UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-K

☒	Annual report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934

For the fiscal year ended December 31, ~~2024~~2025

☐	Transition report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934

For the transition period from _______ to _________

Commission File No. 001-33624

SINTX Technologies, Inc.

(Exact name of registrant as specified in its charter)

Delaware

84-1375299

(State or other jurisdiction of

incorporation or organization)

(IRS Employer

Identification No.)

1885 West 2100 South, Salt Lake City, UT 84119

(Address of principal executive offices and Zip Code)

(801) 839-3500

(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, $0.01 par value		SINT		The ~~NASDAQ~~Nasdaq Capital Market

Securities registered under Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. 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 and post 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 ☒

The aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter was $37,~~592~~651,~~025~~741.

The number of shares outstanding of the registrant’s common stock, $0.01 par value per share, as of March 1113, ~~2025~~2026 was 24,~~515~~121,~~179~~727.

DOCUMENTS INCORPORATED BY REFERENCE:

None

TABLE OF CONTENTS

Item Number and Caption		Page
PART I		6
Item 1.	Business	6
Item 1A.	Risk Factors	2119
Item 1B.	Unresolved Staff Comments	3935
Item 1C.	Cybersecurity	3935
Item 2.	Properties	3935
Item 3.	Legal Proceedings	3935
Item 4.	Mine Safety Disclosures	3935
PART II		4036
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	4036
Item 6.	Reserved	4036
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	4137
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	5146
Item 8.	Financial Statements and Supplementary Data	5146
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	5146
Item 9A.	Controls and Procedures	5146
Item 9B.	Other Information	5247
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.	5247
PART III		5348
Item 10.	Directors, Executive Officers and Corporate Governance	5348
Item 11.	Executive Compensation	5954
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	6460
Item 13.	Certain Relationships and Related Transactions, and Director Independence	6561
Item 14.	Principal Accountant Fees and Services	6662
PART IV		6763
Item 15.	Exhibits and Financial Statement Schedules	6763
Item 16.	Form 10-K Summary	7166
Signatures		7267
Index to Consolidated Financial Statements		F-1

CAUTIONARY NOTE CONCERNING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical fact are forward-looking statements. SINTX Technologies, Inc. (“we”,” “us”, ” “ourselves”,” “the “Company”) has tried to identify forward-looking statements by using words such as “believe,” “may,” “might,” “could,” “should,” “will,” “aim,” “project,” “target,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and similar words. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly and annual results, our ability to manage our growth, our ability to achieve and sustain profitability, demand for our products, our ability to compete successfully, our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changes and applicable laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, and general economic conditions, and other risks set forth throughout this Annual Report, including under “Item 1, Business,” “Item 1A, Risk Factors,” and “Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and those discussed in other documents we file with the Securities and Exchange Commission (the “SEC”). Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this Annual Report speak only as of the date of this Annual Report. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

WHERE YOU CAN FIND MORE INFORMATION

We are subject to the informational requirements of the Exchange Act. Accordingly, we file periodic reports and other information with the SEC. We will make our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports available through our Internet site, https://investors.sintx.com/~~investorsv2/~~ as soon as reasonably practicable after electronically filing such materials with the SEC. They may also be obtained free of charge by writing to SINTX Technologies, Inc., Attn: Investor Relations, 1885 West 2100 South, Salt Lake City, UT 84119. In addition, copies of these reports may be obtained through the SEC’s website at www.sec.gov or by visiting the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549 or by calling the SEC at 800-SEC-0330.

Our common stock trades on ~~The~~the ~~NASDAQ~~Nasdaq Capital Market under the symbol “SINT.”

SUMMARY OF PRINCIPAL RISK FACTORS

Our business operations are subject to numerous risks, factors and uncertainties, including those outside of our control, that could cause our actual results to be harmed, including risks regarding the following:

Risks Related to Our Capital Resources and Impairments

	●	We will require additional financing and our failure to obtain additional funding would force us to delay, reduce or eliminate our product development programs or commercialization efforts.

	●	Raising additional capital by issuing securities or through debt financings or licensing arrangements may dilute existing stockholders, restrict our operations or require us to relinquish proprietary rights.

Risks Related to Our Business and Strategy

● We have incurred net losses since our inception and may never achieve or sustain profitability. ● Our success depends on our ability to successfully commercialize advanced ceramic products for biomedical, technical, and antipathogenic applications, which to date have experienced only limited market acceptance and which we may not be able to successfully commercialize. ● We may not be able to compete effectively against the larger, well-established companies that dominate these markets or emerging and small innovative companies seeking to increase their share of the market. ● We depend on our aerospace and biomedical customers’ ability to sell the products ~~they~~we manufacture. If our customers are not able to sell such products, our business and operating results will be adversely affected. ● If we are unable to manufacture our advanced ceramic products on a timely basis consistent with our quality standards, our results of operation will be adversely impacted. ● We depend on a limited number of third-party suppliers for key raw materials, and the loss of these third-party suppliers or their inability to supply us with adequate raw materials could harm our business. ● Part of our strategy is to establish and develop OEM partnerships and arrangements, which subjects us to various risks. ● If hospitals and other healthcare providers are unable to obtain coverage or adequate reimbursement for procedures performed with our products, it is unlikely our products will be widely used. ● Prolonged negative economic conditions in domestic and international markets may adversely affect us and could harm our financial position. ● We are dependent on our senior management team, engineering team, and external advisors, and the loss of any of them could harm our business. ● Cyber security risks and the failure to maintain the integrity of company, employee or guest data could expose us to business disruptions, data loss, litigation and liability, and our reputation and operating results could be significantly harmed.

Risks Related to Regulatory Approval of Our Products and Other Government Regulations

● Contracting with government entities exposes us to additional risks and regulatory requirements. ● We cannot be certain that we will be able to obtain regulatory clearance or approval and thereafter commercialize our biomedical or antipathogenic product candidates in a timely manner or at all. ● We have little experience conducting clinical trials, therefore, they may proceed more slowly than anticipated, and we cannot be certain that our product candidates will be shown to be safe and effective for human use. ● Our current and future relationships with third-party payers and current and potential customers in the United States and elsewhere may be subject, directly or indirectly, to various laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings. ● U.S. federal income tax reform could adversely affect us. ● Legislation may increase the difficulty and cost for us to obtain and monitor regulatory approval or clearance of our product candidates and affect the prices we may obtain for our products.

Risks Related to Our Intellectual Property and Litigation

● If our patents, trade secrets and contractual provisions are inadequate to protect our intellectual property, we may not be able to successfully commercialize our products or operate our business profitably. ● We have no patent protection covering the composition of matter for our solid silicon nitride or components of the related manufacturing process, and competitors may create formulations or processes substantially similar to ours. ● We could become subject to intellectual property litigation that could consume significant amounts of our resources and adversely affect our business and results of operations. ● We may be subject to damages resulting from claims that we have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition agreements with our competitors or non-solicitation agreements. ● If our advanced ceramic products or our product candidates’ conflict with the intellectual property rights of others, we may not be able to manufacture or market our products or product candidates.

Risks Related to Potential Litigation from Operating Our Business

●

We may become subject to potential product liability claims or claims relating to our improper handling, storage or disposal of biological or hazardous materials, which could be time consuming and costly.

Risks Related to Public Companies

● We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors. ● We may not be able to maintain our listing on the ~~NASDAQ~~Nasdaq Capital Market, which would adversely affect the price and liquidity of our common stock.

