UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-K

(Mark One)

☒	ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE FISCAL YEAR ENDED MARCH 31, ~~2025~~2026

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission file number: 001-38892

BEYOND AIR, INC.

(Exact name of registrant as specified in its charter)

Delaware

47-3812456

(State or other jurisdiction

of incorporation or organization)

(I.R.S. Employer

Identification No.)

900 Stewart Avenue, Suite 301

Garden City, NY

11530

(Address of principal executive offices)

(Zip Code)

516-665-8200

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class:		Trading Symbol		Name of each exchange on which registered:
Common Stock, par value $0.0001 per share		XAIR		The Nasdaq Stock Market LLC

Securities registered pursuant to Section 12(g) of the Act:

None

Indicate by a check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes ☐

No ☒

Indicate by a check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934.

Yes ☐

No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒

No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes ☒

No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐ 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐

No ☒

As of September 30, ~~2024~~2025, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the registrant’s voting stock held by non-affiliates was approximately $2415.95 million based on the last reported sale price of the registrant’s common stock on the Nasdaq Capital Market.

There were 9214,~~794~~410,~~777~~621 shares of common stock of the registrant, par value $0.0001 per share, outstanding as of June 1923, ~~2025~~2026.

DOCUMENTS INCORPORATED BY REFERENCE

None.

Beyond Air, Inc.

TABLE OF CONTENTS

FORM 10-K

For the Year Ended March 31, ~~2025~~2026

INDEX

PART I		6
Item 1.	Business	6
Item 1A.	Risk Factors	3127
Item 1B.	Unresolved Staff Comments	7369
Item 1C.	Cybersecurity	7369
Item 2.	Properties	7470
Item 3.	Legal Proceedings	7470
Item 4.	Mine Safety Disclosures	7470
PART II		7571
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	7571
Item 6.	(Reserved)	7571
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	7672
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	8278
Item 8.	Financial Statements and Supplementary Data	8278
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	8278
Item 9A.	Controls and Procedures	8379
Item 9B.	Other Information	8379
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspection	8379
PART III		8480
Item 10.	Directors, Executive Officers and Corporate Governance	8480
Item 11.	Executive Compensation	9186
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	9690
Item 13.	Certain Relationships and Related Transactions, and Director Independence	9993
Item 14.	Principal Accountant Fees and Services	9993
PART IV		~~100~~94
Item 15.	Exhibits and Financial Statement Schedules	~~100~~94
Item 16.	Form 10-K Summary	~~104~~97
SIGNATURES		~~105~~98

References in this Annual Report on Form 10-K (this “Annual Report”) to the “Company,” “Beyond Air,” “we,” “our,” or “us” mean Beyond Air, Inc. and its subsidiaries except where the context otherwise requires.

FORWARD-LOOKING STATEMENTS AND MARKET DATA

This Annual Report contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933 (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). All statements other than statements of historical facts contained in this Annual Report, including statements regarding our future results of operations and financial position, business strategy, approved product and product candidates, certifications or approvals, timing of our clinical development activities, research and development costs, our commercialization plans and the expected timing thereof, timing and likelihood of success, and the plans and objectives of management for future operations and future results of anticipated products are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “expect,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” or “continue” or the negative of these terms or other similar conditional expressions. The forward-looking statements in this Annual Report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Annual Report and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the factors described under the sections in this Annual Report titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” as well as the following:

- our ability to successfully commercialize our LungFit^® PH system;

- our expectation to incur losses for the next year;

- our ability to predict accurately the demand for our products, and products under development and to develop strategies to address markets successfully;

- the possibility that products may contain undetected errors or defects or otherwise not perform as anticipated;

- the anticipated development of markets we sell our products into and the success of our products in these markets;

- our future capital needs and our need to raise additional funds;

- our ability to build a pipeline of product candidates and develop and commercialize our approved products;

- our ability to enroll patients in clinical trials, timely and successfully complete those trials and receive necessary certifications or regulatory approvals;

- our ability to maintain our existing or future collaborations or licenses;

- our ability to protect and enforce our intellectual property rights;

- federal, state, and foreign regulatory requirements, including the U.S. Food and Drug Administration (“FDA”) regulation of our approved product and product candidates;

- our ability to obtain and retain key executives and attract and retain qualified personnel; and

- our ability to successfully manage our growth, including as a commercial-stage company.

Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.

You should read this Annual Report and the documents that we reference in this Annual Report completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Beyond Air, Inc., the Beyond Air logo, and other trademarks or service marks of Beyond Air, Inc. appearing in this Annual Report are the property of Beyond Air, Inc. This Annual Report also includes trademarks, tradenames and service marks that are the property of other organizations. Solely for convenience, trademarks and tradenames referred to in this Annual Report may appear without the ^® and ™ 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 trademarks and tradenames.

MARKET, INDUSTRY AND OTHER DATA

This Annual Report contains estimates, projections, market research and other information concerning our industry, our business, markets for LungFit^® PH and our product candidates and the size of those markets, the prevalence of certain medical conditions, LungFit^®PH market access, prescription data and other physician, patient and payor data. Unless otherwise expressly stated, we obtain this information from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources as well as from our own internal estimates and research and from publications, research, surveys and studies conducted by third parties on our behalf. Information that is based on estimates, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances that are reflected in this information. As a result, you are cautioned not to give undue weight to such information.

SUMMARY OF PRINCIPAL RISK FACTORS

This summary briefly lists the principal risks and uncertainties facing our business, which are only a select portion of those risks. A more complete discussion of those risks and uncertainties is set forth in Part I, Item 1A of this Annual Report, entitled Risk Factors. Additional risks not presently known to us or that we currently deem immaterial may also affect us. If any of these risks occur, our business, financial condition or results of operations could be materially and adversely affected.

Our business is subject to the following principal risks and uncertainties:

Risks Related to our Financial Position and Capital Requirements

●	Our independent registered public accounting firm’s report contains an explanatory paragraph that expresses substantial doubt about our ability to continue as a “going concern.”
●	Numerous factors, including the incurring of significant losses, are relevant to our financial success and any or all such factors could have a disproportionate impact on our bottom line.
●	We will need to raise additional capital, and such capital raising may be costly or difficult to obtain, and could dilute current stockholders’ ownership interests.
●	Our failure to comply with the covenants or other terms of the Loan Agreement (as defined below), including as a result of events beyond our control, could result in a default under the Loan Agreement that could materially and adversely affect the ongoing viability of our business.

Risks Related to Commercialization of our Approved Product or Product Candidates

●	If the market opportunities for our approved product or product candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.
●	Intense competition and rapid technological changes may adversely affect our ability to successfully commercialize our approved product or product candidates.
●	If we are unable to scale sales and marketing capabilities or enter into agreements with third parties to market and sell our approved product or product candidates, we may be unable to generate revenue.
●	Our approved product and any future product candidates that we may bring to market may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, and the market opportunity for our approved product or product candidates may be smaller than we estimate.
●	If we fail to properly manage our anticipated growth, our business could suffer.
●	Pricing pressure from our competitors and our customers may impact our ability to sell our products at prices necessary to support our current business strategies.
●	Many of our current and potential competitors have substantially greater financial, technical and marketing resources than we do, and they may succeed in developing products that would render our approved product and any future product candidates obsolete or noncompetitive.
●	We may be subject to enforcement action if we engage in improper marketing or promotion of our products.
●	Healthcare legislative or regulatory reform measures, including government restrictions on pricing and reimbursement, may have a negative impact on our business and results of operations.
●	Cybersecurity risks and the failure to maintain the confidentiality, integrity, and availability of our computer hardware, software, and Internet applications and related tools and functions could result in harm to our business and/or subject us to costs, fines or lawsuits.
●	Failure to comply with applicable privacy, data and security regulations could result in substantial penalties, liability and negative publicity which could adversely affect our business operations.

Risks Related to the Discovery and Development of Our Product Candidates

●	We cannot give any assurance that any of our product candidates will receive certification or regulatory approval, which is necessary before they can be commercialized.
●	We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of our product candidates.
●	We have conducted, and may in the future conduct, clinical trials for certain of our product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations.
●	If we experience any of a number of possible unforeseen events in connection with clinical trials of our product candidates, potential certification or marketing approval or commercialization of our product candidates could be delayed or prevented.
●	Our subsidiaries are exploring novel therapeutic processes with NO and once they develop product candidates, those product candidates are likely to be classified as pharmaceutical drugs by the FDA and thus face stringent regulation.
●	We may experience delays or difficulties in the enrolment of patients in clinical trials.
●	Serious adverse events (“SAEs”), or undesirable side effects of our product candidates may be identified.
●	Even if we obtain certification or regulatory approvals for our product candidates, we will still face extensive, ongoing regulatory requirements and review, and our products may face future development and regulatory difficulties.

Risks Related to our Reliance on Third Parties

●	We rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily.
●	Any failure by a third-party supplier or manufacturer to produce or deliver supplies for us or to provide necessary servicing may delay or impair our ability to complete our clinical trials or commercialize our approved product or product candidates.
●	We may seek to enter into collaborations with third parties for the development and commercialization of our product candidates. If we fail to enter into such collaborations, or such collaborations are not successful, we may not be able to capitalize on the market potential of our approved product or product candidates.
●	The third-party manufacturing facilities on which we rely are subject to significant regulation and may not continue to meet regulatory requirements.
●	Our reliance on third parties necessitates the sharing of trade secrets, which increases the possibility of their improper disclosure or appropriation.

Risks Related to our Intellectual Property

●	If we fail to obtain and maintain sufficiently broad patent protection of our technology, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.
●	We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.
●	We may be subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
●	Patent policy and rule changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
●	We may not be successful in obtaining or maintaining necessary intellectual or proprietary rights to our approved product or product candidates including, but not limited to acquisitions and in-licenses.

Risks Related to our Business Operations

●	We manage our business through a small number of employees and key consultants.
●	We may need to expand our operations and increase the size of our Company, which may expose us to difficulties in managing growth as well as additional regulatory operational and financial risks.
●	Our international operations and plans to expand such operations present challenges and risks related to doing business internationally.
●	Conditions in Israel may materially and adversely affect our business.
●	The use of our product or any of our product candidates could result in product liability or similar claims that could be expensive, damage our reputation and harm our business.
●	Natural disasters, geopolitical unrest, war, terrorism, public health issues or other catastrophic events could disrupt the supply, delivery or demand of products, which could negatively affect our operations and performance.
●	We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity breaches and data leakage.

Risks Related to the Ownership of our Common Stock

●	Our failure to maintain our compliance with Nasdaq’s continued listing standards or other requirements could result in our common stock being delisted from Nasdaq, which could adversely affect our liquidity and the trading volume and market price of our common stock and decrease or eliminate your investment.
●	Stockholder disputes may be limited by the terms of our amended and restated certificate of incorporation.
●	Trading in our common stock has been volatile and may continue to be volatile in the future.
●	Anti-takeover provisions in our amended and restated certificate of incorporation and bylaws, as well as Delaware law, may discourage, delay, or prevent a change of control of our Company.

Risks Related to Employee Matters

●	Our business could suffer if we lose the services of key members of our senior management, key advisors or personnel.
●	Our employees may engage in misconduct or other non-compliant activities.
●	We are subject to various healthcare laws; failure to comply with such laws may result in substantial penalties.
●	Employee litigation and unfavorable publicity could negatively affect our future business.
●	We may not be able to enforce covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees.

General Risk Factors

●	The increasing use and relevance of social media platforms may present new risks.
●	Our business may be affected by unfavorable global or U.S. economic conditions.

PART I

ITEM 1. BUSINESS

Business Overview

We are a commercial-stage medical device and biopharmaceutical company developing a platform of nitric oxide (“NO”) generators and delivery systems (the “LungFit® platform”) capable of generating NO from ambient air. The Company’s first device, LungFit® PH received premarket approval (“PMA”) from the FDA in June 2022. The NO generated by the LungFit® PH system is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. This condition is commonly referred to as persistent pulmonary hypertension of the newborn (“PPHN”). The LungFit® platform can generate NO up to 400 parts per million (“ppm”) for delivery to a patient’s lungs directly or via a ventilator. LungFit® can deliver NO either continuously or for a fixed amount of time at various flow rates and has the ability to either titrate dose on demand or maintain a constant dose. In ~~September~~July 2022, we commenced marketing LungFit® PH in the United States for PPHN as a medical device.

On In November ~~26,~~ 2024, the Company received European CE mark approval of the LungFit PH® system for the following:

	●	The treatment of infants >34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation; and
	●	The treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation

LungFit® can be used to treat patients on ventilators that require NO, as well as patients with chronic or acute severe lung infections via delivery of NO at concentrations > 100 parts per million (ppm) through a breathing mask or similar apparatus. Furthermore, we believe that there is a high unmet medical need for patients suffering from certain severe lung infections that the LungFit® ~~platform~~ platform can potentially address. The Company’s other areas of focus with the LungFit® platform beyond PPHN ~~are~~ are nontuberculous mycobacteria (“NTM”) lung infection and those with various severe lung infections with underlying chronic obstructive pulmonary disease (“COPD”). Our current product candidates will be subject to premarket reviews and ~~approvals~~ approvals by the FDA, certification through the conduct of a conformity assessment by a notified body in the EU for the product to be CE marked, as well as comparable foreign regulatory authorities.

With Beyond Air’s focus on NO and its effect on the human condition, there are two additional programs that do not utilize our LungFit® system. Through our majority-owned affiliate Beyond Cancer, ~~Bermuda~~Ltd. ~~Limited~~ (“Beyond Cancer”), NO is used to target solid tumors. ~~The~~ The LungFit® platform is not utilized for the solid tumor indication due to the need for ultra-high concentrations of ~~gaseous~~ gaseous nitric oxide (“UNO”). A proprietary delivery system has been developed that is designed to safely deliver UNO in excess of 10,000 ppm directly to a solid tumor. This program isrecently ~~currently~~completed ina phase 1 human clinical ~~trials~~trial.

On November 4, 2021, Beyond Air reorganized its oncology business into a new private company called Beyond Cancer. Beyond Air’s preclinical oncology team and the exclusive right to the intellectual property portfolio utilizing UNO for the treatment of solid tumors now reside with Beyond Cancer. Beyond Air has 80% ownership in Beyond Cancer.

The second program, which does not utilize the LungFit® platform, partially inhibits neuronal nitric oxide synthase (“nNOS”) in the brain to treat neurological and neuro-oncology conditions. The first target indication is autism spectrum disorder (“ASD”). On June 15, 2023, the Company announced that it has entered into an agreement with Yissum Research Development Company of the Hebrew University of Jerusalem, LTD. (the “University”) to acquire the commercial rights for nNOS inhibitors being developed for the treatment of ASD and other neurological conditions. Currently, there are no FDA-approved therapies specifically for the treatment of ASD. Under the terms of the agreement, Beyond Air shall pay to the University compensation for pre-clinical work over the three-year period from the date of the agreement. Also, the Company will pay to to the University a low single-digit royalty on net sales and certain one-time payments based on clinical, regulatory and sales milestones. ~~The Company expects this program to progress from preclinical to a phase 1 first-in-human clinical trial by the end of 2026.~~

On March 24, 2025, Beyond Air reorganized its neurology business into a new private company called NeuroNOS Limited (“NeuroNOS”). Beyond Air’s infrastructure, for example regulatory, quality, legal, etc, ~~will~~is ~~continue~~currently tosupporting ~~support~~ the ~~NeruoNOS~~NeuroNOS team. Beyond Air has 8884.275% ownership in NeuroNOS.

Our approved commercial product and ~~active~~ development pipeline of product candidates is shown in the tables below:

LungFit® PH is the first FDA-approved and CE Mark system using our patented plasma pulse technology to generate on-demand NO from ambient air and, regardless of dose or flow, deliver it to a ventilator circuit. The device uses a medical air compressor to drive room air through a plasma chamber in the center of the unit where pulses of electrical discharge are created between two electrodes. The system uses the power equivalent to a 60-watt lightbulb to ionize the nitrogen and oxygen molecules, which then combine as NO with low levels of nitrogen dioxide (“NO2”) created as a byproduct. The products are then passed through a Smart Filter, which removes the toxic NO2 from the internal circuit. With respect to PPHN, the novel LungFit® PH is designed to deliver a dosage of NO to the lungs that is consistent with current guidelines for delivery of 20 ppm NO with a range of 0.5 ppm – 80 ppm (low concentration NO) for ventilated patients.

We believe the ability of LungFit® PH to generate NO from ambient air provides us with many competitive advantages over the ~~current~~ current standard of NO delivery systems in the U.S., the EU, Japan and other markets. For example, LungFit® PH does not require the use of a high-pressure cylinder, does not require cumbersome purging procedures and places less burden on hospital staff in carrying out ~~logistics and~~ safety procedures.

Our novel LungFit® platform can also deliver a high concentration (>150 ppm) of NO directly to the lungs, which we believe has the potential to eliminate microbial infections including bacteria, fungi and viruses, among others. We believe that current FDA-approved NO vasodilation treatments would have limited success in treating microbial infections given the low concentrations of NO being delivered (<100 ppm). Given that NO is produced naturally by the body as an innate immunity mechanism, at a concentration of 200 ppm, supplemental high dose NO should aid in the body’s fight against infection. Based on our preclinical studies and clinical trials, we believe that 150 ppm is the minimum therapeutic dose to achieve the desired pulmonary antimicrobial effect of NO. To date, neither the FDA nor comparable foreign regulatory agencies in other countries or regions have approved any NO formulation and/or delivery system for >80 ppm NO.

LungFit® PH for the treatment of Persistent Pulmonary Hypertension of the Newborn (PPHN)

In June 2022, the FDA approved LungFit® PH to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

On In November ~~26,~~ 2024, the company received European CE mark approval of the LungFit PH® system for the following:

●	The treatment of infants >34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation; and
●	The treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation

LungFit® PH is the inaugural device from the LungFit® platform of NO generators that use patented ionizer technology and is the ~~first~~ first FDA-approved and CE Marked product for Beyond Air.

We ~~submitted a~~ PMA supplement to the FDA in November 2023 for the expansion of the label to include certain cardiac surgeries. According to the most recent year-end report from Mallinckrodt Pharmaceuticals (“Mallinckrodt”), sales of NO were $261.4 million in 2024 (down from $303.2 million in 2023) for the United States, Canada, Japan, Mexico and Australia, with ~90% in the United States. Outside of the U.S. there are multiple market participants which translates to considerably lower relative sales than in the U.S. We believe the U.S. sales potential of LungFit® PH to be approximately $350 million and worldwide sales potential to be approximately $700 million or greater. We initiated the first phase of our commercial launch in July 2022 (the limited launch phase to introduce Lungfit® PH and Beyond Air to hospitals), and entered into phase 2 (target initial market share gains in certain geographies) with an expanded commercial presence during the spring of 2023 in the U.S. ~~We recently entered the final phase of our launch process where we will equip our commercial organization to become the market leader in the U.S. in a few years.~~ Since receiving CE Mark in late November, 2024, we have received regulatory approvals in more ~~Australia,~~than ~~New~~27 ~~Zealand,~~other ~~Hong~~countries ~~Kong~~outside ~~and~~of ~~Thailand with~~the ~~our~~United ~~partner~~States ~~Getz Healthcare~~ and ~~are awaiting approvals in several other countries in South East Asia~~EU. Additionally, we have signed ~~new~~ distribution agreements covering ~~France,~~over 40 ~~Italy,~~countries ~~Turkey,~~outside ~~India,~~of ~~Saudi~~the ~~Arabia,~~United ~~and Morocco, among others~~States. We anticipate significant contribution to revenues in fiscal ~~2026~~2027 and beyond from these and future partnerships.

A PMA supplement to the US FDA for the expansion of the label to include certain cardiac surgeries was withdrawn in favor of our submission of our second generation LungFit® ~~PRO~~PH II. The LungFit® PH II PMA supplement was submitted to the FDA in June 2025. LungFit® PH II is smaller, lighter, and fully transport-ready. The ability of the device to be used in air and ground transportation significantly increases our addressable market compared to our first generation product. We believe the estimated total addressable market for inhaled NO in the ~~treatment~~U.S. is approximately $350 million and worldwide to be approximately $700 million or greater. We believe the approval and subsequent launch of the LungFit® PH II will equip our commercial ~~viral~~organization ~~lung~~to ~~infections~~become the market leader in ~~hospitalized~~the ~~patients~~U.S. in the near-term.

~~Viral~~LungFit® PRO ~~Community-Acquired~~for ~~Pneumonia~~the ~~(including~~treatment ~~COVID-19)~~of viral lung infections in hospitalized patients

Viral ~~pneumonia in adults is most~~ ~~commonly~~Community-Acquired ~~caused~~Pneumonia ~~by rhinovirus, respiratory syncytial virus~~ (~~“RSV”) and influenza virus. However, newly emerging viruses (~~including ~~SARS-CoV-1,~~ ~~SARS-CoV-2, avian influenza A, and H1N1 viruses) have been identified as pathogens contributing to the overall burden of adult viral pneumonia.~~ COVID-19 is an infectious disease caused by SARS-CoV-2, that resulted in a global pandemic, causing millions of hospitalizations and over 6.6 million deaths worldwide as of January 2023 according to the World Health Organization. Excluding the pandemic, there are approximately 350,000 annual viral pneumonia hospitalizations in the U.S., and up to 16 million annual viral pneumonia hospitalizations globally. For the broader annual viral pneumonia hospitalizations, we believe U.S. market potential to be greater than $1.5 billion and worldwide market potential to be greater than $3 billion.)

WeViral pneumonia ~~initiated~~in aadults ~~pilot~~is ~~clinical~~most commonly caused by rhinovirus, respiratory syncytial virus (“RSV”) and influenza virus. However, ~~trial~~newly inemerging ~~late~~viruses ~~2020~~(including ~~using~~SARS-CoV-1, ~~our~~SARS-CoV-2, ~~novel~~avian ~~LungFit®~~influenza ~~PRO~~A, ~~system~~and atH1N1 ~~150~~viruses) ~~ppm~~have been identified as pathogens contributing to ~~treat~~the ~~patients~~overall ~~with~~burden ~~VCAP~~of adult viral pneumonia. ~~The~~COVID-19 ~~trial~~is ~~was~~an ainfectious ~~multi-center,~~disease ~~open~~caused by SARS-~~label~~CoV-2, ~~randomized~~ ~~clinical~~that ~~trial~~resulted in ~~Israel~~a global pandemic, causing ~~including~~millions ~~patients~~of ~~infected~~hospitalizations ~~with~~and ~~COVID-19~~over 7.1 ~~Patients~~million ~~were~~deaths ~~randomized~~worldwide inreported aas ~~1:1~~of ~~ratio~~March 2026, according to ~~receive~~the ~~either~~World Health Organization. ~~inhalations~~Excluding ofthe ~~150~~pandemic, ~~ppm~~there NOare ~~given~~approximately ~~intermittently~~350,000 ~~for~~annual 40viral ~~minutes~~pneumonia ~~four~~hospitalizations ~~times~~in ~~per~~the ~~day~~U.S., ~~for~~and up to ~~seven~~16 ~~days~~million inannual viral ~~addition~~pneumonia tohospitalizations ~~standard~~globally. ~~supportive treatment~~For ~~(“NO+SST”)~~the orbroader ~~standard~~annual ~~supportive~~viral ~~treatment~~pneumonia ~~alone~~hospitalizations, ~~(“SST”).~~we ~~Endpoints~~believe ~~related~~U.S. market potential to ~~safety~~be ~~(primary~~greater ~~endpoint), oxygen~~than ~~saturation~~$1.5 billion and ~~ICU~~worldwide ~~admission,~~market ~~among~~potential ~~others,~~to ~~were~~be ~~assessed~~greater than $3 billion.

8We initiated a pilot clinical trial in late 2020 using our novel LungFit® PRO system at 150 ppm to treat patients with VCAP. The trial was a multi-center, open-label, randomized clinical trial in Israel, including patients infected with COVID-19. Patients were randomized in a 1:1 ratio to receive either inhalations of 150 ppm NO given intermittently for 40 minutes four times per day for up to seven days in addition to standard supportive treatment (“NO+SST”) or standard supportive treatment alone (“SST”). Endpoints related to safety (primary endpoint), oxygen saturation and ICU admission, among others, were assessed.

We presented results from the pilot clinical trial at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022), which took place from April 23, 2022 through April 26, 2022 as a hybrid event both onsite in Lisbon, Portugal and online. At the time of the data cut off, the trial enrolled a total of 40 patients hospitalized for VCAP (SARS-CoV-2, n=39; other viruses n=1). The intent-to-treat population included 35 patients with 16 patients in the inhaled NO group and 19 patients in the control group. The primary COVID-19 treatments used during the clinical trial were Remdesivir (>30%) and Dexamethasone (>65%). Safety data from the clinical trial show that inhaled NO treatment was well tolerated overall with no treatment related adverse events as assessed by the investigators. There were two serious adverse events (“SAEs”) reported in the group receiving inhaled NO along with SST, which were determined to be related to underlying conditions and unrelated to clinical trial drug/device. From an efficacy perspective, results show a trend of shortening length of stay (“LOS”) by a factor 1.8 in favor of inhaled NO treatment. Duration of oxygen support, measured in-hospital and at home, was significantly shorter (p=0.0339) for inhaled NO treated patients. Patients with unstable oxygen saturation during hospitalization, 66.7% of the inhaled NO treatment group, reached stable saturation of ≥93% during hospital stay as compared to 26.7% in the SST group.

~~Following~~We presented ~~completion~~results offrom the pilot clinical trial ~~and~~at the ~~180-day~~32nd ~~follow-up~~European ~~period~~Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022), ~~incremental~~which ~~data~~took ~~were~~place ~~provided~~from inApril a23, ~~poster~~2022 ~~presentation~~through atApril ~~IDWeek~~26, 2022. Inas ~~addition~~a tohybrid ~~the~~event ~~positive~~both onsite in Lisbon, Portugal and online. ~~clinical~~At ~~results~~the ~~provided~~time atof ~~ECCMID~~the ~~2022~~data cut off, the ~~poster~~trial ~~showed~~enrolled a ~~larger~~total ~~decline~~of in40 ~~c-reactive~~patients ~~protein~~hospitalized for VCAP (~~“CRP”)~~SARS-CoV-2, ~~from~~n=39; ~~baseline~~other ~~for~~viruses n=1). ~~patients~~The ~~treated~~intent-to-treat population included 35 patients with 16 patients in the inhaled NO +group ~~SST~~and ~~compared~~19 topatients in the control group. ~~Analysis~~The primary ofCOVID-19 treatments used during the clinical trial were Remdesivir (>30%) and Dexamethasone (>65%). Safety data ~~provides~~from ~~compelling~~the clinical ~~evidence~~trial show that ~~high~~inhaled ~~concentration~~ NO ~~delivery~~treatment was well tolerated overall with no treatment related adverse events as assessed by the investigators. ~~LungFit®~~There ~~PRO~~were ~~generator~~two ~~and~~serious ~~delivery~~adverse ~~system~~events ~~can~~(“SAEs”) bereported ain ~~powerful~~the ~~tool~~group ~~against~~receiving ~~any~~inhaled ~~type~~NO ofalong ~~pneumonia~~with SST, which ~~especially~~were ~~COVID-19~~determined to be related to underlying conditions and unrelated to clinical trial drug/device. From an efficacy perspective, ~~The~~results ~~Company~~show ~~commenced~~a trend of shortening length of stay (“LOS”) by a ~~clinical~~factor ~~trial~~1.8 in ~~the~~favor ~~second~~of ~~half~~inhaled NO treatment. Duration of ~~calendar~~oxygen support, ~~2023~~measured in-hospital ~~the~~and ~~United~~at ~~States~~home, ~~and~~was ~~has~~significantly ~~made~~shorter (p=0.0339) for inhaled NO treated patients. Patients with unstable oxygen saturation during hospitalization, 66.7% of the ~~decision~~inhaled toNO ~~pause~~treatment ~~this~~group, reached stable saturation of ≥93% during hospital ~~study~~stay ~~pending~~as ~~future~~compared ~~funding~~to 26.7% in the SST group.

~~Bronchiolitis~~Following completion of the clinical trial and the 180-day follow-up period, incremental data were provided in a poster presentation at IDWeek 2022. In addition to the positive clinical results provided at ECCMID 2022, the poster showed a larger decline in c-reactive protein (~~BRO~~“CRP”) from baseline for patients treated with NO + SST compared to the control group. Analysis of the data provides compelling evidence that high concentration NO delivery with the LungFit® PRO generator and delivery system can be a powerful tool against any type of pneumonia, especially COVID-19. The Company commenced a clinical trial in the second half of calendar 2023 in the United States and made the decision to terminate this study.

Bronchiolitis ~~is the leading cause of hospital admission in children less than 1 year of age. The incidence is estimated to be 150 million new cases a year worldwide, with 2-3%~~ (~~over 3 million~~BRO) of them severe enough to require hospitalization. Worldwide, 95% of all cases occur in developing countries. In the U.S., there are approximately 120,000 annual bronchiolitis hospitalizations and approximately 3.2 million annual child hospitalizations globally. Currently, there is no approved treatment for bronchiolitis. The treatment for acute viral lung infections that cause bronchiolitis in infants is largely supportive care and is based primarily on prolonged hospitalization during which the infant receives a constant flow of oxygen to treat hypoxemia, a reduced concentration of oxygen in the blood. In addition, systemic steroids and inhalation with bronchodilators are sometimes utilized until recovery, but we believe that these treatments do not successfully reduce hospital LOS. We believe the U.S. market potential for bronchiolitis to be greater than $500 million and worldwide market potential to be greater than $1.2 billion.

~~The~~Bronchiolitis ~~pivotal~~is ~~clinical~~the ~~trial~~leading ~~for~~cause ~~bronchiolitis~~of ~~was~~hospital ~~originally~~admission ~~set~~in tochildren beless ~~performed~~than in1 ~~the~~year ~~winter~~ of ~~2020/21~~age. ~~but~~The ~~was~~incidence ~~delayed~~is ~~due~~estimated to ~~the~~be ~~COVID-19~~150 ~~pandemic.~~million Wenew ~~have~~cases ~~completed three~~a ~~successful~~year ~~pilot~~worldwide, ~~studies~~with 2-3% ~~for~~(over ~~bronchiolitis.~~3 Amillion) ~~further~~of ~~analysis~~them ofsevere ~~the~~enough ~~three~~to ~~previously~~require ~~reported~~hospitalization. ~~pilot~~Worldwide, ~~studies~~95% ~~was~~of ~~presented~~all atcases ~~the ATS~~occur ~~International~~in ~~Conference~~developing ~~2021~~countries. ~~Analysis across~~ In the ~~studies (n=198 infants~~U.S., ~~mean~~there ~~age~~are ~~3.9~~approximately ~~months)~~120,000 ~~showed~~annual ~~that~~bronchiolitis ~~150~~hospitalizations ~~ppm – 160 ppm NO administered intermittently was generally safe~~ and ~~well~~approximately ~~tolerated~~3.2 ~~with~~million ~~adverse~~annual ~~event~~child ~~rates~~hospitalizations globally. ~~similar~~Currently, ~~among~~there ~~treatment~~is ~~groups with~~ no ~~reported~~ approved treatment~~-related~~ ~~serious~~for ~~adverse events~~bronchiolitis. The ~~short~~treatment ~~course~~for ofacute ~~treatments~~viral ~~with~~lung ~~intermittent~~infections ~~high~~that ~~concentration~~cause ~~inhaled NO was effective~~bronchiolitis in ~~shortening~~infants ~~hospital~~is ~~LOS~~largely ~~and~~supportive ~~accelerating~~care ~~time~~and tois ~~fit~~based ~~for~~primarily ~~discharge~~on –prolonged ahospitalization ~~composite~~during ~~endpoint~~which ofthe ~~clinical~~infant ~~signs~~receives ~~and~~a ~~symptoms~~constant flow toof ~~indicate readiness~~oxygen to betreat ~~evaluated~~hypoxemia, ~~for~~a ~~hospital~~reduced ~~discharge.~~concentration ~~This~~of ~~treatment~~oxygen ~~was~~in ~~also~~the ~~effective~~blood. inIn ~~accelerating~~addition, ~~time~~systemic tosteroids ~~stable~~and ~~oxygen~~inhalation ~~saturation –~~with ~~measured~~bronchodilators asare ~~SpO2~~sometimes ≥utilized ~~92%~~until inrecovery, ~~room~~but ~~air.~~we ~~Additionally,~~believe NOthat atthese atreatments ~~dose~~do ofnot 85successfully ~~ppm~~reduce NOhospital ~~showed~~LOS. noWe believe ~~difference~~the ~~compared~~U.S. tomarket ~~control~~potential for ~~all~~bronchiolitis ~~efficacy endpoints,~~to ~~while~~be ~~150~~greater ~~ppm~~than NO$500 ~~showed~~million ~~statistical~~and ~~significance~~worldwide ~~when~~market ~~compared~~potential to ~~control~~be greater than $1.2 billion.

~~Additionally,~~The ~~long-term~~pivotal ~~safety data~~clinical trial for bronchiolitis ~~high~~was ~~concentration~~originally ~~inhaled~~set NOto be performed in ~~bronchiolitis~~the winter of 2020/21 but was ~~presented~~delayed atdue to the ~~Pediatric~~COVID-19 ~~Academic~~pandemic. ~~Societies~~We ~~Meeting~~have ~~2022~~completed three ~~(PAS~~successful ~~22)~~pilot studies for bronchiolitis. A ~~total of~~further ~~101~~analysis ~~infants~~of ~~from~~ the three ~~prior~~previously reported pilot studies ~~for~~was ~~bronchiolitis~~presented at the ATS International Conference 2021. Analysis across the studies (n=198) ~~participated~~infants, inmean ~~the~~age ~~long-term~~3.9 ~~follow-up~~months) ~~clinical~~showed ~~trial.~~that ~~Clinical trial~~150 ~~endpoints~~ppm ~~for~~– ~~the~~160 ~~long-term~~ppm NO ~~safety~~administered ~~clinical~~intermittently ~~trial~~was ~~included~~generally ~~percentage~~safe ofand ~~patients~~well ~~re-hospitalized~~tolerated ~~for~~with ~~bronchiolitis~~adverse ~~related~~event ~~reasons, such~~rates ~~reasons~~similar ~~included~~among ~~wheezing~~treatment ~~episodes,~~groups ~~pneumonia,~~with ~~and~~no ~~asthma~~reported treatment-related ~~and~~serious ~~the~~adverse ~~percentage~~events. The short course of ~~patients~~treatments ~~re-hospitalized~~with ~~for~~intermittent ~~any~~high ~~reason.~~concentration ~~Data~~inhaled ~~from~~NO was effective ~~the~~in ~~clinical~~shortening ~~trial~~hospital ~~showed~~LOS ~~the~~and ~~re-hospitalization~~accelerating ~~rate~~time ~~per~~to ~~100~~fit ~~Patient~~for ~~Exposure~~discharge ~~Years~~– ~~(PEY)~~a ~~due~~composite toendpoint ~~bronchiolitis~~of ~~related~~clinical ~~reasons~~signs ~~trended~~and symptoms to indicate ~~favorably~~readiness ~~for~~to ~~the~~be ~~inhaled~~evaluated NOfor ~~group~~hospital discharge. InThis ~~addition,~~treatment ~~the~~was ~~long-term~~also ~~patient~~effective ~~re-hospitalization~~in ~~rate~~accelerating ~~for~~time ~~any~~to ~~reason~~stable ~~was~~oxygen ~~similar~~saturation ~~between inhaled~~– NOmeasured ~~and~~as ~~control~~SpO2 ~~groups.~~≥ As92% ~~such,~~in ~~the~~room ~~clinical~~air. ~~trial~~Additionally, ~~concluded~~NO ~~that~~at ~~the~~a ~~treatment~~dose of ~~hospitalized~~85 ~~infants~~ppm ~~with~~NO ~~acute~~showed ~~bronchiolitis~~no bydifference ~~intermittent~~compared to control for all efficacy ~~high~~endpoints, ~~dose~~while ~~inhaled~~150 ppm NO ~~shows~~showed astatistical ~~favorable~~significance ~~long-term~~when ~~safety~~compared ~~profile~~to control.

WeAdditionally, ~~believe~~long-term ~~that~~safety data for high concentration inhaled NO in bronchiolitis was presented at the ~~entirety~~Pediatric ofAcademic Societies Meeting 2022 (PAS 22). A total ~~data~~of at101 ~~150~~infants ~~ppm~~from –the ~~160~~three ~~ppm~~prior NOpilot studies for bronchiolitis (n=198) participated in ~~both~~the ~~adult~~long-term ~~and~~follow-up ~~infant~~clinical ~~patient~~trial. ~~populations~~Clinical trial ~~supports~~endpoints ~~further~~for ~~development~~the long-term safety clinical trial included percentage of ~~LungFit®~~patients ~~PRO~~re-hospitalized for bronchiolitis related reasons, insuch areasons ~~pivotal~~included wheezing episodes, pneumonia, and asthma and the percentage of patients re-hospitalized for any reason. Data from the clinical trial showed the re-hospitalization rate per 100 Patient Exposure Years (PEY) due to bronchiolitis related reasons trended favorably for ~~patients~~the inhaled NO group. In addition, the long-term patient re-hospitalization rate for any reason was similar between inhaled NO and control groups. As such, the clinical trial concluded that the treatment of hospitalized infants with ~~VCAP~~acute or bronchiolitis by intermittent high dose inhaled NO shows a favorable long-term safety profile.

9We believe that the entirety of data at 150 ppm – 160 ppm NO in both adult and infant patient populations supports further development of LungFit® PRO in a pivotal clinical trial for patients hospitalized with VCAP or bronchiolitis.

LungFit® GO for the treatment of Nontuberculous mycobacteria (NTM)

NTM lung infection is a rare and serious pulmonary disease associated with increased morbidity and mortality. Patients with NTM lung disease may experience a multitude of symptoms such as fever, weight loss, cough, lack of appetite, night sweats, blood in the sputum and fatigue. Patients with NTM lung disease, specifically Mycobacterium abscessus (M. abscessus) representing 20% to 25% of all NTM and other forms of NTM that are refractory to antibiotic therapy, frequently require lengthy and repeated hospital stays to manage their condition. There are no treatments specifically indicated for the treatment of M. Abscessus lung disease in North America, Europe or Japan.

There are approximately 50,000 to 90,000 people with NTM infections in the U.S. In Asia, the number of patients suffering from NTM surpasses what is seen in the U.S. There is one inhaled antibiotic approved for the treatment of refractory Mycobacterium avium complex (“MAC”). Current guideline-based approaches to treat NTM lung disease involve multi-drug regimens of antibiotics that may cause severe, long lasting side effects, and treatment can be longer than 18 months. Median survival for NTM MAC patients is approximately 13 years while median survival for patients with other variations of NTM is typically 4.6 years. The prevalence of human disease attributable to NTM has increased over the past two decades. In a clinical trial conducted between 2007 and 2016, researchers found that the prevalence of NTM in the U.S. is increasing at approximately 7.5% per year. M. abscessus treatment costs are estimated to be more than double that of MAC. A 2015 publication by co-authors from several U.S. government departments stated that cases in 2014 alone cost the U.S. healthcare system approximately $1.7 billion. For this indication, we believe U.S. sales potential to be greater than $1 billion and worldwide sales potential to be greater than $2.5 billion.

In December 2020 we began a 12-week, multi-center, open-label clinical trial in Australia intended to enroll approximately 20 adult patients with chronic refractory NTM lung disease. We received a grant of up to $2.17 million from the Cystic Fibrosis Foundation (“CFF”) to fund this clinical trial and advance the clinical development of inhaled NO to treat NTM pulmonary disease. The trial enrolled both cystic fibrosis (“CF”) and non-CF patients infected with MAC, M. abscessus or any strain of NTM. The clinical trial consisted of a run-in period followed by two treatment phases. The run-in period provided a baseline for the efficacy endpoints. The first treatment phase took place over a two-week period and began in the hospital setting where patients were titrated from 150 ppm NO up to 250 ppm NO over several days. During this phase patients received NO for 40 minutes, four times per day while Methemoglobin (“MetHb”) levels were monitored. Patients were also trained to use LungFit® GO and subsequently discharged to complete the remaining portion of the two-week treatment period at their home at the highest tolerated NO concentration. For the second treatment phase, a 10-week maintenance phase, the administration was twice daily at 250 ppm NO. The clinical trial evaluated safety, quality of life, physical function, and bacterial load among other parameters.

At the American Thoracic Society International Conference 2022 (ATS 2022), we presented positive interim data from the ~~ongoing~~ aforementioned clinical trial. At the time of data cutoff on April 4, 2022, a total of 15 patients were enrolled in the pilot clinical trial. The mean age of patients was 62.1 years (range: 22 – 82 years) with the majority female (80%), a distribution consistent with real-world NTM disease. All 15 patients were successfully titrated to 250 ppm NO in the hospital setting, and no patients required dose reductions during the subsequent at-home portion of the clinical trial. Patients were followed up for 12 weeks after the 12-week treatment period was completed.

After completion of the clinical trial, we presented positive results at the 2022 American College of Chest Physicians (“CHEST”) annual meeting, further supporting development of intermittent high dose NO for the treatment of NTM. The clinical trial demonstrated that high dose NO treatment was well-tolerated in both the home and hospital settings. During the 10-week at-home treatment period of the clinical trial, a total of 2,492 inhalations were self-administered with overall high treatment compliance (>90%). There were no SAEs related to treatment discontinuations reported over the 12-week treatment or 12-week follow up periods. Key efficacy endpoints showed strong results with improvement seen in the majority of quality-of-life domains. Respiratory function and physical function were maintained during treatment and follow-up. Trends in the reduction of microbial load were observed and one patient achieved culture conversion with three consecutive negative sputum samples. We anticipate ~~commencing~~ ahaving ~~pivotal~~discussions ~~clinical~~with ~~trial,~~the ~~pending~~FDA ~~funding,~~ in calendar ~~year~~ 2026 ~~following~~to ~~discussions~~identify ~~with~~a ~~the~~path ~~FDA~~forward.

Our program in COPD is in the preclinical stage and will move forward subject to obtaining additional financing.

109

Ultra-High Concentration NO (UNO) in solid tumors through majority-owned affiliate Beyond Cancer.

In the fourth calendar quarter of 2021, Beyond Cancer, our majority-owned ~~affiliate~~subsidiary, raised $30.0 million in a private placement of common shares. The investors purchased a 20% equity ownership in Beyond Cancer, while Beyond Air maintained 80% equity ownership. The funding is being used to accelerate ongoing preclinical work, including the completion of IND-enabling studies, completion of a Phase 1 human clinical trial, expansion of preclinical programs for combination studies, hiring of additional Beyond Cancer team members, and optimization of the delivery system, as well as for general corporate purposes.

Beyond Cancer ~~benefits~~will benefit from Beyond Air’s NO expertise, IP portfolio, ~~preclinical oncology team,~~ and regulatory progress, and will pay Beyond Air a single-digit royalty on all future revenues. ~~Beyond Cancer is being led by a seasoned leadership team with experience in emerging healthcare companies and clinical oncology.~~

UNO has shown anticancer properties in preclinical trials by eliciting an immune response from the host. We have released preclinical data at several medical/scientific conferences showing the promise of delivering NO directly to tumors at concentrations of 20,000 ppm – 200,000 ppm. Results showed that local tumor ablation with NO conveyed anti-tumor immunity to the host. In April 2022, we presented in vivo and in vitro preclinical data at the American Association for Cancer Research (“AACR”) 2022 annual meeting. The in vivo study assessed the mode of action following a single 5-minute gaseous NO (“gNO”) treatment which provided data showing an effect on the primary tumor 14 days post-treatment. These data showed that intratumoral injections of concentrations of gNO at 20,000 and 50,000 ppm led to increased recruitment of T cells, B cells, macrophages, and dendrocytes to the primary tumor. An elevated number of T cells and B cells were also detected in the spleen and blood 21 days following gNO treatment. In addition, at the same time point, a marked reduction in the number of myeloid-derived suppressor cells was observed in the spleen. Results from the in vitro study showed that exposure of six different cancer cell lines – including human ovarian and pancreatic and mouse lung, melanoma, colon, and breast – to UNO ranging from 10,000 ppm to 100,000 ppm for up to 10 minutes resulted in a dose-dependent cytotoxic response. The higher concentration doses of gNO led to near-instant cell death, while the lower concentration doses required a longer exposure period to elicit cell death. Cell viability was assessed using two assays: XTT and clonogenic assay. After one minute of exposure to 25,000 ppm gNO, less than 10% viability was observed in all cell lines.

The second half of calendar year 2022 was a time of significant progress for Beyond Cancer. On August 23, 2022, we announced that the first patient was treated in a first-in-human Phase 1 clinical trial to assess the safety and immune biomarkers of UNO therapy. In November, at the annual meeting of the Society for Immunotherapy of Cancer (“SITC”), we presented new in vivo combination data that support the potential of our novel UNO therapy to treat various types of solid tumors in combination with immune checkpoint inhibitor (“ICI”) therapies, including anti-PD-1. The data presented at SITC appears to indicate that UNO in combination with anti-PD-1 treatment may lead to higher tumor regression rates and prolonged survival. On December 13, 2022, we announced the publication of preclinical data in the peer-reviewed journal Cancer Cell International (CCI), which showed that our proprietary tumor ablation technology utilizing UNO induced a potent innate and adaptive immune response that prevented metastases and resulted in a statistically significant survival benefit.

11In April 2023, Beyond Cancer presented additional preclinical data for UNO therapy in solid tumors during the AACR 2023 annual meeting. Data showed a statistically significant survival benefit for repeat dosing of UNO compared to anti-mCTLA-4 as monotherapy and repeat doses of UNO prolonged survival in combination with anti-PD-1 compared to gNO alone. With regard to tumor volume, statistically significant reductions were observed with repeat dosing of UNO versus anti-mPD-1 as a monotherapy and in combination with anti-CTLA-4 versus anti-CTLA-4 alone. Additionally, the data shows that short exposures between 10 seconds to one minute of tumor cells to UNO at increasing concentrations of 25,000 ppm to 100,000 ppm NO significantly upregulate mPD-L1 expression in a dose and time-dependent manner. Also, in vivo experiments exhibited a statistically significant day 1 increase in M1 macrophages, decrease in Tregs, and reduction in tumor cell viability was directionally maintained through day 5. We believe that together with the known ability of NO to activate and recruit the immune system, the data presented at this year’s AACR annual meeting appears to indicate that repeat dosing of UNO is feasible and may be effective even in difficult-to-treat, non-immunogenic tumor types.

In October ~~April~~ 2023, Beyond Cancer presented ~~additional~~ ~~preclinical~~positive pre-clinical data ~~for~~at ~~UNO~~the ~~therapy~~EORTC inInternational ~~solid~~Conference ~~tumors~~on ~~during~~Molecular ~~the~~Targets ~~AACR~~and ~~2023~~Cancer Therapeutics, ~~annual~~demonstrating ~~meeting. Data showed~~ a statistically significant survival benefit ~~for repeat dosing of UNO compared to anti-mCTLA-4 as monotherapy and repeat doses of UNO prolonged survival~~ in ~~combination with~~mice ~~anti-PD-1~~treated ~~compared to gNO alone. With regard to tumor volume, statistically significant reductions were observed~~ with ~~repeat dosing of~~ UNO ~~versus~~plus anti-~~mPD-1~~PD1 ~~as a monotherapy and in combination with anti-CTLA-4~~ versus anti-~~CTLA-4~~PD1 alone. ~~Additionally, the data shows that~~ ~~short~~This ~~exposures~~was ~~between~~a 10pooled ~~seconds~~analysis ~~to one minute~~ of ~~tumor~~multiple ~~cells~~studies todone ~~UNO~~with ~~at increasing concentrations of 25~~50,000 ~~ppm~~or to 100,000 ppm NO ~~significantly upregulate~~for ~~mPD-L1~~a ~~expression~~single inadministration aof ~~dose~~5 ~~and~~or ~~time-dependent~~10 ~~manner~~minutes. ~~Also~~Additionally, ~~in vivo experiments exhibited a statistically significant day~~ 1Beyond ~~increase~~Cancer’s insecond M1manuscript ~~macrophages,~~was ~~decrease~~published in ~~Tregs,~~the ~~and~~Cells ~~reduction~~Journal in ~~tumor~~an ~~cell~~article ~~viability~~titled ~~was~~“Intratumoral ~~directionally maintained through day 5. We~~Administration ~~believe that together with the known ability~~ of NOHigh-Concentration toNitric ~~activate~~Oxide and ~~recruit~~Anti-mPD-1 ~~the~~Treatment ~~immune~~Improves ~~system,~~Tumor ~~the~~Regression ~~data~~Rates ~~presented at this year’s AACR annual meeting appears to indicate that repeat dosing of UNO is feasible~~ and ~~may~~Survival ~~be effective even~~ in ~~difficult-to-treat,~~CT26 ~~non~~Tumor-~~immunogenic tumor~~Bearing ~~types~~Mice.”

