reduced rates of U.S. federal income tax. The deductibility of capital losses is subject to certain limitations. U.S. holders who hold different blocks of shares of common stock (shares of common stock purchased or acquired on different dates or at different prices) should consult their tax advisors to determine how the above rules apply to them.

Upon a sale or other taxable disposition of our common stock , a U.S. Holder generally will recognize capital gain or loss in an amount equal to the difference between the amount realized and the U.S. Holder’s adjusted tax basis in the common stock. Capital gain or loss will constitute long-term capital gain or loss if the U.S. Holder’s holding period for the common stock exceeds one year. The deductibility of capital losses is subject to certain limitations. U.S. Holders who recognize losses with respect to a disposition of our common stock should consult their own tax advisors regarding the tax treatment of such losses.79

Information Reporting and Backup Withholding

~~Information~~A U.S. ~~reporting~~holder ~~requirements~~may ~~generally will~~be ~~apply~~subject to ~~payments~~information ofreporting ~~dividends~~and ~~(including~~backup ~~constructive~~withholding ~~dividends)~~when such holder receives payments on the common stock ~~and~~or receives ~~to the~~ proceeds offrom athe sale or other taxable disposition of common stock ~~paid by us to a U~~.S. ~~Holder~~Certain ~~unless such~~ U.S. ~~Holder~~holders isare an exempt ~~recipient,~~from ~~such~~backup ~~as a corporation. Backup~~ withholding, ~~will~~including ~~apply~~corporations toand ~~those~~certain ~~payments~~tax-exempt iforganizations. ~~the~~A U.S. ~~Holder fails to provide the~~ holder’s ~~taxpayer~~will ~~identification~~be ~~number,~~subject orto ~~certification of~~backup ~~exempt~~withholding ~~status, or~~ if ~~the~~such holder is not otherwise ~~fails~~exempt toand ~~comply~~such ~~with applicable requirements to establish an exemption.~~holder:

~~Backup~~● ~~withholding~~fails isto ~~not~~furnish anthe ~~additional~~holder’s ~~tax. Rather~~taxpayer identification number, ~~any~~which ~~amounts~~for ~~withheld~~an ~~under~~individual ~~the~~is ~~backup~~ordinarily ~~withholding~~his ~~rules~~or ~~will~~her besocial ~~allowed~~security asnumber; a● ~~refund~~furnishes oran aincorrect ~~credit~~taxpayer ~~against~~identification ~~the~~number; ~~U.S.~~● ~~Holder’s U.S.~~is ~~federal~~notified ~~income~~by ~~tax~~the ~~liability~~IRS ~~provided~~that the ~~required~~holder ~~information~~previously isfailed ~~timely~~to ~~furnished~~properly toreport ~~the~~payments ~~IRS.~~of ~~U.S.~~interest ~~Holders~~or ~~should~~dividends; ~~consult~~or ~~their own~~● ~~tax~~fails ~~advisors~~to ~~regarding~~certify ~~their~~under ~~qualification~~penalties ~~for~~of ~~exemption~~perjury ~~from~~that ~~information~~the ~~reporting~~holder ~~and~~has ~~backup~~furnished ~~withholding~~a correct taxpayer identification number and that the ~~procedure~~IRS ~~for obtaining~~has ~~such~~not ~~exemption~~notified the holder that the holder is subject to backup withholding.

67Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules may be allowed as a refund or a credit against a U.S. holder’s U.S. federal income tax liability, provided the required information is timely furnished to the IRS. U.S. holders should consult their tax advisors regarding their qualification for an exemption from backup withholding and the procedures for obtaining such an exemption.

Tax Considerations Applicable to Non-U.S. Holders

The following is a summary of the U.S. federal income tax consequences that will apply to a non-U.S. holder of the shares. For purposes of this discussion, a “non-U.S. holder” is a beneficial owner of the shares that is neither a U.S. holder nor an entity treated as a partnership for U.S. federal income tax purposes.