PART I

ITEM 1.

BUSINESS

Overview – SINTX Technologies

SINTX Technologies is an advanced ceramics company formed in December 1996, ~~focused~~that ondevelops, ~~providing~~manufactures, ~~biomedical~~and ~~solutions~~commercializes ~~for~~silicon ~~medical~~nitride biomaterials, composites, devices., Weand ~~have~~related ~~grown~~technologies ~~from~~for ~~focusing~~medical ~~primarily~~and onother ~~the research,~~high-value ~~development~~applications. ~~and~~SINTX ~~commercialization~~provides ofbiomedical solutions for medical devices ~~manufactured~~specializing ~~with~~in silicon nitride to(Si₃N₄) ~~becoming~~for anmusculoskeletal ~~advanced ceramics company engaged in diverse fields, including biomedical~~ and antipathogenic applications. We ~~This~~also ~~diversification~~manufacture ~~enables~~parts usmade tofrom ~~focus~~silicon onnitride ~~our~~for ~~core competencies~~customers ~~which~~in ~~are~~ the ~~manufacturing~~electrical, ~~research,~~aerospace and ~~development~~other ofindustrial ~~products~~sectors. ~~comprised~~SINTX ~~from~~is a ~~advanced~~global ~~ceramic~~leader ~~materials.~~in Wethe ~~seek~~research, ~~to connect with new customers~~development, ~~partners~~ and ~~manufacturers~~manufacturing toof ~~help~~silicon ~~them~~nitride, ~~realize~~and ~~the~~its ~~goal~~products ofhave ~~leveraging~~been ~~our~~implanted ~~expertise~~ in ~~advanced~~humans ~~ceramics~~since ~~to create new, innovative products across these sectors~~2008.

SINTX Core Business

Biomedical Applications: Since its inception, SINTX has been focused on medical grade silicon nitride. SINTX biomedical products have been shown to be biocompatible, bioactive, antipathogenic, and to have superb bone affinity. Spinal implants made from SINTX silicon nitride have been successfully implanted in humans since 2008 in the U.S., Europe, South America and Asia. This established use, along with its inherent resistance to bacterial adhesion and bone affinity suggests that it may also be suitable in other fusion device applications such as arthroplasty implants, foot wedges, and dental implants. ~~Bacterial~~More ~~infection~~recently, ofin ~~any~~October ~~biomaterial~~2025, ~~implants~~SINTX isreceived ~~always~~U.S. aFood ~~concern.~~and ~~SINTX~~Drug ~~silicon~~Administration (FDA) ~~nitride~~510(k) ~~has~~clearance ~~been~~for ~~shown~~the SiNAPTIC® Foot & Ankle Osteotomy Wedge System, enabling SINTX’s commercial entry into reconstructive tofoot beand ~~resistant~~ankle tosurgery ~~bacterial~~in ~~colonization~~the United States. These next-generation implants blend advanced biomaterials science with surgical precision and ~~biofilm~~are ~~formation,~~designed ~~making~~to itelevate ~~antibacterial~~standards in orthopedic procedures. SINTX silicon nitride products can be polished to a smooth and wear-resistant surface for articulating applications, such as bearings for hip and knee replacements.

We believe that silicon nitride has a superb combination of properties that make it suited for long-term human implantation. Other biomaterials are based on bone grafts, metal alloys, and polymers- all of which have well-known practical limitations and disadvantages. In contrast, silicon nitride has a legacy of success in the most demanding and extreme industrial environments. Bacterial infection of any biomaterial implants is always a concern. SINTX silicon nitride has been shown to be resistant to bacterial colonization and biofilm formation, making it antibacterial. As a human implant material, silicon nitride offers bone ingrowth, resistance to bacterial and viral infection, ease of diagnostic imaging, resistance to corrosion, and superior strength and fracture resistance, all of which claims are validated in our large and growing inventory of peer-reviewed, published literature reports. We believe that our versatile silicon nitride manufacturing expertise positions us favorably to introduce new and innovative devices in the medical and non-medical fields.

Antipathogenic Applications: Today, there is a global need to improve protection against pathogens in everyday life. SINTX believes that by incorporating its unique composition of silicon nitride antipathogenic powder into products such as face masks, drapes, filters, sutures, and wound care devices, it is possible to manufacture surfaces that inactivate pathogens, thereby limiting the spread of infection and disease. The discovery in 2020 that SINTX silicon nitride inactivates SARS-CoV-2, the virus which causes the disease COVID-19, has potentially opened new markets and applications for our material.

We presently manufacture advanced ceramic powders and components in our manufacturing facilities based in Salt Lake City, Utah. The SINTX Salt Lake City facility is registered with the FDA, is cGMP and ANVISA RDC 665 compliant, as well as being ISO 9001:2015, ISO 13485:2016 certified, and AS9100D certified. The Company’s products are primarily sold in the United States.

Our Products

Silicon Nitride

To control the quality, cost and availability of our silicon nitride products and product candidates, we operate our own silicon nitride manufacturing facility. Our 3130,~~000~~764 square foot corporate facility includes a 19,000 square foot FDA registered ISO 13485:2016 certified, and AS9100D certified manufacturing space. It is equipped with state-of-the-art powder processing, spray drying, pressing and computerized machining equipment, sintering furnaces, and other testing equipment that enables us to control the entire manufacturing process for our silicon nitride products and product candidates. All operations, with the exception of raw material production, are performed in-house. We purchase raw materials, consisting of silicon nitride ceramic powder and dopant chemical compounds, from several vendors which are ISO registered and approved by us. These raw materials are characterized and tested in accordance with our specifications and then blended to formulate our silicon nitride. We believe that there are multiple vendors that can supply us these raw materials, and we continually monitor the quality and pricing offered by our vendors to ensure high quality and cost-effective supply of these materials.

The chemical composition of our in-house formulation of silicon nitride and our processing and manufacturing experience allows us to produce silicon nitride in multiple distinct forms. This capability provides us with the ability to utilize our silicon nitride in a variety of ways depending on the intended application, which, together with our silicon nitride’s key characteristics, distinguishes us from other manufacturers of silicon nitride products.

We currently produce silicon nitride for use in our commercial products and product candidates in the following forms:

● Monolithic Solid Silicon Nitride. This form of silicon nitride is a fully dense, load-bearing solid which can be used for devices that require high strength, toughness, fracture resistance and low wear. Applications include medical devices – such as interbody spinal fusion implants and foot and ankle wedges – and non-medical such as electrical and aerospace components. ● Porous Silicon Nitride. While this form of silicon nitride has a chemical composition that is identical to that of our monolithic solid silicon nitride, this formulation has a porous structure, which is engineered to mimic cancellous bone, the spongy bone tissue that typically makes up the interior of human bones. Our porous silicon nitride has interconnected pores similar to that of cancellous bone ranging in size between about 90 and 600 microns~~, which is similar to that of cancellous bone~~. This form of silicon nitride can be used for the promotion of bone in-growth and attachment. We believe our porous silicon nitride can act as a substitute for the orthobiologics currently used to fill interbody devices ~~in an effort~~ to stimulate fusion, as a bone void filler, and as a porous scaffold for medical devices. ● Silicon Nitride Powder. We can produce silicon nitride powder that is osteogenic and antipathogenic. This powder can then be utilized to produce composites or coatings. ● Composites of Silicon Nitride and PEEK and PEKK. We have demonstrated that it is possible to compound our silicon nitride powder and the polymers PEEK (Polyether Ether Ketone) and PEKK (Polyether Ketone Ketone) and that the ensuing composite material maintains the bioactive properties of silicon nitride. We have engaged academic and commercial partners to assist us in developing this technology and have received NIH grants to assist in advancing this work. This composite material would allow the straightforward 3D printing of complex spine and CMF devices that would be more challenging to manufacture from silicon nitride alone. ● Silicon Nitride Coating. With a similar chemical composition as our other forms of silicon nitride, this form of silicon nitride can be applied as an adherent coating to metallic substrates, including cobalt-chromium, titanium and steel alloys, polymers, and ceramics. We believe applying an extremely thin layer of silicon nitride as a coating may provide a highly wear-resistant articulation surface, such as on femoral heads, which may reduce problems associated with metal or polymer wear debris. We also believe that the silicon nitride coating can be applied to devices that require firm fixation and functional connections between the device or implant and the surrounding tissue, such as hip stems and screws. The use of silicon nitride coating may also create an antibacterial, antiviral, and antifungal barrier between the device and the adjacent bone or tissue. We are currently evaluating several different coating technologies.