In late ~~October~~December 2023, ~~Beyond Cancer presented positive pre-clinical data at~~ the ~~EORTC~~Company’s ~~International~~safety ~~Conference~~review oncommittee ~~Molecular~~completed ~~Targets~~its ~~and~~review ~~Cancer~~of ~~Therapeutics,~~the ~~demonstrating a~~first ~~statistically~~6 ~~significant~~human ~~survival~~subjects ~~benefit in mice~~ treated with UNO ~~plus~~and reported ~~anti-PD1~~that ~~versus~~there ~~anti-PD1~~were ~~alone.~~no ~~This~~dose ~~was~~limiting atoxicities ~~pooled~~at ~~analysis of~~the ~~multiple studies done with 50~~25,000 ~~or 100,000~~ ppm NO ~~for~~concentration aand ~~single~~the ~~administration~~study ofmay 5progress orto ~~10 minutes. Additionally, Beyond Cancer’s second manuscript was published in~~ the ~~Cells~~next ~~Journal in an article titled “Intratumoral Administration~~ concentration of ~~High-Concentration Nitric~~50,000 ~~Oxide~~ppm ~~and Anti-mPD-1 Treatment Improves Tumor Regression Rates and Survival in CT26 Tumor-Bearing Mice~~NO.”

In June ~~late~~2024 ~~December~~at ~~2023~~the American Society of Clinical Oncology (ASCO), the Company’s presented single agent treatment in relapsed or refractory ~~safety~~unresectable, ~~review~~primary ~~committee~~or ~~completed~~metastatic ~~its~~cutaneous ~~review~~and subcutaneous malignancies at UNO doses of ~~the~~25,000 ~~first~~and 650,000 ~~human~~parts ~~subjects~~per ~~treated~~million. ~~with~~The immune biomarker data at Day 21, following a single 5-minute dose of UNO 50,000 ppm, demonstrated increases in dendritic cells, cytotoxic T-cells, central memory T-cells and ~~reported~~a ~~that~~favorable ~~there~~increase ~~were~~in nothe ~~dose~~M1/M2 ~~limiting~~ratio. Myeloid Derived Suppressor Cells (MDSCs) also showed a 54% ~~toxicities~~decrease. atIn the 25,000 ppm NOcohort, ~~concentration~~the ~~and~~same ~~the~~stimulatory ~~study~~immune ~~may~~biomarkers ~~progress~~were toupregulated. ~~the~~UNO ~~next~~was ~~concentration~~generally ofwell tolerated with primarily Grade 1 related toxicities. One Grade 3 adverse event was deemed a dose limiting toxicity in the 50,000 ppm NOcohort resulting in the expansion of the cohort to six total subjects.

~~In June 2024 at the American Society~~The ~~of Clinical Oncology (ASCO), the~~ Company ~~presented~~also ~~single~~reported ~~agent~~a ~~treatment~~case inof relapsed or /refractory ~~unresectable,~~Triple ~~primary~~Negative orBreast ~~metastatic cutaneous~~Cancer ~~and~~(TNBC) ~~subcutaneous~~in ~~malignancies~~which atthe ~~UNO~~subject ~~doses~~showed ofno ~~25,000~~evidence ~~and 50,000 parts per million. The immune biomarker data at Day 21, following a single 5-minute dose~~ of ~~UNO 50,000 ppm, demonstrated increases in dendritic cells, cytotoxic T-cells, central memory T-cells and a favorable~~malignancy ~~increase~~ in ~~the M1/M2 ratio. Myeloid Derived Suppressor Cells (MDSCs) also showed~~ a ~~54%~~satellite ~~decrease.~~lesion In21 ~~the~~days ~~25,000~~following ~~ppm cohort, the same stimulatory immune biomarkers were upregulated.~~ UNO ~~was~~treatment ~~generally~~and ~~well tolerated with primarily Grade 1 related toxicities. One Grade 3 adverse event was deemed~~ a ~~dose limiting toxicity in the 50~~corollary,~~000~~ ~~ppm~~rapid ~~cohort~~and ~~resulting~~durable inclinical ~~the~~resolution ~~expansion~~ of ~~the~~radiation-induced ~~cohort to six total subjects~~dermatitis.

The phase ~~Company~~1a ~~also~~study, ~~reported~~between August 2022 and November 2024, enrolled a ~~case~~total of 10 patients treated with either 25,000 ppm or 50,000 ppm NO for a single intra-tumoral administration over 5 minutes. All subjects had significant advanced stage metastatic disease. The mean number of ~~relapsed/refractory~~treatments ~~Triple~~prior ~~Negative~~to ~~Breast~~entering ~~Cancer~~the study was 10.3 (~~TNBC~~min 4, max 18), inwith ~~which~~5.5 ~~the~~being ~~subject~~medication ~~showed~~treatments no(min ~~evidence~~2, ofmax ~~malignancy~~14). inTumors were a ~~satellite~~mix ~~lesion 21~~of ~~days~~squamous ~~following~~cell ~~UNO~~carcinoma, ~~treatment~~melanoma, breast and atriple ~~corollary~~negative breast. At the time of treatment, ~~rapid~~life ~~and~~expectancy ~~durable~~for ~~clinical~~all ~~resolution~~patients was less than 12 months, with some as low as 3 months. The majority of ~~radiation-induced~~patients ~~dermatitis~~are still alive as of February 2, 2026.

A Phase 1b trial protocol was approved by the Israeli Ministry of Health (IMOH) in December 2024. ~~This~~The ~~trial~~initiation will enroll up to 15 subjects with prior exposure to anti-PD-1 antibody that have either progressed, not achieved a response, or have prolonged stable disease (12 weeks) on single agent anti-PD-1 without radiographic evidence of ~~continued tumor reduction. Subjects enrolled in~~ the ~~Phase 1b trial will be treated with the UNO + anti-PD-1 combination.~~study ~~Both safety and efficacy will be evaluated. Completion of enrollment~~ is ~~anticipated~~pending byfuture ~~the end of calendar 2025~~funding.

~~Selective neuronal nitric oxide synthase (nNOS) inhibitor for the treatment of neurological conditions in collaboration with Hebrew University of Jerusalem~~10

~~On June 15, 2023, we announced~~Selective ~~that we had entered into an agreement with Yissum Research Development Company of the Hebrew University of Jerusalem, LTD. (the “University”) to acquire the commercial rights for~~ neuronal nitric oxide synthase (nNOS) ~~inhibitors~~inhibitor ~~being developed~~ for the treatment of ~~autism spectrum disorder (“ASD”) and other~~ neurological conditions. ~~Currently,~~in ~~there~~collaboration ~~are~~with noHebrew ~~FDA-approved therapies utilizing nNOS inhibitors specifically for the treatment of ASD. Under the terms of the agreement, Beyond Air shall pay to the~~ University ~~compensation for pre-clinical~~ ~~work over the two-year period from the date~~ of ~~the agreement. Also, we will pay a low single-digit royalty on net sales and certain one-time payments based on clinical, regulatory and sales milestones.~~Jerusalem

InOn June ~~the~~15, ~~first calendar~~2023, ~~quarter~~we announced that we had entered into an agreement with Yissum Research Development Company of ~~2025,~~the ~~NeuroNos~~Hebrew University of Jerusalem, ~~our~~LTD. ~~majority-owned~~(the ~~affiliate,~~“University”) ~~raised~~to ~~$2.0~~acquire ~~million~~the incommercial arights ~~private~~for ~~placement~~neuronal nitric oxide synthase (nNOS) inhibitors being developed for the treatment of ~~common~~autism ~~shares~~spectrum disorder (“ASD”) and other neurological conditions. ~~The~~Currently, there ~~investors~~are ~~purchased~~no aFDA-approved ~~11.8%~~therapies ~~equity~~utilizing ~~ownership~~nNOS ininhibitors ~~NeuroNos,~~specifically ~~while~~for ~~Beyond~~the ~~Air~~treatment ~~maintained~~of 88ASD.2% ~~equity~~Under ~~ownership.~~the ~~The~~terms ~~private~~of ~~placement~~the agreement, Beyond ~~remains~~Air ~~open~~shall pay to ~~investment~~the atUniversity ~~this~~compensation ~~time.~~for ~~The~~pre-clinical ~~funding~~work isover ~~being~~the ~~used~~three-year toperiod ~~accelerate~~from ~~ongoing~~the ~~preclinical~~date ~~work~~of the agreement. Also, ~~including~~we will ~~IND~~pay a low single-~~enabling~~digit ~~studies~~royalty ason ~~well~~net assales ~~for~~and ~~general~~certain ~~corporate~~one-time ~~purposes~~payments based on clinical, regulatory and sales milestones.

~~Work~~In the isfirst ~~currently~~calendar ~~being~~quarter ~~done~~of by2025, ~~the~~NeuroNos, ~~University~~our majority-owned affiliate, raised $2.0 million in a ~~preclinical~~private ~~setting~~placement of common shares. An Weadditional ~~expect~~$0.5 ~~this~~million ~~program~~and to$0.2 ~~progress~~million ~~from~~was ~~preclinical~~raised toin the private placement offering during the third and fourth calendar quarter of 2025, respectively. In total, the investors purchased a ~~phase~~15.25% 1equity ~~first-~~ownership in NeuroNos, while Beyond Air maintained 84.75% equity ownership. The funding is being used to accelerate ongoing preclinical work, including IND-~~human~~enabling ~~clinical~~studies ~~trial~~as bywell ~~the~~as ~~end~~for ofgeneral ~~2026~~corporate purposes.

~~Background~~In April 2025, the FDA granted Orphan Drug Designation (“ODD”) to NeuroNos’ investigational therapy, BA-102, for the treatment of Phelan-McDermid Syndrome (“PMS”), a syndrome associated with ASD. PMS is a rare genetic disorder most commonly caused by deletions or mutations affecting the SHANK3 gene leading to a range of symptoms, including global developmental delay, intellectual disability, severe speech impairments, and NOin ~~Mechanism~~many cases features of ~~Action~~ASD.

NOIn isSeptember ~~recognized~~2025, asthe ~~a vital molecule~~FDA ~~involved~~granted inODD ~~many~~to ~~physiological and pathological processes. NO is naturally produced by the body~~NeuroNos’s ~~immune~~investigational ~~system~~therapy, ~~to provide a first line of defense against invading pathogens. It is a powerful molecule with a short half~~BA-~~life of a few seconds in the blood~~101, ~~enabling~~for ~~it to be cleared rapidly from~~ the ~~body.~~treatment ~~NO has been shown to play a critical role in the function~~ of ~~several~~Glioblastoma ~~body systems~~(“GBM”). ~~For~~GBM ~~example, as vasodilator of smooth muscles, NO enhances blood flow and circulation. In addition, NO~~ is ~~involved in regulation of wound healing and~~an ~~immune~~aggressive ~~responses~~primary tobrain ~~infection.~~tumor ~~The~~with ~~pharmacology,~~limited ~~toxicity~~treatment ~~and~~options ~~other data for NO in humans is generally well known,~~ and ~~its~~poor ~~use~~prognosis ~~has~~under ~~been approved~~current ~~by the FDA as a vasodilator. The precise effect~~ standard-of-care ~~inhaled NO is dependent on concentration, oxidation state and type of pathogen~~approaches.

12Background and NO Mechanism of Action

NO ~~has multiple immunoregulatory~~ ~~and~~is ~~antimicrobial~~recognized ~~functions~~as ~~that~~a ~~are~~vital ~~likely~~molecule toinvolved bein ofmany ~~relevance~~physiological toand ~~inhaled~~pathological ~~NO therapy~~processes. InNO ~~vitro~~is ~~studies~~naturally ~~suggest~~produced ~~that~~by NOthe ~~possesses~~body’s ~~anti-microbial~~immune ~~activity~~system ~~against~~to ~~common~~provide ~~bacteria,~~a ~~gram~~first ~~positive~~line ~~and~~of ~~gram~~defense ~~negative,~~against asinvading ~~well as mycobacteria, fungi, yeast, parasites and helminths~~pathogens. It ~~has~~is ~~the~~a ~~potential~~powerful tomolecule ~~eliminate~~with ~~multi-drug~~a ~~resistant~~short ~~strains~~half-life of ~~the~~a ~~above.~~few seconds ~~Anti-viral~~in ~~activity~~the ~~covers~~blood, ~~respiratory~~enabling ~~viruses such~~it asto ~~influenza,~~be ~~corona~~cleared ~~viruses,~~rapidly ~~RSV~~from ~~and~~the ~~others~~body. ~~In healthy humans,~~ NO has been shown to ~~stimulate~~play ~~mucociliary~~a ~~clearance,~~critical ~~and~~role ~~low~~in ~~levels~~ the function of ~~nasal~~several body NOsystems. ~~correlate~~For ~~with~~example, ~~impaired~~as ~~mucociliary~~vasodilator ~~function~~of insmooth ~~the~~muscles, ~~human~~NO ~~upper~~enhances ~~airway.~~blood ~~Unlike~~flow ~~other~~and ~~inhaled~~circulation. ~~drugs~~In addition, NO is ~~also~~involved ain ~~smooth muscle~~regulation ~~relaxant~~of ~~and~~wound ~~avoids~~healing ~~the~~and ~~concomitant~~immune ~~bronchial~~responses ~~constriction~~to ~~often~~infection. ~~associated~~The ~~with~~pharmacology, ~~inhaled~~toxicity ~~antibiotics~~ and ~~mucolytics.~~other Adata ~~potential~~for ~~benefit of~~NO ~~these~~in ~~multiple~~humans ~~mechanisms~~is ~~may~~generally bewell ~~that~~known, and inits ~~addition~~use tohas ~~treating~~been ~~lung~~approved ~~infections~~by inthe CFFDA ~~patients,~~as ~~this~~a ~~suggests~~vasodilator. ~~that~~The NOprecise ~~may~~effect beof ~~useful~~inhaled ~~in directly~~NO ~~treating~~is ~~the~~dependent ~~mucus~~on ~~caused by CF~~concentration, ~~which~~oxidation state isand ~~the~~type ~~principal manifestation~~ of ~~the disease~~pathogen.

~~Nitric~~NO has ~~Oxide~~multiple immunoregulatory and ~~Infection~~antimicrobial functions that are likely to be of relevance to inhaled NO therapy. In vitro studies suggest that NO possesses anti-microbial activity against common bacteria, gram positive and gram negative, as well as mycobacteria, fungi, yeast, parasites and helminths. It has the potential to eliminate multi-drug resistant strains of the above. Anti-viral activity covers respiratory viruses such as influenza, corona viruses, RSV and others. In healthy humans, NO has been shown to stimulate mucociliary clearance, and low levels of nasal NO correlate with impaired mucociliary function in the human upper airway. Unlike other inhaled drugs, NO is also a smooth muscle relaxant and avoids the concomitant bronchial constriction often associated with inhaled antibiotics and mucolytics. A potential benefit of these multiple mechanisms may be that in addition to treating lung infections in CF patients, this suggests that NO may be useful in directly treating the mucus caused by CF, which is the principal manifestation of the disease.

~~NO possesses broad-spectrum anti-microbial~~Nitric ~~activity~~Oxide ~~acting against bacteria, fungi~~ and viruses. NO is produced at high output as part of the innate immune response. NO and its by-products (for example, reactive nitrogen species (“RNS”)) are responsible for the process of killing microorganisms within white blood cells called macrophages and in organs such as the lungs and other mucolytic tissues.Infection

~~More~~NO possesses ~~than~~broad-spectrum aanti-microbial ~~decade~~activity ~~ago,~~acting ~~several research~~against ~~groups~~bacteria, ~~showed~~fungi ~~that~~and viruses. NO ~~and~~is ~~RNS~~produced ~~possess~~at ~~anti-viral~~high ~~activity~~output ~~and~~as ~~affect~~part ~~several~~of the ~~viruses~~innate ~~including~~immune ~~coxsackievirus,~~response. ~~RSV,~~NO ~~influenza~~and its by-products (for example, ~~severe~~ ~~acute~~reactive ~~respiratory~~nitrogen ~~syndrome~~species (~~SARS~~“RNS”),) ~~coronavirus,~~are ~~rhinovirus,~~responsible ~~herpes~~for ~~simplex~~the process ~~virus,~~of ~~Epstein-Barr~~killing ~~virus~~microorganisms ~~(EBV),~~within ~~and~~white ~~others.~~blood NOcells ~~has also~~called ~~been~~macrophages ~~shown~~and toin beorgans ~~useful~~such inas ~~preventing~~the ~~bacterial~~lungs ~~growth~~and onother ~~surfaces~~mucolytic tissues.

~~Continuous exposure to 150 ppm~~More NOthan ~~and~~a ~~above,~~decade ~~especially in the lungs~~ago, ~~may~~several ~~have~~research ~~side~~groups ~~effects~~showed ~~and~~that ~~cause damage to host cells. Intermittent exposure to~~ NO inand ~~cycles~~RNS ~~retains NO~~possess anti-~~microbial~~viral activity ~~both in vitro~~ and inaffect ~~animal~~several ~~model~~viruses ofincluding ~~infection. Exposure of bacteria to concomitant 30-minute treatments with~~coxsackievirus, ~~160~~RSV, ~~ppm~~influenza, NOsevere ~~resulted~~acute inrespiratory asyndrome ~~significant reduction in bacterial load. A similar dose has been shown to reduce viruses~~ (~~common influenza~~SARS) ~~by 30-100% in a canine kidney infection model. In vivo~~, ~~in a pneumonia model in rats~~coronavirus, ~~inhaled 160 ppm NO~~rhinovirus, ~~for~~herpes 30simplex ~~minutes~~virus, ~~every~~Epstein-Barr 4virus ~~hours~~(EBV), ~~resulted~~ ~~in significant reduction in bacteria counts in the lungs, without affecting the body’s defense mechanisms,~~ and ~~without~~ ~~any other adverse effect~~others. InNO ~~addition,~~has wealso ~~believe~~been ashown ~~daily~~to ~~dose~~be ofuseful ~~160~~in ~~ppm~~preventing ofbacterial NOgrowth ~~can~~on ~~treat bovine respiratory disease (BRD) in cattle~~surfaces.

~~Importantly,~~Continuous exposure ~~several~~to ~~studies~~150 ~~report synergy~~ppm ~~between~~ NO and ~~antibiotic~~above, ~~drugs.~~especially ~~Adjunctive~~in ~~treatment~~the ~~combining~~lungs, NOmay ~~together~~have ~~with~~side ~~inhaled~~effects ~~tobramycin~~and ~~antibiotics~~cause ordamage ~~other~~to host cells. Intermittent exposure to NO in cycles retains NO anti-microbial ~~agents~~ ~~has~~activity ~~been~~both ~~shown~~in tovitro ~~greatly~~and ~~enhance~~in ~~the~~animal ~~efficacy~~model of ~~the~~infection. ~~antibiotics~~Exposure of bacteria to concomitant 30-minute treatments with 160 ppm NO resulted in ~~dispersing~~a Psignificant reduction in bacterial load. ~~aeruginosa~~A ~~biofilms~~similar ~~and~~dose has been shown to ~~increase~~reduce ~~their~~viruses ~~ability~~(common toinfluenza) ~~elicit~~by ~~anti~~30-~~microbial~~100% ~~activity~~in a canine kidney infection model. ~~These~~In ~~studies~~vivo, ~~suggest~~in ~~that~~a ~~adjuvant~~pneumonia ~~treatment~~model ~~combining~~in NOrats, ~~with~~inhaled ~~antibiotics~~160 ~~might~~ppm ~~have~~NO, afor ~~beneficial~~30 minutes, ~~role~~every by4 ~~reducing~~hours, ~~bacterial~~resulted ~~infectivity~~in significant reduction in bacteria counts in the lungs, without affecting the body’s defense mechanisms, and ~~therefore~~without ~~reduce~~any ~~the~~other ~~dependency~~adverse oneffect. ~~antibiotics~~In addition, we believe a daily dose of 160 ppm of NO can treat bovine respiratory disease (BRD) in cattle.

~~Beyond~~Importantly, several ~~Air~~studies ~~Technology~~report synergy between NO and antibiotic drugs. Adjunctive treatment combining NO together with inhaled tobramycin antibiotics or other anti-microbial agents has been shown to greatly enhance the efficacy of the antibiotics in dispersing P. aeruginosa biofilms and to increase their ability to elicit anti-microbial activity. These studies suggest that adjuvant treatment combining NO with antibiotics might have a beneficial role by reducing bacterial infectivity, and therefore reduce the dependency on antibiotics.

~~We have developed the~~ Beyond ~~Air~~ NOAir generator and delivery system which we call LungFit®, a novel and precise delivery system that uses NO generated from ambient air with a novel NO generator, the ionizer. Our system provides continuous monitoring and control of the gaseous content administered during intermittent and continuous NO inhalation treatments, as well as a precise and reliable monitoring system that is able to monitor patient status and alert medical staff to any adverse effects.Technology

~~The LungFit® system~~We ishave ~~innovatively~~developed ~~designed~~the toBeyond ~~provide~~Air ~~patients with a gaseous dose of~~ NO ~~(ranging~~generator ~~from~~and ~~0.5~~delivery ~~ppm~~system upwhich towe ~~400~~call ~~ppm) combined with ambient air. The gaseous blend is supplied to the patient via a ventilator, face mask, or similar apparatus.~~ LungFit®, isa ~~designed~~novel ~~to minimize~~and ~~the~~precise ~~time~~delivery system that uses NO isgenerated ~~mixed~~from ~~with~~ambient ~~oxygen and~~ air. ~~The~~with ~~system~~a isnovel ~~also designed to continuously monitor inhaled~~ NO ~~concentration~~generator, ~~NO2~~ ~~concentration~~the ~~and oxygen~~ionizer. AOur ~~dedicated~~system ~~screen~~provides ~~allows~~continuous ~~for~~ monitoring and control of the ~~gas~~gaseous ~~mixture.~~content ~~Further,~~administered ~~our~~during ~~approved~~intermittent ~~product~~ and ~~product~~ ~~candidates~~continuous ~~resemble~~NO ~~other~~ inhalation ~~systems~~treatments, ~~making~~as ~~them~~well ~~user~~as ~~friendly,~~a ~~with~~precise ~~operation~~ and ~~maintenance~~reliable monitoring system that weis ~~believe~~able ~~will be immediately familiar~~ to ~~medical~~monitor ~~staff.~~patient ~~Our~~status ~~LungFit®~~and ~~system~~alert ~~has~~medical ~~been~~staff ~~manufactured~~to atany ~~commercial~~adverse ~~scale with a contract manufacturer~~effects.

1311

~~When~~The LungFit® ~~programmed~~system ~~for~~is ~~lung~~innovatively ~~infections,~~designed to provide patients with a gaseous dose of NO (ranging from 0.5 ppm up to 400 ppm) combined with ambient air. The gaseous blend is supplied to the ~~LungFit®~~patient via a ventilator, face mask, or similar apparatus. LungFit® is designed to ~~specifically~~minimize ~~deliver~~ the time that NO atis ~~concentrations~~mixed ofwith ~~150~~oxygen ~~ppm~~and air. The system is also designed to continuously monitor inhaled NO concentration, NO2 concentration and ~~higher~~oxygen. WeA ~~believe~~dedicated ~~that~~screen allows for monitoring of the ~~LungFit®~~gas mixture. Further, our ~~has~~approved aproduct ~~number~~and ofproduct ~~advantages~~candidates ~~over~~resemble other NOinhalation ~~formulation~~systems, ~~delivery~~making ~~systems.~~them ~~For~~user ~~example~~friendly, itwith ~~is:~~operation and maintenance that we believe will be immediately familiar to medical staff. Our LungFit® system has been manufactured at commercial scale with a contract manufacturer.

●When programmed ~~optimized~~for tolung ~~deliver 150 ppm and higher of NO~~infections, ~~whereas existing NO delivery systems on~~ the ~~market~~LungFit®, ~~consist~~is ofdesigned ato ~~maximum~~specifically ~~deliverable~~deliver NO ~~concentration~~at concentrations of 80150 ppm; ~~● equipped with a monitoring system that continuously monitors system parameters (e~~and higher.~~g.,~~ ~~NO,~~We ~~NO2 and inhaled fraction of inspired oxygen (“FiO2”) concentrations); ● capable of providing constant flow of NO, which we~~ believe ~~allows~~that ~~it to adequately cover~~ the ~~surface~~LungFit® ~~area~~has ~~of the lung to eliminate bacteria, viruses, fungi and other microbes; ● programmable and able to deliver different dosage regimens for~~ a ~~wide~~number ~~range~~ of ~~lung~~advantages ~~infections;~~over ●other ~~able to generate~~ NO ~~from~~formulation ~~ambient~~delivery ~~air,~~systems. ~~eliminating~~For ~~the need for the use of high-pressure cylinders; ● designed to be used by the patient~~example, it thus convenient and portable; and ● administered non-invasively through a facial mask, which has the potential to address severe infections in large, underserved chronic-care markets, such as CF and COPD.is:

We● ~~believe~~optimized to deliver 150 ppm and higher of NO, whereas existing NO delivery systems on the market consist of a maximum deliverable NO concentration of 80 ppm; ● equipped with a monitoring system that ~~our~~continuously ~~solution~~monitors ~~has~~ system parameters (e.g., NO, NO2 and inhaled fraction of inspired oxygen (“FiO2”) concentrations); ● capable of providing constant flow of NO, which we believe allows it to adequately cover the ~~potential~~surface area of the lung to eliminate bacteria, viruses, fungi and other microbes; ● programmable and able to deliver different dosage regimens for a ~~number~~wide range of ~~additional~~lung ~~benefits~~infections; ● able to generate NO from ambient air, eliminating the need for the use of high-pressure cylinders; ● designed to be used by the patient, thus convenient and ~~opportunities~~portable; and ● administered non-invasively through a facial mask, which has the potential to address severe infections in large, underserved chronic-care markets, such as ~~follows:~~CF and COPD.

●We believe ~~The~~that ~~antimicrobial~~our ~~and~~solution ~~multiple~~has ~~other properties of~~ the ~~NO molecule delivered to the lungs suggest the~~ potential for ~~application in~~ a ~~wide~~number ~~range~~ of ~~respiratory~~additional diseases. In contrast to the often arduous and slow drug discovery process for small molecules, proteins, and peptides, the use of NO in medicine is well-known, and therefore the identification of conditions where NO provides benefits ~~has been,~~ and ~~we expect will continue to be~~opportunities, ~~much simpler, quicker and less costly. ● The FDA approved the use of NO~~ as an inhaled drug for the treatment of PPHN in 1999. More than 20 years of clinical experience in the delivery, monitoring and understanding of NO in the clinical environment for vascular uses has been documented. ● NO is naturally produced by the immune system and acts as a first line of defense against infectious diseases. We believe therapeutic use of NO for viral and bacterial co-infections would potentially improve the success of antimicrobial and anti-viral treatments by mimicking the body’s natural defense mechanism and thereby directly reduce viral infectivity, as well as antibiotic drug resistant bacteria. ● NO is used naturally by the body for vasodilation and we believe that the benefits to patients with various medical conditions will be seen via vasodilation when delivered with our system.follows:

~~NitricGen~~● ~~License~~The antimicrobial and multiple other properties of the NO molecule delivered to the lungs suggest the potential for application in a wide range of respiratory diseases. In contrast to the often arduous and slow drug discovery process for small molecules, proteins, and peptides, the use of NO in medicine is well-known, and therefore the identification of conditions where NO provides benefits has been, and we expect will continue to be, much simpler, quicker and less costly. ● The FDA approved the use of NO as an inhaled drug for the treatment of PPHN in 1999. More than 20 years of clinical experience in the delivery, monitoring and understanding of NO in the clinical environment for vascular uses has been documented. ● NO is naturally produced by the immune system and acts as a first line of defense against infectious diseases. We believe therapeutic use of NO for viral and bacterial co-infections would potentially improve the success of antimicrobial and anti-viral treatments by mimicking the body’s natural defense mechanism and thereby directly reduce viral infectivity, as well as antibiotic drug resistant bacteria. ● NO is used naturally by the body for vasodilation and we believe that the benefits to patients with various medical conditions will be seen via vasodilation when delivered with our system.

On January 31, 2018, the Company entered into a definitive agreement to acquire a global, exclusive, perpetual, transferable license to the eNOGenerator and associated critical assets including intellectual property, know-how, trade secrets and confidential information (the “License”) from NitricGen ~~Inc. (“NitricGen”). The eNOGenerator is a novel and precise delivery system that uses NO generated from ambient~~ ~~air with a novel NO generator.~~License

~~The~~On January ~~Beyond~~31, ~~Air LungFit® system~~2018, ~~which incorporates~~ the ~~eNOGenerator,~~Company ~~has~~entered ~~been~~into ~~designated as~~ a ~~medical~~definitive ~~device~~agreement byto ~~the~~acquire ~~FDA.~~a ~~The~~global, ~~eNOGenerator~~exclusive, ~~can~~perpetual, ~~generate~~transferable NOlicense ~~on demand~~to ~~for~~the ~~delivery~~eNOGenerator toand ~~the~~associated ~~lungs~~critical atassets ~~concentrations~~including ~~ranging~~intellectual ~~from~~property, ~~0.5~~know-how, totrade ~~400~~secrets ~~ppm.~~and ~~With~~confidential information (the “License,”) ~~the~~from ~~Company~~NitricGen ~~expects~~Inc. ~~that~~(“NitricGen”). itThe ~~will~~eNOGenerator beis ~~able~~a ~~to target~~novel ~~all~~and ~~conditions~~precise ~~requiring~~delivery NOsystem atthat uses ~~any~~NO ~~concentration,~~generated ~~regardless~~from ofambient ~~the~~air ~~need~~with ~~for~~a ~~intermittent~~novel orNO ~~continuous dosing~~generator.

~~Under~~The Beyond ~~the~~Air ~~terms~~LungFit® ~~of the License~~system, ~~the~~ ~~Company~~which ~~agreed~~incorporates tothe ~~pay~~eNOGenerator, ~~NitricGen~~has anbeen ~~aggregate~~designated ofas $2a ~~million~~medical indevice ~~up-front,~~by ~~clinical, and regulatory milestone payments, with~~ the ~~majority~~FDA. The ~~pertaining~~eNOGenerator tocan ~~regulatory~~generate ~~milestones,~~NO ~~as well as royalties~~ on ~~net~~demand ~~sales~~for ~~of the~~ delivery ~~system~~to ~~containing~~ the ~~eNOGenerator~~lungs at aconcentrations ~~percentage in~~ranging ~~the~~from ~~low-single digits~~0.5 Asto ~~partial~~400 ~~consideration~~ppm. ~~for~~With the License, wethe Company ~~issued~~expects tothat ~~NitricGen~~it ~~warrants~~will tobe ~~purchase~~able ~~100,000~~to ~~shares~~target ofall ~~our common~~conditions ~~stock~~requiring NO at anany ~~exercise~~concentration, ~~price~~regardless of ~~$6.90~~the ~~per~~need ~~share. To date, $1.7 million has been paid~~ for ~~milestones that were earned. As of March~~intermittent ~~31,~~or ~~2025~~continuous ~~the remaining future milestone payments totaled $0~~dosing.~~3 million.~~

14Under the terms of the License, the Company agreed to pay NitricGen an aggregate of $2 million in up-front, clinical, and regulatory milestone payments, with the majority pertaining to regulatory milestones, as well as royalties on net sales of the delivery system containing the eNOGenerator at a percentage in the low-single digits. As partial consideration for the License, we issued to NitricGen warrants to purchase 100,000 shares of our common stock at an exercise price of $6.90 per share. To date, $1.7 million has been paid for milestones that were earned. As of March 31, 2026 the remaining future milestone payments totaled $0.3 million.

Strategies

Our objective is to build a leading medical device and biopharmaceutical company that develops and commercializes patented and proprietary products for the treatment of respiratory infections and diseases, with an initial focus on the treatment of PPHN, NTM and severe infections in COPD patients, among others. We are exploring and testing the effects of NO on solid tumors through our subsidiary, Beyond Cancer. Additionally, we are exploring the development of nNOS inhibitors for the treatment of ASD and other neurological conditions through our subsidiary, NeuroNos. If our clinical trials for our product candidates are successful, we expect to seek certification or marketing approval from the FDA and other worldwide authorities and notified regulatory bodies.

~~Our Clinical Results to Date~~12

~~We have conducted several clinical~~Cystic ~~trials~~Fibrosis toand ~~assess~~NTM ~~our~~Clinical ~~150-250 ppm NO inhalation-treatment in various indications. These trials include:~~Development

Date	Study	Indication	Primary	Results
2011	Pilot Safety (n=10)	All comers	Safety	No SAEs
2013 – 2014	Proof of Concept (“POC”) double blind randomized (n=43)	Bronchiolitis (due to any virus)	Safety & Efficacy	No SAEs; 24 hour reduction in hospital length of stay
2013 – 2014	Pilot open label (n=9)	Cystic Fibrosis (CF)	Safety & Efficacy	No SAEs; Lowered bacterial load
2016	Compassionate use investigator sponsored research (“ISR”) (n=2)	NTM abscessus (CF)	Safety & Efficacy	No SAEs; clinical & surrogate endpoints improved
2017	Compassionate use National Institute of Health, U.S. (n=1)	NTM abscessus (CF)	Safety & Efficacy	No SAEs; Improvements in clinical endpoints
2017	Pilot open label (n=9)	NTM abscessus	Safety & Efficacy	No SAEs; clinical & surrogate endpoints improved
2017-2018	Pilot; double blind randomized (n=68)	Bronchiolitis (due to any virus)	Safety & Efficacy	No SAEs; 27 hour reduction in hospital length of stay
2018	Compassionate use ISR (n=1)	NTM abscessus (CF)	Safety	No SAEs at 250 ppm NO dose
2019-2020	Pilot; double blind randomized (n=87)	Bronchiolitis (due to any virus)	Safety & Efficacy	No SAEs; 150 ppm treatment showed statistically significant improvements in primary and key secondary endpoints compared to both 85 ppm and control
2020-2022	Pilot; randomized, controlled (n=35)	VCAP (due to any virus, including COVID-19)	Safety & Efficacy	No SAEs related to treatment; 150 ppm NO showed statistically significant improvement in duration of oxygen use
2020-2022	Pilot open label (n=15)	NTM (all strains)	Safety & Efficacy	All patients titrated to 250 ppm NO with no treatment related discontinuations during 11+ weeks of self-administration at home; Improvements in QoL
2021-2022	Pilot; randomized, controlled (n=101)	Bronchiolitis Long Term Follow-up	Safety	Favorable long term safety profile based on re-hospitalization rate

In 2011, a prospective, open label, controlled, single-center pilot safety study was conducted on ten healthy adults between 20 and 62 years of age. The data were published in the Journal of Cystic Fibrosis in 2012. Subjects received 160 ppm NO for 30 minutes, five times a day, for five consecutive days via direct inhalation to the lungs using a prototype delivery system. The primary objective of the study was to determine the effect of inhaled 160 ppm NO on pulmonary function tests and characterize the relationship between high-concentration NO administration and MetHb – a form of hemoglobin that is a biproduct of NO and hemoglobin that cannot bind oxygen – and establish a MetHb safety threshold level to assess adverse events associated with the treatment. Secondary objectives of the study were to assess the changes in cytokine levels. Multiple safety markers were continuously monitored including: NO levels, NO₂ (a biproduct of NO and O₂ that can be toxic at high concentrations), FiO₂, as well as MetHb and oxygen saturation (“SaO₂”). Vital signs, lung function, blood chemistry (including nitrite/nitrates), hematology, prothrombin time, inflammatory cytokine/chemokines levels and endothelial activation (angiopoietin ratio) were also closely monitored. All individuals tolerated the NO formulation treatment courses well. No SAEs occurred. The maximum amount of air one can forcefully exhale in one second, known as forced expiratory volume in one second (“FEV1”) and other lung function parameters, serum nitrites/nitrates, prothrombin, pro-inflammatory cytokine and chemokine levels did not differ between baseline and day 5, while MetHb increased during the study period by an average of 0.9%, as expected. These data suggest that inhalation of 160 ppm NO for 30 minutes, five times a day, for five consecutive days is well tolerated in healthy individuals.

15In 2014, we completed a pilot open label, multi-center study in nine CF patients (≥10 years old). Patients received intermittent (30 minutes, three times a day) inhalation of 160 ppm NO formulation, five days a week, over a two-week period. The study was performed in two centers, Soroka Medical Center and Schneider Children’s Medical Center of Israel. The primary endpoints of the study were to determine the MetHb percentage, adverse events associated with inhaled NO and the percentage of subjects who prematurely discontinued the study due to adverse events (“AEs”) and/or SAEs, or for any other reason. AEs were reported by five (55.5%) subjects. There were no SAEs related to NO therapy, no treatment-related withdrawals due to AEs, and no deaths. AEs considered by the investigator as possibly or probably related to treatment were reported for two (22.2%) subjects. There were no AEs of MetHb elevation >5% or NO 2 elevation >5 ppm (study safety threshold of MetHb and NO2, respectively). In total, seven cases of hemoptysis were reported in two subjects and all events were mild in severity. There was no cumulative effect of MetHb exposure during the study. The maximum MetHb level reported was 4.6%. Several secondary efficacy analyses were conducted in this study, and though the study was not powered for efficacy, results show various positive effects of the treatment regime. Bacterial and fungal sputum load analysis results were highly variable, though marked reductions of Methicillin-sensitive Staphylococcus aureus (“MSSA”), Achromabacter, P. aeruginosa, and Aspergillus were seen in several subjects. These results suggest non-specific targeting of bacteria and fungi that commonly manifest in CF patients. In subjects with systemic inflammation (CRP >5 mg/mL) at baseline, CRP levels decreased over the treatment period, showing the effect of NO in the reduction of systemic inflammation. There were no statistically significant or clinically relevant changes in FEV1 over time, and lung function indices also remained relatively constant throughout the study duration.

~~Cystic~~In 2016, ~~Fibrosis~~Rambam healthcare campus in Israel conducted a compassionate use treatment for two patients with CF who suffer from M, abscessus lung infections. The data were published in the Pediatric Infectious Disease Journal in 2017. The NO treatment regime, as well as the device for this treatment, was supplied by BA Ltd. (as defined below), our wholly owned subsidiary. Patients received intermittent 30-minute treatments of 160 ppm NO, with two different regimes including hospitalization (5 times a day) and ~~NTM~~ambulatory ~~Clinical~~treatment ~~Development~~(2-3 inhalations a day). Treatment was well tolerated with no evidence of any serious side effects. We observed significant improvement in sputum production (up to 5-10 times more sputum), and subjective improvement in the well-being of both patients. Significant reduction in systemic inflammation was observed in the first patient, as observed by reduction of CRP (C-reactive protein, a systemic inflammation marker that rises in response to inflammation) levels during treatment. In addition, the first patient had a 2 log (100-fold) reduction in M. abscessus during treatment (an effect that was lost after the treatment regime changed to ambulatory). The second patient showed a significant increase in the 6-minute walk (“6MW”) test and the sputum culture became negative, which is consistent with eradication of M. abscessus. Further information is needed, but we believe these results suggest that the treatment of M. abscessus with high-concentration inhaled NO is effective.

In ~~2011, a prospective, open label,~~ ~~controlled~~2017, ~~single-center~~we ~~pilot~~treated ~~safety~~one ~~study~~patient ~~was~~with ~~conducted~~CF onwho ~~ten~~suffered ~~healthy~~from ~~adults~~NTM ~~between~~infections 20(specifically, ~~and 62 years of age~~M. ~~The~~abscessus) ~~data~~under ~~were~~compassionate ~~published in~~use in the ~~Journal~~United ofSates ~~Cystic~~at ~~Fibrosis~~the inNational ~~2012. Subjects received 160 ppm NO for 30 minutes~~Heart, ~~five~~Lung ~~times~~and aBlood ~~day,~~Institute ~~for~~with ~~five~~our ~~consecutive~~generator ~~days~~based ~~via direct~~NO ~~inhalation to the lungs using a prototype~~ delivery system. The ~~primary~~patient ~~objective~~saw ~~of the study was to determine the effect of inhaled~~improvements ~~160~~in ~~ppm~~6MW, NOFEV1, onmost ~~pulmonary function tests and characterize the relationship between high~~Quality-~~concentration NO administration and MetHb – a form~~ of-Life ~~hemoglobin~~measures ~~that is a biproduct of NO~~ and ~~hemoglobin~~had ~~that~~no ~~cannot~~SAEs. ~~bind~~The ~~oxygen~~bacteria –was ~~and~~not ~~establish a MetHb safety threshold level to assess adverse events associated with the treatment~~eradicated. ~~Secondary~~The ~~objectives~~patient ofrequested ~~the study were~~ to ~~assess the changes in cytokine levels. Multiple safety markers were continuously monitored including: NO levels, NO2 (a biproduct of NO and O2 that can~~ be ~~toxic~~treated ~~at high concentrations), FiO2, as well as MetHb and oxygen saturation (“SaO2”). Vital signs,~~again ~~lung function, blood chemistry (including nitrite/nitrates), hematology, prothrombin time, inflammatory cytokine/chemokines levels~~ and ~~endothelial~~ ~~activation~~this ~~(angiopoietin ratio) were also closely monitored. All individuals tolerated the NO formulation~~ treatment ~~courses well.~~commenced Noin ~~SAEs~~February ~~occurred~~2018. ~~The~~A ~~maximum~~total ~~amount~~ of ~~air~~38 ~~one~~treatments ~~can~~were ~~forcefully~~administered ~~exhale~~over in8 ~~one second~~days, ~~known~~29 as forced expiratory volume in one second (“FEV1”) and other lung function parameters, serum nitrites/nitrates, prothrombin, pro-inflammatory cytokine and chemokine levels did not differ between baseline and day 5, while MetHb increased during the study period by an average of ~~0.9%,~~them asat ~~expected.~~a ~~These~~concentration ~~data suggest that inhalation~~ of ~~160~~240 ppm ~~NO for 30 minutes~~, ~~five~~with ~~times~~no aSAEs ~~day,~~believed ~~for~~to ~~five~~be ~~consecutive~~related ~~days~~to isNO ~~well tolerated in healthy individuals~~reported.

InAdditionally in ~~2014~~2017, we completed a ~~pilot open label~~single-arm, ~~multi~~open-~~center~~label ~~study~~Pilot trial in nine CF patients ~~(≥10~~with ~~years old)~~M. ~~Patients~~abcessus ~~received~~lung ~~intermittent (30 minutes~~disease, ~~three~~who ~~times~~were ~~a day)~~refractory ~~inhalation~~to standard-of ~~160 ppm NO formulation, five days a week, over a two~~-~~week~~care ~~period~~(“SOC”). The ~~study~~patients ~~was~~were ~~performed~~treated inwith ~~two~~inhaled ~~centers,~~NO ~~Soroka~~at ~~Medical Center~~a ~~and~~concentration ~~Schneider Children’s Medical Center~~ of ~~Israel.~~160 ~~The~~ppm ~~primary~~for ~~endpoints~~30 ofminutes, ~~the~~in ~~study were~~ addition to ~~determine~~treatment ~~the~~with ~~MetHb~~SOC. ~~percentage, adverse~~Our ~~events associated with~~ inhaled NO ~~and~~treatment ~~the~~was ~~percentage~~administered ofintermittently ~~subjects~~five ~~who~~times ~~prematurely~~per ~~discontinued~~day ~~the~~over ~~study~~a ~~due~~14-day toperiod, ~~adverse~~followed ~~events~~by ~~(“AEs”)~~a ~~and/or~~seven-day ~~SAEs,~~period orwith ~~for~~three ~~any~~treatments ~~other~~per ~~reason~~day. ~~AEs~~The ~~were~~primary ~~reported~~endpoint byof ~~five~~safety, ~~(55.5%)~~as ~~subjects.~~measured ~~There~~by ~~were no SAEs related to~~ NO ~~therapy, no treatment~~-related ~~withdrawals due to AEs~~SAEs, ~~and~~over ~~no deaths. AEs considered by~~ the ~~investigator~~21-day ~~as possibly or probably related~~treatment toperiod ~~treatment~~was ~~were~~met ~~reported~~with ~~for~~no ~~two~~SAEs ~~(22~~reported.~~2%)~~ ~~subjects.~~Secondary ~~There~~endpoints ~~were no AEs~~ of ~~MetHb~~a ~~elevation~~6MW ~~>5%~~test orFEV1, NOQuality ~~2 elevation >5 ppm (study safety threshold~~ of ~~MetHb~~Life and ~~NO2, respectively)~~M. Inabscessus ~~total,~~load ~~seven cases of hemoptysis were reported~~ in ~~two subjects~~sputum ~~and~~ all ~~events~~trended ~~were mild in severity~~positively. ~~There~~6MW ~~was~~showed noan ~~cumulative~~increase ~~effect~~ of ~~MetHb~~>40 ~~exposure~~meters ~~during~~at the ~~study.~~end ~~The~~of ~~maximum~~treatment ~~MetHb~~at ~~level~~day ~~reported was~~21 ~~4.6%.~~versus ~~Several~~baseline ~~secondary efficacy analyses were conducted in this study,~~ and ~~though~~an ~~the~~increase ~~study~~of >25 ~~was~~meters ~~not~~on ~~powered~~day ~~for~~81 ~~efficacy,~~(60 ~~results show~~days ~~various~~after ~~positive~~the ~~effects~~cessation of ~~the treatment regime~~therapy). ~~Bacterial~~The ~~and~~mean ~~fungal~~percentage ~~sputum~~change ~~load~~in ~~analysis~~FEV1 ~~results~~at ~~were~~day ~~highly~~21 ~~variable,~~and ~~though marked~~day ~~reductions~~51 ~~of Methicillin-sensitive Staphylococcus aureus~~ (~~“MSSA”),~~30 ~~Achromabacter,~~days ~~P. aeruginosa, and Aspergillus~~after ~~were~~the ~~seen~~cessation ~~in several subjects. These results suggest non-specific targeting~~ of ~~bacteria~~treatment) ~~and~~was ~~fungi~~> ~~that commonly manifest in CF patients~~3. In5% ~~subjects~~ with ~~systemic~~FEV1 ~~inflammation~~returning ~~(CRP~~to >5baseline ~~mg/mL)~~ at ~~baseline,~~day ~~CRP~~81 ~~levels~~(60 ~~decreased~~days ~~over~~after the ~~treatment~~cessation ~~period,~~of ~~showing~~therapy). ~~the~~At ~~effect~~day of81 NO(60 indays after the ~~reduction~~cessation of ~~systemic~~therapy) ~~inflammation.~~bacterial ~~There~~load ~~were~~was no65% ~~statistically~~lower ~~significant~~than orbaseline. ~~clinically~~1 ~~relevant~~of ~~changes~~9 inpatients ~~FEV1~~saw ~~over~~culture ~~time,~~conversion. This ~~and~~study ~~lung~~was ~~function~~published ~~indices~~in ~~also~~the ~~remained~~Journal ~~relatively~~of ~~constant~~Cystic ~~throughout~~Fibrosis ~~the~~in ~~study duration~~2019.