Distributions

~~Any~~Subject ~~distribution~~to ~~(including~~the ~~constructive~~discussion ~~distributions)~~ below on ~~our~~backup ~~common~~withholding and ~~stock~~foreign ~~that~~accounts, isdividends ~~treated as a dividend~~ paid to a ~~Non~~non-U.S. ~~Holder~~holder of our common stock that isare not effectively connected with the non-U.S. holder’s conduct of a trade or business inwithin the ~~United~~U.S. ~~States~~ will ~~generally~~ be subject to ~~withholding tax at a 30% rate or such lower rate as may be specified by an applicable income tax treaty between the United States and the Non-~~U.S. ~~Holder’s~~federal ~~country~~withholding oftax ~~residence.~~at ~~To obtain~~ a ~~reduced~~ rate of ~~withholding~~30% ~~under~~of ~~a treaty, a Non-U.S. Holder generally will be required to provide~~ the ~~applicable~~gross ~~withholding agent~~amount ~~with a properly executed IRS Form W-8BEN, IRS Form W-8BEN-E or other appropriate form, certifying the Non-U.S. Holder’s entitlement~~of ~~to benefits under that treaty. Such form must be provided prior to~~ the ~~payment of~~ dividends ~~and must be updated periodically. If a Non-U.S. Holder holds stock through a financial institution~~ (or ~~other agent acting on the holder’s behalf, the holder will be required to provide appropriate documentation to~~ such ~~agent.~~lower ~~The holder’s agent may then be required to provide certification to the applicable withholding agent, either directly or through other intermediaries. If you are eligible for a reduced~~ rate ofspecified ~~U.S.~~by ~~withholding tax under~~ an applicable income tax treaty~~, you should consult with your own tax advisor to determine if you are able to obtain a refund or credit of any excess amounts withheld by timely filing an appropriate claim for a refund with the IRS~~).

We generally are not required to withhold tax on dividends paid (or constructive dividends deemed paid) to a Non-U.S. Holder that are effectively connected with the holder’s conduct of a trade or business within the United States (and, if required by an applicable income tax treaty, are attributable to a permanent establishment or fixed base that the holder maintains in the United States) if a properly executed IRS Form W-8ECI, stating that the dividends are so connected, is furnished to us (or, if stock is held through a financial institution or other agent, to the applicable withholding agent). In general, such effectively connected dividends will be subject to U.S. federal income tax on a net income basis at the regular graduated rates applicable to U.S. persons. A corporate Non-U.S. Holder receiving effectively connected dividends may also be subject to an additional “branch profits tax,” which is imposed, under certain circumstances, at a rate of 30% (or such lower rate as may be specified by an applicable treaty) on the corporate Non-U.S. Holder’s effectively connected earnings and profits, subject to certain adjustments.80

~~See~~Non-U.S. ~~also~~holders ~~the~~will ~~sections~~be ~~below~~entitled ~~titled~~to “—a reduction in or an exemption from withholding on dividends as a result of either (a) ~~Backup~~an applicable income tax treaty or (b) the non-U.S. holder holding our ~~Withholding~~common ~~and~~stock ~~Information~~in ~~Reporting”~~connection with the conduct of a trade or business within the U.S. and “—the dividends being effectively connected with that trade or business. To claim such a reduction in or exemption from withholding, the non-U.S. holder must provide the applicable withholding agent with a properly executed (y) ~~Foreign~~IRS ~~Accounts”~~Form W-8BEN ~~for~~or ~~additional~~W-8BEN-E (or other applicable documentation) claiming an exemption from or reduction of the withholding ~~rules~~tax under the benefit of an income tax treaty between the U.S. and the country in which the non-U.S. holder resides or is established, or (z) IRS Form W-8ECI stating that the dividends are not subject to withholding tax because they are effectively connected with the conduct by the non-U.S. holder of a trade or business within the U.S., as may ~~apply~~be applicable. These certifications must be provided to ~~dividends~~the ~~paid~~applicable withholding agent prior to ~~certain~~the ~~foreign~~payment ~~financial~~of ~~institutions~~dividends orand ~~non~~must be updated periodically. Non-~~financial~~U.S. ~~foreign~~holders ~~entities~~that do not timely provide the applicable withholding agent with the required certification, but that qualify for a reduced rate under an applicable income tax treaty, may obtain a refund of any excess amounts withheld by timely filing an appropriate claim for refund with the IRS.