We believe we are the only FDA-registered and ISO 13485:2016 certified silicon nitride medical device manufacturing facility in the world, and the only provider of structural ceramics-based medical devices used for spinal fusion applications. ~~Silicon nitride is a chemical compound comprised of the element’s silicon and nitrogen, with the chemical formula Si3N4.~~

We believe our silicon nitride is ideal as an implant material and is superior to other biomaterials currently used in the spine implant market such as PEEK, allograft and autograft bone, metal and traditional oxide ceramics, none of which possess all of the favorable characteristics of silicon nitride:

● Promotes Bone Growth. Our silicon nitride is osteointegrative through its inherent surface topography and surface chemistry. The surface topography provides scaffolding for new bone growth. As a hydrophilic material, silicon nitride attracts protein cells and nutrients that stimulate osteoprogenitor cells to differentiate into osteoblasts, which are needed for optimal bone growth environments. Our silicon nitride has an inherent surface chemistry that favors bone formation and healing, much more so than PEEK and metals. These properties were highlighted in an in vivo study, where we measured the force required to separate devices from the spine after being implanted for three months, which indicates the quality of osteointegration. In the absence of bacteria, the force required to separate our silicon nitride from its surrounding bone was approximately three times that of PEEK, and nearly two times that of titanium. In the presence of bacteria, the force required to separate our silicon nitride from its surrounding bone was over five times that of titanium, while there was effectively no separation force required for PEEK, indicating essentially no osteointegration in a septic environment. ● Antibacterial. We have demonstrated in in vitro and in vivo studies that silicon nitride has inherent surface antibacterial properties, which reduce the risk of bacterial infection and biofilm in and around a silicon nitride device. PEEK, traditional ceramics, metals and bone do not have this bacterial resistance. These properties were highlighted in an in vitro study (Acta Biomater. 2012 Dec;8(12):4447-54. Doi: 10.1016/j.actbio.2012.07.038. Epub 2012 Jul 31.), where live bacteria counts were between 8 and 30 times lower on our silicon nitride than PEEK and up to 8 times lower on our silicon nitride than titanium. In addition to improving patient outcomes, we believe the antibacterial properties of our silicon nitride should make it an attractive biomaterial to hospitals and surgeons who are not reimbursed by third-party payers for the treatment of acute, implant-related infections. Additionally, silicon nitride is synthetic and, therefore, there is a lower risk of disease transmission through cross-contamination or of an adverse auto-immune response, sometimes associated with the use of allograft bone. ● Antiviral: Solid-surface inactivation of microbial pathogens has ancient roots; the Smith Papyrus (2600~2200 B.C.) described the use of copper surfaces to sterilize chest wounds and drinking water. Today, brass and bronze on doorknobs help prevent microbial spread in hospitals, and metal particles and surface coatings of selected metals are used in hygiene-sensitive environments, both as inactivators and adjuvants in inducing cellular immunity. Cellular toxicity limits these approaches because while the reactive oxygen radicals generated at metal surfaces efficiently kill bacteria and viruses, they also damage cells by oxidizing their proteins and lipids. Recent data have shown that silicon nitride surfaces are effective against several types of viruses. With surface-contact transmission of viral pathogens, particularly influenza, and the increasing use of consumer touchscreens in various retail industries, we believe that our material ~~has~~may have value to OEM partners focused on consumer glass-based surface coatings and treatments. We have filed a U.S. patent application on this effect. ● Antifungal: We have conducted preliminary studies which suggest that our silicon nitride may be effective against fungal microbes. Plant-based viruses, bacteria, and fungi affect some 15% of the world’s edible crops, or about 1 billion metric tons of edible produce annually, with an economic impact in the US and Canada alone estimated to be between $1.5 to $5.0 ~~Billion~~billion per year. The mycotoxins produced by these plant fungi have an overall negative impact on human health and longevity. The inorganic nature of silicon nitride may prove to be more beneficial than the use of petrochemical or organometallic fungicides which are known to have residual effects in soil, on plants, and in fruit. In 2025, we received the issuance of International Patent No. 7635292, which covers novel agricultural uses of our silicon nitride, particularly in plant protection and antimicrobial treatment. This patent, combined with issued U.S. Patent No. 11,591,217, creates a family of patents focused on addressing the antimicrobial agribiotech market. ● Imaging Compatible. Our silicon nitride interbody spinal fusion devices are semi-radiolucent, clearly visible in X-rays, and produce no distortion under MRI and no scattering under CT. These characteristics enable an exact view of the device for precise intra-operative placement and post-operative bone fusion assessment in spinal fusion procedures. These qualities provide surgeons with greater certainty of outcomes with our silicon nitride devices than with other biomaterials, such as PEEK and metals.

	●	Hard, Strong and Resistant to Fracture. Our silicon nitride is hard, strong and possesses superior resistance to fracture over traditional ceramics and greater strength than polymers currently on the market. For example, our silicon nitride’s flexural strength is more than five times that of PEEK and our silicon nitride’s compressive strength is over twenty times that of PEEK. Unlike PEEK interbody spinal fusion devices, we believe our silicon nitride interbody spinal fusion devices can withstand the forces exerted during implantation and daily activities over the long term.

	●	Resistant to Wear. We believe our silicon nitride joint implant product candidates could have higher resistance to wear than metal-on-cross-linked polyethylene and traditional oxide ceramic-on-cross-linked polyethylene joint implants, the two most commonly used total hip replacement implants. Wear debris associated with metal implants increases the risk of metal sensitivity and metallosis. It is a primary reason for early failures of metal and polymer articulating joint components.

	●	Non-Corrosive. Our silicon nitride does not have the drawbacks associated with the corrosive nature of metal within the body, including metal sensitivity and metallosis, nor does it result in the release of metal ions into the body. As a result, we believe our silicon nitride products will have lower revision rates and fewer complications than comparable metal and traditional oxide ceramic products.

We are leveraging our proprietary Silicon Nitride (SiN) and Polyether Ether Ketone (PEEK) formulation to advance AI designed 3D printing capabilities for Custom and Patient-Specific medical implants. This innovative material combination integrates the superior biocompatibility, osteointegration, and antimicrobial properties of ~~Silicon~~silicon ~~Nitride~~nitride with the strength, durability, and radiolucency of PEEK, resulting in next-generation implants that enhance mechanical performance, reduce infection risks, and improve imaging compatibility.