In ~~2016~~ 2018, ~~Rambam~~an ~~healthcare~~additional ~~campus in~~CF ~~Israel~~patient ~~conducted~~infected ~~a compassionate use treatment for two patients~~ with ~~CF who suffer from~~ M,. abscessus ~~lung infections. The data were published in the Pediatric Infectious Disease Journal in 2017. The NO treatment regime, as well as the device for this treatment,~~ was ~~supplied~~treated byover ~~BA Ltd. (as defined below), our wholly owned subsidiary. Patients received intermittent 30-minute treatments of 160 ppm NO, with two different regimes including hospitalization (5 times~~ a ~~day) and ambulatory treatment (2~~4-3week ~~inhalations~~period ~~a day). Treatment was well tolerated~~ with no76 ~~evidence~~ of ~~any~~84 ~~serious~~treatments ~~side~~at ~~effects.~~250 ~~We observed significant improvement in sputum production (up to 5-10 times~~ppm ~~more~~NO ~~sputum), and subjective improvement~~ in ~~the~~Israel ~~well-being~~at ofSoroka ~~both~~Medical ~~patients~~Center. ~~Significant~~The ~~reduction~~patient insaw ~~systemic~~improvements ~~inflammation was observed~~ in ~~the first patient~~6MW, asFEV1 ~~observed~~and bymost ~~reduction~~ Quality-of ~~CRP (C~~-~~reactive~~Life ~~protein, a systemic inflammation marker that rises in response to inflammation) levels during treatment~~measures. ~~In addition, the first patient had a 2 log (100-fold) reduction in M. abscessus during treatment (an effect that was lost after the treatment regime changed to ambulatory).~~ The ~~second~~bacteria ~~patient showed a significant increase in the 6-minute walk~~were ~~(“6MW”)~~not ~~test and the sputum culture became negative, which is consistent with eradication of M~~eradicated. ~~abscessus. Further information is needed~~Importantly, ~~but~~there wewere ~~believe~~no ~~these~~SAE’s ~~results~~reported ~~suggest~~and ~~that~~all ~~the~~treatments ~~treatment~~were ofcompleted M.without ~~abscessus with high-concentration inhaled NO is effective~~incident.

In 2017, we treated one patient with CF who suffered from NTM infections (specifically, M. abscessus) under compassionate use in the United Sates at the National Heart, Lung and Blood Institute with our generator based NO delivery system. The patient saw improvements in 6MW, FEV1, most Quality-of-Life measures and had no SAEs. The bacteria was not eradicated. The patient requested to be treated again and this treatment commenced in February 2018. A total of 38 treatments were administered over 8 days, 29 of them at a concentration of 240 ppm, with no SAEs believed to be related to NO reported.13

~~Additionally~~In December in2020 ~~2017,~~ we ~~completed~~ began a ~~single~~12-~~arm~~week, multi-center, open-label ~~Pilot~~clinical trial in ~~nine~~Australia ~~patients~~intended to enroll approximately 20 adult patients with M.chronic ~~abcessus~~refractory NTM lung disease,. ~~who~~We ~~were~~received ~~refractory~~a togrant ~~standard-~~of~~-care~~ ~~(“SOC”)~~up to $2. ~~The~~2 ~~patients~~million ~~were~~from ~~treated~~the ~~with~~CFF to fund this study and advance the clinical development of inhaled NO atto atreat ~~concentration~~NTM ofpulmonary ~~160~~disease. ~~ppm~~The ~~for~~trial 30enrolled ~~minutes,~~both inCF ~~addition~~and tonon-CF ~~treatment~~patients infected with ~~SOC~~MAC, M. ~~Our inhaled~~abscessus NOor ~~treatment~~any ~~was~~strain ~~administered~~of ~~intermittently~~NTM. ~~five~~The ~~times~~study ~~per~~consisted ~~day~~of ~~over~~ a 14run-~~day~~in period, followed by atwo ~~seven~~treatment phases. The run-~~day~~in period ~~with~~provided ~~three~~a ~~treatments~~baseline ~~per~~for ~~day~~the efficacy endpoints. The ~~primary~~first ~~endpoint~~treatment ofphase ~~safety,~~took asplace ~~measured~~over bya NOtwo-~~related~~week ~~SAEs,~~period ~~over~~and begun in the ~~21-day~~hospital ~~treatment~~setting ~~period~~where ~~was~~patients were ~~met~~titrated ~~with~~from no150 ~~SAEs~~ppm ~~reported~~NO up to 250 ppm NO over several days. ~~Secondary~~ ~~endpoints~~During ofthis aphase ~~6MW~~patients ~~test~~received ~~FEV1~~NO for 40 minutes, ~~Quality~~four oftimes ~~Life~~per day ~~and~~while M.MetHb ~~abscessus~~levels ~~load~~were inmonitored. ~~sputum~~Patients ~~all~~were ~~trended~~also ~~positively.~~trained ~~6MW~~to ~~showed~~use anLungFit® ~~increase of~~GO ~~>40~~and ~~meters~~subsequently atdischarged to complete the ~~end~~remaining portion of the two-week treatment period at ~~day~~their 21home ~~versus~~at ~~baseline~~the ~~and~~highest antolerated ~~increase~~NO ofconcentration. ~~>25~~For ~~meters~~the onsecond ~~day~~treatment phase, 81a ~~(60~~10-week ~~days~~maintenance ~~after~~phase, the ~~cessation of~~administration ~~therapy)~~was twice daily. The ~~mean~~study ~~percentage~~was ~~change~~evaluating insafety, ~~FEV1~~quality atof ~~day~~life, 21physical function, and ~~day~~bacterial 51load ~~(30~~among ~~days~~other ~~after~~parameters. ~~the~~The ~~cessation~~mean age of ~~treatment)~~subjects was ~~> 3~~62.5%1 ~~with~~years ~~FEV1 returning~~(range: to22 ~~baseline~~– at82 ~~day~~years) 81with the majority female (6080%), ~~days~~a ~~after~~distribution ~~the~~consistent ~~cessation~~with ofreal-world ~~therapy)~~NTM disease. AtAll ~~day~~15 81subjects ~~(60~~were ~~days~~successfully ~~after~~titrated ~~the~~to ~~cessation~~250 ofppm ~~therapy)~~NO ~~bacterial~~in the hospital ~~load~~setting, ~~was~~and ~~65%~~no ~~lower~~patients ~~than~~required ~~baseline.~~dose 1reductions ofduring 9the ~~patients~~subsequent ~~saw~~at-home ~~culture~~portion ~~conversion.~~of ~~This~~the study. ~~was~~Patients ~~published~~were infollowed up for 12 weeks after the ~~Journal~~12-week oftreatment ~~Cystic~~period ~~Fibrosis~~was ~~in 2019~~completed.

16The Company presented positive results at the 2022 CHEST annual meeting, further supporting development of intermittent high dose NO for the treatment of NTM. The study demonstrated that high dose NO treatment was safe and well-tolerated in both the home and hospital settings. During the 10-week at-home treatment period of the study, a total of 2,492 inhalations were self-administered with overall high treatment compliance (>90%). There were no SAEs related to treatment discontinuations reported over the 12-week treatment or 12-week follow up periods. Key efficacy endpoints showed strong results with improvement seen in the majority of quality-of-life domains. Respiratory function and physical function were maintained during treatment and follow-up. Trends in the reduction of microbial load were observed and one subject achieved culture conversion with three consecutive negative sputum samples. We anticipate having discussions with the FDA in calendar year 2026 with respect to commencing a pivotal clinical trial.

~~In 2018, an additional CF patient~~Our ~~infected~~program ~~with M. abscessus was treated over a 4-week period with 76 of 84 treatments at 250 ppm NO~~ in ~~Israel~~COPD atis ~~Soroka Medical Center. The patient saw improvements~~ in ~~6MW,~~the ~~FEV1~~preclinical stage and ~~most~~will ~~Quality-of-Life~~move ~~measures.~~forward ~~The~~subject ~~bacteria~~to ~~were~~obtaining ~~not~~additional ~~eradicated~~financing. ~~Importantly, there were no SAE’s reported and all treatments were completed without incident.~~

In ~~December 2020 we began a 12-week,~~ ~~multi-center,~~addition ~~open-label clinical trial in Australia intended~~ to ~~enroll~~further ~~approximately~~supporting 20development ~~adult patients with chronic refractory NTM lung disease. We received a grant~~ of upintermittent tohigh ~~$2.2~~dose ~~million~~NO ~~from~~for the ~~CFF~~treatment ~~to fund this study and advance the clinical development~~ of ~~inhaled NO to treat~~ NTM ~~pulmonary disease. The trial enrolled both CF and non-CF patients infected with MAC~~, M.we ~~abscessus~~believe orthis ~~any strain of NTM. The~~ study ~~consisted~~breaks ofnew ~~a run-in period followed by two treatment phases. The run-in period provided a baseline for the efficacy endpoints.~~ground ~~The first treatment phase took place over a two-week period and begun~~ in the ~~hospital~~development ~~setting~~of ~~where patients were titrated from 150 ppm~~ NO uptherapy toby ~~250~~showing ~~ppm~~the NOpotential ~~over several days. During this phase patients received NO~~ for ~~40 minutes, four times per day while MetHb levels were monitored. Patients were also trained to use LungFit® GO and subsequently discharged to complete~~ the ~~remaining~~Company’s ~~portion of the two-week treatment period~~ at ~~their~~ -home ~~at the highest tolerated NO concentration. For the second treatment phase, a 10~~generator-~~week~~based ~~maintenance phase,~~system ~~the~~to ~~administration~~be ~~was~~used ~~twice~~safely ~~daily. The study was evaluating safety, quality of life, physical function,~~ and ~~bacterial load among~~ ~~other~~consistently ~~parameters.~~by ~~The~~this ~~mean~~patient ~~age~~population ofin ~~subjects was 62.1 years (range: 22 – 82 years) with the majority female (80%),~~ a ~~distribution consistent with~~ real-world ~~NTM disease. All 15 subjects were successfully titrated to 250 ppm NO in the hospital~~ setting~~, and no patients required dose reductions during the subsequent at-home portion of the study~~. ~~Patients were followed up for 12 weeks after the 12-week treatment period was completed.~~

~~The Company presented positive~~VCAP ~~results at the 2022 CHEST annual meeting, further supporting development of intermittent high dose NO for the treatment of NTM. The study demonstrated that high dose NO treatment was safe~~ and ~~well-tolerated~~BRO inClinical both the home and hospital settings. During the 10-week at-home treatment period of the study, a total of 2,492 inhalations were self-administered with overall high treatment compliance (>90%). There were no SAEs related to treatment discontinuations reported over the 12-week treatment or 12-week follow up periods. Key efficacy endpoints showed strong results with improvement seen in the majority of quality-of-life domains. Respiratory function and physical function were maintained during treatment and follow-up. Trends in the reduction of microbial load were observed and one subject achieved culture conversion with three consecutive negative sputum samples. We anticipate commencing a pivotal clinical trial in calendar year 2026 following discussions with the FDA.Development

~~Our~~In 2014, ~~program~~we completed a double blind, randomized Pilot study for infants with bronchiolitis (n=43) for which the data were published in the ~~COPD~~Pediatric isPulmonology Journal in 2017. The study was performed at Soroka University Medical Center in Israel. Forty-three infants between the ages of two to 12 months diagnosed with bronchiolitis were randomly assigned to either the treatment group or the control ~~preclinical~~group. ~~stage~~The treatment group comprised 21 subjects who received intermittent (30 minutes, five times a day) inhalation of 160 ppm NO formulation, in addition to supportive O2 treatment for up to five days. The control group, 22 subjects, received ongoing inhalation of the supportive O2 treatment. Primary endpoints included determination of the MetHb levels, adverse events associated with the inhaled NO formulation and ~~will~~proportion ~~move~~of ~~forward~~subjects who prematurely discontinued the study. Baseline clinical score, indicating disease severity at screening, was similar between treatment groups (~8). Results were encouraging, with similar overall incidence of AEs between the treatment groups. Out of 43 patients, 39 (~90%) completed the study per protocol (“PP”), with similar percentages (90%) for both the control and the treatment groups, individually. Only one subject from the treatment group discontinued treatment due to an ~~obtaining~~adverse ~~additional~~event, ~~financing~~namely – repeated MetHb levels above 5%. Adverse events were reported by 23 (53.5%) subjects overall, with ten (47.6%) subjects in the NO group reporting a total of 22 AEs, and 13 (59.1%) subjects in the control group reporting a total of 22 AEs. SAEs were reported by four (19.0%) subjects in the NO group and four (18.2%) in the standard treatment group. There were no treatment-related SAEs in the NO treatment group.

In the ~~addition~~NO togroup, ~~further~~six ~~supporting development~~(28.6%) ofsubjects ~~intermittent~~had ~~high~~any ~~dose~~MetHb NOmeasurement ~~for~~>5% during the study treatment period, and three of ~~NTM,~~these wesubjects ~~believe~~had more than one MetHb >5%. The maximum MetHb level was 5.6% in one subject in the NO group. There was no cumulative effect of MetHb exposure during the study. The MetHb levels in this study ~~breaks~~were ~~new~~defined ~~ground~~to <5% as a safety measure, though previous findings have shown that higher levels (6.4%) are non-toxic in children. Secondary and exploratory analyses were performed, and results show positive impact of the ~~development~~treatment regime. In a subgroup of subjects that stayed at the hospital at least 24 hours (LOS >24 hours), a statistically significant treatment benefit of NO ~~therapy~~versus standard treatment was demonstrated. Mean results for subjects with LOS > 24 hours show that LOS was shortened by ~~showing~~approximately 34% in the ~~potential~~NO ~~for~~group compared to the ~~Company’s~~standard ~~at-home~~treatment ~~generator~~group, with a one-~~based~~day ~~system~~difference between the groups (PP, N=24). Time to benormal ~~used~~oxygenation ~~safely~~(SaO2 ~~and~~of ~~consistently~~92%) was shortened by ~~this~~approximately ~~patient~~44% ~~population~~(27.75 hours) in the NO group compared to the standard treatment group (PP, N=24). An 80% improvement in atime ~~real-world~~to ~~setting~~clinical score (indicating improvement in disease severity) and time to normal oxygenation (92%) was observed in favor of the NO group (PP, N=24).

17In 2018 we completed a second pilot study in bronchiolitis in 6 centers in Israel. The data were published in Nature in 2020. The prospective, randomized, double blind, controlled pilot study enrolled 67 patients, aged 0-12 months, who were hospitalized due to bronchiolitis. The patients received either SOC (typically oxygen and hydration) or SOC plus inhaled NO at a concentration of 160 ppm for 30 minutes 5 times per day for up to 5 days. The primary endpoint of hospital LOS was met with a 26.7-hour reduction in hospital length of stay demonstrated (p=0.04). Secondary endpoints of time required to achieve a clinical score of 5 or less on the modified Tal score and time required to achieve SaO2 of 92% or greater showed improvement versus the SOC. There were no issues with NO2 or MetHb and no SAEs were recorded.

~~VCAP~~In 2020 we completed a third pilot study in bronchiolitis in 8 centers in Israel and ~~BRO~~presented ~~Clinical~~the ~~Development~~data at 2020 CHEST annual meeting. The prospective, randomized, double blind, controlled pilot study enrolled 89 patients (ITT n=87), aged 0-12 months, who were hospitalized due to bronchiolitis. The patients were randomized 1:1:1 to receive either SOC (typically oxygen and hydration) or SOC plus inhaled NO at 85 ppm or SOC plus inhaled NO at 150 ppm for 40 minutes 4 times per day for up to 5 days. There were no SAEs related to NO therapy. Efficacy results are shown in the table below.

In 2014, we completed a double blind, randomized Pilot study for infants with bronchiolitis (n=43) for which the data were published in the Pediatric Pulmonology Journal in 2017. The study was performed at Soroka University Medical Center in Israel. Forty-three infants between the ages of two to 12 months diagnosed with bronchiolitis were randomly assigned to either the treatment group or the control group. The treatment group comprised 21 subjects who received intermittent (30 minutes, five times a day) inhalation of 160 ppm NO formulation, in addition to supportive O2 treatment for up to five days. The control group, 22 subjects, received ongoing inhalation of the supportive O2 treatment. Primary endpoints included determination of the MetHb levels, adverse events associated with the inhaled NO formulation and proportion of subjects who prematurely discontinued the study. Baseline clinical score, indicating disease severity at screening, was similar between treatment groups (~8). Results were encouraging, with similar overall incidence of AEs between the treatment groups. Out of 43 patients, 39 (~90%) completed the study per protocol (“PP”), with similar percentages (90%) for both the control and the treatment groups, individually. Only one subject from the treatment group discontinued treatment due to an adverse event, namely – repeated MetHb levels above 5%. Adverse events were reported by 23 (53.5%) subjects overall, with ten (47.6%) subjects in the NO group reporting a total of 22 AEs, and 13 (59.1%) subjects in the control group reporting a total of 22 AEs. SAEs were reported by four (19.0%) subjects in the NO group and four (18.2%) in the standard treatment group. There were no treatment-related SAEs in the NO treatment group.

	150 ppm vs. 85 ppm Hazard Ratio (p-value)	150 ppm vs. SST Hazard Ratio (p-value)
Fit for Discharge	2.11 (0.041)	2.32 (0.049)
Hospital Length of Stay (LOS)	2.01 (0.046)	2.28 (0.043)
Oxygen Saturation of > 92%	2.15 (0.056)	2.62 (0.039)

~~In the NO group, six (28.6%) subjects~~We ~~had~~plan any MetHb measurement >5% during the study treatment period, and three of these subjects had more than one MetHb >5%. The maximum MetHb level was 5.6% in one subject in the NO group. There was no cumulative effect of MetHb exposure during the study. The MetHb levels in this study were defined to ~~<5%~~seek ascertification aor ~~safety~~regulatory ~~measure,~~approval ~~though~~for ~~previous~~our ~~findings~~remaining ~~have~~current ~~shown~~product ~~that~~candidates ~~higher levels (6.4%) are non-toxic in children. Secondary~~ and ~~exploratory analyses were performed~~, ~~and~~if ~~results show positive impact of the treatment regime. In a subgroup of subjects that stayed at the hospital at least 24 hours (LOS >24 hours)~~approved, awe ~~statistically~~expect ~~significant~~they ~~treatment benefit of NO versus~~will ~~standard~~be ~~treatment~~marketed ~~was~~as ~~demonstrated.~~medical Mean results for subjects with LOS > 24 hours show that LOS was shortened by approximately 34% in the NO group compared to the standard treatment group, with a one-day difference between the groups (PP, N=24)devices. Time to normal oxygenation (SaO2 of 92%) was shortened by approximately 44% (27.75 hours) in the NO group compared to the standard treatment group (PP, N=24). An 80% improvement in time to clinical score (indicating improvement in disease severity) and time to normal oxygenation (92%) was observed in favor of the NO group (PP, N=24).

~~In 2018~~ If we ~~completed~~reach athe ~~second pilot~~commercialization ~~study~~stage infor ~~bronchiolitis~~any inof 6our ~~centers~~remaining inproduct ~~Israel.~~candidates, ~~The~~we ~~data~~expect ~~were~~that ~~published~~we inwill ~~Nature~~collaborate inwith ~~2020.~~companies ~~The prospective, randomized, double blind,~~outside ~~controlled~~the ~~pilot~~U.S. ~~study~~for ~~enrolled~~all 67indications. ~~patients,~~We ~~aged~~are ~~0-12~~still ~~months,~~determining ~~who~~whether ~~were~~to ~~hospitalized~~attempt ~~due~~ to ~~bronchiolitis.~~collaborate ~~The patients received either SOC (typically oxygen and hydration) or SOC plus inhaled NO at a concentration of 160 ppm~~ for 30any ~~minutes~~indication 5in ~~times~~the ~~per~~U.S. ~~day~~We ~~for~~are ~~up to 5 days.~~commercializing ~~The~~LungFit® ~~primary~~PH ~~endpoint of hospital LOS was met with a 26.7-hour reduction~~ in ~~hospital~~the ~~length of stay demonstrated (p=0~~U.~~04)~~S. ~~Secondary~~ourselves ~~endpoints of~~and ~~time~~expect ~~required~~ to ~~achieve~~partner awith ~~clinical~~third ~~score~~parties ~~of 5 or less on the modified Tal score and time required~~ to ~~achieve~~commercialize ~~SaO2~~LungFit® ~~of 92%~~PH oroutside ~~greater showed improvement versus~~ the ~~SOC~~U. ~~There were no issues with NO2 or MetHb and no SAEs were recorded~~S.

In 2020 we completed a third pilot study in bronchiolitis in 8 centers in Israel and presented the data at 2020 CHEST annual meeting. The prospective, randomized, double blind, controlled pilot study enrolled 89 patients (ITT n=87), aged 0-12 months, who were hospitalized due to bronchiolitis. The patients were randomized 1:1:1 to receive either SOC (typically oxygen and hydration) or SOC plus inhaled NO at 85 ppm or SOC plus inhaled NO at 150 ppm for 40 minutes 4 times per day for up to 5 days. There were no SAEs related to NO therapy. Efficacy results are shown in the table below.14

	150 ppm vs. 85 ppm Hazard Ratio (p-value)	150 ppm vs. SST Hazard Ratio (p-value)
Fit for Discharge	2.11 (0.041)	2.32 (0.049)
Hospital Length of Stay (LOS)	2.01 (0.046)	2.28 (0.043)
Oxygen Saturation of > 92%	2.15 (0.056)	2.62 (0.039)

Our PreClinical Results to Date for LungFit^®

We ~~plan to seek certification~~ orhave ~~regulatory~~completed ~~approval~~4 ~~for~~separate ~~our~~toxicology ~~remaining~~studies ~~current~~in ~~product candidates and, if approved, we expect they will be marketed as medical devices~~animals.

If● weRats: ~~reach~~30 ~~the~~days ~~commercialization stage~~of ~~for~~intermittent ~~any~~treatments ofwith ~~our~~LungFit® ~~remaining~~at ~~product~~400 ~~candidates,~~ppm weNO ~~expect~~showed ~~that~~no weobservations ~~will~~(differences) ~~collaborate~~between ~~with~~control ~~companies~~rats ~~outside~~and ~~the~~treated ~~U.S.~~rats ~~for~~on ~~all~~observation ~~indications. We~~during ~~are~~the ~~still~~treatment ~~determining~~period ~~whether~~prior to ~~attempt~~sacrifice toand ~~collaborate~~no ~~for~~observations ~~any~~on ~~indication~~histopathology in● ~~the~~Rats: ~~U.S.~~12 Weweeks ~~are~~of ~~commercializing~~intermittent treatments with LungFit® PH inat ~~the~~250 ~~U.S.~~ppm ~~ourselves~~NO showed no observations (differences) between control rats and ~~expect~~treated rats on observation during the treatment period prior to ~~partner~~sacrifice and no observations on histopathology ● Dogs: 12 weeks of intermittent treatments with ~~third~~LungFit® ~~parties~~at 250 ppm NO showed no observations (differences) between control dogs and treated dogs on observation during the treatment period prior to ~~commercialize~~sacrifice and no observations on histopathology ● Rats: Geno toxicology study of intermittent with LungFit® PHNO ~~outside~~at ~~the~~200 ~~U.S.~~– 400 ppm showed a non-genotoxic response at all concentrations

18Additional Programs

~~Our~~Beyond Cancer’s ~~PreClinical~~research ~~Results~~data has shown that UNO has anticancer properties and elicits an immune response from the host. Beyond Cancer utilizes an intratumoral UNO technology as a gas delivery of NO at high concentrations to ~~Date~~tumors to induce an immune response. Gas based intratumoral therapies for ~~LungFit®~~the treatment of cancer are considered novel and new medical science. Beyond Cancer’s efforts are currently also focused on utilizing UNO in combination with Keytruda, a PD-1 inhibitor or other PD-1 or PDL-1 inhibitors as a treatment for cancers. To date, no such gas-based therapy has been approved for commercialization by the FDA or other regulatory agencies.

WeNeuroNos has ~~have~~entered ~~completed~~into 4an ~~separate~~agreement ~~toxicology~~with Yissum Research Development Company of the Hebrew University of Jerusalem, LTD. to acquire the commercial ~~studies~~rights infor ~~animals~~neuronal nitric oxide synthase (nNOS) inhibitors being developed for the treatment of autism spectrum disorder (“ASD”) and other neurological conditions. Currently, there are currently no FDA approved therapies utilizing nNOS inhibitors specifically for the treatment of ASD.

● Rats: 30 days of intermittent treatments with LungFit® at 400 ppm NO showed no observations (differences) between control rats and treated rats on observation during the treatment period prior to sacrifice and no observations on histopathology ● Rats: 12 weeks of intermittent treatments with LungFit® at 250 ppm NO showed no observations (differences) between control rats and treated rats on observation during the treatment period prior to sacrifice and no observations on histopathology ● Dogs: 12 weeks of intermittent treatments with LungFit® at 250 ppm NO showed no observations (differences) between control dogs and treated dogs on observation during the treatment period prior to sacrifice and no observations on histopathology ● Rats: Geno toxicology study of intermittent with LungFit® NO at 200 – 400 ppm showed a non-genotoxic response at all concentrationsCompetition

~~Additional~~The biotechnology, ~~Programs~~pharmaceutical and medical device industries are highly competitive. There are many pharmaceutical companies, biotechnology companies, medical device companies, public and private universities and research organizations actively engaged in the research and development (“R&D”) of products that may be similar to our approved product or product candidates. We are aware of several companies currently developing and selling NO therapies for various indications such as hypoxic respiratory failure (HRF). For example, Mallinckrodt commercializes INOMAX® (nitric oxide) for inhalation, which is approved for use to treat newborns suffering from hypoxic respiratory failure (“HRF”)-PPHN, in the U.S., Canada, Australia, Mexico and Japan. Linde Group markets a generic version of the Mallinckrodt offering with their delivery system called NOxBOX®. The Linde Group has marketing rights to INOMAX® in Europe. Air Liquide sells a similar product in Europe, called KINOX™, together with their delivery platform called SoKINOX™, for the treatment of pulmonary hypertension of the newborn. In Europe, EKU, International Biomedical, Cahouet and ITC each have a device that delivers nitric oxide. VERO Biotech LLC received FDA approval for their delivery system GENOSYL DS for HRF associated with PPHN in 2019, and received FDA approval for a third generation of that delivery system in 2023. In addition, other companies may be developing inhaled NO delivery systems at various concentrations. Novan Inc. has recently received approval for a nitric oxide-based prescription treatment called berdazimer for molluscum, a contagious skin infection. SaNOtize has an NO nasal spray that has received approval in India, Israel and eight other countries for preventing COVID-19 after exposure. Third Pole has reported the development of an NO generator and delivery system, but we are not aware of any display of any product at any medical/scientific conference in recent years. Our patents surrounding LungFit® have priority date over those of Third Pole. NovLead Biotechnology (Nanjing, China) has a device that produces NO through a process of passing an electric current through an electrolyte solution and Shenzhen Respomed Medical Technology (Shenzhen, China) has developed a machine that uses an electric charge to generate nitric oxide.

~~Beyond Cancer’s research~~Some ~~data~~of ~~has~~our ~~shown~~competitors, ~~that~~either ~~UNO~~alone ~~has~~or ~~anticancer~~through ~~properties~~their ~~and~~strategic ~~elicits~~partners, anmight ~~immune~~have ~~response~~substantially ~~from~~greater ~~the~~name ~~host.~~recognition ~~Beyond~~and ~~Cancer utilizes an intratumoral~~financial, ~~UNO~~technical, ~~technology~~manufacturing, asmarketing aand ~~gas~~human ~~delivery~~resources ofthan NOwe atdo ~~high~~and ~~concentrations~~greater toexperience ~~tumors~~and toinfrastructure ~~induce~~in ~~an immune response. Gas based intratumoral therapies for~~ the ~~treatment~~research ~~of cancer are considered novel~~ and ~~new medical science. Beyond Cancer’s efforts are currently also focused on~~clinical ~~utilizing~~development ~~UNO~~of inpharmaceutical ~~combination with Keytruda~~products, aobtaining ~~PD-1~~FDA ~~inhibitor~~and or other ~~PD-1~~regulatory orapprovals ~~PDL-1~~of ~~inhibitors~~those asproducts aand ~~treatment~~commercializing ~~for~~those ~~cancers. To date, no~~products ~~such~~around ~~gas-based therapy has been approved for commercialization by~~ the ~~FDA or other regulatory agencies~~world.

~~NeuroNos~~As it ~~has~~relates ~~entered~~to ~~into~~Beyond anCancer’s ~~agreement with~~programs, ~~Yissum~~no ~~Research~~such ~~Development~~gas-based ~~Company~~therapies ofhave ~~the~~been ~~Hebrew~~approved ~~University~~for ofcommercialization ~~Jerusalem,~~by ~~LTD. to acquire~~ the ~~commercial~~FDA ~~rights~~or ~~for neuronal nitric~~other ~~oxide~~regulatory ~~synthase~~agencies ~~(nNOS)~~to ~~inhibitors~~date. ~~being~~Similarly, ~~developed~~as ~~for~~it ~~the~~relates ~~treatment~~to ~~of autism spectrum disorder (“ASD”) and other neurological conditions. Currently~~NeuroNos, there are currently no FDA approved therapies utilizing nNOS inhibitors specifically for the treatment of ASD.

~~Competition~~15

~~The biotechnology, pharmaceutical~~Manufacturing and medical device industries are highly competitive. There are many pharmaceutical companies, biotechnology companies, medical device companies, public and private universities and research organizations actively engaged in the research and development (“R&D”) of products that may be similar to our approved product or product candidates. We are aware of several companies currently developing and selling NO therapies for various indications such as hypoxic respiratory failure (HRF). For example, Mallinckrodt commercializes INOMAX® (nitric oxide) for inhalation, which is approved for use to treat newborns suffering from hypoxic respiratory failure (“HRF”)-PPHN, in the U.S., Canada, Australia, Mexico and Japan. Linde Group markets a generic version of the Mallinckrodt offering with their delivery system called NOxBOX®. The Linde Group has marketing rights to INOMAX® in Europe. Air Liquide sells a similar product in Europe, called KINOX™, together with their delivery platform called SoKINOX™, for the treatment of pulmonary hypertension of the newborn. In Europe, EKU, International Biomedical, Cahouet and ITC each have a device that delivers nitric oxide. Bellerophon Therapeutics is developing an NO delivery system for patients with chronic pulmonary diseases such as COPD, PH-sarcoidosis, or fibrotic interstitial lung disease. VERO Biotech LLC received FDA approval for their delivery system GENOSYL DS for HRF associated with PPHN in 2019, and received FDA approval for a third generation of that delivery system in 2023. In addition, other companies may be developing inhaled NO delivery systems at various concentrations. Novan Inc. has recently received approval for a nitric oxide-based prescription treatment called berdazimer for molluscum, a contagious skin infection. SaNOtize has an NO nasal spray that has received approval in India, Israel and eight other countries for preventing COVID-19 after exposure. Third Pole has reported the development of an NO generator and delivery system, but we are not aware of any display of any product at any medical/scientific conference in recent years. Our patents surrounding LungFit® have priority date over those of Third Pole. NovLead Biotechnology (Nanjing, China) has a device that produces NO through a process of passing an electric current through an electrolyte solution and Shenzhen Respomed Medical Technology (Shenzhen, China) has developed a machine that uses an electric charge to generate nitric oxide. Neither of these devices have approval outside of China.Distribution

~~Some~~We have ofcontracted ~~our~~with ~~competitors,~~third-party ~~either alone~~contract ormanufacturers, ~~through~~Spartronics ~~their~~LLC ~~strategic~~(“Spartronics”), ~~partners~~Plexus Corp. (“Plexus”), ~~might~~and ~~have~~Medisize ~~substantially~~Ireland ~~greater~~Limited ~~name~~(“Medisize”) ~~recognition~~who ~~and~~have ~~financial,~~completed ~~technical,~~a ~~manufacturing, marketing~~substantial ~~and~~portion ~~human~~of ~~resources~~the commercial ~~than~~manufacturing weprocess dofor ~~and~~our ~~greater~~LungFit® ~~experience~~PH ~~and~~system. ~~infrastructure~~Spartronics inis the ~~research~~contract manufacturer and ~~clinical~~maintenance ~~development~~provider of ~~pharmaceutical~~our ~~products,~~first ~~obtaining~~generation ~~FDA~~LungFit® ~~and~~PH ~~other~~device, ~~regulatory~~Plexus ~~approvals~~is the contract manufacturer of ~~those~~our ~~products~~second ~~and~~generation ~~commercializing~~LungFit® ~~those~~PH ~~products~~device ~~around~~and will be the ~~world~~contract manufacturer of all devices beginning in April 2027.

~~As it relates to Beyond Cancer’s~~In ~~programs~~addition, nowe ~~such~~will ~~gas-based~~be ~~therapies~~reliant ~~have~~on ~~been~~our ~~approved~~partners for ~~commercialization~~commercial bymanufacture ~~the~~of ~~FDA~~our orsystems ~~other~~for ~~regulatory~~both ~~agencies~~clinical tostudies ~~date.~~and ~~Similarly,~~commercial assupply. itIn ~~relates~~the toyear ~~NeuroNos,~~ended ~~there~~March ~~are~~31, ~~currently~~2026, nowe ~~FDA~~purchased ~~approved~~approximately ~~therapies~~74% ~~utilizing~~of ~~nNOS~~our ~~inhibitors~~materials ~~specifically~~from ~~for the treatment of ASD~~Spartronics.

19We have a central warehouse in Atlanta, Georgia for the staging of products to be deployed to forward-stocking locations (“FSL”) in major cities close to our potential customers. We contract with third-party logistics providers to manage both the central warehouse and the FSLs. FSLs allow us to supply LungFit® devices and consumables in a timely manner to customers.

~~Manufacturing~~We market directly to our customers through our field sales team. A separate team of clinical specialists provides the training necessary to use the devices. Invoicing and ~~Distribution~~cash collection are managed by our Garden City, New York headquarters.

~~We have contracted with third-party~~Intellectual contract manufacturers, Spartronics LLC (“Spartronics”), and Medisize Ireland Limited (“Medisize”) who have completed a substantial portion of the commercial manufacturing process for our LungFit® PH system. In addition, we will be reliant on our partners for commercial manufacture of our systems for both clinical studies and commercial supply. In the year ended March 31, 2025, the Company purchased approximately 87% of our materials from Spartronics.Property

We own or have aexclusively ~~central~~licensed ~~warehouse in Atlanta~~patents, ~~Georgia~~pending ~~for~~patent ~~the~~applications, ~~staging~~know-how ofand ~~products~~trade tosecrets bethat ~~deployed~~relate to ~~forward-stocking~~our ~~locations~~NO ~~(“FSL”)~~generator, ~~in major cities close to~~NO2 ~~our~~filtration, ~~potential~~delivery ~~customers.~~systems, Wedevices ~~contract~~configured ~~with~~for ~~third-party~~delivering ~~logistics~~NO ~~providers~~ to ~~manage~~patients ~~both~~by ~~the~~inhalation, ~~central~~methods ~~warehouse~~of ~~and~~exposing ~~the~~patients ~~FSLs.~~to ~~FSLs allow~~inhalation usof toNO, ~~supply~~and ~~LungFit®~~methods ~~devices~~for ~~and~~treating ~~consumables~~subjects in aneed ~~timely~~of ~~manner~~NO ~~to customers~~inhalation.

We are ~~market~~party ~~directly~~to a global, exclusive, transferable license agreement with NitricGen for the eNOGenerator, its components, and all associated patents and know how related thereto. Additionally, we have a broad intellectual property portfolio directed to our ~~customers~~product candidates ~~through~~and ~~our~~mode ~~field~~of ~~sales~~delivery, ~~team~~monitoring parameters and methods of treating specific disease indications. AOur ~~separate~~intellectual ~~team~~property portfolio consists of ~~clinical~~issued ~~specialists~~patents ~~provides~~and ~~the~~pending ~~training~~applications, ~~necessary~~which toincludes ~~use~~patents we acquired pursuant to the ~~devices.~~exercise ~~Invoicing~~of ~~and cash~~an ~~collection~~option ~~are~~in ~~managed~~2017 granted byto ~~our~~us ~~Garden~~by ~~City,~~Pulmonox ~~New~~Technologies ~~York~~Corporation ~~headquarters~~(“Pulmonox”).

~~Intellectual~~On August ~~Property~~31, 2015 the Company entered into an agreement with Pulmonox (the “Option Agreement”) whereby we acquired the option to purchase certain intellectual property assets, including Pulmonox’s rights in 17 issued U.S. patents, including eight patents jointly owned with CareFusion which are directed to:

We● ~~own~~devices orand ~~have~~methods ~~exclusively~~for ~~licensed patents,~~delivering ~~pending~~NO ~~patent~~formulations ~~applications,~~to ~~know-how~~a ~~and~~patient ~~trade~~at ~~secrets~~steady ~~that~~and ~~relate~~alternating toconcentrations ~~our~~(80-400 ~~NO generator~~ppm), ~~NO2~~including ~~filtration,~~intermittent delivery ~~systems,~~ ~~devices~~of ~~configured for delivering~~ NO; to● ~~patients~~a bydevice ~~inhalation,~~and methods for treatment of ~~exposing~~surface ~~patients~~infections; toand ~~inhalation~~● use of NO, as a mucolytic agent and ~~methods~~ for ~~treating~~treatment ~~subjects~~and indisinfection ~~need~~ of ~~NO inhalation~~biofilms.

We exercised ~~are~~the ~~party~~Option toin aJanuary ~~global~~2017, ~~exclusive, transferable~~acquiring ~~license~~Pulmonox’s ~~agreement~~rights ~~with~~in ~~NitricGen~~the ~~for~~patents described above. Upon exercise of the ~~eNOGenerator~~Option, we ~~its~~became ~~components,~~obligated ~~and~~to ~~all~~make ~~associated~~certain ~~patents~~one-time development and ~~know~~sales ~~how~~milestone ~~related~~payments ~~thereto. Additionally~~to Pulmonox, commencing with the date on which we ~~have~~receive aregulatory ~~broad~~approval ~~intellectual~~for ~~property~~the ~~portfolio~~commercial ~~directed~~sale toof ~~our~~the first product ~~candidates~~candidate ~~and~~qualifying ~~mode~~under ofthe ~~delivery,~~agreement. ~~monitoring~~These ~~parameters~~milestone payments are almost entirely sales-related and ~~methods~~are capped at a total of ~~treating~~$87 ~~specific~~million ~~disease~~across ~~indications.~~three ~~Our~~separate ~~intellectual~~and ~~property~~distinct ~~portfolio~~indications ~~consists~~that fall ofunder ~~issued~~the ~~patents~~agreement ~~and~~with ~~pending~~the ~~applications~~majority of them, ~~which~~ ~~includes~~approximately ~~patents~~$83 wemillion, ~~acquired~~being ~~pursuant~~sales-related tobased ~~the~~on ~~exercise~~cumulative ofsales anmilestones for ~~option~~each inof ~~2017~~the ~~granted~~three toproducts. usTo bydate, ~~Pulmonox~~no ~~Technologies~~payments ~~Corporation~~have ~~(“Pulmonox”)~~been made.

~~On August 31, 2015 the Company~~Patent ~~entered~~Applications. ~~into~~We anhave ~~agreement~~over ~~with~~40 ~~Pulmonox~~pending ~~(the~~patent ~~“Option~~applications ~~Agreement”) whereby we acquired the option to purchase certain intellectual property assets~~worldwide, including ~~Pulmonox’s rights in 17 issued~~ U.S. ~~patents~~, ~~including~~foreign ~~eight~~and ~~patents~~Patent ~~jointly~~Corporation ~~owned~~Treaty ~~with CareFusion which~~(“PCT”) ~~are~~patent ~~directed to:~~applications.

●A PCT ~~devices~~patent application is a filing under the Patent Cooperation Treaty to which the U.S. and ~~methods~~a number of other countries are a party. It provides a unified procedure for ~~delivering~~filing NOa ~~formulations~~single patent application to aprotect ~~patient~~inventions atin ~~steady~~those ~~and~~countries. ~~alternating~~A ~~concentrations~~search ~~(80-400~~with ~~ppm)~~respect to the application is conducted by the International Searching Authority, ~~including~~accompanied ~~intermittent~~by ~~delivery~~a written opinion regarding the patentability of ~~NO;~~the ●invention. aA ~~device~~PCT ~~and~~application ~~methods~~does ~~for~~not ~~treatment~~itself result in the grant of ~~surface~~a ~~infections;~~patent, and ●the ~~use~~grant of NOpatent asis a ~~mucolytic~~prerogative ~~agent~~of ~~and~~each national ~~for~~or ~~treatment~~regional ~~and~~authority ~~disinfection~~where ofthe ~~biofilms~~PCT application is filed during national phase filings.

We exercised the Option in January 2017, acquiring Pulmonox’s rights in the patents described above. Upon exercise of the Option, we became obligated to make certain one-time development and sales milestone payments to Pulmonox, commencing with the date on which we receive regulatory approval for the commercial sale of the first product candidate qualifying under the agreement. These milestone payments are almost entirely sales-related and are capped at a total of $87 million across three separate and distinct indications that fall under the agreement with the majority of them, approximately $83 million, being sales-related based on cumulative sales milestones for each of the three products.16

~~Patent Applications. We~~Settlement ~~have over 72 pending patent applications worldwide, including U.S., foreign and Patent Corporation Treaty (“PCT”) patent applications.~~Agreement

~~A PCT patent application is a~~On ~~filing~~January ~~under~~23, ~~the~~2019, ~~Patent~~we ~~Cooperation~~entered ~~Treaty~~into toan ~~which~~agreement ~~the U.S. and a number of other countries are a party. It provides a unified procedure~~ for ~~filing~~commercial arights ~~single~~(the ~~patent~~“Circassia ~~application~~Agreement”) ~~to protect inventions in those countries. A search~~ with ~~respect~~Circassia toLimited ~~the application is conducted~~and byits ~~the~~affiliates ~~International Searching Authority~~(collectively, ~~accompanied~~“Circassia”) byfor aPPHN ~~written~~and ~~opinion~~future ~~regarding~~related ~~the~~indications ~~patentability~~at concentrations of ~~the~~< ~~invention.~~80 ~~A PCT application~~ppm ~~does~~in ~~not~~the ~~itself~~hospital ~~result~~setting in the ~~grant~~United ofStates ~~a patent,~~ and ~~the~~China. ~~grant~~On ofDecember ~~patent~~18, is2019, awe ~~prerogative~~terminated ofthe ~~each~~Circassia ~~national~~Agreement. orCircassia ~~regional authority where~~contended that the ~~PCT~~termination ~~application~~was ~~is filed during national phase filings~~wrongful.

20On May 25, 2021, the Company and Circassia entered into a settlement agreement (the “Settlement Agreement”) resolving all claims by and between both parties and mutually terminating the Circassia Agreement. Pursuant to the terms of the Settlement Agreement, the Company agreed to pay Circassia $10.5 million in three installments, all of which has been paid. Additionally, starting in 2025, Circassia began receiving a quarterly royalty payment equal to 5% of LungFit® PH net sales in the U.S. This royalty will terminate once the aggregate payment reaches $6.0 million. As of March 31, 2026, approximately $0.4 million of royalties have been paid.

~~Settlement Agreement~~Government Regulation

OnU.S. Regulation. ~~January~~In ~~23,~~the ~~2019~~U.S., wethe ~~entered into~~FDA anregulates ~~agreement~~drug ~~for~~and ~~commercial~~medical ~~rights~~device (products under the ~~“Circassia~~Federal ~~Agreement~~Food, Drug, and Cosmetic Act (“FD&C Act”), ~~with~~and ~~Circassia~~its ~~Limited~~implementing regulations. Our products have been designated as devices by the FDA and ~~its~~will ~~affiliates~~be ~~(collectively,~~regulated by the Center for Devices and Radiological Health (“~~Circassia~~CDRH”). ~~for~~Given ~~PPHN~~that currently approved NO products and ~~future~~delivery ~~related~~systems ~~indications~~were atapproved either ~~concentrations~~separately of(NO <drug 80approval ~~ppm~~and inNO ~~the~~delivery ~~hospital~~systems ~~setting~~cleared as devices) or as drug-device combinations in the United States, we ~~and~~expect ~~China.~~our Ondevice ~~December~~to ~~18,~~not ~~2019,~~only webe ~~terminated~~reviewed ~~the~~by ~~Circassia~~CDRH, ~~Agreement.~~but ~~Circassia~~also ~~contended~~have ~~that~~input from the ~~termination~~Center ~~was~~for ~~wrongful~~Drug Evaluation and Research (“CDER”).

OnFDA Premarket ~~May~~Clearance ~~25,~~and ~~2021~~Approval Requirements for Medical Devices. Unless an exemption applies, each medical device commercially distributed in the ~~Company~~United ~~and~~States ~~Circassia~~requires ~~entered~~either FDA clearance of a 510(k) premarket notification, authorization of a de novo application, ~~into~~or approval of a ~~settlement~~PMA ~~agreement~~application. (Under the ~~“Settlement~~FD&C ~~Agreement”)~~Act, ~~resolving~~medical ~~all~~devices ~~claims~~are byclassified ~~and~~into ~~between~~one ~~both~~of ~~parties~~three ~~and~~classes—Class ~~mutually~~I, ~~terminating~~Class ~~the~~II ~~Circassia~~or ~~Agreement.~~Class ~~Pursuant~~III—depending toon the ~~terms~~degree of ~~the~~risk ~~Settlement~~associated ~~Agreement,~~with each medical device and the ~~Company~~extent ~~agreed~~of manufacturer and regulatory control needed to ~~pay~~ensure ~~Circassia~~its ~~$10~~safety and effectiveness.5 ~~million~~Class inI ~~three~~includes devices with the lowest risk to the patient and are those for ~~installments~~which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, ~~all~~which include compliance with the applicable portions of ~~which~~the ~~has~~Quality ~~been~~System ~~paid.~~Regulation ~~Additionally~~(“QSR”) facility registration and product listing, ~~starting~~reporting of inadverse ~~2025~~medical events, ~~Circassia~~and ~~began~~truthful ~~receiving~~and anon-misleading ~~quarterly~~labeling, ~~royalty~~advertising, ~~payment~~and ~~equal~~promotional materials. Class II devices are subject to 5%the ofFDA’s ~~LungFit®~~General PHControls, ~~net~~and ~~sales~~special incontrols ~~the~~as ~~U.S.~~deemed ~~This~~necessary ~~royalty~~by ~~will~~the ~~terminate~~FDA ~~once~~to ensure the ~~aggregate~~safety ~~payment~~and ~~reaches~~effectiveness ~~$6.0~~of ~~million.~~the Asdevice. ofThese ~~March~~special ~~31,~~controls ~~2025,~~can ~~less~~include ~~than~~performance ~~$0.1~~standards, ~~million~~post-market ~~was~~surveillance, ~~paid~~patient toregistries ~~Circassia~~and inFDA ~~royalties~~guidance documents.

~~Government~~While most ~~Regulation~~Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FFDCA requesting permission to commercially distribute the device. The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance. Devices deemed by the FDA to pose the greatest risks, such as life sustaining, life supporting or some implantable devices, or devices that have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in Class III, requiring approval of a PMA. Some pre-amendment devices are unclassified, but are subject to FDA’s premarket notification and clearance process in order to be commercially distributed.