~~Disposition~~If dividends paid to a non-U.S. holder are effectively connected with the non-U.S. holder’s conduct of ~~our~~a ~~Common~~trade ~~Stock~~or business within the U.S. (and, if required by an applicable income tax treaty, the non-U.S. holder maintains a permanent establishment in the U.S. to which such dividends are attributable), then, although exempt from U.S. federal withholding tax (provided the non-U.S. holder provides appropriate certification, as described above), the non-U.S. holder will be subject to U.S. federal income tax on such dividends on a net income basis at the regular graduated U.S. federal income tax rates. In addition, a non-U.S. holder that is a corporation may be subject to a branch profits tax at a rate of 30% (or such lower rate specified by an applicable income tax treaty) on its effectively connected earnings and profits for the taxable year that are attributable to such dividends, as adjusted for certain items. Non-U.S. holders should consult their tax advisors regarding their entitlement to benefits under any applicable income tax treaty.

~~Subject~~Sale to the discussions below under the sections titled “— Backup Withholding and Information Reporting” and “— Foreign Accounts” a Non-U.S. Holder generally will not be subject to U.S. federal income or ~~withholding~~Other ~~tax~~Disposition ~~with respect to gain realized on a sale or other disposition~~ of ~~our~~Common ~~common stock unless:~~Stock

●Subject ~~the~~to ~~gain is effectively connected with~~ the ~~Non-U.S.~~discussions ~~Holder’s~~below ~~conduct~~on ofbackup ~~a trade or business in the United States,~~ withholding and ifforeign ~~an applicable income tax treaty so provides~~accounts, ~~the gain is attributable to~~ a ~~permanent establishment or fixed base maintained by the Non~~non-U.S. ~~Holder~~holder inwill ~~the~~not ~~United~~be ~~States;~~subject into ~~these cases, the Non-~~U.S. ~~Holder~~federal ~~will~~income betax ~~taxed~~ on aany ~~net~~gain ~~income~~realized ~~basis~~upon at the ~~regular graduated rates and in the manner applicable to U.S. persons~~sale, ~~and~~exchange ifor other ~~the~~taxable ~~Non-U.S.~~disposition ~~Holder is a corporation, an additional branch profits tax at a rate~~ of ~~30%,~~our orcommon astock ~~lower rate as may be specified by an applicable income tax treaty, may also apply;~~unless:

● the ~~Non~~gain is effectively connected with the non-U.S. ~~Holder~~holder’s conduct of a trade or business within the U.S. (and, if required by an applicable income tax treaty, the non-U.S. holder maintains a permanent establishment or a fixed base maintained in the U.S. to which such gain is attributable); ● the non-U.S. holder is a nonresident alien individual present in the ~~United~~U.S. ~~States~~ for 183 days or more induring the taxable year of the disposition and certain other requirements are met,; inor ~~which~~● ~~case~~our ~~the~~common ~~Non-~~stock constitutes U.S. ~~Holder~~real ~~will~~property beinterests ~~subject~~(“USRPIs”) toby reason of our status as a ~~30%~~U.S. real property holding corporation (“USRPHC”) for U.S. federal income tax purposes for a five-year preceding such disposition (or ~~such~~the ~~lower~~non-U.S. ~~rate~~holders asholding ~~may~~period, beif ~~specified~~shorter). byGenerally, ana ~~applicable~~corporation ~~income~~is ~~tax~~a ~~treaty~~USRPHC ~~between~~if the ~~United~~fair ~~States~~market ~~and~~value ~~such~~of ~~holder’s~~its ~~country~~USRPIs equals or exceeds 50% of ~~residence)~~the onsum of the ~~net~~fair ~~gain~~market ~~derived~~value ~~from~~of ~~the~~its ~~disposition,~~worldwide ~~which~~real ~~may~~property beinterests ~~offset~~plus byits ~~certain~~other ~~U.S.-source~~assets ~~capital~~used ~~losses~~or ofheld ~~the~~for ~~Non-U.S.~~use ~~Holder,~~in ifa ~~any;~~trade or business.

68Gains described in the first bullet point above will generally be subject to U.S. federal income tax on a net income basis at the regular graduated U.S. federal income tax rates. A non-U.S. holder that is a foreign corporation also may be subject to a branch profits tax at a rate of 30% (or such lower rate specified by an applicable income tax treaty) on such effectively connected gain, as adjusted for certain items.

~~● our common stock constitutes a U.S. real property interest because we are, or have been at any time during the five~~A non-~~year period preceding such disposition (or the Non-~~U.S. ~~Holder’s~~holder ~~holding~~described ~~period~~in ~~for~~ the ~~common~~second ~~stock,~~bullet ifpoint ~~shorter),~~above awill ~~“U.S.~~be

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