The demand for personalized implants is growing as surgeons seek optimized solutions tailored to individual patient anatomy, improving surgical outcomes and reducing complications. ~~Additionally,~~While ~~the~~demand for patient-matched implants continues to increase, regulatory ~~pathway~~pathways ~~for~~vary ~~custom~~depending on device classification and intended use. Many patient-specific ~~medical~~ devices isare ~~significantly~~reviewed ~~more~~under ~~streamlined than~~ traditional ~~premarket approval~~ 510(~~PMA~~k), De Novo, or ~~even~~PMA ~~510(k)~~pathways, depending ~~clearance~~on ~~routes~~risk classification. ~~Under~~Although ~~the~~ FDA’s ~~existing~~provides ~~framework,~~guidance ~~many~~regarding additive manufacturing and patient-matched devices, regulatory ~~implants~~requirements ~~can~~remain besubstantial ~~commercialized~~and ~~through~~may ~~the~~require extensive validation and, in some cases, clinical data. The Custom Device Exemption ~~(CDE)~~is available ~~pathway~~only orin ~~through~~limited ~~rapid~~circumstances ~~510(k)~~and ~~clearances,~~is ~~expediting~~not ~~market entry~~applicable ~~and~~to ~~adoption~~most commercially marketed patient-specific implants.

The benefits of AI designed 3D-printed SiN/PEEK implants extend across the entire healthcare ecosystem. For hospitals, these implants ~~can~~ may reduce hospital stays and operative times related to traditional ~~Custom~~custom implant manufacturing. It may also lower the costs associated with revision surgeries and improve patient satisfaction scores.

Physicians may benefit from ~~precision-engineered~~ implants ~~that~~designed ~~enhance~~to ~~surgical~~match ~~predictability~~patient anatomy and ~~performance,~~incorporate ~~minimizing~~radiolucent ~~intraoperative~~materials, ~~adjustments.~~which Ascan ~~well~~assist ~~as accurate~~with intraoperative visualization ~~placement~~using ofstandard ~~the~~imaging ~~implants~~modalities. ~~because~~Silicon ofnitride ~~radiolucency~~has ofbeen ~~SiN/PEEK.~~studied ~~Additionally~~for its material properties, ~~the~~including ~~Patients~~surface characteristics that may ~~experience~~inhibit ~~better functional~~bacterial ~~outcomes~~adhesion under laboratory conditions. However, ~~faster~~clinical outcomes, recovery times, and acomplication ~~reduced~~rates ~~risk~~depend on ofnumerous ~~complications~~factors, ~~due~~including topatient ~~the~~condition ~~antimicrobial~~and ~~nature~~surgical oftechnique, ~~Silicon Nitride~~ and the ~~superior~~Company ~~biomechanical~~makes ~~properties~~no guarantee of ~~the~~improved ~~SiN/PEEK~~outcomes ~~composite~~relative to other available materials.

With our ~~its~~ unique expertise and proprietary formulation and advanced manufacturing techniques of SiN/PEEK, we are well-positioned to capitalize on this rapidly expanding market, providing innovative solutions that meet the needs of healthcare providers and patients alike.

We and ~~a number of~~ independent third parties have conducted ~~extensive~~ biocompatibility, biomechanical, in ~~vivo~~vitro, and in ~~vitro~~vivo testing onof our silicon nitride composition to ~~establish~~support ~~its~~regulatory ~~safety~~submissions ~~and~~for ~~efficacy~~certain inof ~~support~~our ofdevices. ~~regulatory~~Additional ~~clearance~~testing ofhas ~~our~~been ~~biomaterial,~~performed on specific products and product candidates. WeFindings ~~have also~~from ~~completed~~laboratory, ~~additional~~animal, ~~testing~~and oflimited ~~our~~human ~~silicon~~clinical ~~nitride~~investigations ~~products~~have been described in peer-reviewed publications and ~~product~~scientific ~~candidates~~presentations. The results of this testing have been published in over 130 peer reviewed publications and presentations that include basic science studies, small- and large-animal data, and human clinical studies. WeWhile ~~believe~~these ~~that~~studies ~~our~~contribute ~~product~~to ~~development~~the ~~strategy~~scientific understanding isof ~~consistent~~silicon ~~with~~nitride ~~the~~as ~~manner~~a inbiomaterial, ~~which~~regulatory ~~other~~clearance ~~biomaterials~~and ~~have~~market ~~been successfully~~adoption ~~introduced~~depend ~~into~~on ~~the~~multiple ~~market~~factors, including demonstration of safety and ~~adopted~~performance asfor ~~the~~specific ~~standard~~indications ofand ~~care~~physician acceptance.

Our Competitive Strengths

We believe we can use our silicon nitride technology platform to become a leading advanced ceramic company and have the following principal competitive strengths:

● Sole Provider of Silicon Nitride Medical Devices. We believe we are the only company that designs, develops, manufactures and sells medical grade silicon nitride-based products. Due to its key characteristics, we believe our silicon nitride enables us to offer new and transformative products across multiple medical specialties. In addition, with the FDA clearance of our silicon nitride Valeo products and SiNAPTIC® Foot & Ankle Osteotomy Wedge System, we are the only company to develop and manufacture a ceramic for use in FDA cleared spinal fusion medical devices, and FDA cleared osteotomy wedges, in the United States. ● In-House Manufacturing Capabilities. We operate a 19,000 square foot manufacturing facility located at our corporate headquarters in Salt Lake City, Utah. This operation complies with the FDA’s quality system regulation, or QSR, and is certified under the International Organization for Standardization’s, or ISO, standard 13485:2016 for medical devices. This facility allows us to ~~rapidly~~ design and produce silicon nitride products while controlling the entire manufacturing process from raw material to finished components. ● Extensive Network of Scientific Collaborators. We have developed strong, multi-year, collaborative relationships with surgeons who have used our products. These surgeons have supported us in collecting clinical data on silicon nitride and on reporting the successful patient outcomes they have observed. We also have long standing relations with university laboratories in ~~Japan and~~ the USU.S. and participate in a European consortium on silicon nitride. ● Highly Experienced Management and Technical Advisory Team. Members of our management team have extensive experience in silicon nitride, ceramics, research and development, manufacturing and operations, product development, and launching of new silicon nitride products into multiple industries. We also collaborate with a network of leading technical advisors in the design, development and use of our silicon nitride products and product candidates.

Our Strategy

Our goal is to become a leading advanced ceramics company. Key elements of our strategy to achieve this goal are the following:

● Develop new silicon nitride manufacturing technologies. Our current manufacturing process has allowed us to successfully produce spinal implants for over 10 years. We have made advancements in our processes – including the purchase of new manufacturing equipment – which we have leveraged to develop new porous and textured implants~~. In 2021~~, ~~SINTX purchased new equipment for its research~~ and ~~development team to develop~~ new composite products of silicon nitride with rigid polymers and fabrics. We have received three NIH grants to develop 3D printed silicon nitride / polymer implantable medical devices. ● Apply our silicon nitride technology platform to new medical opportunities. We believe our biomaterial expertise, flexible manufacturing process, and strong intellectual property will allow us to transition currently available medical device products made of inferior biomaterials and manufacture them using silicon nitride and our technology platform to improve their characteristics. We are seeking partnerships to utilize our capabilities and manufacture products for medical OEM and private label partnerships. We see specific opportunities in markets such as foot and ankle, dental, maxillofacial, and arthroplasty. ● Develop new products with ~~anti-pathogenic~~antipathogenic properties, including inactivation of the SARS-CoV-2 virus, utilizing our silicon nitride technology. We have conducted ~~multiple~~ tests ~~over the last nine years~~ which have identified and verified the antipathogenic properties of our silicon nitride powders, fully dense components, and silicon nitride-containing composites. Our research has explored the fundamental mechanisms responsible for these antipathogenic properties with the objective of developing commercial products and revenue from them. We have several partnerships exploring opportunities in face masks, filters, wound care, and coatings. In 2025, the United States Patent and Trademark Office (“USPTO”) granted our patent application titled, “Antipathogenic Fibrous Materials.” This patent secures broad protection for our proprietary silicon nitride-based antipathogen platform. Additionally, in 2025, the USPTO issued a Notice of Allowance for our patent application containing method claims covering our antipathogenic fabric technology.