~~U.S.~~510(k) Clearance ~~Regulation~~Marketing Pathway. InTo ~~the U.S.~~obtain 510(k) clearance, a company must submit to the FDA ~~regulates~~a ~~drug~~premarket ~~and~~notification ~~medical~~submission demonstrating that the proposed device ~~products~~is ~~under~~“substantially ~~the~~equivalent” ~~Federal~~to ~~Food,~~a ~~Drug,~~predicate ~~and~~device ~~Cosmetic~~already ~~Act~~on ~~(“FD&C~~the ~~Act”),~~market. A predicate device is ~~and~~a ~~its~~legally ~~implementing~~marketed ~~regulations.~~device ~~Our~~that ~~products~~is ~~have~~not ~~been~~subject ~~designated~~to asPMA, ~~devices~~i.e., bya ~~the~~device ~~FDA~~that ~~and~~was ~~will~~legally bemarketed ~~regulated~~prior byto ~~the~~May ~~Center~~28, ~~for~~1976 ~~Devices~~(pre-amendments device) and ~~Radiological~~for ~~Health~~which ~~(“CDRH”).~~a ~~Given~~PMA is not required, a device that ~~currently~~has ~~approved~~been NOreclassified ~~products~~from ~~and~~Class ~~delivery~~III ~~systems~~to ~~were~~Class ~~approved~~II ~~either~~or ~~separately~~I, or a device that was ~~(NO~~found ~~drug~~substantially ~~approval~~equivalent ~~and~~through NOthe ~~delivery~~510(k) ~~systems~~process. ~~cleared~~The asFDA’s ~~devices~~510(k) orclearance asprocess ~~drug-device~~usually ~~combinations~~takes infrom ~~the~~three ~~United~~to ~~States~~twelve months, webut ~~expect~~often ~~our~~takes ~~device to~~longer. ~~not~~The ~~only~~FDA bemay ~~reviewed~~require byadditional ~~CDRH~~information, ~~but~~including ~~also~~clinical ~~have~~data, ~~input~~to ~~from~~make a determination regarding substantial equivalence. In addition, the ~~Center~~FDA collects user fees for ~~Drug~~certain ~~Evaluation~~medical device submissions and ~~Research~~annual ~~(“CDER”)~~fees for medical device establishments.

FDA Premarket Clearance and Approval Requirements for Medical Devices. Unless an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket notification, authorization of a de novo application, or approval of a PMA application. Under the FD&C Act, 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 manufacturer and regulatory control needed to ensure its safety and effectiveness. Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the Quality System Regulation (“QSR”) facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials. Class II devices are subject to the FDA’s General Controls, 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.17

~~While most Class I devices are~~If ~~exempt from~~ the ~~510(k)~~FDA ~~premarket~~agrees ~~notification~~that ~~requirement,~~the ~~manufacturers~~device ofis ~~most~~substantially ~~Class~~equivalent IIto ~~devices~~a ~~are~~predicate ~~required~~device tocurrently ~~submit~~on to the ~~FDA~~market, ~~a premarket~~it ~~notification~~will ~~under~~grant ~~Section~~ 510(k) ~~of the FFDCA requesting permission~~ clearance to commercially ~~distribute~~market the device. ~~The~~If the FDA~~’s permission~~ todetermines ~~commercially~~that ~~distribute~~the a device ~~subject to a 510(k) premarket notification~~ is ~~generally~~“not ~~known~~substantially asequivalent” ~~510(k)~~to ~~clearance.~~a ~~Devices~~previously ~~deemed~~cleared bydevice, the ~~FDA~~device tois ~~pose~~automatically ~~the~~designated ~~greatest risks, such~~ as ~~life~~a ~~sustaining,~~Class ~~life~~III ~~supporting~~device. orThe ~~some~~device ~~implantable~~sponsor ~~devices,~~must orthen ~~devices~~fulfill ~~that~~more ~~have~~rigorous PMA arequirements ~~new intended use,~~ or ~~use~~can ~~advanced~~request ~~technology~~a ~~that~~risk-based isclassification ~~not~~determination ~~substantially~~for ~~equivalent~~the todevice ~~that~~in ofaccordance awith ~~legally~~the ~~marketed~~“de ~~device,~~novo” ~~are placed in~~process, ~~Class~~which ~~III,~~is ~~requiring~~a ~~approval~~route ofto amarket ~~PMA.~~for ~~Some~~novel ~~pre-amendment~~medical devices ~~are~~that ~~unclassified, but~~ are ~~subject~~low to ~~FDA’s~~moderate ~~premarket~~risk ~~notification~~ and ~~clearance~~are ~~process~~not insubstantially ~~order~~equivalent to bea ~~commercially distributed~~predicate device.

~~510(k) Clearance Marketing~~After ~~Pathway.~~a Todevice ~~obtain~~receives 510(k) marketing clearance, aany ~~company~~modification ~~must~~that ~~submit~~could tosignificantly ~~the~~affect ~~FDA~~its asafety ~~premarket~~or ~~notification~~effectiveness, ~~submission~~or ~~demonstrating~~ that ~~the proposed~~would ~~device~~constitute ~~is “substantially equivalent” to~~ a ~~predicate~~major ~~device~~change ~~already~~or onmodification ~~the~~in ~~market.~~its Aintended ~~predicate~~use, ~~device~~will isrequire a ~~legally~~new ~~marketed device~~510(k) ~~that~~clearance isor, ~~not~~depending ~~subject~~on tothe ~~PMA~~modification, PMA iapproval.~~e.,~~ aThe ~~device~~FDA ~~that~~requires ~~was~~each ~~legally~~manufacturer ~~marketed prior~~ to ~~May~~determine ~~28,~~whether ~~1976~~the ~~(pre-amendments~~proposed ~~device)~~change ~~and~~requires ~~for~~submission ~~which~~ of a ~~PMA~~510(k) isor ~~not required,~~ a ~~device~~PMA ~~that~~in the ~~has~~first ~~been~~instance, ~~reclassified~~but ~~from~~the ~~Class~~FDA ~~III~~can toreview ~~Class~~any IIsuch ordecision I,and ordisagree with a ~~device~~manufacturer’s ~~that~~determination. ~~was~~If ~~found~~the ~~substantially~~FDA ~~equivalent~~disagrees ~~through~~with ~~the~~a ~~510(k) process. The FDA~~manufacturer’s ~~510(k)~~determination, ~~clearance~~the ~~process~~FDA ~~usually~~can ~~takes~~require ~~from~~the ~~three~~manufacturer to ~~twelve~~cease ~~months,~~marketing ~~but~~and/or ~~often~~request ~~takes~~the ~~longer. The~~recall ~~FDA~~of ~~may~~the ~~require~~modified device ~~additional~~until ~~information,~~510(k) ~~including~~marketing ~~clinical data~~clearance, toauthorization ~~make~~of a ~~determination~~de ~~regarding~~novo ~~substantial~~application, ~~equivalence.~~or InPMA ~~addition, the~~approval ~~FDA~~is ~~collects~~obtained. ~~user~~Also, ~~fees~~in ~~for~~these ~~certain~~circumstances, the ~~medical~~manufacturer ~~device~~may ~~submissions~~be ~~and~~subject ~~annual~~to ~~fees~~significant ~~for~~regulatory ~~medical~~fines ~~device~~or ~~establishments~~penalties.

21PMA Approval Pathway. Class III devices require approval of a PMA before they can be marketed, although some pre-amendment Class III devices for which the FDA has not yet required a PMA are cleared through the 510(k) process. The PMA process is more demanding than the 510(k) premarket notification process. 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 PMA application must also contain a full description of the device and its components, a full description of the methods, facilities, and controls used for manufacturing, and proposed labeling. Following receipt of a PMA application, the FDA determines whether the application is sufficiently complete to permit a substantive review. If the FDA accepts the application for review, it has 180 days under the FFDCA to complete its review of a PMA application, although in practice, the FDA’s review often takes significantly longer, and can take up to several years. An advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. The FDA may or may not accept the panel’s recommendation. In addition, the FDA will generally conduct a pre-approval inspection of the applicant or its third-party manufacturers’ or suppliers’ manufacturing facility or facilities to ensure compliance with the QSR. PMA devices are also subject to the payment of user fees.

IfThe FDA will approve the ~~FDA~~new ~~agrees~~device for commercial distribution if it determines that the ~~device~~data and information in the PMA application constitute isvalid ~~substantially~~scientific ~~equivalent~~evidence toand athat ~~predicate~~there ~~device~~is ~~currently~~reasonable onassurance that the ~~market,~~device itis ~~will~~safe ~~grant~~and ~~510~~effective for its intended use(ks). ~~clearance~~A toPMA may ~~commercially~~include ~~market~~post-approval ~~the~~conditions ~~device. If~~intended to ensure the ~~FDA~~safety ~~determines~~and ~~that~~effectiveness of the device, isincluding, ~~“not~~among ~~substantially~~other ~~equivalent”~~things, torestrictions on alabeling, ~~previously~~promotion, ~~cleared~~sale ~~device~~and distribution, and collection of long-term follow-up data from patients in the ~~device~~clinical isstudy ~~automatically~~that supported ~~designated~~the asPMA aor ~~Class~~requirements ~~III~~to ~~device~~conduct additional clinical studies post-approval. The ~~device~~FDA ~~sponsor~~may ~~must~~condition ~~then~~PMA ~~fulfill~~approval ~~more~~on ~~rigorous~~some ~~PMA~~form ~~requirements~~of post-market surveillance when deemed necessary to protect the public health or ~~can~~to ~~request~~provide aadditional ~~risk-based~~safety ~~classification determination~~and efficacy data for the device in ~~accordance~~a larger ~~with~~population ~~the~~or ~~“de~~for ~~novo”~~a ~~process~~longer period of use. In such cases, ~~which~~the ismanufacturer amight ~~route~~be required to ~~market~~follow ~~for~~certain ~~novel~~patient ~~medical~~groups ~~devices~~for ~~that~~a ~~are~~number ~~low~~of years and to ~~moderate~~make ~~risk~~periodic ~~and~~reports ~~are~~to ~~not~~the ~~substantially~~FDA ~~equivalent~~on the clinical status of those patients. Failure to acomply ~~predicate~~with ~~device~~the conditions of approval can result in material adverse enforcement action, including withdrawal of the approval.

~~After~~Certain changes ato an approved device, ~~receives~~such ~~510(k) marketing~~as ~~clearance~~changes in manufacturing facilities, ~~any~~methods, ~~modification~~or ~~that~~quality ~~could~~control ~~significantly~~procedures, or changes in the design performance specifications, which affect ~~its~~the safety or effectiveness, orof ~~that~~the ~~would~~device, ~~constitute~~require submission of a ~~major~~PMA ~~change~~supplement. PMA orsupplements ~~modification~~often inrequire ~~its~~submission ~~intended~~of ~~use,~~the ~~will~~same ~~require~~type aof ~~new~~information ~~510(k)~~as ~~clearance~~a orPMA, ~~depending~~except onthat the ~~modification,~~supplement ~~PMA~~is ~~approval.~~limited ~~The~~to ~~FDA~~information ~~requires~~needed ~~each~~to ~~manufacturer~~support toany ~~determine~~changes ~~whether~~from the ~~proposed~~device ~~change~~covered ~~requires~~by ~~submission~~the oforiginal aPMA ~~510(k)~~and ormay anot ~~PMA~~require inas ~~the~~extensive ~~first~~clinical ~~instance,~~data ~~but~~or the ~~FDA~~convening of ~~can~~an ~~review~~advisory ~~any~~panel. ~~such~~Certain ~~decision~~other ~~and~~changes ~~disagree~~to ~~with~~an aapproved ~~manufacturer’s~~device ~~determination.~~require If the ~~FDA~~submission ~~disagrees~~of ~~with~~ a ~~manufacturer’s determination~~new PMA, such as when the ~~FDA~~design ~~can~~change ~~require~~causes a ~~the~~different ~~manufacturer~~intended touse, ~~cease~~mode ~~marketing~~of operation, and/ technical basis of operation, or ~~request~~when the ~~recall~~design change is so significant that a new generation of the ~~modified~~ device ~~until~~will ~~510(k)~~be ~~marketing clearance~~developed, ~~authorization~~and ofthe adata dethat ~~novo~~were ~~application,~~submitted orwith the original PMA ~~approval~~are isnot ~~obtained.~~applicable ~~Also,~~for the change in ~~these~~demonstrating ~~circumstances,~~a ~~the~~reasonable ~~manufacturer~~assurance ~~may~~of ~~be subject~~safety toand ~~significant~~effectiveness. ~~regulatory~~None ~~fines~~of orour ~~penalties~~products are currently marketed pursuant to a PMA.

~~PMA Approval Pathway. Class~~On ~~III~~November ~~devices require approval of a PMA before they can be marketed~~10, ~~although~~2020 ~~some~~we ~~pre-amendment~~submitted ~~Class III devices for which the FDA has not yet required~~ a PMA ~~are cleared through the 510(k) process. The PMA process is more demanding than the 510(k) premarket notification process. 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 PMA application must also contain a full description of the device and its components, a full description of the methods, facilities, and controls used for manufacturing, and proposed labeling. Following receipt of a PMA application, the FDA determines whether the application is sufficiently complete to ~~permit~~ ~~a substantive review. If~~ the FDA ~~accepts the application~~ for ~~review, it has 180 days under~~ the ~~FFDCA~~use ~~to complete its review~~ of a ~~PMA~~LungFit® ~~application,~~PH ~~although~~ in ~~practice,~~PPHN ~~the FDA’s review often takes significantly longer,~~ and ~~can~~subsequently ~~take up to several years. An~~received ~~advisory~~PMA panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. The FDA may or may not accept the panel’s recommendation. In addition, the FDA will generally conduct a pre-approval ~~inspection~~in ofJune ~~the applicant or its third-party manufacturers’ or suppliers’ manufacturing facility or facilities to ensure compliance with the QSR~~2022. ~~PMA devices are also subject to the payment of user fees.~~

The FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA application constitute valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s). A PMA may include post-approval conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported the PMA or requirements to conduct additional clinical studies post-approval. The FDA may condition PMA approval on some form of post-market surveillance when deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger population or for a longer period of use. In such cases, the manufacturer might be required to follow certain patient groups for a number of years and to make periodic reports to the FDA on the clinical status of those patients. Failure to comply with the conditions of approval can result in material adverse enforcement action, including withdrawal of the approval.18

~~Certain~~De-Novo Pathway. ~~changes~~Another ~~to an approved device~~pathway, ~~such~~known as ~~changes~~de-novo indown-classification ~~manufacturing~~also ~~facilities,~~can ~~methods,~~be orused ~~quality~~for ~~control~~lower ~~procedures,~~risk ordevices ~~changes~~for inwhich ~~the~~there ~~design~~is ~~performance~~no ~~specifications,~~existing ~~which~~product ~~affect~~code ~~the~~or ~~safety~~predicate ordevice. ~~effectiveness~~The ofFood ~~the~~and ~~device,~~Drug ~~require~~Administration ~~submission~~Modernization Act of 1997 established the de-novo down-classification procedure as a ~~PMA~~new ~~supplement.~~route ~~PMA~~to ~~supplements~~market ~~often~~for ~~require~~low ~~submission of~~to ~~the~~moderate ~~same~~risk ~~type~~medical ofdevices ~~information~~that asautomatically require a PMA, ~~except~~due ~~that~~to the ~~supplement~~absence isof ~~limited~~a predicate todevice. ~~information~~This ~~needed~~procedure toallows ~~support~~a ~~any~~manufacturer ~~changes~~whose ~~from~~novel ~~the~~ device ~~covered~~automatically byrequires ~~the~~a ~~original~~ PMA ~~and~~to ~~may~~request ~~not~~down-classification of ~~require~~its asmedical ~~extensive~~device ~~clinical~~(to ~~data~~allow orclearance through the ~~convening~~510(k) ofpathway) anon ~~advisory~~the ~~panel.~~basis ~~Certain~~that ~~other changes~~the todevice anpresents ~~approved~~low ~~device~~or ~~require~~moderate risk, rather than requiring the submission and approval of a ~~new~~ PMA, ~~such~~application. asManufacturers ~~when~~can ~~the~~request ~~design~~de-novo ~~change~~down-classification ~~causes~~directly without first submitting a ~~different~~510(k) ~~intended~~premarket ~~use,~~notification ~~mode of~~to ~~operation,~~the FDA and ~~technical~~receiving ~~basis~~a of“not ~~operation,~~substantially orequivalent” ~~when~~determination. Under ~~the~~this ~~design~~pathway, ~~change~~the FDA is sorequired ~~significant~~to ~~that~~classify athe ~~new~~device ~~generation~~within 120 days following receipt of the ~~device~~de-novo ~~will~~application. ~~be developed,~~If ~~and~~ the ~~data~~manufacturer seeks ~~that~~reclassification ~~were~~into ~~submitted~~Class ~~with~~II, the ~~original~~manufacturer ~~PMA~~must ~~are~~include ~~not~~a ~~applicable~~draft proposal for ~~the~~special ~~change~~controls inthat ~~demonstrating~~are necessary to provide a reasonable assurance of the safety and effectiveness of the medical device. ~~None~~In ofaddition, ~~our~~the ~~products~~FDA ~~are~~may ~~currently~~reject the reclassification petition if it identifies a legally marketed ~~pursuant~~predicate todevice that would be appropriate for a ~~PMA~~510(k) or determines that the device is not low to moderate risk or that general controls would be inadequate to control the risks and special controls cannot be developed.

OnClinical Trials. ~~November~~Clinical 10trials are almost always required to support a PMA and are sometimes required to support a 510(k) submission. All clinical investigations of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s Investigational Device Exemption (“IDE”) regulations which govern investigational device labeling, ~~2020~~prohibit wepromotion ~~submitted~~of the investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If the device presents a ~~PMA~~“significant risk,” to human health, as defined by the FDA, the FDA requires the device sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials. A significant risk device is one that presents a potential for serious risk to the ~~use~~health, safety or welfare of ~~LungFit®~~a PHpatient and either is implanted, used in ~~PPHN~~supporting or sustaining human life, substantially important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a subject. An IDE application must be supported by appropriate data, such as animal and ~~subsequently~~laboratory ~~received~~test ~~PMA~~results, ~~approval~~showing that it is safe to test the device in ~~June~~humans ~~2022~~and that the testing protocol is scientifically sound. The IDE will automatically become effective 30 days after receipt by the FDA unless the FDA notifies the Company that the investigation may not begin. If the FDA determines that there are deficiencies or other concerns with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under a conditional approval.

22In addition, the study must be approved by, and conducted under the oversight of, an Institutional Review Board (“IRB”) for each clinical site. The IRB is responsible for the initial and continuing review of the IDE study, and may pose additional requirements for the conduct of the study. If an IDE application is approved by the FDA and one or more IRBs, human clinical trials may begin at a specific number of investigational sites with a specific number of patients, as approved by the FDA. If the device presents a non-significant risk to the patient, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate approval from the FDA, but must still follow abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping requirements. Acceptance of an IDE application for review does not guarantee that the FDA will allow the IDE to become effective and, if it does become effective, the FDA may or may not determine that the data derived from the trials support the safety and effectiveness of the device or warrant the continuation of clinical trials. An IDE supplement must be submitted to, and approved by, the FDA before a sponsor or investigator may make a change to the investigational plan that may affect its scientific soundness, study plan or the rights, safety or welfare of human subjects.

~~De-Novo Pathway. Another~~During ~~pathway~~a study, ~~known~~the assponsor ~~de-novo~~is ~~down-classification~~required ~~also~~to ~~can~~comply bewith ~~used~~the ~~for~~applicable ~~lower~~FDA ~~risk~~requirements, ~~devices~~including, for ~~which~~example, ~~there~~trial ismonitoring, ~~no existing product code or predicate~~selecting ~~device.~~clinical ~~The~~investigators ~~Food~~ and ~~Drug~~providing ~~Administration~~them ~~Modernization~~with ~~Act~~the ofinvestigational ~~1997~~plan, ~~established~~ensuring ~~the~~IRB ~~de-novo~~review, ~~down-classification~~adverse ~~procedure~~event asreporting, arecord ~~new route~~keeping toand ~~market~~prohibitions ~~for~~on ~~low~~the topromotion ~~moderate~~of ~~risk~~investigational ~~medical~~ devices ~~that~~or ~~automatically~~on ~~require~~making asafety ~~PMA~~or ~~due~~effectiveness toclaims ~~the~~for ~~absence of a predicate device~~them. ~~This~~The ~~procedure allows~~clinical ~~a manufacturer whose novel device automatically requires a PMA to request down-classification of its medical device (to allow clearance~~investigators ~~through~~in the ~~510(k)~~clinical ~~pathway)~~study onare ~~the~~also ~~basis~~subject ~~that~~to ~~the~~FDA ~~device~~regulations ~~presents~~and ~~low~~must orobtain ~~moderate~~patient ~~risk~~informed consent, ~~rather~~rigorously ~~than~~follow ~~requiring~~ the ~~submission and approval~~investigational ofplan ~~a PMA application. Manufacturers can request de-novo down-classification directly without first submitting a 510(k) premarket notification to the FDA~~ and ~~receiving~~study ~~a “not substantially equivalent” determination. Under this pathway~~protocol, ~~the~~control ~~FDA is required to classify~~ the ~~device~~disposition ~~within 120 days following receipt~~ of the ~~de-novo~~investigational ~~application.~~device, Ifand ~~the~~comply ~~manufacturer~~with ~~seeks~~all ~~reclassification~~reporting ~~into~~and ~~Class~~recordkeeping IIrequirements. Additionally, ~~the manufacturer~~after ~~must include~~ a ~~draft~~trial ~~proposal~~begins, ~~for special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the medical device. In addition~~we, the FDA ~~may~~or ~~reject~~ the ~~reclassification~~IRB ~~petition~~could ifsuspend itor ~~identifies~~terminate a ~~legally~~clinical ~~marketed predicate~~trial ~~device~~at ~~that~~any ~~would~~time befor ~~appropriate~~various ~~for~~reasons, including a ~~510(k)~~belief ~~or determines~~ that the ~~device~~risks ~~is not low~~ to ~~moderate~~study ~~risk~~subjects oroutweigh ~~that general controls would be inadequate to control~~ the ~~risks~~anticipated ~~and special controls cannot be developed~~benefits.

Clinical Trials. Clinical trials are almost always required to support a PMA and are sometimes required to support a 510(k) submission. All clinical investigations of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s Investigational Device Exemption (“IDE”) regulations which govern investigational device labeling, prohibit promotion of the investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If the device presents a “significant risk,” to human health, as defined by the FDA, the FDA requires the device sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials. A significant risk device is one that presents a potential for serious risk to the health, safety or welfare of a patient and either is implanted, used in supporting or sustaining human life, substantially important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a subject. An IDE application must be supported by appropriate data, such as animal and laboratory test results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. The IDE will automatically become effective 30 days after receipt by the FDA unless the FDA notifies the Company that the investigation may not begin. If the FDA determines that there are deficiencies or other concerns with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under a conditional approval.19

~~In addition, the study must be~~Post-market ~~approved by, and conducted under the oversight of, an Institutional Review Board (“IRB”) for each clinical site~~Regulation. ~~The~~After ~~IRB~~a ~~is responsible~~device ~~for the initial and continuing review of the IDE study, and may pose additional requirements for the conduct of the study. If an IDE application~~ is ~~approved~~cleared ~~by the FDA and one~~ or ~~more IRBs, human clinical trials may begin at a specific number of investigational sites with a specific number of patients, as~~ approved ~~by the FDA. If the device presents a non-significant risk to the patient, a sponsor may begin the clinical trial after obtaining approval~~ for ~~the trial by one or more IRBs without separate approval from the FDA~~marketing, ~~but~~numerous ~~must still follow abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent,~~ and ~~labeling~~pervasive ~~and~~regulatory ~~record-keeping~~ requirements. ~~Acceptance~~continue ~~of an IDE application for review does not guarantee that the FDA will allow the IDE~~ to become effective and, if it does become effective, the FDA may or may not determine that the data derived from the trials support the safety and effectiveness of the device or warrant the continuation of clinical trialsapply. ~~An IDE supplement must be submitted to, and~~ ~~approved~~These ~~by, the FDA before a sponsor or investigator may make a change to the investigational plan that may affect its scientific soundness, study plan or the rights, safety or welfare of human subjects.~~include:

~~During~~● aestablishment ~~study,~~registration ~~the~~and ~~sponsor~~device ~~is required~~listing ~~to comply~~ with the ~~applicable~~ FDA; ● QSR requirements, ~~including~~which require manufacturers, ~~for~~including ~~example~~third-party manufacturers, ~~trial~~to ~~monitoring~~follow stringent design, ~~selecting~~testing, ~~clinical~~control, ~~investigators~~documentation and ~~providing~~ ~~them~~other ~~with~~quality ~~the~~assurance ~~investigational~~procedures ~~plan,~~during ~~ensuring~~all ~~IRB~~aspects ~~review,~~of ~~adverse~~the ~~event~~design ~~reporting,~~and ~~record~~manufacturing ~~keeping~~process; ● labelling regulations and FDA prohibitions onagainst the promotion of investigational ~~devices~~products, or onthe ~~making~~promotion of off-label (as defined below) uses of cleared or approved products; ● requirements related to promotional activities; ● clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness ~~claims~~or ~~for~~that ~~them.~~would ~~The~~constitute ~~clinical~~a ~~investigators~~major change in ~~the~~intended ~~clinical~~use ~~study~~of ~~are also~~one ~~subject~~of our cleared devices, or approval of certain modifications to ~~FDA~~PMA-approved ~~regulations~~devices; ~~and~~● ~~must~~medical ~~obtain~~device ~~patient~~reporting ~~informed~~regulations ~~consent,~~which ~~rigorously~~require ~~follow~~that a manufacturer report to the ~~investigational~~FDA ~~plan~~if ~~and~~a ~~study~~device ~~protocol~~it markets may have caused or contributed to death or serious injury, ~~control~~ ~~the~~or ~~disposition~~has ofmalfunctioned and the ~~investigational~~device or a similar device, ~~and~~that ~~comply~~it ~~with~~markets ~~all~~would ~~reporting~~be ~~and~~likely ~~recordkeeping~~to ~~requirements.~~cause ~~Additionally,~~or ~~after~~ contribute to a ~~trial~~death ~~begins~~or serious injury, weif the malfunction were to recur. ● correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or ~~the~~removals ~~IRB~~if ~~could~~undertaken ~~suspend~~to reduce a risk to health posed by the device or ~~terminate~~to remedy a ~~clinical~~violation ~~trial~~of atthe ~~any~~FFDCA ~~time~~that ~~for~~may ~~various~~present ~~reasons~~a risk to health; ● the FDA’s recall authority, ~~including~~whereby the agency can order device manufacturers to recall from the market a ~~belief~~ product that is in violation of governing laws and regulations; and ● post-market surveillance activities and regulations, which apply when deemed by the ~~risks~~FDA to ~~study~~be ~~subjects~~necessary ~~outweigh~~to protect the ~~anticipated~~public ~~benefits~~health or to provide additional safety and effectiveness data for the device.

23The manufacturing processes for medical devices are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use. The QSR also requires, among other things, maintenance of a device master file, device history file, and complaint files. These requirements impose certain procedural and documentation requirements upon us and our third-party manufacturers related to the methods used in and the facilities and controls used for designing, manufacturing, packaging, labeling, storing, medical devices. As a manufacturer, we are subject to periodic scheduled or unscheduled inspections by the FDA. Following these inspections, the FDA may assert noncompliance with QSR requirements on a Form 483, which is a report of observations from an inspection, or by way of “untitled letters” or “warning letters” that could cause us or any third-party manufacturers to modify certain activities. A Form 483 notice, if issued at the conclusion of an FDA inspection, can list conditions the FDA investigators believe may have violated QSR or other FDA requirements. We cannot be certain that we or our present or any future third-party manufacturers or suppliers will be able to comply with QSR or other FDA regulatory requirements to the agency’s satisfaction. Failure to comply with these obligations may lead to possible legal or regulatory enforcement action by the FDA.

~~Post-market~~The FDA ~~Regulation~~has broad regulatory compliance and enforcement powers. If the FDA determines that we failed to comply with applicable regulatory ~~After~~requirements, it can take a ~~device~~variety isof ~~cleared~~compliance or ~~approved~~enforcement ~~for marketing~~actions, ~~numerous~~which ~~and~~may ~~pervasive~~result ~~regulatory~~in ~~requirements~~any ~~continue~~of tothe ~~apply.~~following ~~These include~~sanctions:

● ~~establishment~~untitled ~~registration and device listing with the FDA; ● QSR requirements~~letters, ~~which~~warning ~~require manufacturers~~letters, ~~including third-party manufacturers~~fines, ~~to follow stringent design~~injunctions, ~~testing,~~consent ~~control,~~decrees ~~documentation~~ and ~~other~~civil ~~quality assurance procedures during all aspects of the design and manufacturing process~~penalties; ● ~~labelling~~unanticipated ~~regulations~~expenditures ~~and~~to ~~FDA~~address ~~prohibitions against the promotion of investigational products,~~ or ~~the~~defend ~~promotion~~such ~~of off-label (as defined below) uses of cleared or approved products~~actions; ● ~~requirements~~customer ~~related~~notifications ~~to promotional activities; ● clearance~~ or ~~approval~~repair, ofreplacement, ~~product~~refunds, ~~modifications~~recall, todetention ~~510(k)-cleared devices that could significantly affect safety~~ or ~~effectiveness~~seizure ~~or that would constitute a major change in intended use~~ of ~~one of~~ our ~~cleared devices, or approval of certain modifications to PMA-approved devices~~products; ● ~~medical~~operating ~~device reporting regulations which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to death or serious injury~~restrictions, orpartial ~~has~~suspension ~~malfunctioned and the device~~ or atotal ~~similar~~shutdown ~~device~~of ~~that~~production; ~~it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.~~ ● ~~correction,~~refusing ~~removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls~~ or ~~removals~~delaying ifour ~~undertaken~~requests tofor ~~reduce~~regulatory aapprovals ~~risk to health posed by the device~~ or toclearances ~~remedy a violation~~ of ~~the~~new ~~FFDCA~~products ~~that~~or ~~may~~modified ~~present a risk to health~~products; ● ~~the~~withdrawing ~~FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market~~ a ~~product~~PMA that ishas inalready ~~violation~~been ~~of governing laws and regulations~~granted; ~~and~~ ● ~~post-market~~refusal ~~surveillance activities and regulations, which apply when deemed by the FDA~~ to begrant ~~necessary~~export toapproval ~~protect~~for ~~the~~our ~~public~~products; ~~health~~ or to● ~~provide~~criminal ~~additional safety and effectiveness data for the device~~prosecution.

~~The manufacturing processes for~~Advertising ~~medical devices are required to comply with the applicable portions of the QSR, which cover the methods~~ and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human usePromotion. The ~~QSR~~FDA ~~also requires, among other things, maintenance of a device master file, device history file,~~ and ~~complaint~~comparable ~~files.~~foreign ~~These~~regulatory ~~requirements~~authorities ~~impose~~closely ~~certain~~regulate ~~procedural~~the ~~and documentation requirements upon us and our third~~post-~~party~~approval ~~manufacturers~~marketing ~~related to the methods used in~~ and ~~the~~promotion ~~facilities and controls used for designing, manufacturing, packaging,~~of ~~labeling, storing,~~ medical devices., Asincluding astandards ~~manufacturer,~~and weregulations ~~are~~for ~~subject~~ direct-to-consumer ~~periodic scheduled or unscheduled inspections by the FDA. Following these inspections~~advertising, ~~the~~communications ~~FDA~~about ~~may~~unapproved ~~assert noncompliance with QSR requirements on a Form 483~~uses, ~~which is a report of observations from an inspection,~~industry- orsponsored byscientific ~~way~~and ofeducational ~~“untitled~~activities ~~letters”~~and orpromotional ~~“warning letters” that could cause us or any third-party manufacturers to modify certain~~ activities. Ainvolving ~~Form 483 notice, if issued at~~ the ~~conclusion~~internet. ofDevices anmay ~~FDA~~be ~~inspection,~~marketed ~~can~~only ~~list~~for ~~conditions~~ the ~~FDA investigators believe~~ ~~may~~approved ~~have violated QSR~~ or ~~other~~cleared ~~FDA~~indications ~~requirements.~~and Wein ~~cannot~~accordance ~~be certain that we or our present or any future third-party manufacturers or suppliers will be able to comply~~ with ~~QSR~~the orprovisions ~~other~~of ~~FDA regulatory requirements to~~ the ~~agency’s~~approved ~~satisfaction. Failure to comply with these obligations may lead to possible legal~~ or ~~regulatory~~cleared ~~enforcement action by the FDA~~label.

The FDA has broad regulatory compliance and enforcement powers. If the FDA determines that we 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:20

●Healthcare providers ~~untitled~~are ~~letters,~~permitted ~~warning~~to ~~letters,~~prescribe ~~fines,~~approved ~~injunctions~~devices for “off-label” uses—that is, ~~consent~~uses ~~decrees~~not approved by the FDA and therefore ~~civil~~not ~~penalties;~~described ●in ~~unanticipated~~the ~~expenditures~~product’s tolabeling. ~~address~~These oroff-label ~~defend~~uses are common across medical specialties. Physicians may believe that such ~~actions;~~off-label ●uses ~~customer~~are ~~notifications~~the orbest ~~repair,~~treatment ~~replacement,~~for ~~refunds,~~many ~~recall,~~patients ~~detention~~in orvaried ~~seizure~~circumstances. The FDA does not regulate the behavior of physicians ~~our~~in ~~products;~~their ●choice ~~operating~~of ~~restrictions~~treatments. The FDA does, ~~partial~~however, ~~suspension~~impose orstringent ~~total~~restrictions ~~shutdown~~on ofmanufacturers’ ~~production;~~communications regarding ●off-label ~~refusing~~use. orThus, ~~delaying~~we may market our ~~requests~~products, if approved by the FDA, only for ~~regulatory~~their ~~approvals~~approved orindications, ~~clearances~~but ofunder ~~new~~certain conditions ~~products~~may orengage ~~modified~~in ~~products;~~non-promotional, ●balanced ~~withdrawing~~communication aregarding ~~PMA~~off-label ~~that~~uses. ~~has~~Failure ~~already~~to ~~been~~comply ~~granted;~~with ●applicable ~~refusal~~FDA requirements and restrictions in this area may subject us to ~~grant~~adverse ~~export~~publicity ~~approval~~and ~~for~~a ~~our~~variety ~~products;~~of orsanctions, ●which ~~criminal~~could ~~prosecution~~harm our business and financial condition.

~~Advertising and Promotion.~~Combination ~~The~~Products. ~~FDA~~A ~~and~~combination ~~comparable~~product ~~foreign~~is ~~regulatory~~the ~~authorities~~combination ~~closely~~of ~~regulate~~two ~~the~~or ~~post-approval~~more ~~marketing~~regulated ~~and~~components, ~~promotion~~i.e., ofdrug/device, ~~medical devices~~biologic/device, ~~including~~drug/biologic, ~~standards~~or drug/device/biologic, that are combined or mixed and ~~regulations~~produced ~~for~~as ~~direct-to-consumer~~a ~~advertising,~~single ~~communications~~entity; ~~about~~packaged ~~unapproved~~together ~~uses,~~in ~~industry-~~a ~~sponsored~~single ~~scientific~~package ~~and~~or as a unit; ~~educational~~or ~~activities~~a ~~and~~drug, ~~promotional~~device, ~~activities~~or ~~involving~~biological ~~the~~product ~~internet.~~packaged ~~Devices~~separately ~~may~~that beaccording ~~marketed~~to ~~only~~its investigational plan or proposed labeling is intended for ~~the~~use only with an approved individually specified drug, device, or ~~cleared~~biological ~~indications and~~product inwhere ~~accordance~~both ~~with~~are ~~the~~required ~~provisions~~to ofachieve the ~~approved~~intended use, indication, or ~~cleared label~~effect.

24To determine which FDA center or centers will review a combination product candidate submission, companies may submit a request for assignment to the FDA. Those requests may be handled formally or informally. In some cases, jurisdiction may be determined informally based on FDA experience with similar products. However, informal jurisdictional determinations are not binding on the FDA. Companies also may submit a formal Request for Designation to the FDA Office of Combination Products. The Office of Combination Products will review the request and make its jurisdictional determination within 60 days of receiving a Request for Designation.

~~Healthcare providers are permitted~~FDA towill ~~prescribe~~determine ~~approved~~which ~~devices~~center ~~for~~or ~~“off-label”~~centers ~~uses—that~~within ~~is,~~the ~~uses~~FDA ~~not~~will ~~approved~~review by the ~~FDA~~product candidate and ~~therefore~~under ~~not~~what ~~described in~~legal authority the product’s ~~labeling~~candidate will be reviewed. ~~These~~Depending ~~off-label~~on ~~uses~~how ~~are~~the ~~common~~FDA ~~across~~views ~~medical~~the ~~specialties.~~product ~~Physicians~~candidates that are developed, the FDA may ~~believe~~have ~~that~~aspects ~~such~~of ~~off-label~~the product candidate ~~uses~~reviewed ~~are~~by the ~~best~~Center ~~treatment~~ for ~~many~~Biologics ~~patients~~Evaluation inand ~~varied~~Research ~~circumstances.~~(“CBER”), ~~The~~CDRH, ~~FDA~~or ~~does~~CDER, ~~not~~though ~~regulate~~one center will be designated as the ~~behavior~~center ofwith ~~physicians~~primary injurisdiction, ~~their~~based ~~choice~~ on the product candidate’s primary mode of ~~treatments~~action. The FDA ~~does,~~determines ~~however,~~the ~~impose~~primary mode ~~stringent~~of ~~restrictions~~action based on ~~manufacturers’~~the ~~communications~~single ~~regarding~~mode ~~off-label~~of ~~use.~~action ~~Thus, we~~that ~~may~~provides ~~market~~the ~~our~~most ~~products,~~important iftherapeutic ~~approved~~action byof the ~~FDA,~~combination ~~only~~product ~~for~~candidate – ~~their~~the ~~approved~~mode ~~indications,~~of ~~but~~action ~~under~~expected ~~certain~~to ~~conditions~~make ~~may~~the ~~engage~~greatest incontribution ~~non-promotional, balanced~~to ~~communication~~the ~~regarding~~overall ~~off-label~~intended ~~uses~~therapeutic effects of the combination product candidate. ~~Failure~~The toreview ~~comply~~of ~~with~~such ~~applicable~~combination ~~FDA~~product ~~requirements~~candidates is often complex and ~~restrictions~~time-consuming, inas ~~this~~the ~~area~~FDA may select the combination ~~subject~~product uscandidate to ~~adverse~~be ~~publicity~~reviewed and aregulated ~~variety~~by one or multiple of ~~sanctions~~the FDA centers identified above, which could ~~harm~~affect ~~our~~the ~~business~~path ~~and~~to regulatory ~~financial~~clearance ~~condition~~or approval. Furthermore, the FDA may also require submission of separate applications to multiple centers.

~~Combination~~The post-market ~~Products.~~requirements ~~A combination~~that ~~product~~apply isto the ~~combination~~cleared ~~of two~~ or ~~more~~approved ~~regulated~~product ~~components,~~will ~~i.e.,~~largely ~~drug/device,~~be ~~biologic/device,~~aligned ~~drug/biologic,~~with orthe ~~drug/device/biologic, that~~agency ~~are~~center ~~combined~~determined orto ~~mixed~~have primary ~~and~~jurisdiction ~~produced~~over asthe aproduct ~~single~~candidate ~~entity;~~and ~~packaged~~that ~~together~~provided inmarketing aauthorization, ~~single~~but ~~package~~manufacturers ormust asalso acomply ~~unit;~~with orcertain post-market arequirements ~~drug,~~with ~~device,~~respect ~~or biological~~to ~~product~~the ~~packaged~~constituent ~~separately~~parts ~~that~~of ~~according~~combination toproducts. ~~its~~In ~~investigational~~April ~~plan~~2019, orFDA ~~proposed~~published ~~labeling~~a isfinal ~~intended~~guidance document ~~for~~entitled ~~use~~Compliance ~~only~~Policy ~~with~~for ~~an approved~~Combination ~~individually~~Product ~~specified~~Post-Marketing ~~drug,~~Safety ~~device~~Reporting, orwhich ~~biological~~is ~~product~~intended ~~where~~to ~~both~~assist ~~are~~manufacturers of ~~required~~combination toproducts ~~achieve~~comply ~~the~~with ~~intended~~reporting ~~use,~~requirements ~~indication,~~applicable ~~or effect~~to such products.

~~To determine which FDA center~~After orissuing ~~centers~~marketing ~~will~~authorizations, ~~review~~the aFDA ~~combination~~has ~~product~~discretion ~~candidate~~in ~~submission,~~determining ~~companies~~post-approval ~~may~~compliance ~~submit~~requirements ~~a request~~ for ~~assignment~~combination ~~to the FDA~~products. ~~Those requests~~ ~~may~~The beFDA ~~handled~~has ~~formally~~also orpromulgated ~~informally.~~regulations Inpertaining ~~some~~to ~~cases,~~compliance ~~jurisdiction~~with ~~may~~certain becurrent ~~determined~~good ~~informally~~manufacturing ~~based~~practices ~~on FDA experience with similar products.~~(“cGMP”) ~~However,~~requirements ~~informal~~for ~~jurisdictional~~drug ~~determinations~~components ~~are~~as ~~not~~well ~~binding~~as onQSR ~~the~~requirements ~~FDA.~~for ~~Companies~~device ~~also~~constituents ~~may~~of ~~submit~~ a ~~formal~~combination ~~Request~~product. ~~for~~Other ~~Designation~~post-market requirements toin the ~~FDA~~same ~~Office~~vein ofas ~~Combination~~those ~~Products.~~described ~~The~~above ~~Office~~for ofmedical ~~Combination~~devices ~~Products~~and drugs will ~~review~~also ~~the~~apply, ~~request~~depending ~~and~~on ~~make~~the ~~its~~application ~~jurisdictional~~type ~~determination~~and center ~~within~~overseeing 60regulation ~~days~~ of ~~receiving~~the acombination ~~Request~~product, ~~for Designation.~~including:

~~FDA~~● ~~will~~Other ~~determine~~record-keeping ~~which~~requirements; ~~center or~~● ~~centers~~Post-market ~~within~~adverse ~~the~~event ~~FDA will review the product candidate~~ and ~~under~~Medical ~~what~~Device ~~legal~~Reporting ~~authority~~requirements; ~~the~~● ~~product~~Labelling ~~candidate~~regulations ~~will~~and ~~be reviewed. Depending on how the~~ FDA ~~views~~prohibitions ~~the~~against ~~product candidates that are developed,~~ the ~~FDA~~promotion ~~may have aspects~~ of ~~the~~products ~~product candidate reviewed by the Center~~ for ~~Biologics Evaluation and Research (“CBER”)~~uncleared, ~~CDRH,~~unapproved or ~~CDER,~~off-label ~~though~~uses; ~~one~~● ~~center~~Advertising ~~will~~and bepromotion ~~designated~~requirements; as● ~~the~~Restrictions ~~center~~on ~~with primary jurisdiction~~sale, ~~based~~distribution onor ~~the~~use ~~product candidate’s primary mode~~ of ~~action. The FDA determines~~ the ~~primary mode of action based on the single mode of action that provides the most important therapeutic action of the combination~~ product; ~~candidate~~● –Requirements ~~the~~for ~~mode~~recalls ofbeing ~~action expected~~conducted toand ~~make~~recall ~~the~~reporting; ~~greatest~~● ~~contribution~~An toorder ~~the overall intended therapeutic effects~~ of ~~the combination product candidate. The review of such combination product candidates is often complex and time-consuming~~repair, asreplacement ~~the~~or ~~FDA~~refund; ~~may~~● ~~select~~Product ~~the~~tracking ~~combination~~requirements; ~~product candidate to be reviewed~~ and ~~regulated~~● byPost-market ~~one~~surveillance or ~~multiple~~clinical ~~of the FDA centers identified above, which could affect the path to regulatory clearance or approval~~trials. ~~Furthermore, the FDA may also require submission of separate applications to multiple centers.~~

The post-market requirements that apply to the cleared or approved product will largely be aligned with the agency center determined to have primary jurisdiction over the product candidate and that provided marketing authorization, but manufacturers must also comply with certain post-market requirements with respect to the constituent parts of combination products. In April 2019, FDA published a final guidance document entitled Compliance Policy for Combination Product Post-Marketing Safety Reporting, which is intended to assist manufacturers of combination products comply with reporting requirements applicable to such products.21

~~After~~Coverage and ~~issuing~~Reimbursement. ~~marketing~~Coverage ~~authorizations~~and reimbursement for medical devices in the U.S. is determined by third-party payors, including Medicare ~~the~~and ~~FDA~~Medicaid, commercial health insurers, and managed care organizations. Each payor has ~~discretion~~a inunique process for determining ~~post-approval~~whether ~~compliance~~to cover ~~requirements~~a device for ~~combination~~a ~~products~~particular indication and how to set reimbursement rates for the device. ~~The~~A ~~FDA~~payor ~~has~~can ~~also~~decide ~~promulgated~~to ~~regulations~~cover a device yet ~~pertaining~~not provide adequate reimbursement to ~~compliance~~ensure ~~with~~access ~~certain~~to ~~current~~the ~~good~~device. ~~manufacturing~~New ~~practices~~devices ~~(“cGMP”)~~often ~~requirements~~face ~~for~~significant ~~drug~~uncertainty ~~components~~about ascoverage ~~well~~and asreimbursement. ~~QSR~~Payors ~~requirements~~may require additional evidence, beyond the data required for FDA approval, to demonstrate that a device ~~constituents~~should be ofcovered for a ~~combination~~particular ~~product~~indication or that it should be reimbursed at a higher rate than other technologies. ~~Other~~In ~~post-market~~addition, ~~requirements~~health care inspending ~~the~~continues ~~same~~to ~~vein~~be a concern for federal and state governments, as ~~those~~well ~~described above~~as for ~~medical~~commercial ~~devices~~payors. ~~and~~Governments ~~drugs~~continue ~~will~~to debate ~~also~~methods ~~apply~~of controlling health care costs, ~~depending~~including onreductions ~~the~~in ~~application~~reimbursement ~~type~~or ~~and~~additional ~~center~~controls ~~overseeing~~on ~~regulation~~utilization of ~~the~~new ~~combination~~technologies ~~product~~in Medicare and Medicaid, ~~including:~~and commercial payors may similarly seek to limit spending on new devices. Restrictions on coverage and reimbursement could harm our future revenues and ability to realize an appropriate return on our investment.

●Orphan Drug ~~Other~~Designation ~~record-keeping~~and ~~requirements;~~Exclusivity. ●Under ~~Post-market~~the ~~adverse~~Orphan ~~event~~Drug ~~and~~Act, ~~Medical~~the ~~Device~~FDA ~~Reporting~~may ~~requirements;~~grant ●orphan ~~Labelling~~drug ~~regulations~~designation ~~and~~to ~~FDA~~products ~~prohibitions~~that ~~against~~are intended to treat rare diseases or conditions (i.e., those affecting fewer than 200,000 individuals in the ~~promotion~~U.S.), or diseases or conditions that affect more than 200,000 individuals in the U.S. but there is no reasonable expectation that the cost of ~~products~~developing ~~for~~and ~~uncleared~~making the drug product would be recovered from sales in the U.S. Although orphan drug designation does not convey any advantage in the regulatory review and approval process, ~~unapproved~~it orcan ~~off-label~~provide ~~uses;~~certain ●tax ~~Advertising~~benefits and ~~promotion~~access ~~requirements;~~to ●certain ~~Restrictions~~grants. onAdditionally, ~~sale~~FDA user fees, ~~distribution~~which orcan ~~use~~be ofsubstantial, are ~~the~~waived for products that obtain orphan drug designation. Further, if a product; ●with ~~Requirements~~orphan drug designation subsequently receives FDA approval for ~~recalls~~the ~~being~~designated ~~conducted~~disease ~~and~~or ~~recall~~condition, ~~reporting;~~the ●product Anis ~~order~~generally granted seven years of ~~repair~~orphan drug exclusivity, ~~replacement~~which (with orcertain ~~refund;~~limited ●exceptions) ~~Product~~blocks ~~tracking~~for ~~requirements;~~seven ~~and~~years ●FDA ~~Post-market~~approval ~~surveillance~~of another product with the same active ingredient for the same indication. Orphan drug exclusivity does not prevent the FDA from approving a different drug for the same disease or ~~clinical~~condition, ~~trials~~or the same drug for a different disease or condition.

25Healthcare Fraud and Abuse Laws. In addition to the FDA’s ongoing post-approval regulation of devices discussed above, manufacturers are also subject to several other types of laws and regulations, subject to differing enforcement regimes. In recent years, marketing and promotional activities regarding FDA-regulated products have come under intense scrutiny and have been the subject of enforcement action brought by the U.S. Department of Justice and the Office of Inspector General of the Department of Health and Human Services, as well as state authorities and even private individuals.

~~Coverage and Reimbursement.~~Healthcare ~~Coverage~~providers, physicians and ~~reimbursement for medical devices in the U.S. is determined by~~ third-party payors, ~~including~~play ~~Medicare and Medicaid, commercial health insurers, and managed care organizations. Each payor has~~ a ~~unique~~primary ~~process~~role ~~for~~in ~~determining~~the ~~whether~~recommendation ~~to cover a device for a particular indication~~ and ~~how~~selection toof ~~set~~medical ~~reimbursement~~devices ~~rates~~ for ~~the device~~patients. ~~A payor can decide to cover a device yet not provide adequate reimbursement~~ toArrangements ~~ensure~~with ~~access~~third-party topayors ~~the device. New devices often face significant uncertainty about coverage~~ and ~~reimbursement.~~customers ~~Payors~~are ~~may~~subject ~~require additional evidence, beyond the data required for FDA approval,~~ to ~~demonstrate~~broadly ~~that~~applicable afraud ~~device~~and ~~should~~abuse beand ~~covered for a particular indication or that it should be reimbursed at a higher rate than~~ other ~~technologies.~~healthcare Inlaws ~~addition, health care spending continues to be a concern for federal~~ and ~~state governments, as well as for commercial payors~~regulations. ~~Governments continue to debate methods of controlling health care costs, including~~ ~~reductions~~Such inrestrictions ~~reimbursement~~under orapplicable ~~additional~~federal ~~controls on utilization of new technologies in Medicare~~ and ~~Medicaid,~~state ~~and~~healthcare ~~commercial~~laws ~~payors may similarly seek to limit spending on new devices. Restrictions on coverage~~ and ~~reimbursement~~regulations ~~could~~include ~~harm~~the ~~our future revenues and ability to realize an appropriate return on our investment.~~following:

~~Orphan~~● ~~Drug~~The ~~Designation~~federal ~~and Exclusivity.~~health ~~Under~~care ~~the~~program ~~Orphan~~Anti-Kickback ~~Drug~~Statute ~~Act~~(“AKS”) prohibits, ~~the~~among ~~FDA~~other ~~may~~things, ~~grant~~persons ~~orphan~~from ~~drug~~knowingly ~~designation~~and towillfully ~~products~~soliciting, ~~that~~offering, ~~are~~receiving ~~intended~~or toproviding ~~treat~~remuneration, ~~rare~~directly ~~diseases~~ or ~~conditions (i.e.~~indirectly, ~~those~~in ~~affecting~~cash ~~fewer~~or ~~than~~in ~~200~~kind,~~000~~ ~~individuals~~to induce or in return for purchasing, leasing, ordering or arranging for the ~~U.S.)~~purchase, lease or ~~diseases~~order of any good or ~~conditions~~service, ~~that~~for ~~affect~~which ~~more~~payment ~~than~~may ~~200~~be made,~~000 individuals~~ in ~~the~~whole Uor in part, under a federal healthcare program such as Medicare and Medicaid.S. ~~but~~This ~~there~~statute ishas nobeen ~~reasonable~~interpreted ~~expectation~~to ~~that~~apply ~~the~~to ~~cost~~arrangements ofbetween ~~developing~~pharmaceutical ~~and~~or ~~making~~device manufacturers, on the ~~drug~~one ~~product~~hand, ~~would~~and beprescribers, ~~recovered from~~purchasers ~~sales~~and informulary managers and others on the Uother.S. ~~Although~~The ~~orphan~~term ~~drug~~“remuneration” ~~designation~~has ~~does~~been ~~not~~broadly ~~convey~~interpreted ~~any~~to ~~advantage~~apply into ~~the~~anything ~~regulatory~~of ~~review~~value including, for example, gifts, cash payments, donations, waivers of payment, ownership interests, and ~~approval~~providing ~~process~~any item, service, or compensation for something other than fair market value. Liability under the AKS may be established without proving actual knowledge of the statute or specific intent to violate it ~~can~~. ~~provide~~Although ~~certain~~there ~~tax~~are ~~benefits~~a number of statutory exceptions and ~~access~~regulatory safe harbors to the AKS protecting certain ~~grants.~~common ~~Additionally,~~business ~~FDA~~arrangements ~~user~~and ~~fees,~~activities ~~which~~from ~~can~~prosecution beor ~~substantial~~regulatory sanctions, the exceptions and safe harbors are ~~waived~~drawn ~~for~~narrowly. ~~products~~ Practices that ~~obtain~~involve ~~orphan~~remuneration ~~drug~~to ~~designation.~~those ~~Further~~who prescribe, ifpurchase, aor ~~product~~recommend ~~with~~medical ~~orphan~~device ~~drug~~products, ~~designation~~including ~~subsequently~~certain ~~receives~~discounts, ~~FDA~~or ~~approval~~engaging ~~for~~such ~~the~~individuals ~~designated disease~~as orconsultants, ~~condition~~advisors and speakers, ~~the~~may ~~product~~be issubject ~~generally~~to ~~granted~~scrutiny ~~seven~~if ~~years~~they ofdo ~~orphan~~not ~~drug~~fit ~~exclusivity~~squarely within an exception or safe harbor. Moreover, ~~which~~there ~~(with~~are ~~certain~~no ~~limited~~safe ~~exceptions) blocks~~harbors for ~~seven~~many ~~years~~common ~~FDA~~practices, ~~approval~~such ofas ~~another~~educational ~~product~~grants ~~with~~and ~~the~~reimbursement ~~same~~support ~~active~~programs. ~~ingredient~~Violations ~~for~~are ~~the~~punishable ~~same~~by ~~indication.~~up ~~Orphan~~to ~~drug~~10 ~~exclusivity does~~years ~~not~~in ~~prevent~~prison, ~~the~~criminal ~~FDA~~fines, ~~from~~administrative ~~approving~~civil amonetary ~~different~~penalties ~~drug~~and ~~for~~exclusion ~~the~~from ~~same~~participation ~~disease~~in federal healthcare programs. Any sales or ~~condition~~marketing practices that involve remuneration intended to induce prescribing, purchases or ~~the~~recommendations ~~same~~may ~~drug~~be ~~for~~subject ato ~~different~~scrutiny ~~disease~~under ~~or condition.~~the AKS;

Healthcare Fraud and Abuse Laws. In addition to the FDA’s ongoing post-approval regulation of devices discussed above, manufacturers are also subject to several other types of laws and regulations, subject to differing enforcement regimes. In recent years, marketing and promotional activities regarding FDA-regulated products have come under intense scrutiny and have been the subject of enforcement action brought by the U.S. Department of Justice and the Office of Inspector General of the Department of Health and Human Services, as well as state authorities and even private individuals.22

~~Healthcare~~● ~~providers~~the federal civil False Claims Act (“FCA”) imposes liability on individuals or entities for, ~~physicians~~ among other things, knowingly presenting, or causing to be presented, false or fraudulent, claims for payment of government funds, knowingly making, using, or causing to be made or used a false statement or record material to an obligation to pay money to the government, or knowingly concealing or knowingly and ~~third-party~~improperly ~~payors~~avoiding, ~~play~~decreasing or concealing an obligation to pay money to the federal government. A claim including items or services resulting from a ~~primary~~violation ~~role~~of the AKS constitutes a false or fraudulent claim for purposes of the FCA. Actions under the FCA may be brought by the government or as a qui tam action by a private individual in the ~~recommendation~~name of the government, who may also share in any monetary recovery. Qui tam actions are filed under seal and ~~selection~~impose a mandatory duty on the U.S. Department of ~~medical~~Justice ~~devices~~to investigate such allegations. Manufacturers have faced liability under the FCA for ~~patients~~providing inaccurate billing or coding information to customers or promoting a product off-label. ~~Arrangements~~FCA ~~with~~liability is potentially significant in the healthcare industry because the statute provides for treble damages and significant mandatory penalties per false or fraudulent claim or statement for violations, as well as exclusion from participation in federal healthcare programs; ● the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, and their respective implementing regulations (collectively, “HIPAA”), imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, or knowingly and ~~customers~~willfully ~~are~~falsifying, ~~subject~~concealing, or covering up a material fact or making any materially false, fictitious, or fraudulent statement or representation, or using any false writing or document knowing the same to ~~broadly~~contain any materially false, fictitious, or fraudulent statement or entry, in connection with the delivery of or payment for healthcare benefits, items, or services; ● the federal Physician Payments Sunshine Act (the “Sunshine Act”) requires applicable ~~fraud~~manufacturers of devices, biologics and ~~abuse~~medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to payments and other ~~healthcare~~transfers ~~laws~~of value to physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and ~~regulations.~~certified ~~Such~~nurse ~~restrictions~~midwives, ~~under applicable~~and ~~federal~~teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. ● analogous state ~~healthcare~~and foreign laws and regulations, ~~include~~such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. Several states have enacted legislation requiring medical device manufacturers to, among other things, establish marketing compliance programs; file periodic reports with the ~~following:~~state, including reports on gifts and payments to individual health care providers; and/or register their sales representatives. Some states prohibit certain sales and marketing practices, including the provision of gifts, meals, or other items to health care providers.

~~● The federal health care program Anti-Kickback Statute (“AKS”) prohibits~~Additionally, ~~among~~ other ~~things,~~laws ~~persons~~such ~~from~~as ~~knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for~~ the ~~purchase, lease or order of any good or service, for which payment may be made, in whole or in part, under a~~ federal ~~healthcare~~Lanham ~~program~~Act ~~such as Medicare~~ and ~~Medicaid.~~similar ~~This~~state ~~statute~~laws ~~has~~allow ~~been~~competitors ~~interpreted to apply to arrangements between pharmaceutical or device manufacturers, on the one hand,~~ and ~~prescribers, purchasers and formulary managers and~~ others onto ~~the~~initiate ~~other.~~litigation ~~The~~relating ~~term “remuneration” has been broadly interpreted~~ to apply to anything of value including, for example, gifts, cash payments, donations, waivers of payment, ownership interests, and providing any item, service, or compensation for something other than fair market valueadvertising claims. ~~Liability~~If ~~under~~we ~~the~~sell ~~AKS~~our ~~may~~device beoutside ~~established without proving actual knowledge of~~ the ~~statute~~United orStates, ~~specific intent to violate~~ it. ~~Although~~must ~~there~~comply ~~are~~with ~~a number of statutory exceptions and regulatory safe harbors to~~ the ~~AKS~~Foreign ~~protecting~~Corrupt ~~certain common business arrangements and activities from prosecution or regulatory sanctions, the exceptions and safe harbors are drawn narrowly.~~ Practices ~~that~~Act ~~involve~~(“FCPA”) ~~remuneration to those who prescribe, purchase, or recommend medical device products, including certain discounts, or engaging such individuals as consultants, advisors~~ and local ~~speakers,~~laws ~~may~~of beother ~~subject to scrutiny if they do not fit squarely within an exception or safe harbor~~countries. ~~Moreover,~~FCPA ~~there~~is ~~are~~a nocomplex ~~safe~~patchwork ~~harbors~~of ~~for~~laws ~~many~~can ~~common~~change ~~practices,~~rapidly ~~such~~with asrelatively ~~educational~~short ~~grants and reimbursement support programs~~notice. Violations are punishable by up to 10 years in prison, criminal fines, administrative civil monetary penalties and exclusion from participation in federal healthcare programs. Any sales or marketing practices that involve remuneration intended to induce prescribing, purchases or recommendations may be subject to scrutiny under the AKS;

26Environmental Laws. Elements of our potential products may be classified as hazardous materials, subject to regulation by the Department of Transportation, the International Air Transportation Association, the International Maritime Organization, the Environmental Protection Agency and the Occupational Safety and Health Administration, which may impose various requirements pertaining to the way we manufacture, transport, store, handle and dispose of our products. At this time, we have no material costs associated with environmental laws.

●European Regulation the federal civil False Claims Act (“FCA”) imposes liability on individuals or entities for, among other things, knowingly presenting, or causing to be presented, false or fraudulent, claims for payment of ~~government~~Medical funds, knowingly making, using, or causing to be made or used a false statement or record material to an obligation to pay money to the government, or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal governmentDevices. AIn ~~claim including items or services resulting from a violation of~~ the ~~AKS~~European constitutes a false or fraudulent claim for purposes of the FCA. Actions under the FCA may be brought by the government or as a qui tam action by a private individual in the name of the government, who may also share in any monetary recovery. Qui tam actions are filed under seal and impose a mandatory duty on the U.S. Department of Justice to investigate such allegations. Manufacturers have faced liability under the FCA for providing inaccurate billing or coding information to customers or promoting a product off-label. FCA liability is potentially significant in the healthcare industry because the statute provides for treble damages and significant mandatory penalties per false or fraudulent claim or statement for violations, as well as exclusion from participation in federal healthcare programs; ● the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic ~~and~~Area ~~Clinical Health Act, and their respective implementing regulations~~ (~~collectively,~~ “~~HIPAA~~EEA”), ~~imposes~~we ~~criminal~~expect ~~and~~our ~~civil~~products ~~liability for, among other things, knowingly and willfully executing, or attempting~~ to ~~execute,~~be aregulated ~~scheme~~as ~~to defraud any healthcare benefit program, including private third-party payors, or knowingly and willfully falsifying, concealing, or covering up~~ a material fact or making any materially false, fictitious, or fraudulent statement or representation, or using any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry, in connection with the delivery of or payment for healthcare benefits, items, or services; ● the federal Physician Payments Sunshine Act (the “Sunshine Act”) requires applicable manufacturers of devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to payments and other transfers of value to physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse midwives, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. ● analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. Several states have enacted legislation requiring medical device ~~manufacturers~~product ~~to,~~falling ~~among~~within ~~other things, establish marketing compliance programs; file periodic reports with~~ the ~~state,~~scope including reports on gifts and payments to individual health care providers; and/or register their sales representatives. Some states prohibit certain sales and marketing practices, including the provision of ~~gifts,~~EU ~~meals, or other items to health care providers~~MDR.

~~Additionally~~In the EEA, ~~other~~medical ~~laws~~devices ~~such~~must currently comply with the General Safety and Performance Requirements laid down in Annex I to the EU MDR. asCompliance with these requirements is a prerequisite to be able to affix the ~~federal~~CE ~~Lanham~~mark ~~Act~~on products, without which they cannot be marketed or sold in the EEA. To demonstrate compliance with the General Safety and ~~similar~~Performance ~~state~~Requirements ~~laws~~of ~~allow~~the ~~competitors~~EU MDR and ~~others~~obtain the right to ~~initiate~~affix ~~litigation~~the ~~relating~~CE mark, medical devices manufacturers must undergo a conformity assessment procedure, which varies according to ~~advertising~~the ~~claims~~type of medical device and its classification. IfApart from low risk medical devices (Class I with no measuring function and which are not sterile), wein ~~sell~~relation ~~our~~to ~~device~~which ~~outside~~the manufacturer may issue an EC Declaration of Conformity based on a self-assessment of the ~~United~~conformity ~~States~~of its products with the General Safety and Performance Requirements, ita ~~must~~conformity ~~comply~~assessment ~~with~~procedure requires the ~~Foreign~~intervention ~~Corrupt~~of ~~Practices~~a ~~Act~~notified ~~(“FCPA”)~~body, which is an organization designated by a Competent Authority of an EEA country to conduct conformity assessments. Depending on the relevant conformity assessment procedure, the notified body would audit and ~~local~~examine ~~laws~~the technical documentation and the quality system for the manufacture, design and final inspection of ~~other~~the ~~countries~~medical devices. ~~FCPA~~The isnotified body issues a ~~complex~~CE ~~patchwork~~Certificate of ~~laws~~Conformity ~~can~~following ~~change~~successful completion ~~rapidly~~of a conformity assessment procedure conducted in relation to the medical device and its manufacturer and their conformity with the General Safety and Performance Requirements. This Certificate and the related conformity assessment process entitles the manufacturer to affix the CE mark to its medical devices after having prepared and signed a related EC Declaration of Conformity. Notified bodies must be accredited by the EEA countries’ accreditation bodies to conduct assessment procedures for medical devices in accordance with the EU MDR. There are currently a relatively ~~short~~small ~~notice~~number of notified bodies that have been accredited to conduct these assessments. This may delay conformity assessment procedures in the future in the EU.

Environmental Laws. Elements of our potential products may be classified as hazardous materials, subject to regulation by the Department of Transportation, the International Air Transportation Association, the International Maritime Organization, the Environmental Protection Agency and the Occupational Safety and Health Administration, which may impose various requirements pertaining to the way we manufacture, transport, store, handle and dispose of our products. At this time, we have no material costs associated with environmental laws.23

~~European~~As a ~~Regulation~~general rule, demonstration of ~~Medical~~conformity of medical devices and their manufacturers with the General Safety and Performance Requirements ~~Devices~~must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. InSpecifically, a manufacturer must demonstrate that the ~~European~~device ~~Economic~~achieves ~~Area~~its intended performance during normal conditions of use and that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device (~~“EEA”)~~e.g., weproduct ~~expect~~labeling ~~our~~and ~~products~~instructions for touse) are supported by suitable evidence. This assessment must be ~~regulated~~based ason aclinical ~~medical~~data, which can be obtained from (1) clinical studies conducted on the devices being assessed, (2) scientific literature from similar devices whose equivalence with the assessed device can ~~product~~be ~~falling~~demonstrated or (3) both clinical studies and scientific literature. The conduct of clinical studies in the EEA is governed by ~~within~~detailed regulatory obligations. These may include the ~~scope~~requirement of EUprior ~~MDR~~authorization by the competent authorities of the country in which the study takes place and the requirement to obtain a positive opinion from a competent Ethics Committee. This process can be expensive and time-consuming.

~~In the EEA, medical devices must~~The ~~currently~~EU ~~comply~~MDR ~~with~~repeals ~~the General Safety~~ and ~~Performance~~replaces ~~Requirements laid down in Annex I to~~ the EU ~~MDR.~~Medical ~~Compliance~~Devices ~~with~~Directive ~~these~~93/42/EEC. ~~requirements is~~Unlike ~~a prerequisite to be able to affix the CE mark on products~~directives, ~~without~~ which ~~they~~must ~~cannot~~ be ~~marketed~~implemented orinto ~~sold in~~ the ~~EEA. To demonstrate~~national ~~compliance~~laws ~~with the General Safety and Performance Requirements~~ of the EUEEA ~~MDR~~countries, ~~and obtain~~ the ~~right~~regulations tois ~~affix~~directly ~~the CE mark~~applicable, ~~medical devices manufacturers must undergo a conformity assessment procedure~~i.e., ~~which~~without ~~varies~~the ~~according~~need tofor ~~the~~adoption ~~type~~ of ~~medical~~EEA ~~device~~country ~~and~~laws ~~its classification.~~implementing ~~Apart~~them, ~~from~~in ~~low~~all ~~risk~~countries ~~medical devices (Class I with no measuring function~~ and ~~which~~ are ~~not~~intended ~~sterile), in relation~~ to ~~which~~eliminate ~~the~~current ~~manufacturer may~~differences ~~issue~~in ~~an EC Declaration of Conformity based on a self-assessment of~~ the ~~conformity~~regulation of ~~its~~medical ~~products~~devices ~~with~~among ~~the~~EEA ~~General~~countries. ~~Safety and Performance~~The ~~Requirements~~EU MDR, aamong ~~conformity~~other ~~assessment~~things, ~~procedure~~establishes ~~requires the intervention of~~ a ~~notified body~~uniform, ~~which is an organization designated by a Competent Authority of an EEA country to conduct conformity assessments. Depending on the relevant conformity assessment procedure~~transparent, ~~the notified~~predictable ~~body would audit~~ and ~~examine~~sustainable ~~the~~regulatory ~~technical~~framework ~~documentation~~across ~~and~~ the ~~quality~~EEA ~~system~~ for ~~the manufacture, design and final inspection of the~~ medical devices. ~~The~~and ~~notified~~ensures ~~body issues~~ a CEhigh ~~Certificate~~level of ~~Conformity~~safety ~~following successful completion of a conformity assessment procedure conducted in relation to the medical device~~ and ~~its~~health ~~manufacturer~~while ~~and~~supporting ~~their conformity with the General Safety and Performance Requirements~~innovation. ~~This~~The Certificate and the related conformity assessment process entitles the manufacturer to affix the CE mark to its medical devices after having prepared and signed a related EC Declaration of Conformity. Notified bodies must be accredited by the EEA countries’ accreditation bodies to conduct assessment procedures for medical devices in accordance with the EU MDR. ~~There~~entered ~~are~~into ~~currently~~application aon ~~relatively small~~May ~~number~~26, ~~of notified bodies that have been accredited to conduct these assessments. This may delay conformity assessment procedures~~2021, inand ~~the~~among ~~future~~others ~~in the EU.~~things:

27● strengthens the rules on placing devices on the market and reinforce surveillance once they are available; ● establishes explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market; ● improves the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number; ● sets up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; ● strengthens rules for the assessment of certain high-risk devices which may have to undergo an additional check by experts before they are placed on the market.

~~As a general rule, demonstration~~Continuing ofRegulation. ~~conformity~~As ofin ~~medical devices and their manufacturers with~~ the ~~General Safety and Performance Requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use~~U. ~~Specifically~~S., a ~~manufacturer~~manufacturers ~~must demonstrate that the device achieves its intended performance during normal conditions~~ of ~~use~~medical ~~and~~devices ~~that the known and foreseeable risks, and any adverse events,~~ are ~~minimized~~subject ~~and~~to ~~acceptable~~comprehensive ~~when~~regulatory ~~weighed~~oversight ~~against~~by ~~the~~notified ~~benefits of its intended performance,~~bodies and ~~that any claims made about~~ the ~~performance~~competent ~~and~~authorities ~~safety~~ of the ~~device~~EEA (ecountries.~~g.,~~ ~~product labeling and instructions for use) are supported by suitable evidence.~~ This ~~assessment~~oversight ~~must~~applies be based on clinical data, which can be obtained from (1) clinical studies conducted on the devices being assessed, (2) scientific literature from similar devices whose equivalence with the assessed device can be demonstrated or (3) both ~~clinical~~before ~~studies~~ and ~~scientific~~after ~~literature~~certification. ~~The~~It ~~conduct~~includes ofcontrol ~~clinical studies in the EEA is governed by detailed regulatory~~of ~~obligations.~~compliance ~~These~~with ~~may include~~ the ~~requirement~~EU ofMDR ~~prior~~General ~~authorization~~Safety ~~by the competent authorities of the country in which the study takes place~~ and ~~the~~Performance ~~requirement~~Requirements ~~to obtain a positive opinion from a competent Ethics Committee. This process can be expensive~~ and ~~time~~post-~~consuming~~market surveillance.

~~The~~In the EUEEA, ~~MDR~~the ~~repeals~~advertising and ~~replaces the~~promotion EUof ~~Medical~~our ~~Devices~~products ~~Directive~~will ~~93/42/EEC.~~also ~~Unlike~~be ~~directives,~~subject ~~which~~to ~~must~~EEA becountries ~~implemented~~national ~~into~~laws ~~the~~implementing ~~national~~Directive ~~laws~~2006/114/EC concerning ofmisleading ~~the~~and ~~EEA~~comparative ~~countries~~advertising, ~~the~~ ~~regulations~~and isDirective ~~directly~~2005/29/EC ~~applicable,~~on ~~i.e.~~unfair commercial practices, ~~without~~as ~~the~~well ~~need~~as ~~for~~other ~~adoption~~national legislation of individual EEA ~~country~~countries ~~laws~~governing ~~implementing~~the ~~them,~~advertising inand ~~all~~promotion of medical devices. EEA countries’ ~~and~~legislation ~~are~~may ~~intended~~also torestrict ~~eliminate~~or ~~current~~impose ~~differences~~limitations inon ~~the~~our ~~regulation~~ability ofto ~~medical~~advertise ~~devices~~our ~~among~~products ~~EEA~~directly ~~countries~~to the general public. ~~The~~In addition, voluntary EU ~~MDR,~~and ~~among~~national ~~other~~Codes ~~things, establishes~~of aConduct ~~uniform,~~provide ~~transparent,~~guidelines ~~predictable~~on ~~and~~the ~~sustainable~~advertising ~~regulatory~~and ~~framework~~promotion ~~across~~of ~~the~~our ~~EEA~~products ~~for~~to ~~medical~~the ~~devices~~general public and ~~ensures~~may aimpose ~~high~~limitations ~~level~~on our promotional activities with healthcare professionals. Violations of ~~safety~~the ~~and~~rules ~~health~~governing ~~while~~the ~~supporting~~promotion ~~innovation.~~of ~~The~~medical EUdevices in ~~MDR~~the ~~entered~~EEA ~~into~~could ~~application~~be onpenalized ~~May~~by ~~26,~~administrative ~~2021~~measures, fines and ~~among others things:~~imprisonment.

●Data Privacy ~~strengthens~~Regulation. The collection and use of personal health data in the ~~rules~~EEA onis ~~placing~~governed ~~devices~~by onthe data protection laws and regulations adopted by the ~~market~~EEA countries and ~~reinforce~~the ~~surveillance~~EU ~~once~~General ~~they~~Data ~~are~~Protection ~~available;~~Regulation ●(“GDPR”). ~~establishes~~The ~~explicit~~GDPR ~~provisions~~became applicable on ~~manufacturers’~~May ~~responsibilities~~25, 2018 ~~for~~and repealed the ~~follow-up~~EU ofData ~~the~~Protection ~~quality,~~Directive. ~~performance~~The GDPR is directly applicable in each EEA country and ~~safety~~imposes ofseveral ~~devices~~requirements on ~~placed~~companies that process personal data, strict rules on the ~~market;~~transfer ●of ~~improves~~personal ~~the~~data ~~traceability~~out of ~~medical~~the ~~devices~~EEA, ~~throughout~~including to the ~~supply~~U.S., ~~chain~~and fines and penalties for failure to comply with the ~~end-user~~requirements orof ~~patient~~the ~~through~~GDPR aand ~~unique~~the ~~identification~~related ~~number;~~national ●data ~~sets~~protection uplaws of the EAA countries. The GDPR confers a ~~central~~private ~~database~~right toof ~~provide~~action ~~patients,~~on ~~healthcare~~data ~~professionals~~subjects and ~~the~~consumer ~~public~~associations to lodge complaints with ~~comprehensive~~supervisory ~~information~~authorities, seek onjudicial ~~products~~remedies, ~~available~~and inobtain ~~the~~compensation ~~EU;~~for ●damages ~~strengthens~~resulting ~~rules~~from ~~for~~violations of the ~~assessment~~GDPR. ofFailure ~~certain~~to ~~high-risk~~comply ~~devices~~with ~~which~~the requirements of GDPR may ~~have~~result in fines of up to ~~undergo~~20,000,000 anEuros ~~additional~~or ~~check~~up byto ~~experts~~4% ~~before~~of ~~they~~the ~~are~~total ~~placed~~worldwide onannual turnover of the ~~market~~preceding financial year, whichever is higher, and other administrative penalties.

Continuing Regulation. As in the U.S., manufacturers of medical devices are subject to comprehensive regulatory oversight by notified bodies and the competent authorities of the EEA countries. This oversight applies both before and after certification. It includes control of compliance with the EU MDR General Safety and Performance Requirements and post-market surveillance.24

Orphan Designation and Exclusivity. In the ~~EEA~~EU, the ~~advertising~~Committee ~~and promotion~~for ofMedicinal ~~our~~Products ~~products~~for ~~will~~Human ~~also~~Use begrants ~~subject~~orphan todrug ~~EEA~~designation ~~countries~~to ~~national~~promote the ~~laws~~development ~~implementing~~of ~~Directive~~products ~~2006/114/EC~~that ~~concerning~~are ~~misleading and~~intended ~~comparative~~for ~~advertising~~the diagnosis, ~~and~~prevention ~~Directive~~or ~~2005/29/EC~~treatment onof ~~unfair~~life-threatening ~~commercial~~or ~~practices,~~chronically asdebilitating conditions ~~well~~affecting asnot ~~other~~more ~~national~~than ~~legislation~~five ofin ~~individual EEA~~10,000 ~~countries~~persons ~~governing~~in the ~~advertising~~EU Community and ~~promotion~~for ofwhich ~~medical~~no ~~devices.~~satisfactory ~~EEA~~method ~~countries’~~of ~~legislation~~diagnosis, ~~may~~prevention or ~~also~~treatment ~~restrict~~has orbeen ~~impose limitations~~authorized on(or ~~our~~the ~~ability~~product towould ~~advertise~~be ~~our~~a ~~products~~significant ~~directly~~benefit to ~~the~~those ~~general public~~affected). ~~In addition~~Additionally, ~~voluntary~~designation EUis ~~and national Codes of Conduct~~granted ~~provide~~for ~~guidelines~~products onintended for the ~~advertising~~diagnosis, ~~and~~prevention ~~promotion~~or treatment of ~~our~~a ~~products~~life-threatening, toseriously ~~the~~debilitating ~~general~~or ~~public~~serious and ~~may~~chronic condition ~~impose~~and ~~limitations~~when, onwithout ~~our~~incentives, ~~promotional activities~~it ~~with~~is ~~healthcare~~unlikely ~~professionals.~~that ~~Violations~~sales of the ~~rules~~drug ~~governing~~in the ~~promotion~~EU ofwould ~~medical~~be ~~devices~~sufficient into justify the ~~EEA could be penalized~~necessary byinvestment ~~administrative~~in ~~measures,~~developing ~~fines~~the ~~and~~medicinal ~~imprisonment~~product.

~~Data Privacy Regulation.~~In ~~The collection and use of personal health data in~~ the ~~EEA~~EU, isorphan ~~governed~~drug bydesignation ~~the~~entitles ~~data~~a ~~protection~~party ~~laws~~to ~~and~~financial ~~regulations~~incentives ~~adopted~~such byas ~~the~~reduction ~~EEA~~of ~~countries and~~fees ~~the~~or EUfee ~~General~~waivers ~~Data Protection Regulation (“GDPR”). The GDPR became applicable on May 25, 2018~~ and ~~repealed~~ten ~~the~~years EUof ~~Data~~market ~~Protection~~exclusivity ~~Directive. The GDPR~~ is ~~directly~~granted ~~applicable~~following inmedicinal ~~each~~product ~~EEA country and imposes several requirements on companies that process personal data, strict rules on the transfer of personal data out of the EEA, including to the U~~approval.~~S.,~~ ~~and~~This ~~fines~~period ~~and~~may ~~penalties~~be ~~for~~reduced ~~failure~~ to ~~comply with~~six ~~the~~years ~~requirements~~if of the ~~GDPR~~orphan ~~and~~drug ~~the~~designation ~~related national data protection laws of the EAA countries. The GDPR confers a private right~~criteria ofare ~~action~~no onlonger ~~data subjects and consumer associations to lodge complaints with supervisory authorities~~met, ~~seek~~including ~~judicial~~where ~~remedies,~~it ~~and~~is ~~obtain compensation~~shown ~~for~~that ~~damages resulting from violations of~~ the ~~GDPR.~~product ~~Failure~~is tosufficiently ~~comply~~profitable ~~with~~not ~~the requirements of GDPR may result in fines of up~~ to ~~20,000,000~~justify ~~Euros~~maintenance ~~or up to 4%~~ of ~~the~~market ~~total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties~~exclusivity.

28Orphan drug designation must be requested before submitting an application for marketing approval. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

Exceptional Circumstances/Conditional Approval. Orphan ~~Designation~~medicinal ~~and~~product ~~Exclusivity. In~~or ~~the~~products ~~EU,~~for ~~the~~unmet ~~Committee~~medical ~~for~~needs ~~Medicinal~~may ~~Products~~be eligible for ~~Human~~EU ~~Use~~approval under ~~grants~~exceptional circumstances or with conditional approval. Approval under exceptional circumstances is applicable to orphan ~~drug~~products and ~~designation~~is used when an applicant is unable to ~~promote~~provide comprehensive data on the ~~development~~efficacy and safety under normal conditions of ~~products~~use ~~that~~because ~~are~~the ~~intended~~indication for which the ~~diagnosis~~product is intended is encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence, ~~prevention~~when orthe ~~treatment~~present state of ~~life-threatening~~scientific orknowledge ~~chronically~~does ~~debilitating~~not ~~conditions~~allow ~~affecting~~comprehensive ~~not~~information ~~more~~to be provided, or when ~~than~~it ~~five~~is inmedically ~~10,000~~unethical ~~persons~~to incollect ~~the~~such EUinformation. ~~Community~~Conditional ~~and~~marketing ~~for~~authorization ~~which~~is noapplicable ~~satisfactory~~to ~~method~~orphan ofmedicinal ~~diagnosis~~products, medicinal ~~prevention~~products for seriously debilitating or ~~treatment~~life- ~~has~~threatening ~~been~~diseases ~~authorized (~~or ~~the~~medicinal ~~product~~products ~~would~~to be aused ~~significant~~in ~~benefit~~emergency situations in response to ~~those~~recognized ~~affected)~~public threats. ~~Additionally,~~Conditional ~~designation~~marketing isauthorization can be granted ~~for~~on ~~products~~the ~~intended~~basis ~~for~~of ~~the diagnosis,~~less ~~prevention~~complete ordata ~~treatment~~than is ofnormally arequired ~~life-threatening,~~in ~~seriously~~order ~~debilitating~~to ormeet ~~serious~~unmet medical needs and ~~chronic~~in ~~condition~~the ~~and~~interest ~~when,~~of ~~without~~public ~~incentives~~health, it isprovided ~~unlikely~~the ~~that~~risk-benefit ~~sales~~balance ofis positive, ~~the~~it ~~drug~~is inlikely that the EUapplicant ~~would~~will be ~~sufficient~~able to ~~justify~~provide the ~~necessary~~comprehensive ~~investment~~clinical indata, ~~developing~~and ~~the~~unmet ~~medicinal~~medical ~~product~~needs will be fulfilled.

~~In the EU, orphan drug designation~~Conditional ~~entitles~~marketing aauthorization ~~party to financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity~~ is ~~granted~~subject ~~following medicinal product approval. This period may be reduced~~ to ~~six~~certain ~~years~~specific ifobligations ~~the orphan drug designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not~~ to ~~justify~~be ~~maintenance~~reviewed ~~of market exclusivity~~annually.

~~Orphan~~Other Regulations. ~~drug~~We ~~designation~~are ~~must~~also ~~be requested~~subject ~~before~~to ~~submitting~~numerous anfederal, ~~application~~state ~~for~~and ~~marketing~~local ~~approval.~~laws ~~Orphan~~relating ~~drug~~to ~~designation~~such ~~does~~matters ~~not~~as ~~convey~~safe ~~any~~working ~~advantage~~conditions, inmanufacturing practices, environmental protection, fire hazard control and disposal of hazardous or ~~shorten~~potentially hazardous substances. We may incur ~~the~~significant ~~duration~~costs ~~of,~~to ~~the~~comply ~~regulatory~~with ~~review~~such laws and ~~approval~~regulations ~~process~~now or in the future.

~~Exceptional Circumstances/Conditional~~Regulation ~~Approval~~in Israel. ~~Orphan~~In ~~medicinal~~order ~~product~~to orconduct ~~products~~clinical ~~for~~testing ~~unmet~~on ~~medical~~humans ~~needs~~in ~~may~~the beState ~~eligible~~of ~~for~~Israel, EUspecial ~~approval~~authorization ~~under~~must ~~exceptional~~first ~~circumstances~~be obtained from orthe ~~with~~ethics ~~conditional~~committee ~~approval.~~and ~~Approval~~general ~~under~~manager ~~exceptional~~of ~~circumstances~~the isinstitution ~~applicable~~in towhich ~~orphan~~the ~~products~~clinical ~~and~~studies isare ~~used~~scheduled ~~when~~to anbe ~~applicant~~conducted, as required isunder ~~unable~~the toGuidelines ~~provide~~for ~~comprehensive~~Clinical ~~data~~Trials onin Human Subjects implemented pursuant to the ~~efficacy~~Israeli ~~and~~Public ~~safety~~Health ~~under~~Regulations ~~normal~~(Clinical ~~conditions~~Trials in ofHuman ~~use~~Subjects), ~~because~~as ~~the~~amended ~~indication~~from ~~for~~time ~~which~~to ~~the product~~time, isand ~~intended~~other isapplicable ~~encountered~~legislation. soThese ~~rarely~~regulations ~~that~~require authorization by the ~~applicant~~institutional ethics ~~cannot~~committee ~~reasonably~~and begeneral ~~expected~~manager toas ~~provide~~well ~~comprehensive~~as ~~evidence,~~from ~~when~~ the ~~present~~Israeli ~~state~~Ministry of ~~scientific~~Health, ~~knowledge~~except ~~does~~in ~~not~~certain ~~allow~~circumstances, ~~comprehensive~~and ~~information~~in tothe becase of ~~provided~~genetic trials, orspecial ~~when~~fertility ittrials isand ~~medically~~complex ~~unethical~~clinical ~~to collect~~trials, ~~such~~an ~~information.~~additional ~~Conditional~~authorization ~~marketing~~of ~~authorization~~the isMinistry ~~applicable~~of toHealth’s overseeing ~~orphan~~ethics ~~medicinal~~committee. ~~products,~~The ~~medicinal~~institutional ~~products~~ethics ~~for~~committee ~~seriously debilitating~~must, oramong ~~life-~~other ~~threatening~~things, ~~diseases~~evaluate orthe ~~medicinal~~anticipated ~~products~~benefits that are likely to be ~~used~~derived infrom ~~emergency~~the ~~situations~~project into ~~response~~determine toif ~~recognized~~it ~~public~~justifies ~~threats. Conditional~~the ~~marketing~~risks ~~authorization~~and ~~can~~inconvenience to be ~~granted~~inflicted on the ~~basis~~human ofsubjects, and ~~less~~the ~~complete~~committee ~~data~~must ~~than~~ensure isthat ~~normally~~adequate ~~required~~protection inexists ~~order~~for tothe ~~meet~~rights ~~unmet~~and safety of the participants as well as the accuracy of ~~medical~~the ~~needs~~information ~~and~~gathered in the ~~interest~~course of ~~public~~the ~~health,~~clinical ~~provided~~testing. Since we perform a portion of the ~~risk-benefit~~clinical ~~balance~~studies ison ~~positive~~certain of our therapeutic candidates in Israel, itwe isare ~~likely~~required ~~that~~to obtain authorization from the ~~applicant~~ethics ~~will~~committee and general manager of each institution bein ~~able~~which towe ~~provide~~intend ~~the~~to ~~comprehensive~~conduct our clinical ~~data~~trials, and ~~unmet~~in ~~medical~~most ~~needs~~cases, ~~will~~from bethe ~~fulfilled~~Israeli Ministry of Health.

~~Conditional marketing authorization is subject to certain specific obligations to be reviewed annually.~~25

~~Other Regulations. We are~~Corporate also subject to numerous federal, state and local laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control and disposal of hazardous or potentially hazardous substances. We may incur significant costs to comply with such laws and regulations now or in the future.History

~~Regulation in Israel. In~~We ~~order~~were toincorporated ~~conduct clinical testing~~ on ~~humans~~April ~~in the State of Israel~~24, special authorization must first be obtained from the ethics committee and general manager of the institution in which the clinical studies are scheduled to be conducted, as required under the Guidelines for Clinical Trials in Human Subjects implemented pursuant to the Israeli Public Health Regulations (Clinical Trials in Human Subjects), as amended from time to time, and other applicable legislation2015. ~~These~~On ~~regulations~~June ~~require authorization by the institutional ethics committee and general manager as well as from the Israeli Ministry of Health~~25, ~~except in certain circumstances~~2019, ~~and~~our inname ~~the~~was ~~case~~changed of genetic trials, special fertility trials and complex clinical trials, an additional authorization of the Ministry of Health’s overseeing ethics committee. The institutional ethics committee must, among other things, evaluate the anticipated benefits that are likely to beBeyond ~~derived from the project to determine if it justifies the risks and inconvenience to be inflicted on the human subjects~~Air, ~~and the committee must ensure that adequate protection exists for the rights and safety of the participants as well as the accuracy of the information gathered in the course of the clinical testing~~Inc. ~~Since we perform a portion of the clinical studies on certain of our therapeutic candidates in Israel, we are required to obtain authorization~~ from ~~the~~AIT ~~ethics committee and general manager of each institution in which we intend to conduct our clinical trials~~Therapeutics, ~~and in most cases, from the Israeli Ministry of Health~~Inc.

29We have the following wholly owned subsidiaries:

~~Corporate~~- ~~History~~Beyond Air Ltd. (“BA Ltd.”), incorporated in Israel on May 1, 2011. - Beyond Air Australia Pty Ltd., incorporated on December 17, 2019 in Australia. - Beyond Air Ireland Limited, incorporated on March 5, 2020 in Ireland. We have 88.2% ownership in the following entity: - Jodheary Holdco 18 Limited, incorporated on March 24, 2023 in Ireland. In April 2023, its name was changed to Beyond Air (NO) Limited. In March 2024, its name was changed to NeuroNOS Ltd. NeuroNOS Ltd. has the following wholly owned subsidiaries: - NeuroNOS Ltd Israel, incorporated on March 12, 2024 - NNOS U.S., Inc, incorporated in Delaware on January 10, 2025 - Beyond Air Cyprus Limited, incorporated on October 13, 2021 in Cyprus. We have 80% ownership in the following entity: - Beyond Air Bermuda Limited, incorporated on August 13, 2021 in Bermuda. In September 2022, its name was changed to Beyond Cancer Bermuda Limited. Beyond Air Bermuda Limited has the following wholly owned subsidiaries: - XAIR Israel Ltd, incorporated on October 3, 2021 in Israel. - Beyond Cancer U.S., Inc., incorporated on March 17, 2022 in Delaware.

WeRecent ~~were incorporated on April 24, 2015. On June 25, 2019, our name was changed to Beyond Air, Inc. from AIT Therapeutics, Inc.~~Updates

WeOn ~~have~~April 7, 2026, we received a written notification (the ~~following~~“Notice”) ~~wholly~~from ~~owned~~the Nasdaq Listing Qualifications Department (the “Listing Qualifications ~~subsidiaries:~~Department”) notifying us that for the 30 consecutive business day period between February 23, 2026 through April 6, 2026, our common stock had not maintained a minimum closing bid price of $1.00 per share required for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”). While companies are typically afforded a 180-calendar day compliance period to comply with the Bid Price Rule, the Notice stated that, pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iv), we were not eligible for any compliance period specified in Nasdaq Listing Rule 5810(c)(3)(A) due to the fact that we had effected a reverse stock split over the prior one-year period. We had effected a 1-for-20 reverse stock split on July 14, 2025.

-The ~~Beyond~~Notice ~~Air~~stated ~~Ltd.~~that ~~(“BA~~the ~~Ltd.”),~~Company’s securities ~~incorporated~~will inbe ~~Israel~~subject onto ~~May~~delisting 1,from ~~2011.~~Nasdaq -unless ~~Beyond~~the ~~Air~~Company ~~Australia~~timely ~~Pty~~requests ~~Ltd.,~~a ~~incorporated~~hearing onbefore ~~December~~the ~~17,~~Nasdaq ~~2019~~Hearings inPanel ~~Australia.~~(the “Panel”) -by ~~Beyond~~April ~~Air~~14, ~~Ireland~~2026. ~~Limited~~Accordingly, ~~incorporated~~ on ~~March~~April 513, ~~2020~~2026, inwe ~~Ireland.~~timely Werequested ~~have~~a ~~88.2%~~hearing ~~ownership~~before in the ~~following~~Panel ~~entity:~~to -appeal ~~Jodheary~~the ~~Holdco~~Staff’s determination. 18As ~~Limited,~~a ~~incorporated~~result onof ~~March~~the ~~24,~~timely ~~2023~~hearing inrequest, ~~Ireland.~~any Insuspension ~~April~~or ~~2023,~~delisting ~~its~~action ~~name~~with ~~was~~respect ~~changed~~ to ~~Beyond~~our ~~Air~~common ~~(NO)~~stock ~~Limited. In March 2024, its name~~ was ~~changed~~stayed pending ~~to NeuroNOS Ltd. NeuroNOS Ltd. has~~ the ~~following~~issuance ~~wholly~~of ~~owned~~a ~~subsidiaries:~~written -decision ~~NeuroNOS~~by ~~Ltd~~the ~~Israel,~~Panel ~~incorporated~~following onthe ~~March~~hearing ~~12, 2024 - NNOS U~~process.~~S.,~~ ~~Inc,~~The ~~incorporated~~hearing inwas ~~Delaware~~scheduled onfor ~~January~~May 1014, ~~2025~~2026. -On May ~~Beyond Air Cyprus Limited~~28, ~~incorporated~~2026 onwe ~~October~~received ~~13,~~a ~~2021~~decision inletter ~~Cyprus.~~from ~~We have 80% ownership in~~ the ~~following~~Panel ~~entity:~~granting -our ~~Beyond~~request ~~Air~~for ~~Bermuda~~continued ~~Limited,~~listing ~~incorporated~~ on ~~August 13~~Nasdaq, ~~2021~~subject ~~in Bermuda. In September 2022, its name was changed~~ to ~~Beyond~~certain ~~Cancer Bermuda Limited~~conditions. The ~~Beyond~~Panel’s ~~Air~~decision ~~Bermuda~~was ~~Limited~~issued ~~has the~~ following ~~wholly~~a ~~owned~~hearing ~~subsidiaries:~~held -on ~~XAIR~~May ~~Israel Ltd~~14, ~~incorporated on October 3~~2026, ~~2021~~at inwhich ~~Israel.~~the -Company ~~Beyond~~presented ~~Cancer~~its ~~U.S.,~~compliance ~~Inc.,~~plan ~~incorporated~~to address onits ~~March~~non-compliance ~~17,~~with ~~2022~~the inBid ~~Delaware~~Price Rule.

OnPursuant ~~August~~to 8,the ~~2024~~Panel’s decision, we ~~received a~~must ~~letter~~demonstrate ~~from~~compliance with the ~~Nasdaq~~Bid ~~Listing~~Price ~~Qualifications~~Rule ~~Department~~on ~~notifying~~or usbefore ~~that~~July 31, ~~for~~2026. ~~the~~In 30addition, ~~consecutive~~pursuant ~~business~~to ~~day~~Nasdaq ~~period~~Listing ~~between June~~Rule 255815(d)(4)(A), ~~2024~~we ~~through~~will ~~August~~be 7,subject ~~2024,~~to ~~our~~a ~~common~~Discretionary ~~stock~~Panel ~~had~~Monitor ~~not~~for ~~maintained~~ a ~~minimum~~period ~~closing~~of ~~bid~~one ~~price~~year offrom ~~$1.00~~the ~~per~~date ~~share~~the ~~required~~Company ~~for~~regains ~~continued~~compliance ~~listing~~with onthe ~~The~~Bid ~~Nasdaq~~Price ~~Capital~~Rule. ~~Market~~If ~~pursuant~~the toPanel ~~Nasdaq~~or Listing ~~Rule~~Qualifications ~~5550(a)(2)~~Department (determines that the ~~“Bid~~Company ~~Price~~fails ~~Rule”).~~any ~~Pursuant~~listing tostandard ~~Nasdaq~~during ~~Listing~~the ~~Rule~~one-year ~~5810(c)(3)(A)~~monitoring period, then the Company ~~was~~will ~~provided~~not anbe ~~initial~~permitted ~~period~~to ofprovide ~~180~~a ~~calendar~~plan ~~days,~~of orcompliance ~~until~~with ~~February~~respect 4,to ~~2025~~any ~~(the “Compliance~~deficiency ~~Period”),~~that toarises ~~regain~~during ~~compliance with~~ the ~~Bid~~one-year ~~Price~~monitoring ~~Rule~~period. InRather, ~~order~~the toListing ~~regain~~Qualifications ~~compliance~~Department ~~with~~will ~~the~~promptly ~~Bid~~issue ~~Price~~a ~~Rule,~~written determination to delist our ~~common~~securities ~~stock was~~(the ~~required~~“Staff toDelisting ~~maintain~~Determination”). aIf ~~minimum~~the ~~closing~~Company ~~bid~~does ~~price~~not request review of ~~$1.00~~the ~~for~~Staff aDelisting Determination ~~minimum~~then ofthe ~~ten~~Company’s ~~consecutive~~common ~~business~~stock ~~days~~will ~~during~~be ~~the~~suspended ~~Compliance~~as ~~Period prior~~described toin ~~February~~the 4,Staff ~~2025~~Delisting Determination.