Market Opportunity

Biomedical

We believe our silicon nitride biomaterial technology platform provides us with numerous competitive advantages in the biomaterials market. We manufacture interbody spinal fusion devices for CTL Amedica and have approximately 32 years remaining of a 10-year exclusive right to continue to manufacture them for CTL Amedica. We are developing products on our own behalf and for third party manufacturers – including CTL – for use as components in spine, total hip and knee joint replacements, as well as dental, foot & ankle, and maxillofacial applications. We believe we can also utilize our silicon nitride technology platform to develop future products in additional medical markets.

We believe that the main drivers for growth within the medical device markets are the following:

● Introduction of New Technologies. Better performing and longer-lasting biomaterials, improved diagnostics, and advances in surgical procedures allow for surgical intervention earlier in the continuum of care and better outcomes for patients. We believe surgical options using better performing and longer-lasting biomaterials will gain acceptance among surgeons and ~~younger~~ patients and drive accelerated growth and increase the size of the spinal fusion and joint replacement markets. We are leveraging proprietary Silicon Nitride (SiN) and Polyether Ether Ketone (PEEK) formulation to advance AI designed 3D printing capabilities for Custom and Patient-Specific medical implants. This innovative material combination integrates the superior biocompatibility, osteointegration, and antimicrobial properties of ~~Silicon~~silicon ~~Nitride~~nitride with the strength, durability, and radiolucency of PEEK, ~~resulting~~which inwe believe will lead to next-generation implants that may enhance mechanical performance, reduce infection risks, and improve imaging compatibility. ● Favorable and Changing Demographics. With the growing number of elderly people, age-related ailments are expected to rise sharply, which we believe will increase the demand and need for biomaterials and devices with improved performance capabilities. Also, middle-aged and older patients increasingly expect to enjoy active lifestyles, and consequently demand effective treatments for painful spine and joint conditions, including better performing and longer-lasting interbody spinal fusion devices and joint replacements. ● Market Expansion into New Geographic Areas. We anticipate that demand for biomaterials and the associated medical devices will increase as the applications in which biomaterials are used are introduced to and become more widely accepted in underserved countries, such as South America and Asia.

Intellectual Property

We rely on a combination of patents, trademarks, trade secrets, nondisclosure agreements, proprietary information ownership agreements and other intellectual property measures to protect our intellectual property rights. We believe that to have a competitive advantage, we must continue to develop and maintain the proprietary aspects of our technologies.

We have ~~fifteen~~twenty-one issued U.S. patents, ~~twelve~~ten issued foreign patents, ~~fifteen~~three pending U.S. non-provisional patent applications, ~~eighty~~twenty-~~one~~three pending foreign patent applications and ~~one~~no pending ~~PCT~~ PCT patent ~~application~~applications. Our first issued patent expired in 2016, with the last of these patents expiring in ~~2039~~2042.

We have ~~three~~been issued two U.S. patents directed to articulating implants using our high-strength, high toughness doped silicon nitride solid ceramic. These issued patents, which include U.S. USPatent ~~7,666,229; US~~Nos. 9,051,639; and US 9,517,136 ~~will~~ expire in ~~November 2023, September~~ 2032, and ~~March~~ 2034, respectively.

We ~~also~~ have ~~one~~been issued U.S. ~~patent~~Patent ~~related~~No. ~~to our CSC technology that are directed to implants that have both a dense load-bearing~~10, ~~or cortical~~806, ~~component~~ 831 and aU.S. ~~porous,~~Patent orNo. ~~cancellous~~11, ~~component~~738, ~~together~~122 ~~with~~both adirected ~~surface~~to ~~coating.~~antipathogenic ~~The~~implants ~~issued~~which ~~patent US 9,649,197 will~~ expire in ~~July~~2037 ~~2035~~and 2039, respectively.

InWe ~~addition,~~also have been issued U.S. Patent No. 1011,~~806~~192,~~831 directed~~787; toU.S. ~~antibacterial~~Patent ~~implants~~No. 11,591,217; and U.S. Patent No. 1112,~~191~~017,~~787~~912 directed to antipathogenic devices ~~were recently issued~~ which ~~will~~all expire in ~~2037~~ ~~and 2039, respectively~~2038.

~~With~~We ~~respect~~have tobeen ~~PCT~~issued ~~patent~~U.S. ~~application~~Patent ~~serial no~~No. ~~PCT/US2018/014781 directed to antibacterial biomedical implants~~9, ~~we entered the national stage in Europe~~353, ~~Australia, Brazil, Canada,~~010 ~~China,~~directed ~~Japan, Hong Kong, and South Korea as well as one divisional patent application filed in Europe and two divisional applications filed in Japan~~ to ~~seek~~alumina-zirconia ~~potential~~ceramic ~~patent~~implants ~~protection~~which ~~for~~expires ~~our proprietary technologies~~ in ~~those countries~~2034.

~~With~~We ~~respect~~have tobeen ~~PCT~~issued ~~patent~~U.S. ~~application~~Patent ~~serial no~~No. ~~PCT/US2019/026789~~ 9,353,012 directed to ~~methods~~charge-compensating ~~for~~dopant ~~improving~~stabilized ~~the wear performance of ceramic~~alumina-~~polyethylene~~zirconia or ceramic~~-ceramic~~ ~~articulation couples~~implants ~~utilized~~which inexpires ~~orthopaedic joint prostheses, we entered the national stage~~ in ~~Australia, Brazil, Canada, Europe, Japan, Korea, and Mexico to seek patent protection for our proprietary technologies in those countries~~2034.

~~With~~We ~~respect~~have tobeen ~~PCT~~issued ~~application~~U.S. ~~serial~~Patent noNo. ~~PCT/US2019/048072~~9,399,309 directed to ~~antipathogenic~~directed ~~devices~~to ~~and~~ methods, wefor ~~entered~~threading ~~the~~a ~~national~~ceramic ~~stage~~material inwhich ~~Europe,~~expires ~~Japan, Mexico, Australia, Brazil, Canada, South Korea, China, and India to seek patent protection for our proprietary technologies~~ in ~~those countries~~2034.

~~With~~We ~~respect~~have tobeen ~~PCT~~issued ~~application~~U.S. ~~serial~~Patent noNo. ~~PCT/US2020/037170~~9,925,295 directed to ~~methods~~improved ofceramic ~~surface functionalization of zirconia-toughened alumina with silicon nitride, we entered the national stage in Europe, Australia, Brazil, Canada, China, India, Japan,~~ and/or ~~Mexico~~glass tomaterials ~~seek~~which ~~patent~~expires ~~protection for our proprietary technologies~~ in ~~those countries~~2032.