AsThe ~~of February 4, 2025, the common stock has not regained compliance with the Bid Price Rule. However, in a letter dated February 5, 2025 (the “Second Nasdaq Bid Price Letter”), Nasdaq notified the~~ Company ~~that~~intends ~~Nasdaq’s Staff has determined that the Company is eligible for an additional 180 calendar day period, or until August 4, 2025,~~ to ~~regain compliance (the “Second Compliance Period”). As of the date of this~~actively ~~report~~monitor the ~~common~~bid ~~stock~~price ~~has not regained compliance with the Bid Price Rule. If the Company chooses to implement a reverse stock split, it must complete the split no later than ten business days prior to the end~~ of ~~the~~its ~~Second~~Common ~~Compliance~~Stock ~~Period~~and remain in ~~order to timely regain~~ compliance. ~~If we fail to regain compliance~~ with the ~~Bid~~Nasdaq ~~Price Rule within the Second Compliance Period, or if we fail to continue to meet all applicable continued~~ listing ~~requirements for Nasdaq in the future, Nasdaq could delist our common stock~~standards.

~~The Second Nasdaq Bid Price Letter~~Available has no immediate effect on the listing or trading of our common stock. Our common stock continues to be listed on the Nasdaq Capital Market under the symbol “XAIR”. We are currently evaluating our options for regaining compliance.Information

~~Available~~We file ~~Information~~electronically with the Securities and Exchange Commission (the “SEC”) our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, and amendments related thereto, pursuant to Section 13(a) or 15(d) of the Exchange Act. We make available on our website at www.beyondair.net free of charge, copies of these reports, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Reports filed with the SEC may be viewed at www.sec.gov. The information in or accessible through the SEC and our website is not incorporated into, and is not considered part of, this filing. Further, our references to the URLs for these websites are intended to be inactive textual references only.

~~We file electronically with the~~Human ~~Securities~~Capital and Exchange Commission (the “SEC”) our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, and amendments related thereto, pursuant to Section 13(a) or 15(d) of the Exchange Act. We make available on our website at www.beyondair.net free of charge, copies of these reports, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Reports filed with the SEC may be viewed at www.sec.gov. The information in or accessible through the SEC and our website is not incorporated into, and is not considered part of, this filing. Further, our references to the URLs for these websites are intended to be inactive textual references only.

~~Human~~As of ~~Capital~~March 31, 2026, we had 54 employees globally, all of whom were full-time employees. None of our employees are represented by a labor union and we consider our employee relations to be good.

AsOur workforce is highly educated and diverse, which we believe is important for our continued success as a leading innovator in the medical device market. We employ a number of ~~March~~strategies 31to best enable us to attract, ~~2025~~retain, weand ~~had~~engage 61our team members. Our human capital ~~employees~~resources ~~globally~~objectives include, ~~all~~as ofapplicable, ~~whom~~identifying, ~~were~~recruiting, ~~full-time~~retaining, and incentivizing our management team and our clinical, scientific and other employees and consultants. ~~None~~The principal purposes of our ~~employees~~equity and cash incentive plans are ~~represented~~to byattract, aretain and ~~labor~~motivate ~~union~~personnel through the granting of stock-based and wecash-based ~~consider~~compensation awards, in order to align our ~~employee~~interests and the ~~relations~~interests toof beour ~~good~~stockholders with those of our employees and consultants.

Our workforce is highly educated and diverse, which we believe is important for our continued success as a leading innovator in the medical device market. We employ a number of strategies to best enable us to attract, retain, and engage our team members. Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, and incentivizing our management team and our clinical, scientific and other employees and consultants. The principal purposes of our equity and cash incentive plans are to attract, retain and motivate personnel through the granting of stock-based and cash-based compensation awards, in order to align our interests and the interests of our stockholders with those of our employees and consultants.26

30ITEM 1A. RISK FACTORS

~~ITEM~~Investing in 1Aour common stock involves a high degree of risk. ~~RISK~~You ~~FACTORS~~should consider carefully the risks described below, together with the other information included or incorporated by reference in this Annual Report. If any of the following risks occur, our business, financial condition, results of operations and future growth prospects could be materially and adversely affected. In these circumstances, the market price of our common stock could decline. Other events that we do not currently anticipate or that we currently deem immaterial may also affect our business, prospects, financial condition and results of operations.

~~Investing in our common stock involves a high degree~~Risks ofRelated ~~risk.~~to ~~You~~Our ~~should~~Financial ~~consider~~Position carefully the risks described below, together with the other information included or incorporated by reference in this Annual Report. If any of the following risks occur, our business, financial condition, results of operations and ~~future~~Capital growth prospects could be materially and adversely affected. In these circumstances, the market price of our common stock could decline. Other events that we do not currently anticipate or that we currently deem immaterial may also affect our business, prospects, financial condition and results of operations. Requirements

~~Risks~~Our independent ~~Related~~registered topublic ~~Our~~accounting ~~Financial~~firm’s ~~Position~~report ~~and~~contains ~~Capital~~an explanatory paragraph that expresses substantial doubt about ~~Requirements~~our ability to continue as a “going concern.”

~~Our~~The Company ~~independent~~has ~~registered~~incurred recurring net losses, including a net loss of $34.3 million for the year ended March 31, 2026, compared to $48.5 ~~public~~million ~~accounting~~for ~~firm~~the year ended March 31, 2025 and the Company’s ~~report~~operations ~~contains~~have annot ~~explanatory~~provided ~~paragraph~~net ~~that~~positive ~~expresses~~cash flows in the year ended March 31, 2026. These factors, among others, raise substantial doubt about ~~our~~the Company’s ability to continue as a going concern. The Company’s continuation as a “going concern is dependent upon its ability to generate positive cash flows from operations and to secure additional sources of equity and/or debt financing.” Despite the Company’s intent to fund operations through equity and debt financing arrangements, there is no assurance that such financing will be available on terms acceptable to the Company, if at all.

~~The Company~~Our ~~has~~independent ~~incurred~~auditors ~~recurring~~have ~~net~~included ~~losses,~~an ~~including~~explanatory aparagraph ~~net~~in ~~loss~~their ofaudit ~~$48.5 million for the year ended March 31~~report, ~~2025,~~included ~~compared to $64.3 million for the year ended March 31, 2024 and the Company’s operations have not provided net positive cash flows~~ in ~~the~~this ~~year~~Annual ~~ended~~Report ~~March 31,~~on ~~2025.~~Form ~~These factors~~10-K, ~~among others, raise substantial doubt about~~ regarding the Company’s ability to continue as a going concern. ~~The~~This ~~Company’s continuation as a~~ going concern isrisk ~~dependent~~may ~~upon~~materially ~~its~~limit our ability to ~~generate~~raise ~~positive~~additional funds ~~cash~~through ~~flows~~the ~~from~~issuance ~~operations~~of ~~and~~new todebt ~~secure~~or ~~additional sources of~~ equity ~~and/~~or ~~debt~~may ~~financing.~~adversely ~~Despite~~affect the ~~Company’s~~terms ~~intent~~upon towhich ~~fund~~such ~~operations~~capital ~~through~~may ~~equity~~be ~~and~~available. ~~debt~~The ~~financing arrangements,~~inability ~~there~~to isobtain nosufficient ~~assurance~~financing ~~that~~on ~~such~~acceptable ~~financing~~terms ~~will~~could behave ~~available~~a onmaterial ~~terms~~adverse ~~acceptable~~effect toon the Company’s financial condition, ifresults of atoperations, ~~all~~and business prospects.

~~Our independent~~The ~~auditors~~Company ~~have~~is ~~included~~actively anpursuing ~~explanatory~~strategies ~~paragraph~~to inmitigate ~~their~~these ~~audit~~risks. ~~report~~However, ~~included~~there incan ~~this~~be ~~Annual~~no ~~Report~~assurance onthat ~~Form~~these ~~10-K,~~efforts ~~regarding~~will ~~the~~prove ~~Company’s~~successful ~~ability~~or tothat ~~continue~~the asCompany awill ~~going~~achieve ~~concern.~~its ~~This~~intended ~~going~~financial ~~concern~~stability. ~~risk~~The ~~may~~failure ~~materially limit our ability~~ to ~~raise~~successfully ~~additional~~address ~~funds~~these ~~through~~going ~~the issuance~~concern ofrisks ~~new debt or equity or~~ may materially and adversely affect the ~~terms~~Company’s ~~upon~~business, ~~which~~financial ~~such~~condition, ~~capital~~and ~~may~~results beof ~~available~~operations. ~~The~~Investors ~~inability~~should ~~to obtain sufficient~~consider ~~financing~~the onsubstantial ~~acceptable~~risks ~~terms~~and ~~could~~uncertainties ~~have~~inherent ain ~~material adverse effect on~~ the Company’s ~~financial~~business ~~condition,~~before ~~results~~investing ofin ~~operations, and~~the ~~business~~Company’s ~~prospects~~securities.

~~The Company~~Numerous ~~is actively pursuing strategies to mitigate these risks. However~~factors, ~~there~~including ~~can be no assurance that these efforts will prove successful or that~~ the ~~Company~~incurring ~~will~~of ~~achieve~~significant ~~its~~losses, ~~intended~~are ~~financial~~relevant ~~stability. The failure~~ to ~~successfully~~our ~~address these going concern risks may materially and adversely affect the Company’s business,~~ financial ~~condition,~~success and ~~results~~any ofor ~~operations.~~all ~~Investors~~such ~~should~~factors ~~consider~~could ~~the substantial~~have ~~risks~~a ~~and~~disproportionate ~~uncertainties~~impact ~~inherent~~on inour ~~the~~bottom ~~Company’s business before investing in the Company’s securities~~line.

~~Numerous~~Our ability ~~factors,~~to ~~including~~implement ~~the~~our ~~incurring~~business ~~of significant~~strategy ~~losses,~~is ~~are~~subject ~~relevant~~ to ~~our~~numerous ~~financial~~risks ~~success~~that ~~and~~you ~~any~~should orbe ~~all~~aware ~~such~~of ~~factors~~before ~~could~~making ~~have~~an ainvestment ~~disproportionate~~decision. These ~~impact~~are onnot ~~our~~the ~~bottom line~~only risks we face. These risks include, among others, that:

~~Our~~● ~~ability~~we are a medical device and biopharmaceutical company with only one FDA/CE-approved product and a limited operating history on which to ~~implement~~assess our business ~~strategy~~, ishave ~~subject~~incurred tosignificant ~~numerous~~losses ~~risks~~since ~~that~~our ~~you~~inception ~~should~~and beincurred ~~aware~~a net cash used in operating activities for the year ended March 31, 2026 of ~~before~~approximately ~~making~~$18.1 million. As of March 31, 2026, we have an ~~investment~~accumulated ~~decision~~deficit of approximately $319.6 ~~These~~million and we anticipate losses declining in fiscal 2027 and 2028. ● we are ~~not~~unable to predict the ~~only~~extent ~~risks~~of future losses or when we ~~face~~ will become profitable based on the sale of any product, if at all. ~~These~~Even ~~risks~~if ~~include~~we succeed in scaling the commercialization of our approved product and succeed in developing and commercializing our product candidates, ~~among~~we ~~others~~may never generate revenue to sustain profitability; ● we have only one FDA/CE-approved product, and we expect that: we will need to raise additional funding before we can expect to become profitable from sales of our products; ● we are heavily dependent upon the success of our approved product and product candidates (which are in various stages of clinical development), and we cannot provide any assurance that the FDA or comparable foreign regulatory authorities will allow us to conduct further clinical trials; ● we are in the process of further developing our proprietary NO delivery system, and unexpected delays will adversely impact the timing of our U.S.-based clinical trials and approvals; ● we might be unable to develop product candidates that will achieve commercial success in a timely and cost-effective manner, or ever; ● our competitors may develop or commercialize products faster or more successfully than us; ● because some of the target patient populations of our approved product or product candidates are small, we must be able to successfully identify patients and achieve a significant market share to maintain profitability and growth; ● we rely on third parties to help conduct our preclinical studies, clinical trials and commercial scale manufacturing; ● if we are unable to obtain and maintain effective intellectual property rights for our technologies, approved product or current or future product candidates, we may not be able to compete effectively in our markets; and ● our future success depends in part upon our ability to retain our executive and scientific teams, and to attract, retain and motivate other qualified personnel.

●Because of wethe ~~are~~numerous arisks ~~medical device~~ and ~~biopharmaceutical~~uncertainties ~~company~~associated with ~~only one FDA/CE-approved~~ product ~~and~~development ~~a limited operating history on which to assess our business, have incurred significant losses since our inception~~ and ~~incurred a net cash used in operating activities for the year ended March 31~~commercialization, ~~2025 of approximately $38.2 million. As of March 31, 2025,~~ we ~~have an accumulated deficit of approximately $286.3 million and we anticipate losses declining in fiscal 2026 and 2027. ● we~~ are unable to ~~predict~~accurately predict the ~~extent~~timing ~~of future losses~~ or ~~when~~amount ~~we will become profitable based on the sale~~ of ~~any~~expenses ~~product~~or when, ifor ~~at all. Even~~ if ~~we succeed in scaling the commercialization of our approved product and succeed in developing and commercializing our product candidates~~, we ~~may~~will ~~never~~be ~~generate~~able ~~revenue~~ to ~~sustain~~achieve profitability;. ●If we ~~have~~are ~~only~~required ~~one~~by ~~FDA/CE-approved~~regulatory ~~product, and we expect that we will need~~ authorities to ~~raise~~perform ~~additional~~studies ~~funding~~in ~~before~~addition ~~we can expect~~ to ~~become~~those ~~profitable~~expected ~~from~~or ~~sales~~if ofthere ~~our products; ● we~~ are ~~heavily dependent upon the success of our approved product and product candidates (which are in various stages of clinical development), and we cannot provide~~ any ~~assurance~~delays ~~that the FDA or comparable foreign regulatory authorities will allow us to conduct further clinical trials; ● we are~~ in the ~~process~~initiation ~~of further developing our proprietary NO delivery system,~~ and ~~unexpected~~completion ~~delays will adversely impact the timing~~ of our ~~U.S.-based~~ clinical trials ~~and approvals; ● we might be unable to develop product candidates that will achieve commercial success in a timely and cost-effective manner,~~ or the ~~ever;~~development ~~● our competitors may develop or commercialize products faster or more successfully than us; ● because some~~ of ~~the~~any ~~target patient populations~~ of our ~~approved~~ product ~~or product~~ candidates ~~are small~~, ~~we must be able to successfully identify patients and achieve a significant market share to maintain profitability and growth; ● we rely on third parties to help conduct~~ our ~~preclinical~~expenses ~~studies,~~could clinical trials and commercial scale manufacturing; ● if we are unable to obtain and maintain effective intellectual property rights for our technologies, approved product or current or future product candidates, we may not be able to compete effectively in our markets; and ● our future success depends in part upon our ability to retain our executive and scientific teams, and to attract, retain and motivate other qualified personnelincrease.

Because of the numerous risks and uncertainties associated with product development and commercialization, we are unable to accurately predict the timing or amount of expenses or when, or if, we will be able to achieve profitability. If we are required by regulatory authorities to perform studies in addition to those expected or if there are any delays in the initiation and completion of our clinical trials or the development of any of our product candidates, our expenses could increase.27

31We will need to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or difficult to obtain, and could dilute current stockholders’ ownership interests.

WeOur future capital requirements will ~~need~~depend toon ~~raise~~many ~~additional~~factors, ~~capital~~including tothe success and costs of our commercialization activities, including ~~meet~~product marketing, sales, and distribution progress, the results of our ~~business~~clinical trials, the timing and outcome of regulatory review of our product candidates, commercial manufacturing success, and the number and development requirements inof product candidates that we pursue. Because of the ~~future,~~numerous risks and ~~such~~uncertainties ~~capital~~associated ~~raising~~with ~~may~~the bedevelopment ~~costly~~and orcommercialization ~~difficult~~of toour ~~obtain~~approved product and product candidates, we are unable to reasonably estimate the amounts of additional capital outlays and ~~could~~operating ~~dilute~~expenditures ~~current~~that ~~stockholders’~~our ~~ownership~~business ~~interests~~will require. We will need to raise additional funds through public or private debt or equity financings to meet various objectives including, but not limited to:

~~Our~~● ~~future~~expanding ~~capital~~commercialization ~~requirements will depend on many factors, including the success and costs~~ of our ~~commercialization~~approved ~~activities, including~~ product; ~~marketing,~~● ~~sales, and distribution progress, the results of our~~ clinical trials, ~~the~~for ~~timing and outcome of regulatory review of~~ our product candidates~~, commercial~~; ~~manufacturing~~● ~~success,~~researching and ~~the~~developing ~~number~~new ~~and~~products; ~~development~~● ~~requirements~~pursuing ofgrowth ~~product~~opportunities, ~~candidates~~including ~~that~~more werapid ~~pursue.~~expansion; ~~Because~~● ofacquiring ~~the~~complementary ~~numerous risks~~businesses ~~and~~or ~~uncertainties~~technologies; ~~associated~~● ~~with~~making ~~the~~capital ~~development~~improvements ~~and~~to ~~commercialization~~improve of our ~~approved~~infrastructure; ~~product~~● ~~and~~hiring ~~product~~qualified ~~candidates,~~management ~~we are unable to reasonably estimate the amounts of additional capital outlays~~ and ~~operating~~key ~~expenditures~~employees; ~~that~~● ~~our~~responding ~~business will require. We will need~~ to ~~raise~~competitive ~~additional~~pressures; ~~funds~~● ~~through~~complying ~~public~~with orregulatory ~~private~~requirements; ~~debt~~and or● ~~equity~~maintaining ~~financings~~compliance towith ~~meet~~applicable ~~various objectives including, but not limited to:~~laws.

●Any additional ~~expanding~~capital ~~commercialization~~raised ofthrough ~~our~~the ~~approved~~sale ~~product;~~of ●equity ~~clinical~~or ~~trials~~equity-linked ~~for~~securities may dilute our ~~product~~current ~~candidates;~~stockholders’ ●ownership in ~~researching~~us and ~~developing~~could ~~new~~also ~~products;~~result ●in ~~pursuing~~a ~~growth~~decrease ~~opportunities,~~in ~~including~~the ~~more~~market ~~rapid~~price ~~expansion;~~of ●our ~~acquiring~~common ~~complementary~~stock. ~~businesses~~The orterms ~~technologies;~~of ●those ~~making~~securities ~~capital~~issued ~~improvements~~by tous ~~improve~~in ~~our~~future capital ~~infrastructure;~~transactions ●may ~~hiring~~be ~~qualified~~more ~~management~~favorable to new investors and ~~key~~may ~~employees;~~include ●preferences, ~~responding~~superior tovoting ~~competitive~~rights ~~pressures;~~and ●the ~~complying~~issuance ~~with~~of ~~regulatory~~warrants or ~~requirements;~~other ~~and~~derivative ●securities, ~~maintaining~~which ~~compliance~~may ~~with~~have ~~applicable~~a ~~laws~~further dilutive effect.

~~Any additional capital raised~~Furthermore, ~~through~~any ~~the~~debt ~~sale~~or of equity orfinancing ~~equity-linked~~that ~~securities~~we may ~~dilute~~need ~~our~~may ~~current~~not ~~stockholders’~~be ~~ownership~~available inon ~~us and could also result in a decrease in the market price of our common stock. The~~ terms ~~of those securities issued by us in future capital transactions may be more~~ favorable to ~~new investors and may include preferences~~us, ~~superior voting rights and the issuance of warrants~~ or ~~other~~at ~~derivative securities, which may have a further dilutive effect~~all.

~~Furthermore~~Additionally, we ~~any~~may ~~debt~~incur orsubstantial ~~equity~~ costs in pursuing future capital financing, ~~that~~including weinvestment ~~may~~banking ~~need~~fees, legal fees, accounting fees, securities law compliance fees, printing and distribution expenses and other costs. We may ~~not~~also be ~~available~~required onto ~~terms~~recognize ~~favorable~~non-cash toexpenses in usconnection with certain securities we issue, orsuch atas ~~all~~convertible notes and warrants, which may adversely impact our financial condition.

~~Additionally,~~ If we ~~may~~are ~~incur~~unable ~~substantial costs~~to inobtain ~~pursuing~~required ~~future~~additional capital ~~financing~~, ~~including~~we ~~investment~~may ~~banking~~have ~~fees,~~to ~~legal~~curtail ~~fees,~~our ~~accounting~~growth ~~fees,~~plans ~~securities~~or ~~law~~cut ~~compliance fees,~~back ~~printing~~on ~~and~~existing ~~distribution~~business, ~~expenses~~ and ~~other costs. We~~ we may ~~also~~not be ~~required~~able to ~~recognize~~continue ~~non-cash~~operating ~~expenses~~if ~~in connection with certain securities~~ we ~~issue,~~do ~~such~~not asgenerate ~~convertible~~sufficient ~~notes~~revenues ~~and~~from ~~warrants,~~operations ~~which~~needed ~~may~~to ~~adversely~~stay ~~impact~~in ~~our financial condition~~business.

If we are unable to obtain required additional capital, we may have to curtail our growth plans or cut back on existing business, and we may not be able to continue operating if we do not generate sufficient revenues from operations needed to stay in business.28

32Our failure to comply with the covenants or other terms of the Loan Agreement, including as a result of events beyond our control, could result in a default under the Loan Agreement that could materially and adversely affect the ongoing viability of our business.

~~Our~~On November ~~failure~~1, to2024 ~~comply~~we ~~with~~entered ~~the~~into ~~covenants~~a orloan and security agreement, and subsequently on November 3, 2025, we entered into an amended and ~~other~~restated ~~terms~~loan ofagreement (as amended, the “Amended Loan Agreement,”) for a secured loan with certain lenders including asour former achief ~~result~~executive ofofficer ~~events~~and ~~beyond~~chairman Steven Lisi and Robert Carey, our ~~control~~present Chairman. The Amended Loan Agreement provides for a $13,500,000 ~~could~~loan. ~~result~~The inloan bears interest at a rate per annum (subject to increase during an event of default) ~~under~~equal ~~the~~to ~~Loan~~15% ~~Agreement~~of ~~that~~which ~~could~~3% ~~materially~~shall be payable in cash and ~~adversely~~12% ~~affect~~payable in kind through June 30, 2026 and thereafter all in cash. If not earlier repaid in full, the ~~ongoing~~outstanding ~~viability~~principal amount of ~~our~~the ~~business~~loan, together with any accrued and unpaid interest, shall be due and payable on October 4, 2034. The Company’s obligations under the Loan Agreement are secured by substantially all of the Company’s assets.

~~On November 1, 2024, the Company~~The ~~entered into a loan and security agreement (the “~~Loan Agreement”) ~~for~~contains aaffirmative ~~secured loan with certain lenders including its Chief Executive Officer~~ and ~~Chairman~~negative ~~Steven~~covenants ~~Lisi~~customary ~~and director Robert Carey. The Loan Agreement provides~~ for afinancings ~~$11,500,000 loan. The loan bears interest at a rate per annum (subject to increase during an event~~ of ~~default)~~this ~~equal~~type ~~to 15% of which 3% shall be payable in cash and 12% payable in kind through June 30~~that, ~~2026~~among ~~and~~other ~~thereafter all in cash. If not earlier repaid in full~~things, limit the ability ~~outstanding principal amount~~ of the ~~loan,~~ ~~together~~Company ~~with any accrued~~ and ~~unpaid~~its ~~interest,~~subsidiaries ~~shall~~to beincur ~~due~~additional ~~and~~debtor ~~payable~~or onpay ~~October~~any ~~4, 2034~~dividends. ~~The Company’s obligations under the Loan Agreement are secured by substantially all of the Company’s assets.~~

The Loan Agreement ~~contains~~also ~~affirmative and~~includes ~~negative~~events ~~covenants~~of default customary for financings of this type ~~that~~, ~~among~~in ~~other~~certain ~~things~~cases subject to customary periods to cure, ~~limit~~following which the ~~ability~~lenders ofmay ~~the~~accelerate ~~Company~~all ~~and~~amounts ~~its~~outstanding ~~subsidiaries to~~under ~~incur~~the ~~additional~~loan. ~~debtor~~Events orof ~~pay~~default ~~any~~include, ~~dividends.~~among other things:

~~The~~● ~~Loan~~our ~~Agreement~~failure ~~also~~to ~~includes events~~pay ofany ~~default~~principal ~~customary~~or ~~for~~interest ~~financings~~under ofthe ~~this~~Loan ~~type,~~Agreement or any note in ~~certain~~connection ~~cases~~therewith; ~~subject~~● toany ~~customary~~representation ~~periods~~or towarranty ~~cure,~~made ~~following~~shall ~~which~~prove ~~the~~to ~~lenders may~~have ~~accelerate~~been ~~all~~false ~~amounts~~or ~~outstanding~~misleading ~~under~~in ~~the~~any ~~loan.~~material ~~Events~~respect; ofand ~~default~~● ~~include,~~certain ~~among~~specified ~~other~~insolvency ~~things:~~and bankruptcy-related events.

●Subject to ~~our~~any ~~failure~~applicable cure period set forth in the Loan Agreement, all amounts outstanding with respect to ~~pay~~the ~~any~~loan (principal orand accrued interest), as well as any other obligations and amounts owing under the Loan Agreement, would become due and payable at the option of the lenders. Our assets or ~~any~~cash ~~note~~flow inmay ~~connection~~not ~~therewith;~~be ●sufficient to fully repay our obligations under the Loan Agreement if the obligations thereunder are accelerated upon any ~~representation~~events of default. Further, if we are unable to repay, refinance or ~~warranty~~restructure ~~made~~our ~~shall~~obligations, the ~~prove~~lenders could proceed to ~~have~~protect ~~been~~and ~~false~~enforce their rights under the Loan Agreement by exercising such remedies (including foreclosure on the assets securing our obligations under the Loan Agreement) as are available to the lenders and in respect thereof under applicable law, either by suit in equity or ~~misleading~~by action at law, or both, whether for specific performance of any covenant or other agreement contained in the Loan Agreement or the other loan documents or in aid of the exercise of any ~~material~~power ~~respect;~~granted ~~and~~in ●the ~~certain~~Loan ~~specified~~Agreement ~~insolvency~~or other loan documents. The foregoing would materially and ~~bankruptcy-related~~adversely ~~events~~affect the ongoing viability of our business.

Subject to any applicable cure period set forth in the Loan Agreement, all amounts outstanding with respect to the loan (principal and accrued interest), as well as any other obligations and amounts owing under the Loan Agreement, would become due and payable at the option of the lenders. Our ~~assets~~ ~~or cash flow may not be sufficient to fully repay our obligations under the~~ Loan Agreement ifcontains ~~the~~restrictions ~~obligations~~that ~~thereunder~~limit ~~are accelerated upon any events of default. Further, if we are unable to repay, refinance or restructure~~ our ~~obligations,~~flexibility the lenders could proceed to protect and enforce their rights under the Loan Agreement by exercising such remedies (including foreclosure on the assets securing our obligations under the Loan Agreement) as are available to the lenders and in ~~respect~~operating thereof under applicable law, either by suit in equity or by action at law, or both, whether for specific performance of any covenant or other agreement contained in the Loan Agreement or the other loan documents or in aid of the exercise of any power granted in the Loan Agreement or other loan documents. The foregoing would materially and adversely affect the ongoing viability of our business.

~~Our~~ The Loan Agreement contains ~~restrictions~~various covenants that limit our ~~flexibility~~ ability to engage in ~~operating~~specified ~~our~~types ~~business~~of transactions without the prior consent of the lenders. These covenants limit our ability to, among other things:

~~The~~● ~~Loan~~create, ~~Agreement~~incur ~~contains~~or ~~various covenants~~assume ~~that~~additional ~~limit~~indebtedness; ~~our~~● ~~ability~~subject to ~~engage~~certain inexceptions, ~~specified~~make ~~types~~restricted ofpayments, ~~transactions~~including ~~without~~paying ~~the~~dividends ~~prior~~on, ~~consent~~repurchasing ofor ~~the~~making ~~lenders.~~distributions ~~These~~with ~~covenants limit~~respect to our ~~ability~~common tostock; and ● consolidate, ~~among~~merge, ~~other~~sell ~~things:~~or otherwise dispose of all or substantially all of our assets.

●The covenants ~~create,~~in ~~incur~~the orLoan ~~assume~~Agreement ~~additional~~may ~~indebtedness;~~limit ●our ~~subject~~ability to take certain ~~exceptions,~~actions ~~make~~that ~~restricted~~may ~~payments,~~be ~~including~~in ~~paying~~our ~~dividends~~long-term ~~on,~~best ~~repurchasing~~interests. In the event that we breach one or ~~making~~more ~~distributions~~covenants, ~~with~~the ~~respect~~lenders may choose to ~~our~~declare ~~common~~an ~~stock;~~event of default and ●require ~~consolidate,~~that ~~merge~~we immediately repay all amounts outstanding under the Loan Agreement, ~~sell~~plus orpenalties ~~otherwise~~and ~~dispose~~interest ofand ~~all~~foreclose oron ~~substantially~~the ~~all~~collateral ofgranted to them to secure the obligations under the Loan Agreement. Such repayment could have a material adverse effect on our ~~assets~~business, operating results and financial condition.

The covenants in the Loan Agreement may limit our ability to take certain actions that may be in our long-term best interests. In the event that we breach one or more covenants, the lenders may choose to declare an event of default and require that we immediately repay all amounts outstanding under the Loan Agreement, plus penalties and interest and foreclose on the collateral granted to them to secure the obligations under the Loan Agreement. Such repayment could have a material adverse effect on our business, operating results and financial condition.29

33Risks Related to Commercialization of Our Approved Product or Product Candidates

~~Risks~~If the ~~Related~~market toopportunities ~~Commercialization~~for ofour ~~Our~~approved ~~Approved Product~~product or ~~Product~~product ~~Candidates~~candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.

IfOur projections of both the ~~market~~number ~~opportunities~~of ~~for~~people who have our ~~approved~~target diseases, as well as the subset of people with these diseases who have the ~~product~~potential orto benefit from treatment with LungFit® PH and our product candidates, are ~~smaller~~based on our beliefs and estimates. These estimates have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations or market research and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these diseases. The number of patients may turn out to be lower than expected. The effort to identify patients with diseases we ~~believe~~seek ~~they~~to ~~are~~treat is in early stages, and we cannot accurately predict the number of patients for whom treatment might be possible. Additionally, the potentially addressable patient population for LungFit® PH and each of our ~~revenue~~product candidates may be ~~adversely~~limited ~~affected~~or may not be amenable to treatment with LungFit® PH or our product candidates, and ~~our~~new ~~business~~patients may ~~suffer~~become increasingly difficult to identify or gain access to, which would adversely affect our results of operations and our business.

~~Our projections of both the number~~The ofinsurance ~~people~~coverage ~~who~~and ~~have~~reimbursement ~~our~~status ~~target diseases, as well as the subset~~ of ~~people~~newly-approved ~~with~~products ~~these~~is ~~diseases who have the potential to benefit from treatment with LungFit® PH and our product candidates, are based on our beliefs and estimates~~uncertain. ~~These~~Failure ~~estimates have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations or market research and may prove~~ to be ~~incorrect.~~obtain ~~Further, new studies may change the estimated incidence~~ or ~~prevalence~~maintain ofadequate ~~these diseases. The number of patients may turn~~coverage ~~out to be lower than expected. The effort to identify patients with diseases we seek to treat is in early stages,~~ and wereimbursement ~~cannot accurately predict the number of patients~~ for ~~whom~~new ~~treatment~~or ~~might~~current beproducts ~~possible.~~could ~~Additionally,~~limit ~~the potentially addressable patient population for LungFit® PH and each of~~ our ~~product~~ability ~~candidates may be limited or may not be amenable~~ to ~~treatment~~market ~~with~~those ~~LungFit® PH~~products ~~or our product candidates,~~ and ~~new~~decrease ~~patients~~our ~~may~~ability ~~become increasingly difficult~~ to ~~identify~~generate ~~or gain access to, which would adversely affect our results of operations and our business~~revenue.

The pricing, ~~insurance~~ coverage and reimbursement ~~status~~ of ~~newly-~~our approved ~~products~~product isand ~~uncertain~~product candidates, if approved, must be adequate to support our commercial infrastructure. ~~Failure~~Our per-patient prices must be sufficient to ~~obtain~~recover orour ~~maintain~~development ~~adequate~~and manufacturing costs and potentially achieve profitability. Accordingly, the availability and adequacy of coverage and reimbursement by governmental and private payors are essential for ~~new~~most patients to be able to afford expensive treatments such as ours, assuming certification or ~~current~~approval. ~~products could~~Sales ~~limit~~of our ~~ability~~approved product and product candidates will depend substantially, both domestically and abroad, on the extent to ~~market~~which ~~those~~the ~~products~~costs of our approved product and ~~decrease~~product candidates will be paid for by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government authorities, private health insurers and other third-party payors. If coverage and reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize our ~~ability~~approved product and product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to ~~generate~~allow ~~revenue~~us to establish or maintain pricing sufficient to realize a return on our investment.

~~The~~There is ~~pricing,~~significant ~~coverage~~uncertainty ~~and~~related ~~reimbursement of~~to ~~our~~the ~~approved~~insurance ~~product~~coverage and ~~product~~reimbursement ~~candidates,~~of ifnewly approved, ~~must~~products. beIn ~~adequate~~the toU.S., ~~support~~there ~~our~~is ~~commercial~~no ~~infrastructure.~~uniform system ~~Our~~among ~~per-patient prices~~payors ~~must~~for bemaking ~~sufficient~~coverage toand ~~recover~~reimbursement ~~our~~decisions. ~~development~~In ~~and~~addition, ~~manufacturing~~the ~~costs~~process ~~and~~for ~~potentially~~determining ~~achieve~~whether ~~profitability.~~a ~~Accordingly,~~payor ~~the~~will ~~availability~~provide ~~and~~coverage ~~adequacy~~for ofa ~~coverage~~product ~~and~~or ~~reimbursement~~service bymay ~~governmental~~be ~~and~~separate ~~private~~from ~~payors~~the ~~are~~process ~~essential~~ for ~~most~~setting ~~patients~~the toprice beor ~~able~~reimbursement torate ~~afford~~that ~~expensive treatments~~the ~~such~~payor aswill ~~ours,~~pay for ~~assuming~~the ~~certification~~product or ~~approval.~~service ~~Sales~~once ofcoverage ~~our~~is approved. ~~product~~Payors ~~and~~may ~~product~~limit ~~candidates~~coverage ~~will~~to ~~depend~~specific ~~substantially, both~~products ~~domestically~~or ~~and~~services ~~abroad,~~ on ~~the~~an ~~extent~~approved tolist, or formulary, which ~~the~~might ~~costs~~not include all of ~~our~~the FDA-approved ~~product~~or ~~and~~-cleared ~~product~~products ~~candidates~~for ~~will~~a beparticular ~~paid~~indication. ~~for~~In bythe ~~health maintenance~~U.S., ~~managed~~the ~~care,~~principal decisions ~~pharmacy~~about ~~benefit~~Medicare coverage and ~~similar~~reimbursement ~~healthcare~~for ~~management~~new ~~organizations,~~medical ordevices ~~reimbursed~~are typically made by ~~government~~the ~~authorities,~~Centers for Medicare & Medicaid ~~private~~Services ~~health~~(“CMS”), ~~insurers~~an ~~and~~agency ~~other~~within ~~third-party~~the ~~payors~~U.S. IfDepartment ~~coverage~~of Health and ~~reimbursement~~Human ~~are not available~~Services, or ~~are~~Medicare ~~available~~contractors ~~only~~that ~~to limited~~process ~~levels~~and pay claims, weas ~~may~~CMS ~~not~~and/or bethe ~~able~~contractors decide whether and to ~~successfully~~what ~~commercialize~~extent ~~our~~a ~~approved~~new ~~product~~device will be covered and ~~product~~reimbursed ~~candidates~~under Medicare. Private ~~Even~~payors iftend ~~coverage~~to, isbut ~~provided~~are not required to, follow the ~~approved~~ ~~reimbursement~~coverage ~~amount~~and ~~may~~reimbursement ~~not~~policies beestablished ~~high~~by ~~enough~~CMS to ~~allow~~a ussubstantial degree. It is difficult to ~~establish~~predict what CMS or ~~maintain~~the ~~pricing~~Medicare ~~sufficient~~contractors will decide with respect to ~~realize~~reimbursement afor ~~return~~products onsuch ~~our investment~~as ours.

~~There is significant uncertainty~~Outside ~~related to~~ the ~~insurance coverage and reimbursement of newly approved products. In the~~ U.S., ~~there~~international isoperations noare ~~uniform~~generally ~~system~~subject ~~among~~to ~~payors~~extensive ~~for making~~governmental ~~coverage~~price controls and ~~reimbursement~~other ~~decisions.~~market ~~In addition~~regulations, ~~the~~and ~~process for determining whether a payor will provide coverage for a product~~we orbelieve ~~service~~the ~~may~~increasing beemphasis ~~separate~~on ~~from~~cost-containment ~~the~~initiatives ~~process~~in ~~for setting~~ the ~~price~~EEA, orCanada ~~reimbursement~~and ~~rate~~other ~~that~~countries ~~the~~has ~~payor~~and will ~~pay~~continue ~~for~~to ~~the~~put ~~product or service~~pressure ~~once~~on ~~coverage~~the ispricing ~~approved.~~and ~~Payors~~usage ~~may~~of ~~limit~~our ~~coverage~~approved toproduct ~~specific products~~ or ~~services~~product oncandidates. anIn ~~approved~~many ~~list~~countries, orthe ~~formulary,~~prices ~~which~~of ~~might~~medical ~~not include~~products ~~all~~are ofsubject to ~~the~~varying ~~FDA-approved~~price orcontrol ~~-cleared~~mechanisms ~~products~~as ~~for~~part aof ~~particular~~national ~~indication~~health systems. In ~~the U.S.~~general, the ~~principal~~prices ~~decisions~~of ~~about Medicare coverage and reimbursement for new~~ medical devices ~~are~~under ~~typically~~such ~~made~~systems are bysubstantially ~~the~~lower ~~Centers~~than ~~for~~in ~~Medicare & Medicaid Services (“CMS”), an agency within~~ the U.S. ~~Department~~Other ofcountries ~~Health~~allow ~~and~~companies ~~Human~~to ~~Services,~~fix ortheir ~~Medicare~~own ~~contractors~~prices ~~that~~for ~~process~~medical ~~and pay claims~~products, asbut ~~CMS~~monitor and~~/or~~ ~~the~~control ~~contractors~~company ~~decide~~profits. ~~whether~~Additional ~~and~~foreign toprice ~~what~~controls ~~extent~~or aother ~~new~~changes ~~device~~in ~~will~~pricing beregulation ~~covered~~could ~~and~~restrict ~~reimbursed~~the ~~under~~amount ~~Medicare.~~that ~~Private~~we ~~payors tend to,~~are ~~but~~able ~~are not required~~ to, ~~follow~~charge ~~the~~for ~~coverage~~our ~~and~~approved ~~reimbursement~~product ~~policies~~or ~~established~~product bycandidates. ~~CMS~~Accordingly, toin amarkets ~~substantial~~outside ~~degree~~the U.S., Itthe isreimbursement ~~difficult~~for toour products ~~predict~~may ~~what~~be ~~CMS~~reduced orcompared with the ~~Medicare~~U.S. ~~contractors~~and ~~will~~may ~~decide~~be ~~with~~insufficient ~~respect~~ to ~~reimbursement~~generate ~~for~~commercially ~~products~~reasonable ~~such~~revenue asand ~~ours~~profits.

~~Outside the U.S.~~Moreover, ~~international~~ ~~operations~~increasing ~~are~~efforts ~~generally~~by ~~subject~~governmental toand ~~extensive~~third-party ~~governmental~~payors ~~price~~in ~~controls~~the U.S. and ~~other~~abroad ~~market~~to ~~regulations,~~cap ~~and~~or wereduce ~~believe~~healthcare ~~the~~costs ~~increasing~~may cause such organizations ~~emphasis~~to onlimit ~~cost-containment~~both ~~initiatives~~coverage inand the ~~EEA,~~level ~~Canada~~of ~~and~~reimbursement ~~other~~for ~~countries~~new ~~has~~products approved and, ~~will~~as ~~continue~~a toresult, ~~put~~they ~~pressure~~may onnot ~~the~~cover ~~pricing~~or ~~and~~provide adequate ~~usage~~payment offor our approved product orand product candidates. InWe ~~many~~expect ~~countries, the prices of medical products are subject~~ to ~~varying~~experience ~~price~~pricing ~~control mechanisms~~pressures asin ~~part~~connection ofwith ~~national health systems. In general,~~ the ~~prices~~sale of ~~medical~~any of ~~devices~~our ~~under~~approved ~~such~~product ~~systems~~and ~~are~~product ~~substantially~~candidates ~~lower~~due ~~than in~~to the ~~U.S.~~trend ~~Other~~toward ~~countries~~managed ~~allow~~healthcare, ~~companies~~the toincreasing ~~fix~~influence ~~their~~of ~~own~~health ~~prices~~maintenance organizations ~~for medical products, but monitor~~ and ~~control~~additional ~~company~~legislative ~~profits~~changes. ~~Additional foreign~~The ~~price~~downward ~~controls~~pressure oron ~~other~~healthcare ~~changes~~costs in ~~pricing~~general, ~~regulation~~particularly ~~could~~prescription ~~restrict~~drugs and ~~the~~surgical ~~amount~~procedures ~~that~~and weother ~~are~~treatments, ~~able~~has tobecome ~~charge~~very ~~for our approved product or product candidates~~intense. ~~Accordingly,~~As ina ~~markets outside the U.S.~~result, ~~the~~increasingly ~~reimbursement~~high ~~for~~barriers ~~our~~are ~~products~~being ~~may~~erected beto ~~reduced compared with~~ the ~~U.S.~~ ~~and~~entry ~~may~~of benew ~~insufficient to generate commercially reasonable revenue and profits~~products.

~~Moreover~~Accordingly, ~~increasing efforts by~~ ~~governmental and third-party payors in~~ the ~~U.S.~~certification ~~and abroad to cap~~ or ~~reduce~~approval ~~healthcare costs may cause such organizations to limit both coverage and the level~~ of ~~reimbursement for new products approved and, as a result, they may not cover or provide adequate payment for~~ our ~~approved~~ product and product candidates. Wefor ~~expect~~insurance tocoverage ~~experience pricing pressures in connection with the sale of any of our approved product~~ and ~~product~~reimbursement ~~candidates~~by ~~due~~governmental ~~to the trend toward managed healthcare, the increasing influence of health maintenance organizations~~ and ~~additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical~~private ~~procedures~~payors ~~and~~may ~~other~~impact ~~treatments,~~our ~~has~~ability ~~become very intense. As a result, increasingly high barriers are being erected~~ to ~~the~~generate ~~entry of new products~~revenues.

Accordingly, the certification or approval of our product and product candidates for insurance coverage and reimbursement by governmental and private payors may impact our ability to generate revenues.30

34We face intense competition and rapid technological change and the possibility that our competitors may discover, develop or commercialize therapies that are similar, more advanced or more effective than ours, which may adversely affect our financial condition and our ability to successfully commercialize LungFit® PH and our product candidates.

We are ~~face~~working ~~intense~~on ~~competition~~PPHN which is a highly competitive market. A delivery system with a generator of NO has never been commercialized anywhere in the world, and ~~rapid~~market ~~technological~~acceptance at an appropriate price is proving to be a somewhat difficult and lengthy process. The biotechnology, ~~change~~pharmaceutical and medical device industries are highly competitive. There are many pharmaceutical companies, biotechnology companies, medical device companies, public and private universities and research organizations actively engaged in the ~~possibility~~research ~~that~~and ~~our~~development of ~~competitors~~products that may ~~discover,~~be ~~develop~~similar to our approved product or ~~commercialize~~our ~~therapies~~product ~~that~~candidates. We are aware of several companies currently developing and selling NO therapies for various indications such as hypoxic respiratory failure (HRF). For example, Mallinckrodt commercializes INOMAX® (nitric oxide) for inhalation, which is approved for use to treat newborns suffering from HRF-PPHN in the U.S., Canada, Australia, Mexico and Japan. Linde Group markets a generic version of the Mallinckrodt offering with their delivery system called NOxBOX®. The Linde Group has marketing rights to INOMAX® in Europe. Air Liquide sells a similar product in Europe, ~~more~~called ~~advanced~~KINOX™, ortogether ~~more~~with their delivery platform called SoKINOX™, for the treatment of pulmonary hypertension ~~effective~~of ~~than~~the ~~ours~~newborn. In Europe, ~~which~~EKU, International Biomedical, Cahouet and ITC each have a device that delivers nitric oxide. VERO Biotech LLC received FDA approval for their delivery system GENOSYL DS for HRF associated with PPHN in 2019 and received FDA approval for a third generation of that delivery system in 2023. In addition, other companies may ~~adversely~~be ~~affect~~developing ~~our~~inhaled ~~financial~~NO ~~condition~~delivery systems at various concentrations. Novan Inc. has recently received approval for a nitric oxide-based prescription treatment called berdazimer for molluscum, a contagious skin infection. SaNOtize has an NO nasal spray that has received approval in India, Israel, and ~~our~~eight ~~ability~~other countries for preventing COVID-19 after exposure. NovLead Biotechnology (Nanjing, China) has approval in China for a device that produces nitric oxide through a process of passing an electric charge into an electrolyte solution and Shenzhen Respomed Medical Technology (Shenzhen, China) also has approval in China for a device that uses electrical discharge to ~~successfully~~generate ~~commercialize~~nitric ~~LungFit®~~oxide gas. Neither of these devices have approval PHoutside of China. Third Pole has reported the development of an NO generator and ~~our~~delivery system, but we are not aware of any display of any product ~~candidates~~at any medical/scientific conference in recent years. Our patents surrounding LungFit® have priority date over those of Third Pole.

~~We are working on PPHN which is~~In aaddition ~~highly~~to ~~competitive market. A delivery system with a generator of~~ NO ~~has~~treatments ~~never~~currently ~~been~~available ~~commercialized~~or ~~anywhere~~under ~~in the world~~development, ~~and~~we ~~market acceptance~~also atface ancompetition ~~appropriate~~from ~~price~~non-NO-based isdrugs ~~proving to be a somewhat difficult~~ and ~~lengthy process~~therapies. ~~The biotechnology, pharmaceutical and medical~~For ~~device industries are highly competitive. There are many pharmaceutical companies~~example, ~~biotechnology companies, medical device companies, public and private universities and research organizations actively engaged in~~ the ~~research~~successful ~~and~~ development of ~~products~~immunizations ~~that may be similar to our approved product or our product candidates. We are aware of several companies currently developing and selling NO therapies~~ for ~~various~~ ~~indications~~bronchiolitis ~~such~~may asrender ~~hypoxic~~useless ~~respiratory~~any failure (HRF). For example, Mallinckrodt commercializes INOMAX® (nitric oxide) for inhalation, which is approved for use to treat newborns suffering from HRF-PPHN in the U.S., Canada, Australia, Mexico and Japan. Linde Group markets a generic version of the Mallinckrodt offering with their delivery system called NOxBOX®. The Linde Group has marketing rights to INOMAX® in Europe. Air Liquide sells a similar product inwe ~~Europe,~~develop ~~called KINOX™, together with their delivery platform called SoKINOX™,~~ for ~~the~~that ~~treatment of pulmonary hypertension of the newborn~~indication. ~~In Europe, EKU,~~ ~~International Biomedical~~Also, ~~Cahouet~~antibiotic ~~and~~treatments ~~ITC each have a device that delivers nitric oxide. VERO Biotech LLC received FDA approval~~ for ~~their delivery~~infections ~~system GENOSYL DS for HRF~~ associated with ~~PPHN~~CF ~~in 2019~~ and ~~received~~other ~~FDA~~underlying ~~approval~~lung ~~for~~conditions ~~a third generation of that delivery system in 2023. In addition, other companies~~ may be ~~developing~~preferred ~~inhaled~~over NOany ~~delivery systems at various concentrations. Novan Inc. has recently~~product ~~received~~that ~~approval~~we ~~for a nitric oxide-based prescription treatment called berdazimer for molluscum, a contagious skin infection~~develop. ~~SaNOtize has~~Even anif NOwe ~~nasal~~successfully ~~spray~~develop ~~that~~our ~~has~~product ~~received approval in India~~candidates, ~~Israel,~~ and ~~eight~~obtain ~~other~~certification ~~countries~~or ~~for preventing COVID-19 after exposure. NovLead Biotechnology (Nanjing, China) has~~ approval ~~in China~~ for ~~a device that produces nitric oxide through a process of passing an electric charge into an electrolyte solution and Shenzhen Respomed Medical Technology (Shenzhen~~them, ~~China)~~other ~~also has approval in China for a device~~treatments ~~that~~may ~~uses~~be ~~electrical~~preferred ~~discharge to generate nitric oxide gas. Neither of these devices have approval outside of China. Third Pole has reported the development of an NO generator~~ and ~~delivery system, but~~ we ~~are~~may not ~~aware~~be ofsuccessful ~~any~~in ~~display~~commercializing ofour ~~any~~ product ~~at any medical/scientific conference in recent years~~candidates. ~~Our patents surrounding LungFit® have priority date over those of Third Pole.~~

InSome of ~~addition~~our tocompetitors NOhave ~~treatments~~substantially ~~currently available~~greater orfinancial, ~~under~~technical ~~development~~and other resources, wesuch ~~also~~as ~~face~~larger ~~competition~~research ~~from~~and ~~non-NO-based~~development ~~drugs~~staff and experienced marketing and ~~therapies~~manufacturing organizations. ~~For~~Additional ~~example,~~mergers and acquisitions in the ~~successful~~medical ~~development of~~device, ~~immunizations~~biotechnology ~~for~~and pharmaceutical ~~bronchiolitis~~industries may ~~render~~result ~~useless~~in ~~any~~even ~~product~~more weresources ~~develop~~being ~~for~~concentrated ~~that~~in ~~indication~~our competitors. ~~Also~~As a result, ~~antibiotic~~these ~~treatments~~companies ~~for~~may ~~infections~~obtain ~~associated~~certification ~~with~~or CFregulatory approval more rapidly than we are able to and ~~other~~may ~~underlying~~be ~~lung~~more ~~conditions~~effective in selling and marketing their products as well. Smaller or early-stage companies may also prove to be ~~preferred~~significant ~~over~~competitors, ~~any~~particularly ~~product~~through ~~that~~collaborative wearrangements with ~~develop~~large, established companies. ~~Even~~Competition ifmay weincrease ~~successfully~~further ~~develop~~as a result of advances in the commercial applicability of technologies ~~our~~and greater availability of capital for investment in these industries. Our competitors may succeed in developing, acquiring or licensing on an exclusive basis, products that are more effective or less costly than LungFit® PH or any product ~~candidates~~candidate that we may develop, ~~and~~or ~~obtain~~achieve earlier patent protection, certification or regulatory approval, ~~for~~product ~~them~~commercialization and market penetration than we do. Additionally, ~~other~~technologies ~~treatments~~developed by our competitors may berender ~~preferred~~LungFit® PH or our potential product candidates uneconomical or obsolete, and we may not be successful in ~~commercializing~~marketing LungFit® PH or our product candidates against competitors.

Some of our competitors have substantially greater financial, technical and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations. Additional mergers and acquisitions in the medical device, biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors. As a result, these companies may obtain certification or regulatory approval more rapidly than we are able to and may be more effective in selling and marketing their products as well. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. Our competitors may succeed in developing, acquiring or licensing on an exclusive basis, products that are more effective or less costly than LungFit® PH or any product candidate that we may develop, or achieve earlier patent protection, certification or regulatory approval, product commercialization and market penetration than we do. Additionally, technologies developed by our competitors may render LungFit® PH or our potential product candidates uneconomical or obsolete, and we may not be successful in marketing LungFit® PH or our product candidates against competitors.31

35We currently have a limited marketing and sales organization. If we are unable to scale sales and marketing capabilities or enter into agreements with third parties to market and sell LungFit® PH or our product candidates, we may be unable to generate revenue.

WeAlthough some ~~currently~~of our employees may have sold other similar products in the past while employed at other companies, we as a company have limited experience selling and marketing our product candidates and we currently have a nascent marketing and sales organization. IfTo successfully commercialize LungFit® PH or any other products that may result from our development programs, we ~~are~~will ~~unable~~need to ~~scale~~further develop ~~sales~~these ~~and~~capabilities, ~~marketing~~either ~~capabilities~~on our own or ~~enter~~with ~~into~~others. ~~agreements~~We continue to refine our commercialization efforts for LungFit® PH and intend to establish a more complete sales and marketing organization with ~~third~~technical ~~parties~~expertise to ~~market~~potentially reach all U.S. hospitals using or capable of using NO. This will be an expensive, difficult and ~~sell~~time-consuming ~~LungFit®~~endeavor. PHAny failure or delay in the development of our ~~product~~internal ~~candidates~~sales, wemarketing ~~may~~and bedistribution ~~unable~~capabilities towould ~~generate~~adversely ~~revenue~~impact the commercialization of our products.

~~Although~~Further, given ~~some~~our oflimited ~~our~~experience ~~employees may~~in ~~have~~marketing ~~sold~~and ~~other~~selling ~~similar~~medical device products, inour estimate of the ~~past~~size ~~while~~of ~~employed~~the atrequired ~~other~~sales ~~companies,~~force wemay be asmaterially amore ~~company~~or ~~have~~less ~~limited~~than ~~experience~~the ~~selling~~size ~~and~~of the sales force actually required to effectively commercialize LungFit® PH ~~marketing~~and our product candidates. ~~and~~As such, we ~~currently~~may ~~have~~be arequired ~~nascent~~to ~~marketing~~hire ~~and~~substantially more sales ~~organization.~~representatives Toto ~~successfully~~adequately ~~commercialize~~support the commercialization of LungFit® PH orand ~~any~~our ~~other~~product ~~products~~candidates, ~~that~~or we may incur excess costs as a result ~~from~~of ~~our~~hiring ~~development~~more ~~programs~~sales representatives than necessary. With respect to certain geographical markets, we ~~will~~may ~~need~~enter into collaborations with other entities to ~~further~~utilize ~~develop~~their ~~these~~local marketing and distribution capabilities, ~~either~~but we may be unable to enter into such agreements on ~~our~~ ~~own~~favorable orterms, ~~with~~if ~~others~~at all. WeIf ~~continue~~our future collaborators do not commit sufficient resources to ~~refine~~commercialize our ~~commercialization~~future ~~efforts~~products, ~~for~~if ~~LungFit®~~any, PH and ~~intend~~we are unable to ~~establish~~develop athe ~~more~~necessary ~~complete~~marketing ~~sales~~capabilities ~~and~~on ~~marketing~~our ~~organization~~own, ~~with~~we ~~technical~~will ~~expertise~~be unable to ~~potentially~~generate ~~reach~~sufficient ~~all~~product ~~U.S.~~revenue ~~hospitals~~to ~~using~~sustain orour ~~capable~~business. ofWe ~~using~~may ~~NO.~~be competing ~~This~~with ~~will~~companies bethat ancurrently ~~expensive,~~have ~~difficult~~extensive and ~~time~~well-~~consuming~~funded ~~endeavor~~marketing and sales operations. ~~Any~~Without ~~failure~~an orinternal ~~delay~~team inor the ~~development~~ support of ~~our~~a ~~internal~~third ~~sales,~~party to perform marketing and ~~distribution~~sales ~~capabilities~~functions, ~~would~~we ~~adversely~~may ~~impact~~be ~~the~~unable ~~commercialization~~to ofcompete ~~our~~successfully ~~products~~against these more established companies.

~~Further, given our limited experience~~The incommercial ~~marketing~~success ~~and selling medical device products, our estimate~~ of ~~the size of the required sales force may be materially more or less than the size of the sales force actually required to effectively commercialize~~ LungFit® PH and ~~our~~any ~~product~~current ~~candidates. As~~or ~~such,~~future weproduct ~~may~~candidate bewill ~~required~~depend toupon ~~hire substantially more sales representatives to adequately support~~ the ~~commercialization~~degree of ~~LungFit® PH~~market ~~and our product candidates, or we may incur excess costs as a result of hiring more sales representatives than necessary. With respect~~acceptance toby ~~certain geographical markets~~physicians, ~~we may enter into collaborations with other entities to utilize their local marketing and distribution capabilities~~patients, but we may be unable to enter into such agreements on favorable terms, if at all. If our future collaborators do not commit sufficient resources to commercialize our future products, if any, and we are unable to develop the necessary marketing capabilities on our own, we will be unable to generate sufficient product revenue to sustain our business. We may be competing with companies that currently have extensive and wellthird-~~funded~~party ~~marketing~~payors and ~~sales~~others ~~operations.~~in ~~Without an internal team or~~ the ~~support~~medical ~~of a third party to perform marketing and sales functions, we may be unable to compete successfully against these more established companies~~community.

~~The~~Even with ~~commercial~~approval from the FDA and potential future certification or approvals from comparable foreign regulatory authorities, the commercial success of LungFit® PH and ~~any~~our ~~current~~product orcandidates ~~future~~will depend in part on the medical community, patients and third-party payors accepting LungFit® PH and our product ~~candidate~~candidates ~~will~~as ~~depend~~medically ~~upon~~useful, cost-effective and safe. Any product that we bring to the ~~degree~~market ofmay not gain market acceptance by physicians, patients, third-party payors and others in the medical community. The degree of market acceptance of LungFit® PH and any of our product candidates that become approved for commercial sale will depend, in part, on a number of factors, including:

~~Even~~● ~~with~~the ~~approval~~safety ~~from~~and efficacy of the ~~FDA and~~product(s) ~~potential~~as ~~future~~demonstrated ~~certification~~in orclinical ~~approvals~~trials ~~from~~and ~~comparable~~potential ~~foreign~~advantages ~~regulatory~~over ~~authorities,~~competing treatments; ● the ~~commercial~~prevalence ~~success~~and severity of ~~LungFit® PH~~any ~~and~~side ~~our~~effects, ~~product~~including ~~candidates~~any ~~will~~limitations ~~depend~~or warnings contained in ~~part~~a onproduct’s approved labeling; ● the ~~medical~~clinical ~~community,~~indications ~~patients~~for ~~and~~which ~~third-party~~certification ~~payors~~or ~~accepting~~approval ~~LungFit® PH~~is granted; ● relative convenience and ~~our~~ease ~~product~~of ~~candidates~~administration; as● ~~medically~~familiarity ~~useful,~~of ~~cost-effective~~group ~~and~~purchasing ~~safe.~~organizations ~~Any~~with ~~product~~our ~~that~~products; we● ~~bring~~the cost of treatment, particularly in relation to competing treatments; ● the ~~market~~willingness ~~may~~of ~~not~~the ~~gain~~target ~~market acceptance~~patient bypopulation ~~physicians,~~to ~~patients,~~try ~~third-party~~new ~~payors~~therapies and ~~others~~of inphysicians ~~the~~to ~~medical~~prescribe ~~community.~~these ~~The~~therapies; ~~degree~~● the strength of ~~market~~marketing ~~acceptance~~and ofdistribution ~~LungFit® PH~~support and ~~any~~timing of ~~our~~market ~~product~~introduction ~~candidates~~of ~~that~~competitive ~~become~~products; ~~approved~~● ~~for~~publicity ~~commercial~~concerning ~~sale~~our ~~will~~products ~~depend,~~or incompeting ~~part,~~products onand atreatments; ~~number~~and of● ~~factors,~~sufficient ~~including:~~third-party insurance coverage and reimbursement.

● the safety and efficacy of the product(s) as demonstrated in clinical trials and potential advantages over competing treatments; ● the prevalence and severity of any side effects, including any limitations or warnings contained in a product’s approved labeling; ● the clinical indications for which certification or approval is granted; ● relative convenience and ease of administration; ● familiarity of group purchasing organizations with our products; ● the cost of treatment, particularly in relation to competing treatments; ● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; ● the strength of marketing and distribution support and timing of market introduction of competitive products; ● publicity concerning our products or competing products and treatments; and ● sufficient third-party insurance coverage and reimbursement.32

36Even if a potential product displays a favorable efficacy and safety profile in preclinical studies and clinical trials, market acceptance of the product will not be fully known until after it is launched. Our efforts to educate the medical community and third-party payors on the benefits of the product candidates may require significant resources and may never be successful. If the LungFit® PH or our product candidates are approved for commercialization but fail to achieve an adequate level of acceptance by physicians, patients, third-party payors and others in the medical community, we will not be able to generate sufficient revenue to become or remain profitable.

Even if a potential product displays a favorable efficacy and safety profile in preclinical studies and clinical trials, market acceptance of the product will not be fully known until after it is launched. Our efforts to educate the medical community and third-party payors on the benefits of the product candidates may require significant resources and may never be successful. If ~~the LungFit® PH or our product candidates are approved~~ ~~for~~we ~~commercialization but~~ fail to ~~achieve~~properly anmanage ~~adequate~~our ~~level~~anticipated ~~of acceptance by physicians~~growth, ~~patients,~~our ~~third-party~~business ~~payors~~could ~~and others in the medical community, we will not be able to generate sufficient revenue to become or remain profitable~~suffer.

IfOur rapid wegrowth ~~fail~~has placed, and will continue to ~~properly~~place, a significant strain on our management and on our operational and financial resources and systems. Failure to manage our ~~anticipated~~growth effectively could cause us to over-invest or under-invest in infrastructure, and result in losses or weaknesses in our infrastructure, which could materially adversely affect us. Additionally, our anticipated growth will increase the demands placed on our suppliers, resulting in an increased need for us to carefully monitor for quality assurance. Any failure by us to manage our ~~business~~growth effectively could ~~suffer~~have an adverse effect on our ability to achieve our development and commercialization goals.

~~Our rapid growth has placed, and~~Pricing ~~will~~pressure ~~continue~~from ~~to place, a significant strain on~~ our ~~management~~competitors and on our ~~operational~~customers ~~and~~may ~~financial~~impact ~~resources and systems. Failure to manage~~ our ~~growth~~ability ~~effectively could cause us~~ to ~~over-invest~~sell ~~or under-invest in infrastructure, and result in losses or weaknesses in~~ our ~~infrastructure,~~ ~~which~~products ~~could~~at ~~materially~~prices ~~adversely~~necessary ~~affect us. Additionally, our anticipated growth will increase the demands placed on our suppliers, resulting in an increased need for us~~ to ~~carefully~~support ~~monitor for quality assurance. Any failure by us to manage~~ our ~~growth effectively~~current ~~could~~business ~~have an adverse effect on our ability to achieve our development and commercialization goals~~strategies.

~~Pricing~~The industry in which we operate is characterized by intense competition, and the market continues to attract numerous new companies and technologies, which has encouraged more established companies to intensify competitive pricing pressure. ~~from~~As ~~our~~a ~~competitors~~result of this increased competition, as well as the challenges of third-party coverage and ~~our~~reimbursement practices, we believe there will be continued pricing ~~customers~~pressure ~~may~~in ~~impact~~the ~~our~~future. ~~ability~~If competitive forces drive down the prices we are able to ~~sell~~charge for our products, atour ~~prices~~profit ~~necessary~~margins will shrink, which will adversely affect our ability to ~~support~~maintain our ~~current~~profitability ~~business~~and ~~strategies~~to invest in and grow our business.

~~The industry in which we operate~~Cybersecurity isrisks ~~characterized by intense competition,~~ and the ~~market~~failure ~~continues~~ to ~~attract~~maintain ~~numerous~~the ~~new~~confidentiality, ~~companies~~integrity, and ~~technologies,~~availability ~~which has encouraged more established companies to intensify competitive pricing pressure. As a result~~ of ~~this~~our ~~increased~~computer ~~competition~~hardware, assoftware, ~~well~~and asInternet ~~the challenges~~applications ofand ~~third-party~~related ~~coverage~~tools and ~~reimbursement~~functions ~~practices,~~could weresult ~~believe there will be continued pricing pressure~~ in ~~the~~harm ~~future. If competitive forces drive down the prices we are able~~ to ~~charge for~~ our ~~products,~~business ~~our~~and/or ~~profit~~subject ~~margins~~us ~~will~~to ~~shrink~~costs, ~~which~~fines ~~will~~or ~~adversely affect our ability to maintain our profitability and to invest in and grow our business~~lawsuits.

~~Cybersecurity~~Our products ~~risks~~may rely on embedded software, digital interfaces, electronic components and ~~the~~interoperability ~~failure~~with tohospital ~~maintain the~~or ~~confidentiality~~clinical infrastructure, including ~~integrity~~ventilators, monitoring systems and ~~availability~~gas-delivery systems. Certain deployments of our ~~computer~~systems ~~hardware~~may operate in limited-connectivity, isolated ~~software~~or “air-gapped” clinical environments. Despite such architecture, ~~and~~these ~~Internet~~systems ~~applications~~may ~~and~~remain ~~related~~vulnerable to cybersecurity incidents through removable media, servicing activities, third-party maintenance tools, ~~and~~software ~~functions~~updates, configuration errors, unauthorized physical access or supply-chain compromise. Any cybersecurity incident affecting our products, infrastructure, suppliers, distributors, hospital customers or service providers could result in ~~harm~~device tomalfunction, ~~our~~interruption ~~business~~of ~~and/or~~therapy ~~subject~~delivery, usdata tointegrity issues, recalls, remediation costs, ~~fines~~litigation, reputational harm, regulatory scrutiny or ~~lawsuits~~patient safety events.

~~We rely on sophisticated information~~Remediation ~~technology~~of ~~systems~~cybersecurity ~~and~~vulnerabilities ~~network~~affecting ~~infrastructure to operate and manage~~ our ~~business.~~products Wemay ~~also~~require ~~maintain~~extensive ~~personally identifiable information (“PII”) about our employees~~validation, ~~and~~customer ~~given the nature of our business~~coordination, weregulatory ~~have~~review ~~access to protected health information (“PHI”).~~or ~~Our business therefore depends~~ on-site ~~the~~servicing ~~continuous~~activities, ~~effective,~~which ~~reliable,~~could ~~and~~delay ~~secure~~implementation ~~operation~~ of ~~our~~corrective ~~computer~~measures ~~hardware, software, networks, Internet servers,~~ and ~~related~~increase ~~infrastructure.~~operational To the extent that our hardware or software malfunctions or access to our data by internal personnel, suppliers or customers through the Internet is interrupted or compromised, our business could suffercosts.

~~The integrity and protection of~~Changes ~~our~~in ~~customer,~~regulatory ~~personnel,~~expectations ~~financial,~~relating ~~research and development, and other confidential data is critical~~ to ~~our~~software-enabled ~~business~~medical devices, ~~and our customers and employees have a high expectation that we will adequately protect their personal information. The regulatory environment governing information~~cybersecurity, ~~security~~or ~~and~~interoperability ~~privacy laws is increasingly demanding and continues to evolve and a number of states have adopted laws and regulations that~~ may ~~affect~~increase our ~~privacy and data security practices regarding the use, disclosure and protection of PII. For example,~~compliance ~~the California Consumer Privacy Act (“the CCPA”)~~costs, ~~among~~require ~~other~~design ~~things~~modifications, ~~creates~~delay ~~individual~~approvals ~~privacy~~or ~~rights~~require ~~and~~additional ~~imposes~~post-market ~~increased obligations on companies handling PII~~controls.

~~Although our computer and communications~~We ~~hardware~~rely ~~are~~on ~~protected~~sophisticated ~~through~~information ~~physical~~technology systems and ~~software~~network ~~safeguards,~~infrastructure ~~they are still vulnerable~~ to ~~system~~operate ~~malfunction, computer viruses, malware~~ and ~~ransomware,~~manage ~~and~~our ~~other cybersecurity threats such as phishing and social engineering attacks~~business. ~~These~~We ~~events~~also ~~could lead to the unauthorized~~maintain ~~access~~personally ofidentifiable ~~our~~ information ~~technology~~(“PII”) ~~systems~~about ~~and~~our ~~result~~employees, ~~in financial loss~~ and given the ~~misappropriation~~nature ~~or unauthorized disclosure~~ of ~~confidential information belonging to us,~~ our ~~employees~~business, ~~partners,~~we ~~customers,~~have oraccess ~~suppliers.~~to protected ~~The~~health ~~techniques~~information ~~used~~(“PHI”). byOur ~~criminal~~business ~~elements~~therefore todepends ~~attack~~on ~~computer systems~~the ~~are~~continuous, ~~sophisticated~~effective, ~~change~~reliable, ~~frequently~~ and ~~may~~secure ~~originate from less regulated and remote areas~~ operation of ~~the~~our ~~world.~~computer Ashardware, asoftware, ~~result~~networks, weInternet ~~may not~~servers, beand ~~able~~related toinfrastructure. ~~address~~To ~~these~~the ~~techniques~~extent ~~proactively~~that ~~or implement adequate preventative measures. If~~ our ~~information~~hardware ~~technology~~or ~~systems~~software ~~are~~malfunctions ~~compromised,~~or weaccess ~~could be subject~~ to ~~fines,~~our ~~damages,~~data ~~litigation~~by ~~and~~internal ~~enforcement actions~~personnel, ~~incur~~suppliers ~~financial~~or ~~losses,~~customers ~~suffer~~through ~~reputational damage,~~the ~~and~~Internet ~~lose~~is ~~trade~~interrupted ~~secrets~~ or ~~other confidential information~~compromised, our ~~each~~business ~~of which~~ could ~~significantly harm our business~~suffer.

37The integrity and protection of our customer, personnel, financial, research and development, and other confidential data is critical to our business, and our customers and employees have a high expectation that we will adequately protect their personal information. The regulatory environment governing information, security and privacy laws is increasingly demanding and continues to evolve and a number of states have adopted laws and regulations that may affect our privacy and data security practices regarding the use, disclosure and protection of PII. For example, the California Consumer Privacy Act (“the CCPA”), among other things, creates individual privacy rights and imposes increased obligations on companies handling PII.

~~Healthcare~~Although our ~~legislative~~computer orand ~~regulatory~~communications ~~reform~~hardware are protected through physical and software safeguards, they are still vulnerable to system ~~measures~~malfunction, ~~including~~computer ~~government~~viruses, ~~restrictions~~malware onand ~~pricing~~ransomware, and ~~reimbursement~~other cybersecurity threats such as phishing and social engineering attacks. These events could lead to the unauthorized access of our information technology systems and result in financial loss and the misappropriation or unauthorized disclosure of confidential information belonging to us, our employees, partners, customers, or suppliers. The techniques used by criminal elements to attack computer systems are sophisticated, change frequently and may ~~have~~originate from less regulated and remote areas of the world. As a ~~negative~~result, ~~impact~~we onmay not be able to address these techniques proactively or implement adequate preventative measures. If our ~~business~~information technology systems are compromised, we could be subject to fines, damages, litigation and ~~results~~enforcement actions, incur financial losses, suffer reputational damage, and lose trade secrets or other confidential information, each of ~~operations~~which could significantly harm our business.

In the U.S., there have been and continue to be a number of legislative and regulatory changes and proposed changes to contain healthcare costs. For example, in March 2010, the Patient Protection and Affordable Care Act (“ACA”) was enacted, which, among other things, substantially changes the way health care is financed by both governmental and private insurers, and significantly impacts the U.S. medical device industry. Some of the provisions of the ACA have been subject to judicial challenges as well as efforts to modify them or alter their interpretation or implementation. For example, the Tax Cuts and Jobs Act of 2017 (“Tax Act”), includes a provision that eliminated the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year, commonly referred to as the “individual mandate,” effective January 1, 2019. It is unclear how efforts to modify or invalidate the ACA or its implementing regulations, or portions thereof, will affect our business. Additional legislative changes, regulatory changes and judicial challenges related to the ACA remain possible. We cannot predict what effect further changes related to the ACA would have on our business.33

~~We cannot be sure whether additional~~Healthcare legislative ~~changes~~or ~~will~~regulatory bereform ~~enacted~~measures, orincluding ~~whether~~ government ~~regulations,~~restrictions ~~guidance or interpretations will be changed, or what the impact of such changes would be~~ on ~~the certification or marketing approvals, sales,~~ pricing, orand reimbursement ~~of our approved product or product candidates~~, ~~if any,~~ may ~~be.~~have Wea ~~expect~~negative ~~that any such healthcare reform measures that may be adopted in the future, may result in more rigorous~~impact ~~coverage criteria and in additional downward pressure~~ on ~~the~~our ~~price~~business ~~that~~and weresults ~~receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation~~ of ~~cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our approved product or product candidates~~operations.

~~Moreover~~In the U.S., inthere ~~order~~have tobeen ~~obtain~~and ~~reimbursement for~~continue ~~our~~to ~~products~~be ina ~~some~~number ~~EEA~~of ~~countries,~~legislative ~~including~~and ~~some~~regulatory EUchanges ~~Member~~and ~~States,~~proposed wechanges ~~may~~to becontain ~~required~~healthcare costs. toFor ~~compile~~example, ~~additional~~in ~~data~~March ~~comparing~~2010, the ~~cost-effectiveness of~~Patient ~~our~~Protection ~~products~~and toAffordable ~~other~~Care ~~available~~Act ~~therapies. Health Technology Assessment~~ (“~~HTA~~ACA”) ofwas ~~both~~enacted, ~~medicinal~~which, ~~products~~among ~~and medical~~other ~~devices~~things, issubstantially ~~becoming~~changes anthe ~~increasingly~~way ~~common~~health ~~part~~care ofis ~~the~~financed ~~pricing~~by ~~and~~both ~~reimbursement~~governmental ~~procedures~~and inprivate ~~some~~insurers, EUand ~~Member~~significantly ~~States,~~impacts ~~including those~~the ~~representing~~U.S. ~~the~~medical ~~larger~~device ~~markets~~industry. ~~The~~Some ~~HTA~~of ~~process,~~the ~~which~~provisions isof ~~currently~~the ~~governed~~ACA byhave ~~national~~been ~~laws~~subject into ~~each~~judicial EUchallenges ~~Member~~as ~~State,~~well isas ~~the~~efforts ~~procedure~~ to ~~assess~~modify them ~~therapeutic,~~or ~~economic~~alter ~~and~~their ~~societal~~interpretation ~~impact~~or ofimplementation. aFor ~~given~~example, ~~medical~~the ~~product~~Tax inCuts ~~the~~and ~~national~~Jobs ~~healthcare~~Act ~~systems~~ of ~~the~~2017 ~~individual~~(“Tax ~~country.~~Act”), includes ~~The~~a ~~outcome~~provision ofthat aneliminated ~~HTA will often influence~~ the ~~pricing~~tax-based ~~and~~shared ~~reimbursement~~responsibility ~~status~~payment ~~granted~~imposed ~~to these medical products~~ by the ~~competent~~ACA ~~authorities of~~on ~~the~~certain ~~respective~~individuals EUwho ~~Member~~fail ~~State.~~to ~~The~~maintain qualifying ~~extent~~health tocoverage ~~which~~for ~~pricing~~all ~~and~~or ~~reimbursement~~part ~~decisions~~of ~~are~~a ~~influenced~~year, bycommonly ~~the~~referred ~~HTA~~to ofas the ~~specific~~“individual ~~medical product~~mandate,” ~~currently~~effective ~~varies~~January 1, ~~between EU Member States~~2019. OnIt ~~December~~is ~~13,~~unclear ~~2021,~~how ~~the~~efforts EUto ~~adopted~~modify aor ~~new~~invalidate ~~HTA~~the ~~Regulation~~ACA ~~which~~or ~~entered~~its ~~into~~implementing ~~force on January 11~~regulations, ~~2022~~or ~~and~~portions thereof, will ~~become~~affect our ~~applicable~~business. toAdditional ~~all~~legislative ~~EU Member States from January 12~~changes, ~~2025.~~regulatory ~~The~~changes ~~new~~and EUjudicial ~~HTA~~challenges ~~regulation~~related ~~aims~~ to ~~harmonize~~ the ~~clinical~~ACA ~~benefit~~remain ~~assessment~~possible. ofWe ~~HTA~~cannot predict ~~across~~what ~~the~~effect EUfurther ~~and~~changes ~~provides~~related ~~the~~to ~~basis for permanent and sustainable cooperation at~~ the EUACA ~~level for~~would ~~joint~~have ~~clinical~~on ~~assessments~~our ~~in these areas~~business.

38We cannot be sure whether additional legislative changes will be enacted, or whether government regulations, guidance or interpretations will be changed, or what the impact of such changes would be on the certification or marketing approvals, sales, pricing, or reimbursement of our approved product or product candidates, if any, may be. We expect that any such healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our approved product or product candidates.

WeMoreover, in ~~are~~order ~~subject~~to obtain reimbursement for our products in some EEA countries, including some EU Member States, we may be required to compile additional ~~federal~~data comparing the cost-effectiveness of our products to other available therapies. Health Technology Assessment (“HTA”) of both medicinal products and ~~state~~medical devices is becoming an increasingly common part of the pricing and reimbursement procedures in some EU Member States, including those representing the larger markets. The HTA process, which is currently governed by national laws in ~~and~~each ~~regulations~~EU ~~relating~~Member State, is the procedure to ~~our~~assess ~~business~~therapeutic, economic and ~~our~~societal ~~failure~~impact of a given medical product in the national healthcare systems of the individual country. The outcome of an HTA will often influence the pricing and reimbursement status granted to ~~comply~~these ~~with~~medical ~~those~~products ~~laws~~by ~~could~~the ~~have~~competent authorities of the respective EU Member State. The extent to which pricing and reimbursement decisions are influenced by the HTA of the specific medical product currently varies between EU Member States. On December 13, 2021, the EU adopted a ~~material~~new ~~adverse~~HTA ~~effect~~Regulation which entered into force on ~~our~~January ~~results~~11, 2022 and will become applicable to all EU Member States from January 12, 2025. The new EU HTA regulation aims to harmonize the clinical benefit assessment of ~~operations~~HTA across the EU and ~~financial~~provides ~~conditions~~the basis for permanent and sustainable cooperation at the EU level for joint clinical assessments in these areas.

We are subject to additional health care regulation and enforcement by the federal government and the states in which we conduct our business. Of note, regulations that may relate to our operations include the following:34

● the federal health care program AKS prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering, or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, or order or arranging for the purchase, lease or order of any good or service, for which payment may be made, in whole or in part, under federal health care programs such as Medicare and Medicaid. This statute has been interpreted to apply to arrangements between pharmaceutical or device manufacturers, on the one hand, and prescribers, purchasers and formulary managers and others on the other. The term “remuneration” has been broadly interpreted to apply to anything of value including, for example, gifts, cash payments, donations, waivers of payment, ownership interests, and providing any item, service, or compensation for something other than fair market value. Liability under the AKS may be established without proving actual knowledge of the statute or specific intent to violate it. Although there We are a number of statutory exceptions and regulatory safe harbors to the AKS protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration to those who prescribe, purchase, or recommend medical device products, including certain discounts, or engaging such individuals as consultants, advisors and speakers, may be subject to ~~scrutiny~~additional ~~if they do not fit squarely within an exception or safe harbor. Moreover, there are no safe harbors for many common practices, such as educational grants and reimbursement support programs; ● the~~ federal civil FCA that prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent, claims for payment of government funds, knowingly making, using or causing to be made or used a false statement or record material to an obligation to pay money to the government, or knowingly concealing or knowingly and ~~improperly~~state ~~avoiding,~~laws decreasing or concealing an obligation to pay money to the federal government. A claim including items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA. Actions under the FCA may be brought by the government or as a qui tam action by a private individual in the name of the government, who may also share in any monetary recovery. Qui tam actions are filed under seal and ~~impose~~regulations arelating ~~mandatory duty on the U.S. Department of Justice~~ to ~~investigate~~our such allegations. Manufacturers have faced liability under the FCA for providing inaccurate billing or coding information to customers or promoting a product off-label. FCA liability is potentially significant in the healthcare industry because the statute provides for treble damages and significant mandatory penalties per false or fraudulent claim or statement for violationsbusiness, ~~as well as exclusion from participation in federal healthcare programs; ● HIPAA imposes criminal~~ and ~~civil~~our ~~liability~~failure ~~for, among other things, knowingly and willfully executing, or attempting~~ to ~~execute,~~comply a scheme to defraud any healthcare benefit program, including private third-party payors, or knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false, fictitious, or fraudulent statement or representation, or using any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry, in connection with ~~the~~those delivery of or payment for healthcare benefits, items, or services; ● the federal Sunshine Act requires applicable manufacturers of devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to payments and other transfers of value to physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse midwives, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and ● analogous state and foreign laws could and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. Several states have ~~enacted~~a ~~legislation~~material ~~requiring~~adverse ~~medical~~effect ~~device manufacturers to, among other things, establish marketing compliance programs; file periodic reports with the state, including reports~~ on ~~gifts~~our ~~and~~results ~~payments~~of tooperations ~~individual health care providers;~~ and~~/or~~ ~~register~~financial ~~their sales representatives~~conditions. ~~Some states prohibit certain sales and marketing practices, including the provision of gifts, meals, or other items to health care providers.~~

~~Efforts to ensure that our business~~We ~~arrangements~~are with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to ~~challenge~~additional ~~under~~health ~~one~~care orregulation ~~more of such laws. The scope~~ and enforcement ofby ~~these~~the ~~laws~~federal isgovernment ~~uncertain~~ and ~~subject to change in~~ the ~~current~~states ~~environment of health care reform. We cannot predict the impact on our business of any changes~~ in ~~these~~which ~~laws. Federal or state regulatory authorities may challenge our current or future activities under these laws. Any such challenge, even if~~ we ~~are~~ ~~able~~conduct ~~to successfully defend against it, could have a material adverse effect on~~ our ~~reputation,~~ business~~, results of operations, and~~. ~~financial~~Of ~~condition. Any state or federal regulatory review of us~~note, ~~regardless of the outcome, would be costly and time-consuming. If our operations are found to be in violation of any of the laws described above or any other governmental~~ regulations that ~~apply to us, we~~ may berelate ~~subject~~ to penalties, including civil and criminal penalties, damages, fines, exclusion from participation in government health care programs, such as Medicare and Medicaid, imprisonment and the curtailment or restructuring of our operations, ~~any~~include ofthe ~~which could adversely affect our ability to operate our business and our results of operations.~~following:

39● the federal health care program AKS prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering, or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, or order or arranging for the purchase, lease or order of any good or service, for which payment may be made, in whole or in part, under federal health care programs such as Medicare and Medicaid. This statute has been interpreted to apply to arrangements between pharmaceutical or device manufacturers, on the one hand, and prescribers, purchasers and formulary managers and others on the other. The term “remuneration” has been broadly interpreted to apply to anything of value including, for example, gifts, cash payments, donations, waivers of payment, ownership interests, and providing any item, service, or compensation for something other than fair market value. Liability under the AKS may be established without proving actual knowledge of the statute or specific intent to violate it. Although there are a number of statutory exceptions and regulatory safe harbors to the AKS protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration to those who prescribe, purchase, or recommend medical device products, including certain discounts, or engaging such individuals as consultants, advisors and speakers, may be subject to scrutiny if they do not fit squarely within an exception or safe harbor. Moreover, there are no safe harbors for many common practices, such as educational grants and reimbursement support programs; ● the federal civil FCA that prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent, claims for payment of government funds, knowingly making, using or causing to be made or used a false statement or record material to an obligation to pay money to the government, or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government. A claim including items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA. Actions under the FCA may be brought by the government or as a qui tam action by a private individual in the name of the government, who may also share in any monetary recovery. Qui tam actions are filed under seal and impose a mandatory duty on the U.S. Department of Justice to investigate such allegations. Manufacturers have faced liability under the FCA for providing inaccurate billing or coding information to customers or promoting a product off-label. FCA liability is potentially significant in the healthcare industry because the statute provides for treble damages and significant mandatory penalties per false or fraudulent claim or statement for violations, as well as exclusion from participation in federal healthcare programs; ● HIPAA imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, or knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false, fictitious, or fraudulent statement or representation, or using any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry, in connection with the delivery of or payment for healthcare benefits, items, or services; ● the federal Sunshine Act requires applicable manufacturers of devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to payments and other transfers of value to physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse midwives, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and ● analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers. Several states have enacted legislation requiring medical device manufacturers to, among other things, establish marketing compliance programs; file periodic reports with the state, including reports on gifts and payments to individual health care providers; and/or register their sales representatives. Some states prohibit certain sales and marketing practices, including the provision of gifts, meals, or other items to health care providers.

IfEfforts to weensure ~~fail~~that toour business arrangements with third parties will comply with applicable ~~privacy~~healthcare laws and regulations will involve substantial costs. Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, ~~data~~it is ~~protection~~possible that some of our business activities could be subject to challenge under one or more of such laws. The scope and ~~data~~enforcement of ~~security~~these laws is uncertain and ~~regulations~~subject to change in the current environment of health care reform. We cannot predict the impact on our business of any changes in these laws. Federal or state regulatory authorities may challenge our current or future activities under these laws. Any such challenge, even if we ~~could~~are ~~face~~able ~~substantial~~to ~~penalties~~successfully defend against it, ~~liability~~could ~~and~~have a material adverse ~~publicity~~ ~~and~~effect on our reputation, business, results of operations, and financial condition. ~~could~~Any state or federal regulatory review of us, regardless of the outcome, would be costly and time-consuming. If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from participation in government health care programs, such as Medicare and Medicaid, imprisonment and the curtailment or restructuring of our operations, any of which could adversely ~~affected~~affect our ability to operate our business and our results of operations.

We are subject to various laws and regulations globally regarding privacy and data protection, including laws and regulations relating to the collection, storage, handling, use, disclosure, transfer and security of personal data. The restrictions under applicable privacy, data protection and data security laws and regulations that may affect our ability to operate include but are not limited to:35

● HIPAA governs the use, disclosure, and security of protected health information by HIPAA “covered entities” and their “business associates.” Covered entities are health plans, health care clearinghouses and health care providers that engage in specific types of electronic transactions. A business associate is any person or entity (other than members of a covered entity’s workforce) that performs a service for or on behalf of a covered entity involving the use or disclosure of protected health information. Most healthcare providers who prescribe our products and from whom If we ~~obtain~~fail ~~patient health information are subject~~ to ~~privacy~~comply and security requirements under HIPAA, as are we in certain circumstances. The U.S. Department of Health and Human Services (through the Office for Civil Rights) has direct enforcement authority against covered entities and business associates with ~~regard~~applicable to compliance with HIPAA regulations. We also could be subject to criminal penalties if we knowingly obtain individually identifiable health information from a covered entity in a manner that is not authorized or permitted by HIPAA or for aiding and abetting and/or conspiring to commit a violation of HIPAA. We are unable to predict whether our actions could be subject to prosecution in the event of an impermissible disclosure of health information to us; ● numerous U.S. federal and state laws and regulationsprivacy, ~~including state~~ data ~~breach notification laws, state health information privacy laws and federal and state consumer~~ protection ~~laws, govern the collection, use, disclosure~~ and ~~protection~~data of personal information. These laws may impose a number of compliance obligations on us, including requiring that we obtain consent before we collect, use, or disclose personal information, implement certain security ~~protections to safeguard personal information, and notify individuals or regulators in the event of a breach; ● other countries also have, or are developing,~~ laws ~~governing the collection, use, disclosure~~ and ~~protection of personal information. The GDPR~~regulations, ~~for~~we example, imposes restrictions on the processing (e.g., collection, use, disclosure) of personal data in the EEA and also imposes strict restrictions on the transfer of personal data out of the EU to the U.S. Our business could beface ~~adversely~~substantial ~~impacted if our ability to transfer personal data outside of the EEA or Switzerland is restricted~~penalties, liability ~~which could adversely impact our operating results. For example, in July 2020, the Court of Justice of the European Union (the CJEU) declared the EU-U.S. Privacy Shield framework between the EU~~ and ~~U.S.~~adverse topublicity ~~be invalid~~ and ~~raised concerns about other data transfer mechanisms in a case known colloquially as “Schrems II”, which could adversely impact~~ our ~~ability to transfer personal data from the EU to the U.S or otherwise may cause us to incur significant costs to do so legally. At present~~business, ~~there~~operations ~~are few viable alternatives to the EU-U.S. Privacy Shield~~ and ~~the~~financial ~~Standard~~condition ~~Contractual Clauses (“SCCs”). If the level of protection in the U.S. or any other importing country is called into question under the SCCs, this~~ could further impact our ability to transfer data outside of the EEA or Switzerland. Furthermore, following the Brexit and the UK’s exit from the EU, the UK became a third country to the EU in terms of personal data transfers. The European Commission has adopted an Adequacy Decision concerning the level of personal data protection in the UK under which personal data may now flow freely from the EU to the UK. However, personal data transfers from the EU to the UK may nevertheless be atadversely ~~a greater risk than before because the Adequacy Decision could in theory someday be suspended~~affected. On December 13, 2022, the European Commission adopted a draft adequacy decision for the EU-U.S. Data Privacy Framework. This draft decision follows the signature of a U.S. Executive Order by President Biden on October 7, 2022, along with the regulations issued by the U.S. Attorney General Merrick Garland. These two instruments implemented into U.S. law the agreement in principle announced by President von der Leyen and President Biden in March 2022. The draft decision concludes that the U.S. ensures an adequate level of protection for personal data transferred from the EU to U.S. companies. On February 14, 2023, the European Parliament’s Committee on Civil Liberties, Justice and Home Affairs published its draft motion for a resolution regarding the adequacy of the protection of personal data. On February 28, 2023, the European Data Protection Committee (EDPB) published its Opinion 5/2023 on the European Commission’s draft adequacy decision. The two sides are now expected to finalize the details of this agreement and translate it into legal texts that will form the basis of a draft adequacy decision to be proposed by the European Commission; and ● the legislative and regulatory landscape for privacy and data security continues to evolve, and there has been an increasing amount of focus on privacy and data security issues with the potential to affect our business. For example, the CCPA, as amended by the California Privacy Rights Act (CPRA), contains disclosure obligations for businesses that collect personal information about California residents and affords those individuals new rights relating to their personal information that may affect our ability to use personal information. Other states, including Virginia, Colorado, Utah, Connecticut, Indiana, Iowa, Tennessee, Utah, and others have enacted privacy laws similar to the CCPA that impose new obligations or limitations in areas affecting our business and we continue to assess the impact of these state legislation, on our business as additional information and guidance becomes available. The federal government has also considered similar privacy laws that could impose new obligations or limitations in areas affecting our business.

~~These~~We are ~~privacy~~subject ~~and~~to ~~data~~various ~~security~~ laws and regulations ~~could~~globally ~~increase~~regarding ~~our~~privacy ~~cost~~and ofdata ~~doing business~~protection, ~~and~~including ~~failure to comply with these~~ laws and regulations ~~could~~relating ~~result in~~to ~~government~~the ~~enforcement~~collection, ~~actions~~storage, ~~(which~~handling, ~~could~~use, ~~include civil or criminal penalties)~~disclosure, ~~private~~transfer ~~litigation~~ and~~/or~~ ~~adverse~~security ~~publicity~~of ~~and~~personal ~~could materially and negatively affect our operating results and business~~data. ~~Although~~The arestrictions ~~thorough~~under ~~privacy~~applicable ~~compliance program could mitigate the~~privacy, ~~risk~~data ofprotection ~~investigation~~ and ~~prosecution~~data ~~for~~security ~~violations of these~~ laws and regulations, ~~the~~that ~~risks~~may ~~cannot~~affect beour ~~entirely~~ability ~~eliminated. Any action against us for violation of these laws or regulations, even if we successfully defend against it, could cause us~~ to ~~incur~~operate ~~significant legal~~include ~~expenses~~but ~~and~~are ~~divert~~not ~~our~~limited management’s attention from the operation of our business. Moreover, achieving and sustaining compliance with applicable federal, state, and foreign privacy and data security laws and regulations may prove costly.to:

40● HIPAA governs the use, disclosure, and security of protected health information by HIPAA “covered entities” and their “business associates.” Covered entities are health plans, health care clearinghouses and health care providers that engage in specific types of electronic transactions. A business associate is any person or entity (other than members of a covered entity’s workforce) that performs a service for or on behalf of a covered entity involving the use or disclosure of protected health information. Most healthcare providers who prescribe our products and from whom we obtain patient health information are subject to privacy and security requirements under HIPAA, as are we in certain circumstances. The U.S. Department of Health and Human Services (through the Office for Civil Rights) has direct enforcement authority against covered entities and business associates with regard to compliance with HIPAA regulations. We also could be subject to criminal penalties if we knowingly obtain individually identifiable health information from a covered entity in a manner that is not authorized or permitted by HIPAA or for aiding and abetting and/or conspiring to commit a violation of HIPAA. We are unable to predict whether our actions could be subject to prosecution in the event of an impermissible disclosure of health information to us; ● numerous U.S. federal and state laws and regulations, including state data breach notification laws, state health information privacy laws and federal and state consumer protection laws, govern the collection, use, disclosure and protection of personal information. These laws may impose a number of compliance obligations on us, including requiring that we obtain consent before we collect, use, or disclose personal information, implement certain security protections to safeguard personal information, and notify individuals or regulators in the event of a breach; ● other countries also have, or are developing, laws governing the collection, use, disclosure and protection of personal information. The GDPR, for example, imposes restrictions on the processing (e.g., collection, use, disclosure) of personal data in the EEA and also imposes strict restrictions on the transfer of personal data out of the EU to the U.S. Our business could be adversely impacted if our ability to transfer personal data outside of the EEA or Switzerland is restricted, which could adversely impact our operating results. For example, in July 2020, the Court of Justice of the European Union (the CJEU) declared the EU-U.S. Privacy Shield framework between the EU and U.S. to be invalid and raised concerns about other data transfer mechanisms in a case known colloquially as “Schrems II”, which could adversely impact our ability to transfer personal data from the EU to the U.S or otherwise may cause us to incur significant costs to do so legally. At present, there are few viable alternatives to the EU-U.S. Privacy Shield and the Standard Contractual Clauses (“SCCs”). If the level of protection in the U.S. or any other importing country is called into question under the SCCs, this could further impact our ability to transfer data outside of the EEA or Switzerland. Furthermore, following the Brexit and the UK’s exit from the EU, the UK became a third country to the EU in terms of personal data transfers. The European Commission has adopted an Adequacy Decision concerning the level of personal data protection in the UK under which personal data may now flow freely from the EU to the UK. However, personal data transfers from the EU to the UK may nevertheless be at a greater risk than before because the Adequacy Decision could in theory someday be suspended. On July 10, 2023, the European Commission adopted an adequacy decision for the EU-U.S. Data Privacy Framework (“EU-U.S. DPF”), concluding that participating U.S. organizations certified under the framework provide an adequate level of protection for personal data transferred from the European Economic Area (“EEA”) to the United States. The United Kingdom has also adopted the UK Extension to the EU-U.S. DPF, and Switzerland has recognized the Swiss-U.S. Data Privacy Framework as a valid transfer mechanism for personal data transferred from Switzerland to participating U.S. organizations. Accordingly, personal data transfers from the EEA, the United Kingdom and Switzerland to the United States may, in certain circumstances, be based on participation in the applicable Data Privacy Framework program. In addition, Standard Contractual Clauses (“SCCs”) and other lawful transfer mechanisms remain available for cross-border transfers of personal data. However, the legal landscape governing international data transfers remains subject to ongoing regulatory developments, judicial scrutiny and potential legal challenges. Future decisions by European courts, regulators or lawmakers could invalidate, restrict or impose additional requirements on the EU-U.S. DPF, SCCs or other transfer mechanisms. Any such developments could require us to implement additional safeguards, modify our business practices, incur significant compliance costs, suspend certain data transfers or otherwise adversely affect our ability to process personal data across jurisdictions. If we are unable to transfer personal data lawfully between jurisdictions in which we operate, our business, financial condition, results of operations and prospects could be materially adversely affected; and ● the legislative and regulatory landscape for privacy and data security continues to evolve, and there has been an increasing amount of focus on privacy and data security issues with the potential to affect our business. For example, the CCPA, as amended by the California Privacy Rights Act (CPRA), contains disclosure obligations for businesses that collect personal information about California residents and affords those individuals new rights relating to their personal information that may affect our ability to use personal information. Other states, including Virginia, Colorado, Utah, Connecticut, Indiana, Iowa, Tennessee, Utah, and others have enacted privacy laws similar to the CCPA that impose new obligations or limitations in areas affecting our business and we continue to assess the impact of these state legislation, on our business as additional information and guidance becomes available. The federal government has also considered similar privacy laws that could impose new obligations or limitations in areas affecting our business.