~~With~~We ~~respect~~have tobeen ~~PCT~~issued ~~application~~U.S. ~~serial~~Patent noNo. ~~PCT/US2021/014725~~11,672,252 directed to antifungal composites ~~and~~which ~~methods~~expires ~~thereof, we entered the national stage~~ in ~~Europe, Brazil, Japan, Australia, Canada, China, India, Mexico, and South Korea to seek patent protection for our proprietary technologies in those countries~~2040.

~~With~~We ~~respect~~have tobeen ~~PCT~~issued ~~application~~U.S. ~~serial~~Patent noNo. ~~PCT/US2021/027258 directed to antipathogenic face mask~~11, ~~we entered the national stage in Australia~~844, ~~Brazil, Canada, China, Europe, India, Japan, South~~344 ~~Korea,~~directed ~~and Mexico~~ to ~~seek~~rapid ~~patent~~inactivation ~~protection~~of ~~for~~SARS-CoV-2 ~~our~~which ~~proprietary~~expires ~~technologies~~ in ~~those countries~~2039.

~~With~~We ~~respect~~have tobeen ~~PCT~~issued ~~application~~U.S. ~~serial~~Patent noNo. ~~PCT/US2021/027263~~11,850,214 directed to ~~systems~~antiviral ~~and~~compositions ~~methods for rapid inactivation of SARS-CoV2 by silicon nitride, copper,~~ and ~~aluminum~~devices ~~nitride,~~which weexpires ~~entered the national stage~~ in ~~Australia, Brazil, Canada, China, Europe, India, Japan, South Korea, and Mexico to seek patent protection for our proprietary technologies in those countries~~2038.

~~With~~We ~~respect~~have tobeen ~~PCT~~issued ~~application~~U.S. ~~serial~~Patent noNo. ~~PCT/US2021/038364~~11,857,001 directed to antipathogenic ~~devices~~face ~~and~~mask ~~methods~~which ~~thereof~~expires ~~for antifungal applications, we entered the national stage~~ in ~~Australia, Brazil, Canada, China, Europe, India, Japan, South Korea, and Mexico to seek patent protection for our proprietary technologies in those countries~~2038.

We have been issued U.S. Patent No. 12,070,391 directed to improving wear performance of ceramic-polyethylene or ceramic-ceramic articulation couples utilized in orthopedic joint prostheses which expires in 2038.

We have been issued U.S. Patent No. 12,239,761 directed to silicon nitride laser cladding which expires in 2042.

We have been issued U.S. Patent No. 12,162,807 directed to surface functionalization of zirconia-toughened alumina with silicon nitride which expires in 2040.

We have been issued U.S. Patent No. 12,433,294 directed to Directed to methods for treating or preventing a fungal pathogen in a plant which expires in 2039.

We have been issued U.S. Patent No. 12,433,356 directed to a fibrous material with embedded silicon nitride powder which expires in 2039.

We have been issued U.S. Patent No. 12,520,890 directed to methods of embedding silicon nitride powder in a fibrous material which expires in 2039.

With respect to PCT patent application serial no. PCT/US2018/014781 directed to antibacterial biomedical implants, we have a pending patent application in Europe to seek potential patent protection for our proprietary technologies in that country. In addition, we have a separate pending continuation patent application in the United States. We also have issued patents in Australia, Canada, Japan, United States, and South Korea.

With respect to PCT patent application serial no. PCT/US2019/026789 directed to methods for improving the wear performance of ceramic-polyethylene or ceramic-ceramic articulation couples utilized in orthopedic joint prostheses, we have an issued patent in Japan and a separate issued patent in the United States.

With respect to PCT application serial no. PCT/US2019/048072 directed to antipathogenic devices and methods, we have pending national stage applications in Europe and China, to seek patent protection for our proprietary technologies in those countries. In addition, we have two issued patents in Japan and three issued patents in the United States for this technology.

With respect to PCT application serial no. PCT/US2020/037170 directed to methods of surface functionalization of zirconia-toughened alumina with silicon nitride, we have pending national stage application in China to seek patent protection for our proprietary technologies in that country. In addition, we have an issued patent in Japan and an issued patent in the United States for this technology.

With respect to PCT application serial no. PCT/US2021/014725 directed to antifungal composites and methods thereof, we have pending national stage applications in Europe, Australia, Canada, Mexico, and South Korea to seek patent protection for our proprietary technologies in those countries. We also have a separate issued patent in the United States for this technology.

With respect to PCT application serial no. PCT/US2021/027258 directed to antipathogenic face mask, we have pending national stage applications in Japan and Mexico to seek patent protection for our proprietary technologies in those countries. In addition, we have an issued patent in the United States for this technology.

With respect to PCT application serial no. PCT/US2021/027263 directed to systems and methods for rapid inactivation of SARS-CoV2 by silicon nitride, copper, and aluminum nitride, we have no pending national stage applications, although we obtained an issued U.S. patent for this technology.

With respect to PCT application serial no. PCT/US2021/038364 directed to antipathogenic devices and methods thereof for antifungal applications, we have pending national stage applications in South Korea and Mexico to seek patent protection for our proprietary technologies in those countries.

With respect to PCT application serial no. PCT/US2021/028975 directed to methods for laser coating of silicon nitride on a metal substrate, we ~~entered~~have ~~the~~pending national stage application in ~~Australia, Brazil, Canada, China, Europe, India, Japan, South Korea, and~~ Mexico to seek patent protection for our proprietary technologies in those countries.

With respect to PCT application serial no PCT/US2021/028641 directed to methods of silicon nitride laser cladding, we ~~entered~~have ~~the~~a pending national stage application in ~~Australia,~~Mexico ~~Brazil,~~to ~~Canada,~~seek ~~China,~~patent ~~Europe, India,~~protection ~~Japan,~~for ~~South~~our ~~Korea,~~proprietary ~~and~~technologies ~~Mexico~~in tothat ~~seek~~country. ~~patent~~We ~~protection~~also ~~for~~have ~~our~~a ~~proprietary~~separate ~~technologies~~issued patent in ~~those~~the ~~countries~~United States for this technology.

With respect to PCT application serial no. PCT/US2021/027270 directed to antiviral compositions and devices and methods of use thereof, we ~~entered~~have ~~the~~pending national stage applications in ~~Australia, Brazil, Canada,~~ China, ~~Europe, India, Japan, South Korea,~~ and Mexico to seek patent protection for our proprietary technologies in those countries. In addition, we have a separate issued patent in the United States for this technology.

With respect to PCT application serial no. PCT/US2021/056461 directed to systems and methods for selective laser sintering of silicon nitride and metal composites, we ~~entered~~have ~~the~~a pending national stage application in ~~Australia, Brazil, Canada, China, Europe, India, Japan, South Korea, and~~ Mexico to seek patent protection for our proprietary technologies in ~~those~~that ~~countries~~country.

With respect to PCT application serial no. PCT/US2021/056452 directed to systems and methods for hot-isostatic pressing to increase nitrogen content in silicon nitride, we entered the national stage in ~~Australia, Brazil, Canada, China, Europe,~~ India, ~~Japan, South Korea,~~ and Mexico to seek patent protection for our proprietary technologies in those countries.