IfThese privacy weand ordata security laws and regulations could increase our ~~suppliers~~cost ~~fail~~of doing business, and failure to comply with ~~ongoing~~these laws and regulations ~~FDA~~could orresult ~~other~~in ~~foreign~~government ~~regulatory~~enforcement ~~authority~~actions ~~requirements~~(which could include civil or criminal penalties), private litigation and/or ifadverse wepublicity and ~~experience~~could ~~unanticipated~~materially ~~problems~~and ~~with~~negatively affect our ~~products,~~operating ~~these~~results ~~products~~and business. Although a thorough privacy compliance program could mitigate the risk of investigation and prosecution for violations of these laws and regulations, the risks cannot be ~~subject~~entirely toeliminated. ~~restrictions~~Any action against us for violation of these laws or ~~withdrawal~~regulations, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the ~~market~~operation of our business. Moreover, achieving and sustaining compliance with applicable federal, state, and foreign privacy and data security laws and regulations may prove costly.

Any product for which we obtain FDA certification, clearance or approval, and the manufacturing processes, post-market surveillance, post-certification/approval clinical data and promotional activities for such product, remain subject to continued regulatory review, oversight, requirements, and periodic inspections by the FDA and other domestic and foreign regulatory authorities and notified bodies. For such products, we must also comply with equivalent standards in non-U.S. countries should we choose to engage in comparable activity in those jurisdictions. These obligations extend to our third-party suppliers as well.36

~~In particular,~~ If we ~~and~~or our suppliers ~~are~~ ~~required~~fail to comply with ~~the~~ongoing FDA’s ~~QSR~~or ~~in the U.S. and~~ other ~~regulations~~foreign ~~enforced~~regulatory ~~outside~~authority ~~the United States which cover the manufacture of our products and the methods and documentation of the design~~requirements, ~~testing,~~or ~~production,~~if ~~control,~~we ~~quality~~experience ~~assurance, labeling, packaging,~~unanticipated ~~storage~~problems ~~and~~with ~~shipping of medical devices. Regulatory authorities, such as the FDA, and notified bodies enforce the QSR in the U.S. and other regulations through periodic inspections. The failure by us or one of~~ our ~~suppliers to comply with applicable statutes and regulations administered by the FDA~~products, orthese ~~the~~products ~~failure~~could tobe ~~timely~~subject ~~and adequately respond~~ to ~~any~~restrictions ~~adverse inspectional observations~~ or ~~product~~withdrawal ~~safety~~from ~~issues, could result in, among other things, any of~~ the ~~following enforcement actions:~~market.

●Any product ~~untitled~~for ~~letters,~~which ~~warning~~we ~~letters,~~obtain ~~fines,~~FDA ~~injunctions~~certification, ~~consent~~clearance ~~decrees and civil penalties; ● unanticipated expenditures to address~~ or ~~defend~~approval, ~~such~~and ~~actions;~~the ●manufacturing ~~customer notifications for repair~~processes, ~~replacement,~~post-market ~~refunds; ● recall~~surveillance, ~~detention~~post-certification/approval clinical ordata ~~seizure~~and ofpromotional ~~our~~activities ~~products;~~for ●such ~~operating~~product, ~~restrictions~~remain orsubject ~~partial~~to ~~suspension~~continued orregulatory ~~total~~review, ~~shutdown~~oversight, ofrequirements, ~~production;~~and periodic ●inspections ~~refusing~~by orthe ~~delaying~~FDA ~~our~~and ~~requests~~other ~~for~~domestic ~~510(k)~~and ~~clearance,~~foreign deregulatory ~~novo~~authorities ~~authorization~~and ornotified ~~PMA~~bodies. ~~approval~~For ofsuch ~~new~~ products, orwe ~~modified~~must also ~~products;~~comply ●with ~~operating~~equivalent ~~restrictions;~~standards ●in ~~withdrawal~~non-U.S. ofcountries ~~510(k)~~should ~~clearances~~we onchoose ~~PMA~~to ~~approvals~~engage ~~that~~in ~~have~~comparable ~~already~~activity ~~been~~in ~~granted;~~those ●jurisdictions. These ~~refusal~~obligations extend to ~~grant export approval for~~ our ~~products;~~third-party orsuppliers ●as ~~criminal prosecution~~well.

IfIn particular, ~~any~~we ofand ~~these~~our ~~actions~~suppliers ~~were~~are required to comply with the FDA’s QSR in the U.S. and other regulations enforced outside the ~~occur,~~United itStates ~~would~~which ~~harm~~cover the manufacture of our ~~reputation~~products and ~~cause~~the ~~our~~methods ~~product~~and ~~sales~~documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and ~~profitability~~shipping toof ~~suffer~~medical devices. Regulatory authorities, such as the FDA, and ~~may~~notified bodies ~~prevent~~enforce usthe ~~from~~QSR ~~generating~~in ~~revenue~~the U. ~~Furthermore,~~S. ~~our~~and ~~key~~other ~~component~~regulations ~~suppliers~~through ~~may~~periodic ~~not~~inspections. ~~currently~~The befailure orby ~~may~~us ~~not~~or ~~continue~~one toof beour insuppliers ~~compliance~~to comply with ~~all~~ applicable ~~regulatory~~statutes ~~requirements which~~and ~~could~~regulations ~~result~~administered inby ~~our~~the FDA, or the failure to ~~produce~~timely ~~our~~and ~~products~~adequately onrespond ato ~~timely~~any ~~basis~~adverse ~~and~~inspectional observations or product safety issues, could result in, ~~the~~among ~~required~~other ~~quantities~~things, ifany atof ~~all.~~the following enforcement actions:

In● ~~addition~~untitled letters, wewarning ~~are~~letters, ~~required~~fines, ~~to conduct~~injunctions, ~~costly~~consent ~~post-market~~decrees ~~testing~~ and ~~surveillance~~civil topenalties; ~~monitor~~● ~~the~~unanticipated ~~safety~~expenditures orto ~~effectiveness~~address ofor ~~our~~defend ~~approved~~such ~~products,~~actions; ~~and~~● wecustomer ~~must~~notifications ~~comply with~~for ~~medical~~repair, ~~device~~replacement, ~~reporting~~refunds; ~~requirements~~● recall, ~~including~~detention ~~the~~or ~~reporting~~seizure of ~~adverse events and malfunctions related to~~ our products.; ~~Later discovery~~● ofoperating ~~previously~~restrictions ~~unknown~~or ~~problems~~partial ~~with~~suspension ~~such products, including unanticipated adverse events~~ or ~~adverse~~total ~~events~~shutdown of ~~unanticipated severity~~production; or● ~~frequency,~~refusing ~~manufacturing problems,~~ or ~~failure~~delaying toour ~~comply~~requests ~~with~~for ~~regulatory~~510(k) ~~requirements such as QSR~~clearance, ~~may~~de ~~result~~novo inauthorization ~~changes to labeling, restrictions on such products~~ or ~~manufacturing~~PMA ~~processes,~~approval ~~withdrawal~~ of ~~the~~new products ~~from the market, voluntary~~ or ~~mandatory recalls,~~modified aproducts; ~~requirement~~● tooperating ~~repair,~~restrictions; ~~replace~~● orwithdrawal ~~refund~~of ~~the~~510(k) ~~cost~~clearances ofon ~~any~~PMA ~~medical~~approvals ~~device~~that wehave ~~manufacture~~already orbeen ~~distribute,~~granted; ~~fines,~~● ~~suspension~~refusal ~~of certification~~to orgrant ~~regulatory~~export approval, ~~product~~for ~~seizures,~~our ~~injunctions~~products; or ~~the~~● ~~imposition of civil or~~ criminal ~~penalties which would adversely affect our business, operating results and prospects~~prosecution.

41If any of these actions were to occur, it would harm our reputation and cause our product sales and profitability to suffer and may prevent us from generating revenue. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with all applicable regulatory requirements which could result in our failure to produce our products on a timely basis and in the required quantities, if at all.

~~Moreover~~In addition, we ~~may~~are be required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our approved products, inand ~~the~~we ~~EEA. We~~ must comply with medical device reporting requirements, including the reporting of adverse events and malfunctions related to our products. Later discovery of previously unknown problems with ~~our~~such products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as QSR, may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of certification, ~~regulatory clearances~~ or ~~approvals~~regulatory approval, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.

Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA or comparable foreign regulatory authorities, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or comparable foreign regulatory authorities, could have a negative impact on us.37

~~As a commercial-stage company~~Moreover, we ~~are~~may ~~subject~~be required to ~~the~~conduct ~~FDA’s~~costly ~~medical~~post-market ~~device~~testing ~~reporting regulations~~ and ~~similar~~surveillance ~~foreign regulations, which require us~~ to ~~report~~monitor to the ~~FDA~~safety ~~when we receive~~ or ~~become~~effectiveness ~~aware~~ of ~~information that reasonably suggests that one or more of~~ our products ~~may~~in ~~have caused or contributed~~the toEEA. aWe ~~death~~must orcomply ~~serious~~with ~~injury~~medical ordevice ~~malfunctioned~~reporting ~~in a way that~~requirements, ifincluding the ~~malfunction~~reporting ~~were~~of toadverse ~~recur,~~events itand ~~could~~malfunctions ~~cause~~related ~~or contribute~~ to ~~a death~~ orour ~~serious injury~~products. ~~The~~Later ~~timing~~discovery of ~~our~~previously ~~obligation~~unknown toproblems ~~report~~with isour ~~triggered~~products, byincluding ~~the~~unanticipated ~~date~~adverse weevents ~~become~~or ~~aware of the~~ adverse ~~event as well as the~~events ~~nature~~ of ~~the~~unanticipated ~~event.~~severity Weor ~~may~~frequency, ~~fail~~manufacturing toproblems, ~~report~~or ~~adverse~~failure ~~events~~to ofcomply ~~which~~with weregulatory ~~become~~requirements ~~aware within the prescribed timeframe. We~~ may ~~also~~result ~~fail~~in tochanges ~~recognize~~to ~~that~~labeling, werestrictions ~~have~~on ~~become~~such ~~aware~~products ofor amanufacturing ~~reportable adverse event~~processes, ~~especially~~withdrawal ifof itthe isproducts ~~not~~from ~~reported~~the tomarket, usvoluntary ~~as an adverse event~~ or ~~if it~~mandatory isrecalls, ana ~~adverse~~requirement ~~event~~to ~~that~~repair, isreplace ~~unexpected~~ or ~~removed~~refund ~~in time from~~ the ~~use~~cost of ~~the~~any ~~product.~~medical Ifdevice we ~~fail~~manufacture toor ~~comply~~distribute, ~~with our reporting obligations~~fines, ~~the~~ ~~FDA~~suspension ~~could take action~~of certification, ~~including~~regulatory ~~warning~~clearances ~~letters,~~or ~~untitled letters~~approvals, ~~administrative~~product ~~actions~~seizures, ~~criminal~~injunctions ~~prosecution,~~or the imposition of civil ~~monetary~~ ~~penalties,~~or ~~revocation~~criminal ofpenalties ~~our~~which would ~~device~~adversely ~~clearance~~affect orour ~~approval~~business, ~~seizure~~operating ofresults ~~our~~and ~~products or delay in clearance or approval of future products~~prospects.

~~The FDA and comparable foreign~~Our ~~regulatory~~products ~~authorities~~may ~~have~~cause ~~the~~or ~~authority~~contribute to ~~require~~adverse ~~the~~medical ~~recall~~events ~~of commercialized products in the event of material deficiencies~~ or ~~defects in~~be ~~design~~subject orto ~~manufacture~~failures ~~of a product~~ or inmalfunctions ~~the event~~ that awe ~~product~~are ~~poses~~required anto ~~unacceptable~~report ~~risk~~ to the ~~health. The~~ FDA’s ~~authority~~or ~~to require~~comparable aforeign ~~recall~~regulatory ~~must~~authorities, beand ~~based~~if onwe afail ~~finding~~to ~~that~~do ~~there~~so, iswe ~~reasonable~~would ~~probability~~be ~~that~~subject ~~the~~to ~~device~~sanctions that could ~~cause~~harm ~~serious~~our ~~injury or death.~~reputation, Webusiness, ~~may~~financial ~~also~~condition ~~choose~~and toresults ~~voluntarily~~of ~~recall~~operations. aThe ~~product~~discovery ifof ~~any~~serious ~~material~~safety ~~deficiency~~issues iswith ~~found.~~our Aproducts, ~~government-mandated~~ or ~~voluntary~~a recall byof usour ~~could~~products ~~occur~~either asvoluntarily ~~a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects, labeling~~ or ~~design deficiencies,~~at ~~packaging~~the ~~defects~~direction orof ~~other~~the ~~deficiencies~~FDA or ~~failures~~comparable toforeign ~~comply~~regulatory ~~with~~authorities, ~~applicable~~could ~~regulations.~~have ~~Product~~a ~~defects~~negative ~~or other errors~~impact ~~may~~on ~~occur in the future~~us.

~~Depending~~As a oncommercial-stage ~~the~~company, ~~corrective action~~ we ~~take~~are subject to ~~redress~~the ~~a product~~FDA’s ~~deficiencies~~medical ordevice ~~defects~~reporting regulations and similar foreign regulations, which require us to report to the FDA ~~may~~when ~~require,~~we receive or webecome aware of information that reasonably suggests that one or more of our products may ~~decide,~~have caused or contributed to a death or serious injury or malfunctioned in a way that, weif ~~will~~the ~~need~~malfunction were to ~~obtain~~recur, ~~new~~it ~~clearances~~could cause or ~~approvals~~contribute ~~for~~to ~~the~~a ~~device~~death ~~before~~or serious injury. The timing of our obligation to report is triggered by the date we ~~may~~become ~~market~~aware orof the ~~distribute~~adverse event as well as the ~~corrected~~nature ~~device~~of the event. ~~Seeking~~We ~~such~~may ~~clearances~~fail orto ~~approvals~~report ~~may~~adverse ~~delay~~events ~~our~~of which we become aware within the prescribed ~~ability~~timeframe. We may also fail to ~~replace~~recognize ~~the~~that ~~recalled~~we ~~devices~~have inbecome aware of a ~~timely~~reportable ~~manner.~~adverse ~~Moreover~~event, especially if weit dois not ~~adequately~~reported ~~address~~to us ~~problems~~as ~~associated~~an adverse event or if it is an adverse event that is unexpected or removed in time from the use of the product. If we fail to comply with our ~~devices~~reporting obligations, we ~~may~~the ~~face~~FDA ~~additional~~could ~~regulatory~~take ~~enforcement~~ action, including ~~FDA~~ warning letters, ~~product~~untitled ~~seizure~~letters, ~~injunctions~~administrative actions, criminal ~~administrative~~prosecution, imposition of civil monetary penalties, revocation of our device clearance or approval, seizure of our products or ~~civil~~delay in clearance or ~~criminal~~approval ~~fines~~of future products.

~~Companies~~The FDA ~~are~~and ~~required~~comparable toforeign ~~maintain certain~~regulatory ~~records~~authorities ofhave ~~recalls~~the ~~and~~authority ~~corrections,~~to ~~even~~require ifthe ~~they~~recall ~~are~~of ~~not~~commercialized ~~reportable~~products toin the ~~FDA.~~event Weof material ~~may~~deficiencies ~~initiate~~or ~~voluntary~~defects ~~withdrawals~~in design or ~~corrections for~~manufacture ~~our~~of ~~products~~a product or in the ~~future~~event that wea ~~determine~~product doposes ~~not~~an ~~require~~unacceptable ~~notification~~risk ofto ~~the~~health. The FDA.’s Ifauthority ~~the~~to ~~FDA~~require ~~disagrees~~a ~~with~~recall ~~our~~must ~~determinations, it~~be ~~could~~based ~~require~~on usa tofinding ~~report~~that ~~those~~there ~~actions~~is asreasonable ~~recalls~~probability ~~and~~that wethe ~~may~~device becould ~~subject~~cause serious toinjury ~~enforcement~~or ~~action~~death. AWe ~~future~~may also choose to voluntarily recall ~~announcement~~a ~~could harm~~product ~~our~~if ~~reputation~~any ~~with~~material ~~customers,~~deficiency ~~potentially~~is ~~lead~~found. toA ~~product~~government-mandated or ~~liability~~voluntary ~~claims~~recall ~~against~~by us ~~and~~could ~~negatively~~occur ~~affect~~as ~~our~~a ~~sales.~~result ~~Any~~of ~~corrective action,~~an ~~whether~~unacceptable ~~voluntary~~risk orto ~~involuntary~~health, ascomponent ~~well~~failures, asmalfunctions, ~~defending~~manufacturing defects, ~~ourselves~~labeling inor adesign ~~lawsuit~~deficiencies, ~~will~~packaging ~~require~~defects ~~the~~or ~~dedication~~other ofdeficiencies ~~our~~or ~~time~~failures ~~and~~to ~~capital, will~~comply ~~distract~~with ~~management~~applicable ~~from~~regulations. Product ~~operating~~defects ~~our~~or ~~business~~other ~~and~~errors may ~~harm~~occur ~~our~~in ~~reputation~~the ~~and financial results~~future.

42Depending on the corrective action we take to redress a product’s deficiencies or defects, the FDA may require, or we may decide, that we will need to obtain new clearances or approvals for the device before we may market or distribute the corrected device. Seeking such clearances or approvals may delay our ability to replace the recalled devices in a timely manner. Moreover, if we do not adequately address problems associated with our devices, we may face additional regulatory enforcement action, including FDA warning letters, product seizure, injunctions, administrative penalties or civil or criminal fines.

~~All manufacturers placing medical~~Companies ~~devices on the market in the EEA~~ are ~~legally~~required ~~bound~~ to ~~report~~maintain tocertain ~~the~~records ~~relevant~~of ~~competent~~recalls ~~authorities~~and ~~(a)~~corrections, ~~any~~even ~~serious~~if ~~incident~~they ~~involving devices~~are ~~made~~not ~~available~~reportable onto the ~~EEA~~FDA. ~~market,~~We ~~except~~may ~~expected~~initiate ~~side-effects~~voluntary withdrawals ~~which~~or ~~are~~corrections ~~clearly~~for ~~documented~~our inproducts ~~the product information and quantified~~ in the ~~technical~~future ~~documentation~~that ~~and~~we ~~are~~determine ~~subject~~do tonot ~~trend~~require ~~reporting,~~notification ~~and~~of ~~(b)~~the ~~any~~FDA. ~~field~~If ~~safety~~the ~~corrective~~FDA ~~action in respect of devices made~~disagrees ~~available~~with onour ~~the~~determinations, ~~EEA~~it ~~market,~~could ~~including~~require ~~any~~us ~~field~~to ~~safety~~report ~~corrective~~those ~~action~~actions ~~undertaken~~as inrecalls aand ~~third~~we ~~country~~may inbe ~~relation~~subject to aenforcement ~~device~~action. ~~which~~A future isrecall ~~also~~announcement ~~legally~~could ~~made~~harm ~~available~~our onreputation ~~the~~with ~~EEA market~~customers, ifpotentially ~~the~~lead ~~reason~~to ~~for~~product ~~the~~liability ~~field~~claims ~~safety~~against ~~corrective~~us ~~action~~and ~~is not limited to the device made~~negatively ~~available~~affect inour ~~the third country~~sales. ~~Reports~~Any ~~should~~corrective beaction, ~~submitted~~whether ~~through~~voluntary ~~the~~or ~~electronic~~involuntary, ~~system~~as ~~set~~well upas ~~and~~defending ~~managed~~ourselves ~~by the European Commission~~ in ~~collaboration~~a ~~with~~lawsuit, ~~EEA countries. Reports of serious incidents~~ will ~~be automatically transmitted to~~ require the ~~competent~~dedication ~~authority~~ of ~~the EEA~~our ~~country~~time ~~in which the incident occurred~~ and ~~reports~~capital, ~~on field safety corrections actions~~ will bedistract ~~automatically~~management ~~transmitted~~from tooperating ~~the~~our ~~competent authority~~business ofand ~~the~~may ~~EEA~~harm ~~country~~our inreputation ~~which the field safety corrective action is being or is to be undertaken~~ and ~~the EEA country in which~~financial ~~the manufacturer has its registered place of business~~results.

Under the EU MDR, a “serious incident” means any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person; (b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health; or (c) a serious public health threat. A “field safety corrective action” means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.38

~~Malfunction~~All manufacturers ofplacing ~~our~~medical ~~products~~devices ~~could result~~on inthe ~~future~~market ~~voluntary~~in ~~corrective~~the ~~actions,~~EEA ~~such~~are aslegally ~~recalls,~~bound ~~including~~to ~~corrections,~~report orto ~~customer~~the ~~notifications,~~relevant orcompetent ~~agency~~authorities ~~action, such~~(a) asany ~~inspection~~serious orincident ~~enforcement~~involving ~~actions.~~devices Ifmade ~~malfunctions~~available doon ~~occur~~the EEA market, weexcept ~~may~~expected beside-effects ~~unable~~which toare ~~correct~~clearly documented in the ~~malfunctions~~product ~~adequately~~information orand ~~prevent~~quantified ~~further malfunctions,~~ in ~~which~~the ~~case~~technical wedocumentation ~~may~~and ~~need~~are subject to ~~cease~~trend ~~manufacture~~reporting, and ~~distribution~~(b) any field safety corrective action in respect of devices made available on the ~~affected~~EEA ~~products~~market, ~~initiate~~including ~~voluntary~~any ~~recalls,~~field ~~and~~safety corrective action undertaken in a third country ~~redesign~~in ~~the~~relation ~~products.~~to ~~Regulatory~~a ~~authorities~~device ~~may~~which is also ~~take~~legally ~~actions~~made ~~against~~available ~~us,~~on ~~such~~the asEEA ~~ordering recalls~~market, ~~imposing~~if ~~fines,~~the orreason ~~seizing~~for the ~~affected~~ ~~products.~~field ~~Any~~safety corrective action, is ~~whether~~not ~~voluntary~~limited orto ~~involuntary,~~the device made available in the third country. Reports should be submitted through the electronic system set up and managed by the European Commission in collaboration with EEA countries. Reports of serious incidents will ~~require~~be automatically transmitted to the ~~dedication~~competent authority of ~~our~~the ~~time~~EEA country in which the incident occurred and ~~capital,~~reports ~~distract~~on field safety corrections actions will be ~~management~~automatically ~~from~~transmitted ~~operating~~to ~~our~~the ~~business,~~competent ~~and~~authority ~~may~~of ~~harm~~the ~~our~~EEA ~~reputation~~country in which the field safety corrective action is being or is to be undertaken and ~~financial~~the ~~results~~EEA country in which the manufacturer has its registered place of business.

~~Our~~Under the ~~approved~~EU ~~product~~MDR, a “serious incident” means any incident that directly or ~~product~~indirectly ~~candidates~~led, ~~may~~might have led or might lead to any inof the ~~future~~following: be(a) ~~subject~~the todeath ~~product~~of ~~recalls~~a ~~that~~patient, ~~could~~user ~~harm~~or ~~our~~other ~~reputation~~person; (b) the temporary or permanent serious deterioration of a patient’s, user’s ~~business~~or ~~and~~other ~~financial~~person’s ~~results~~state of health; or (c) a serious public health threat. A “field safety corrective action” means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.

~~Medical~~Malfunction of ~~devices~~our ~~can~~products ~~experience performance~~could ~~problems~~result in ~~the~~future ~~field~~voluntary ~~that~~corrective ~~require~~actions, ~~review~~such ~~and~~as ~~possible~~recalls, ~~corrective~~including ~~action.~~corrections, ~~The~~or ~~occurrence~~customer ~~of component failures~~notifications, ~~manufacturing~~ ~~errors,~~or ~~software~~agency ~~errors~~action, ~~design~~such ~~defects~~as inspection or ~~labeling~~enforcement ~~inadequacies~~actions. ~~affecting~~If amalfunctions ~~medical~~do ~~device~~occur, ~~could~~we ~~lead~~may be unable to acorrect ~~government-mandated~~the ormalfunctions ~~voluntary~~adequately ~~recall~~or byprevent ~~the~~further ~~device manufacturer~~malfunctions, in ~~particular~~which ~~when~~case ~~such~~we ~~deficiencies~~ may ~~endanger~~need ~~health.~~to ~~The~~cease ~~FDA~~manufacture ~~requires~~and ~~that~~distribution ~~certain classifications~~ of ~~recalls be reported to~~ the ~~FDA~~affected ~~within~~products, 10initiate ~~working~~voluntary recalls, ~~days~~and ~~after~~redesign the ~~recall is initiated~~products. ~~Comparable~~Regulatory ~~foreign regulatory~~ authorities ~~impose similar~~may ~~deadlines.~~also ~~Companies~~take ~~are~~actions ~~required~~against tous, ~~maintain~~such ~~certain~~as ~~records~~ordering of recalls, ~~even~~imposing iffines, or ~~they~~seizing ~~are not reportable to~~ the ~~FDA~~affected ~~or to comparable foreign regulatory authorities~~products. WeAny ~~may~~corrective ~~initiate~~action, whether voluntary ~~recalls~~or ~~involving~~involuntary, ~~our~~will ~~products~~require in the ~~future~~dedication ~~that we determine do not require notification~~ of ~~the FDA. If the FDA disagrees with~~ our ~~determinations,~~time ~~they could require us to report those actions as recalls. Product~~and ~~recalls~~capital, ~~may~~distract ~~divert~~ management ~~attention~~from ~~and~~operating ~~financial~~our ~~resources~~business, ~~expose~~and usmay ~~to product liability or other claims,~~ harm our reputation ~~with customers~~ and ~~adversely impact our business,~~ financial ~~condition and~~ results ~~of operations~~.

WeOur approved ~~may~~product beor ~~subject~~product tocandidates ~~regulatory~~may orin ~~enforcement actions~~the iffuture webe ~~engage~~subject into ~~improper~~product ~~marketing~~recalls orthat ~~promotion~~could ofharm our ~~approved~~reputation, ~~product~~business orand ~~product candidates~~financial results.

~~Our~~Medical devices ~~educational~~can ~~and~~experience ~~promotional activities~~performance ~~and~~problems ~~training~~in ~~methods~~the ~~must~~field ~~comply~~that ~~with~~require ~~FDA~~review and ~~other~~possible ~~applicable~~corrective ~~laws~~action. The occurrence of component failures, ~~including~~manufacturing ~~the~~errors, ~~prohibition~~software oferrors, ~~the~~design ~~promotion~~defects ofor alabeling ~~medical device~~inadequacies ~~for~~affecting a ~~use~~medical ~~that~~device ~~has~~could ~~not~~lead ~~been~~to ~~cleared~~a government-mandated or ~~approved~~voluntary recall by the ~~FDA.~~device ~~Use~~manufacturer, ofin aparticular ~~device~~when ~~outside~~such ofdeficiencies ~~its~~may ~~cleared~~endanger orhealth. ~~approved~~The ~~indications~~FDA isrequires ~~known~~that certain asclassifications ~~“off-label”~~of ~~use.~~recalls ~~Physicians~~be ~~may~~reported ~~use~~to ~~our~~the ~~products~~FDA ~~off-label~~within in10 ~~their~~working ~~professional~~days ~~medical~~after ~~judgment,~~the asrecall ~~the~~is ~~FDA~~initiated. ~~does~~Comparable ~~not~~foreign regulatory ~~restrict~~authorities orimpose ~~regulate~~similar adeadlines. ~~physician’s~~Companies ~~choice~~are ofrequired ~~treatment~~to ~~within~~maintain ~~the~~certain ~~practice~~records of ~~medicine. However~~recalls, even if they are not reportable to the FDA ~~determines~~or ~~that~~to ~~our educational~~comparable ~~and~~foreign ~~promotional~~regulatory ~~activities~~authorities. orWe ~~training~~may ~~constitutes~~initiate ~~promotion~~voluntary ofrecalls aninvolving ~~off-label~~our ~~use,~~products itin ~~could~~the ~~request~~future that we ~~modify~~determine ~~our~~do ~~training or~~not ~~promotional~~require ~~materials~~notification orof ~~subject~~the FDA. If the FDA disagrees with our determinations, they could require us to ~~regulatory~~report orthose actions ~~enforcement~~as ~~actions,~~recalls. ~~including~~Product ~~the~~recalls ~~issuance~~may ofdivert ~~warning~~management ~~letters,~~attention ~~untitled~~and ~~letters, fines,~~financial ~~penalties~~resources, ~~injunctions,~~expose us to product liability or ~~seizures~~other claims, ~~any~~harm ofour ~~which~~reputation ~~could~~with ~~have~~customers anand ~~adverse~~adversely impact on our ~~reputation~~business, ~~and~~ financial condition and results of operations.

43We may be subject to regulatory or enforcement actions if we engage in improper marketing or promotion of our approved product or product candidates.

~~It is also possible that other~~Our ~~federal, state or comparable foreign regulatory authorities might take action if they consider our~~ educational and promotional activities or and training methods tomust ~~constitute~~comply ~~promotion~~with ofFDA anand ~~off-label~~other ~~use~~applicable laws, ~~which~~including ~~could~~the ~~result in significant fines or penalties under other statutory~~prohibition ~~authorities,~~of ~~such~~the aspromotion ~~laws~~of ~~prohibiting~~a ~~false~~medical ~~claims~~device for ~~reimbursement.~~a Inuse that ~~event,~~has ~~our~~not ~~reputation~~been ~~could~~cleared beor ~~damaged,~~approved ~~and~~by ~~adoption of~~ the ~~products could be impaired~~FDA. ~~Although~~Use ~~our~~of ~~policy~~a isdevice tooutside ~~refrain~~of ~~from~~its ~~statements~~cleared or ~~that~~approved ~~could~~indications beis ~~considered~~known as “off-label” ~~promotion~~use. ofPhysicians ~~our products,~~may ~~the~~use ~~FDA~~our orproducts ~~comparable foreign regulatory authorities could disagree and conclude that we have engaged in~~ off-label ~~promotion. It~~in istheir ~~also~~professional ~~possible that other federal~~medical judgment, ~~state~~as orthe ~~comparable~~FDA ~~foreign~~does ~~regulatory~~not ~~authorities~~restrict ~~might~~or ~~take~~regulate ~~action,~~a ~~including,~~physician’s ~~but~~choice ~~not~~of ~~limited to,~~treatment ~~through~~within athe ~~whistleblower~~practice ~~action~~of ~~under~~medicine. ~~the FCA~~However, if ~~they~~the ~~consider~~FDA determines that our ~~business~~educational and promotional activities ~~constitute~~or training constitutes promotion of an off-label use, ~~which could~~it ~~result in significant penalties, including, but not limited to, criminal, civil or administrative penalties, treble damages, fines,~~could ~~disgorgement,~~request ~~exclusion~~that ~~from participation in government healthcare programs, reporting requirements and compliance oversight if~~ we ~~become subject~~modify toour atraining ~~corporate~~or ~~integrity~~promotional ~~agreement~~materials or ~~similar~~subject ~~agreement~~us to ~~resolve~~regulatory ~~allegations~~or ofenforcement ~~non-compliance with these laws~~actions, ~~and~~including the ~~curtailment~~issuance ~~or restructuring~~ of ~~our~~warning ~~operations.~~letters, Inuntitled ~~addition~~letters, ~~the~~fines, ~~off-label~~penalties, ~~use~~injunctions, ofor ~~our~~seizures, ~~products~~any ~~may increase the risk~~ of ~~product~~which ~~liability~~could ~~claims. Product~~have ~~liability~~an ~~claims~~adverse ~~are~~impact ~~expensive~~on ~~to defend and could divert~~ our ~~management’s attention, result in substantial damage awards~~reputation ~~against us,~~ and ~~harm~~financial ~~our reputation~~results.

The advertising and promotion of our products in the EEA is subject to EEA countries’ national laws implementing Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other national legislation of individual EEA country governing the advertising and promotion of medical devices. EEA country legislation may also restrict or impose limitations on our ability to advertise our products directly to the general public. In addition, voluntary EU and national Codes of Conduct provide guidelines on the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare professionals.39

WeIt is ~~face~~also ~~extensive~~possible that other federal, ~~ongoing~~state or comparable foreign regulatory ~~requirements~~authorities might take action if they consider our educational and ~~review~~promotional activities or training methods to constitute promotion of an off-label use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement. In that event, our reputation could be damaged, and adoption of the products could be impaired. Although our policy is to refrain from statements that could be considered off-label promotion of our products, ~~may~~the ~~face~~FDA ~~future~~or ~~development~~comparable foreign regulatory authorities could disagree and conclude that we have engaged in off-label promotion. It is also possible that other federal, state or comparable foreign regulatory ~~difficulties~~authorities might take action, including, but not limited to, through a whistleblower action under the FCA, if they consider our business activities constitute promotion of an off-label use, which could result in significant penalties, including, but not limited to, criminal, civil or administrative penalties, treble damages, fines, disgorgement, exclusion from participation in government healthcare programs, reporting requirements and compliance oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations. In addition, the off-label use of our products may increase the risk of product liability claims. Product liability claims are expensive to defend and could divert our management’s attention, result in substantial damage awards against us, and harm our reputation.

The advertising ~~holder~~and promotion of anour ~~approved~~products ~~PMA, de~~in ~~novo~~the ~~authorization,~~EEA ~~or cleared 510(k)~~ is subject to ~~obligations~~EEA tocountries’ ~~monitor~~national ~~and~~laws ~~report~~implementing ~~adverse~~Directive ~~events~~2006/114/EC concerning misleading and ~~instances~~comparative ofadvertising, ~~the~~and ~~failure~~Directive of2005/29/EC on unfair commercial practices, as well as other national alegislation ~~product~~of toindividual ~~meet~~EEA country governing the ~~specifications~~advertising inand ~~the~~promotion ~~marketing~~of ~~application~~medical devices. ~~Application~~EEA ~~holders~~country ~~must~~legislation ~~submit~~may ~~new~~also restrict or ~~supplemental~~impose ~~applications~~limitations ~~and obtain~~on ~~FDA~~our ~~approval~~ability ~~for~~to ~~certain~~advertise ~~changes~~our products directly to the ~~approved~~general ~~product,~~public. ~~product~~In ~~labeling~~addition, orvoluntary ~~manufacturing~~EU ~~process.~~and ~~Legal~~national Codes ~~requirements~~of ~~have~~Conduct ~~also been~~provide ~~enacted~~guidelines toon ~~require~~the ~~disclosure~~advertising and promotion of ~~clinical~~our ~~trial~~products ~~results~~to the general public and may impose limitations on ~~publicly~~our ~~available~~promotional ~~databases~~activities with healthcare professionals.

InWe face ~~addition~~extensive, ~~manufacturers~~ongoing ~~of FDA~~regulatory ~~regulated~~requirements ~~products~~ and ~~their facilities are subject to continual~~ review ~~and periodic inspections by the FDA and comparable foreign regulatory authorities for compliance with the FDA’s QSR and~~, ~~as applicable, cGMP regulations. Our relationships with healthcare providers, physicians~~ and ~~third-party~~our ~~payors must comply with FDA laws and regulations, the AKS, the FCA, HIPAA, various transparency laws, and similar state and foreign laws. If~~ products ~~are~~may ~~made~~face ~~available~~future todevelopment ~~authorized users of the Federal Supply Schedule of the General Services Administration~~ and to low-income patients of certain hospitals, additional laws and requirements apply. Our activities are also potentially subject to federal and state consumer protection and unfair competition laws. If we or our third-party collaborators fail to comply with applicable regulatory ~~requirements, a regulatory authority may take any of the following actions:~~difficulties.

●The holder ~~conduct~~of an ~~investigation~~approved ~~into~~PMA, ~~our~~de ~~practices~~novo ~~and~~authorization, ~~any~~or ~~alleged~~cleared ~~violation~~510(k) ofis ~~law;~~subject ●to ~~issue~~obligations ~~warning~~to ~~letters~~monitor orand ~~untitled~~report ~~letters~~adverse ~~asserting~~events ~~that~~and instances ~~we are in violation~~ of the ~~law;~~failure ●of ~~seek~~a anproduct ~~injunction~~to ormeet ~~impose~~the ~~civil~~specifications orin ~~criminal~~the ~~penalties~~marketing orapplication. ~~monetary~~Application ~~fines;~~holders ●must ~~suspend~~submit ornew ~~withdraw certification~~ or supplemental ~~regulatory approval; ● require that we suspend or terminate any ongoing clinical trials; ● refuse to approve pending~~ applications orand ~~supplements~~obtain toFDA ~~applications~~approval ~~filed~~for bycertain ~~us;~~changes ~~● suspend or impose restrictions on operations, including costly new manufacturing requirements; ● seize or detain products, refuse~~ to ~~permit~~ the ~~import~~approved ~~or export of products~~product, ~~or require us to initiate a~~ product ~~recall;~~labeling, or ●manufacturing ~~exclude~~process. Legal usrequirements ~~from~~have ~~providing~~also ~~our~~been ~~products~~enacted to ~~those~~require ~~participating~~disclosure inof ~~government~~clinical ~~health~~trial ~~care~~results ~~programs,~~on ~~such~~publicly asavailable ~~Medicare and Medicaid, and refuse to allow us to enter into supply contracts, including government contracts~~databases.

44In addition, manufacturers of FDA regulated products and their facilities are subject to continual review and periodic inspections by the FDA and comparable foreign regulatory authorities for compliance with the FDA’s QSR and, as applicable, cGMP regulations. Our relationships with healthcare providers, physicians and third-party payors must comply with FDA laws and regulations, the AKS, the FCA, HIPAA, various transparency laws, and similar state and foreign laws. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration and to low-income patients of certain hospitals, additional laws and requirements apply. Our activities are also potentially subject to federal and state consumer protection and unfair competition laws. If we or our third-party collaborators fail to comply with applicable regulatory requirements, a regulatory authority may take any of the following actions:

~~The~~● ~~occurrence~~conduct ofan investigation into our practices and any alleged violation of law; ● issue warning letters or untitled letters asserting that we are in violation of the ~~foregoing events~~law; ● seek an injunction or impose civil or criminal penalties ~~may~~or ~~force~~monetary usfines; to● ~~expend~~suspend ~~significant~~or ~~amounts~~withdraw ofcertification ~~time~~or ~~and~~regulatory ~~money~~approval; ~~and~~● ~~may~~require ~~significantly~~that ~~inhibit~~we ~~our~~suspend ~~ability~~or terminate any ongoing clinical trials; ● refuse to ~~bring~~approve pending applications or supplements to ~~market~~ applications filed by us; ● suspend or ~~continue~~impose restrictions on operations, including costly new manufacturing requirements; ● seize or detain products, refuse to ~~market~~permit the import or export of products, or require us to initiate a product recall; or ● exclude us from providing our products to those participating in government health care programs, such as Medicare and ~~generate~~Medicaid, ~~revenue.~~and ~~Similar~~refuse ~~regulations~~to ~~apply~~allow inus ~~foreign~~to ~~jurisdictions~~enter into supply contracts, including government contracts.

~~Risks Related to the Discovery and Development of Our Product Candidates~~40

WeThe occurrence ~~are~~of ~~heavily~~any ~~dependent~~of on the ~~success~~foregoing ofevents ~~our product~~or ~~candidates,~~penalties ~~which~~may ~~are~~force inus ~~various~~to ~~stages~~expend significant amounts of ~~clinical~~time ~~development.~~and Wemoney ~~cannot~~and ~~give~~may ~~any~~significantly inhibit ~~assurance~~our ~~that~~ability ~~any~~to ofbring ~~our~~to ~~product~~market ~~candidates will~~or ~~receive~~continue ~~certification~~to ormarket ~~regulatory~~our ~~approval,~~products ~~which~~and isgenerate ~~necessary~~revenue. ~~before~~Similar ~~they~~regulations ~~can~~apply bein ~~commercialized~~foreign jurisdictions.

~~To date,~~Risks weRelated ~~have invested substantially all of our efforts and financial resources~~ to ~~design~~the ~~and~~Discovery ~~develop our product candidates, including conducting clinical trials~~ and ~~providing~~Development ~~general~~of ~~and administrative support for these operations.~~ Our ~~future~~Product ~~success is dependent on our ability to successfully develop, obtain regulatory certification or approval for, and then successfully commercialize one or more product candidates.~~Candidates

~~Several~~We ofare ~~our~~heavily ~~product~~dependent ~~candidates~~on ~~are in~~ the ~~early~~success ~~stages~~ of ~~development~~our and will require additional clinical development (and in some cases additional preclinical development), management of nonclinical, clinical and manufacturing activities, certification or regulatory approval, obtaining adequate manufacturing supply, building of a commercial organization and significant marketing efforts before we generate any revenue from product ~~sales. To date~~candidates, wewhich ~~have~~are ~~conducted 3 pilot clinical trials involving 198 patients with bronchiolitis (mainly caused by RSV) and a pilot clinical trial~~ in ~~nine~~various ~~patients~~stages ~~with~~of ~~CF. In addition, Rambam healthcare campus in Israel conducted a compassionate treatment for two patients with CF who suffer from NTM infections (specifically M. abscessus). Additionally, two pilot~~ clinical ~~trials were completed in 2022, one in viral pneumonia and one in NTM lung infection~~development. ~~Both~~We ofcannot ~~these~~give ~~studies were using our LungFit® system (PRO and GO, respectively).~~any ~~Although~~assurance ~~the~~that ~~results~~any of ~~these trials demonstrated improvements in various endpoints and clinical outcomes which we believe support~~ our ~~efforts~~ ~~towards~~product ~~obtaining~~candidates ~~FDA approval, these trials were small and conducted outside the US, so it is unlikely that the FDA~~ will ~~view them~~receive as significant because of their size and scope. Therefore, we intend to conduct larger clinical trials aiming for statistically and clinically significant favorable results, or we will not be able to obtain certification or regulatory approval, towhich ~~market~~is ~~such~~necessary ~~product candidates. It may be some time~~ before athey ~~pivotal trial is initiated, if at all, for such product candidates. Before a medical device clinical trial~~ can be ~~undertaken in the U.S., the sponsor of the trial must submit an IDE application for a medical device and the FDA must permit~~ ~~the trial to go forward~~commercialized. We cannot assure that we will obtain such agency acquiescence in a timely manner, or at all. In addition to our respiratory program using the LungFit® device, we have programs in Cancer and Autism which require significant further development before submission to the FDA.

~~Although~~To ~~we received approval of LungFit® PH from the FDA~~date, we ~~can~~have ~~make~~invested nosubstantially ~~assurances~~all asof toour ~~what~~efforts ~~any~~and ~~other~~financial ~~comparable~~resources ~~foreign~~to ~~regulatory authorities~~design and ~~notified~~develop ~~bodies~~our ~~where~~product wecandidates, ~~are seeking certification or regulatory approval will do. We are expending significant resources~~including toconducting ~~commercialize~~clinical ~~LungFit®~~trials PHand inproviding ~~the~~general ~~U.S.~~ and weadministrative ~~can~~support ~~make~~for nothese ~~assurances that our efforts will be successful~~operations. WeOur ~~cannot~~future ~~be certain~~success ~~that~~is ~~any~~dependent of on our ~~product~~ability ~~candidates~~to ~~will~~successfully bedevelop, ~~successful~~obtain inregulatory ~~clinical trials or receive~~ certification or ~~regulatory~~ approval. ~~Further~~for, ~~our~~ ~~product~~and ~~candidates~~then ~~may~~successfully ~~not~~commercialize ~~receive~~one ~~certification~~ or ~~regulatory approval even if they are successful in clinical trials. If we do not~~more ~~receive certification or regulatory approvals for our other~~ product candidates~~, we may not be able to continue our operations~~.

45Several of our product candidates are in the early stages of development and will require additional clinical development (and in some cases additional preclinical development), management of nonclinical, clinical and manufacturing activities, certification or regulatory approval, obtaining adequate manufacturing supply, building of a commercial organization and significant marketing efforts before we generate any revenue from product sales. To date, we have conducted 3 pilot clinical trials involving 198 patients with bronchiolitis (mainly caused by RSV) and a pilot clinical trial in nine patients with CF. In addition, Rambam healthcare campus in Israel conducted a compassionate treatment for two patients with CF who suffer from NTM infections (specifically M. abscessus). Additionally, two pilot clinical trials were completed in 2022, one in viral pneumonia and one in NTM lung infection. Both of these studies were using our LungFit® system (PRO and GO, respectively). Although the results of these trials demonstrated improvements in various endpoints and clinical outcomes which we believe support our efforts towards obtaining FDA approval, these trials were small and conducted outside the US, so it is unlikely that the FDA will view them as significant because of their size and scope. Therefore, we intend to conduct larger clinical trials aiming for statistically and clinically significant favorable results, or we will not be able to obtain certification or regulatory approval to market such product candidates. It may be some time before a pivotal trial is initiated, if at all, for such product candidates. Before a medical device clinical trial can be undertaken in the U.S., the sponsor of the trial must submit an IDE application for a medical device and the FDA must permit the trial to go forward. We cannot assure that we will obtain such agency acquiescence in a timely manner, or at all. In addition to our respiratory program using the LungFit® device, we have programs in Cancer and Autism which require significant further development before submission to the FDA.

~~We generally~~Although ~~plan~~we toreceived ~~seek~~approval ~~certification~~of orLungFit® ~~regulatory~~PH ~~approval~~from tothe ~~commercialize~~FDA, ~~our~~we ~~approved~~can ~~product~~make ~~and~~no ~~product~~assurances ~~candidates~~as into ~~the~~what ~~U.S.,~~any ~~the~~other EUcomparable ~~and~~foreign regulatory inauthorities ~~additional~~and ~~foreign~~notified ~~countries,~~bodies aswhere ~~applicable.~~we Toare ~~obtain~~seeking certification or regulatory ~~approvals~~approval wewill ~~must~~do. ~~comply~~We ~~with~~are ~~the~~expending ~~numerous~~significant ~~and varying~~resources ~~regulatory~~to ~~requirements~~commercialize ofLungFit® ~~such~~PH ~~countries~~in ~~regarding~~the ~~safety,~~U.S. ~~efficacy,~~and ~~chemistry,~~we ~~manufacturing~~can ~~and~~make ~~controls,~~no ~~clinical~~assurances ~~trials,~~that ~~commercial sales,~~our ~~pricing~~efforts ~~and~~will ~~distribution~~be ofsuccessful. ~~our~~We ~~approved~~cannot be ~~product~~certain ~~and~~that ~~product~~any ~~candidates.~~of ~~Even~~our ifproduct wecandidates ~~are~~will

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