With respect to PCT application serial no. PCT/US2021/062650 directed to nitride based antipathogenic compositions and devices and method of use thereof, we ~~entered~~have ~~the~~a pending national stage application in ~~Australia, Brazil, Canada, China, Europe, India, Japan, South Korea, and~~ Mexico to seek patent protection for our proprietary technologies in ~~those countries~~that country.

With respect to PCT application serial no. PCT/US2022/023868 directed to systems and methods for physical vapor deposition silicon nitride coatings having antimicrobial and osteogenic enhancements, we ~~entered~~have ~~the~~pending national stage application in ~~Australia, Brazil, Canada, China, Europe, India, Japan, South Korea, and~~ Mexico to seek patent protection for our proprietary technologies in ~~those~~that ~~countries~~country.

With respect to PCT application serial no. PCT/US2022/076863 directed to methods for manufacturing silicon nitride materials, we have a pending national stage application in Europe. In addition, we have a separate pending patent application in the United States for this technology.

In relation to the sale of our spine implant business to CTL Medical under the Asset Purchase Agreement dated September 5, 2018, we assigned our entire right to forty-eight (48) U.S. patents, two (2) foreign patents and three (3) pending patent applications from our patent portfolio to CTL Medical under that transaction. In addition, three (3) U.S. patents (U.S. patent nos. 9,399,309; 9,517,136; and 9,649,197) directed to silicon nitride manufacturing processes were licensed to CTL Medical under an irrevocable, fully paid-up, worldwide license for a ten-year term with CTL Medical also having a Right of First Negotiation to acquire these patents if SINTX decides to later sell these IP assets to a third party.

Our remaining issued patents and pending applications are directed to additional aspects of our products and technologies including, among other things:

	●	designs for intervertebral fusion devices;

	●	designs for hip implants;

	●	designs for coated, variable-density, and thin walled implants;

	●	designs for knee implants;

	●	implants with improved antibacterial characteristics;

	●	implants with improved wear performance and surface functionalization

	●	antipathogenic, antibacterial, antimicrobial, antifungal, and antiviral compositions, devices, and methods; and

	●	methods and systems for hot-isostatic pressing laser cladding, laser coating, and laser sintering of silicon nitride.

We also expect to rely on trade secrets, know-how, continuing technological innovation and in-licensing opportunities to develop and maintain our intellectual property position. However, trade secrets are difficult to protect. We seek to protect the trade secrets in our proprietary technology and processes, in part, by entering into confidentiality agreements with commercial partners, collaborators, employees, consultants, scientific advisors and other contractors and into invention assignment agreements with our employees and some of our commercial partners and consultants. These agreements are designed to protect our proprietary information and, in the case of the invention assignment agreements, to grant us ownership of the technologies that are developed.

Competition

The main alternatives to our silicon nitride biomaterial include: PEEK, which is predominantly manufactured by Invibio; BIOLOX^®delta, which is a traditional oxide ceramic manufactured by CeramTec; allograft bone; metals; and coated metals.

We believe our main competitors in the medical device market, which utilize a variety of competitive biomaterials, include: Medtronic, Inc.; DePuy Synthes Companies, a group of Johnson & Johnson companies; Stryker Corporation; and Zimmer Biomet, Inc. Presently, these companies buy ceramic components on an OEM basis from manufacturers such as CeramTec, Kyocera and CoorsTek, Inc., among others. We anticipate that these and other orthopedic companies and OEMs will seek to introduce new biomaterials and products that compete with ours.

Our main competitors in the antipathogenic market segment include BactiGuard and MicroBan.

Competition within our industries is primarily based on technology, innovation, product quality, and product awareness and acceptance by customers. Our principal competitors have substantially greater financial, technical and marketing resources, as well as significantly greater manufacturing capabilities than we do, and they may succeed in developing products that render our products and product candidates non-competitive. Our ability to compete successfully will depend upon our ability to develop innovative products with advanced performance features.

Government Regulation of Medical Devices

Governmental authorities in the United States, at the federal, state and local levels, and other countries extensively regulate, among other things, the research, development, testing, manufacture, labeling, promotion, advertising, distribution, marketing, and export and import of products such as those we are commercializing and developing. Failure to obtain approval or clearance to market our products and products under development and to meet the ongoing requirements of these regulatory authorities could prevent us from continuing to market or develop our products and product candidates.

United States

Pre-Marketing Regulation

In the United States, medical devices are regulated by the FDA. Unless an exemption applies, a new medical device will require either prior 510(k) clearance or approval of a premarket approval application, or PMA, or authorization through the De Novo classification process, as applicable, before it can be marketed in the United States. The information that must be submitted to the FDA in order to obtain ~~clearance~~ clearance or approval to market a new medical device varies depending on how the medical device is classified by the FDA. Medical devices are classified into one of three classes on the basis of the controls deemed by the FDA to be necessary to reasonably ensure their safety and effectiveness. Class I devices, which are those that have the lowest level or risk associated with them, are subject to general controls, ~~including~~ including labeling, ~~premarket~~establishment ~~notification~~registration and device listing, labeling requirements, and adherence to the Quality System Regulation (“QSR”), which is being harmonized with ISO 13485:2016 under the FDA’s Quality Management System Regulation (“QMSR”), effective February 2, 2026. Class II devices are subject to general controls and special controls, including performance standards. Class III devices, which have the highest level of risk associated with them, are subject to most of the previously identified requirements as well as to premarket approval. Most Class I devices and some Class II devices are exempt from the 510(k) requirements, although manufacturers of these devices are still subject to registration, listing, labeling and ~~QSR~~applicable quality system requirements.

A 510(k) premarket notification must demonstrate that the device in question is substantially equivalent to another legally marketed device, or predicate device, that did not require premarket approval. In evaluating the 510(k), the FDA will determine whether the device has the same intended use as the predicate device, and (a) has the same technological characteristics as the predicate device, or (b) has different technological characteristics, and (i) the data supporting the substantial equivalence contains information, including appropriate clinical or scientific data, if deemed necessary by the FDA, that demonstrates that the device is as safe and as effective as a legally marketed device, and (ii) does not raise different questions of safety and effectiveness than the predicate device. ~~Most~~While many 510(k)s submissions do not require clinical data, ~~for~~FDA ~~clearance,~~may ~~but~~require clinical or other additional data depending on the ~~FDA~~nature of the device, its ~~may~~technological ~~request~~characteristics, ~~such~~and ~~data~~associated risks. The FDA’s ~~goal~~review istimelines toare ~~review~~governed ~~and~~by ~~act~~performance ongoals ~~each~~established ~~510~~under the Medical Device User Fee Amendments (k“MDUFA”), ~~within~~which 90include ~~days~~target oftimeframes ~~submission,~~for substantive interaction and decision-making, but it may take longer based on requests for additional information. In addition, requests for additional data, including clinical data, will increase the time necessary to review the notice. If the FDA does not agree that the new device is substantially equivalent to the predicate device, the new device will be classified in Class III, and the manufacturer must submit a PMA. ~~Since~~or ~~July~~pursue ~~2012, however, with~~ the ~~enactment~~De ofNovo ~~the~~classification ~~Food and Drug Administration Safety and Innovation Act~~pathway, orwhich ~~FDASIA,~~provides a deprocess ~~novo pathway is directly available~~ for certain novel low- to moderate -risk devices ~~that do not qualify~~ for ~~the~~which ~~510(k)~~no ~~pathway~~legally ~~due~~marketed ~~to lack of a~~ predicate device. exists. Modifications to a 510(k)-cleared medical device may require the submission of another 510(k) or a PMA if the changes could significantly affect the safety or effectiveness or constitute a major change in the intended use of the device.

Modifications to a 510(k)-cleared device ~~frequently~~ may require ~~the~~ submission of a ~~traditional~~new 510(k); however, ~~but~~certain modifications ~~meeting certain conditions~~ may be ~~candidates~~eligible for ~~FDA~~ review under aFDA’s Special 510(k) Program. If a device modification requires the submission of a 510(k), but the modification does not affect the intended use of the device or alter the fundamental scientific technology of the device, then summary information that results from the design ~~control~~ control process associated with the cleared device can serve as the basis for clearing the application. AUnder the Special 510(k) ~~allows~~ Program, a manufacturer to ~~declare~~may ~~conformance~~rely toon design ~~controls~~control ~~without~~activities ~~providing~~and ~~new~~risk ~~data~~analysis to support certain modifications, provided eligibility criteria are met; FDA may nevertheless request additional supporting information as needed. When the modification involves a change in material, the nature of the “new” material will determine whether a traditional or Special 510(k) is necessary. For example, in its Device Advice on How to Prepare a Special 510(k), the FDA uses the example of a change in a material in a finger joint prosthesis from a known metal alloy to a ceramic that has not been used in a legally marketed predicate device as a type of change that should not be submitted as a Special 510(k). However, if the “new” material is a type that has been used in other legally marketed devices within the same classification for the same intended use, a Special 510(k) is appropriate. The FDA gives as an example a manufacturer of a hip implant who changes from one alloy to another that has been used in another legally marketed predicate. Review timelines for Special 510(k)s are ~~typically~~subject ~~processed within~~to 30MDUFA ~~days~~performance goals and may vary depending on the complexity of ~~receipt~~the submission.

The PMA process is more complex, costly and time consuming than the 510(k) clearance procedure. A PMA must be supported by extensive data including, but not limited to, technical, preclinical, clinical, manufacturing, control and labeling information to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device for its intended use. After a PMA is submitted, the FDA has 45 days to determine whether it is sufficiently complete to permit a substantive review. If the PMA is complete, the FDA will file the PMA. The FDA is subject to performance goal review times for PMAs ~~and~~under ~~may~~MDUFA, ~~issue~~which aestablish ~~decision~~target ~~letter~~timeframes asfor areview ~~first~~and ~~action on a PMA within 180 days of filing~~decision-making, but if it has questions, it will likely issue a first major deficiency letter within 150 days of filing. It may also refer the PMA to an FDA advisory panel for additional review and will conduct a preapproval inspection of the manufacturing facility to ensure compliance with the ~~QSR~~applicable quality system regulations, including the QMSR once effective, either of which could extend the 180-day response target. ~~While the FDA’s ability to meet its performance goals has generally improved during the past few years, it may not meet these goals in the future.~~ A PMA can take several years to complete and there is no assurance that any submitted PMA will ever be approved. Even when approved, the FDA may limit the indication for which the medical device may be marketed or to whom it may be sold. In addition, the FDA may request additional information or request the performance of additional clinical trials before it will reconsider the approval of the PMA or as a condition of approval, in which case the trials must be completed after the PMA is approved. Changes to the device, including changes to its manufacturing process, may require the approval of a supplemental PMA.

If a medical device is determined to present a “significant risk,” the manufacturer may not begin a clinical trial until it submits an investigational device exemption, or IDE, to the FDA and obtains approval of the IDE from the FDA. The IDE must be supported by appropriate data, such as animal and laboratory testing results and include a proposed clinical protocol. These clinical trials are also subject to the review, approval and oversight of an institutional review board, or IRB, which is an independent and multi-disciplinary committee of volunteers who review and approve research proposals, and the reporting of adverse events and experiences, at each institution at which the clinical trial will be performed. The clinical trials must be conducted in accordance with applicable regulations, including but not limited to the FDA’s IDE regulations and current good clinical practices. A clinical trial may be suspended by the FDA, the IRB or the sponsor at any time for various reasons, including a belief that the risks to the study participants outweigh the benefits of participation in the trial. Even if a clinical trial is completed, the results may not demonstrate the safety and ~~efficacy~~effectiveness of a device or may be equivocal or otherwise not be sufficient to obtain approval.

Post-Marketing Regulation

After a device is placed on the market, numerous regulatory requirements apply. These include:

● compliance with the ~~QSR~~Quality System Regulation and, beginning February 2, 2026, the Quality Management System Regulation (QMSR), which require manufacturers to follow stringent design, testing, testing, control, documentation, record maintenance, including maintenance of complaint and related investigation files, and other quality assurance controls during the manufacturing process; ● labeling regulations, which prohibit the promotion of products for uncleared or unapproved or “off-label” uses and impose other restrictions on labeling; and ● medical device reporting obligations, which require that manufacturers investigate and report to the FDA adverse events, including deaths, or serious injuries that may have been or were caused by a medical device and malfunctions in the device that would likely cause or contribute to a death or serious injury if it were to ~~recur~~occur.

Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions:

	●	warning letters;

	●	fines, injunctions, and civil penalties;

	●	recall or seizure of our products;

	●	operating restrictions, partial suspension or total shutdown of production;

	●	refusal to grant 510(k) clearance or PMA approvals of new products;

	●	withdrawal of 510(k) clearance or PMA approvals; and

	●	criminal prosecution.

To ensure compliance with regulatory requirements, medical device manufacturers are subject to market surveillance and periodic, pre-scheduled and unannounced inspections by the FDA, and these inspections may include the manufacturing facilities of our subcontractors.

International Regulation

~~International sales~~ Sales of our medical devices ~~are~~outside ~~subject to~~the ~~foreign~~United ~~government~~States ~~regulations,~~are ~~which~~subject ~~vary substantially from country~~ to ~~country. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA approval, and~~ the ~~requirements may differ. For example, the primary~~ regulatory ~~authority~~ ~~with~~requirements ~~respect~~of toeach ~~medical~~jurisdiction ~~devices~~ in ~~Europe~~which ~~is that of~~ the ~~European~~products are ~~Union~~marketed. ~~The~~These ~~European~~requirements ~~Union~~vary ~~consists~~by ofcountry ~~28 countries~~ and ~~has a~~may ~~total~~require ~~population~~additional ~~of over 500 million people. The unification of these countries into a common market has resulted in the unification of laws~~testing, ~~standards~~clinical ~~and procedures across these countries~~evidence, ~~which~~quality ~~may~~system ~~expedite the introduction of medical devices like those we are offering~~documentation, ~~and~~product ~~developing. Norway~~registration, ~~Iceland~~labeling modifications, ~~Lichtenstein~~ and ~~Switzerland~~governmental ~~are~~approvals ~~not~~prior ~~members~~to ofcommercialization. ~~the~~Regulatory ~~European~~approval ~~Union~~timelines ~~but have transposed applicable European~~outside ~~medical~~the ~~device~~United ~~laws~~States ~~into~~may ~~their~~differ ~~national~~from ~~legislation.~~those ~~Thus,~~of ~~a device that is marketed in~~ the ~~European~~FDA ~~Union~~and may ~~also~~ be ~~recognized~~longer ~~and accepted~~or inmore ~~those four non-member European countries as well~~burdensome.

~~The~~ European ~~Union has adopted numerous directives~~ and standards regulating the design, manufacture, clinical trials, labeling and adverse event reporting for medical devices. Devices that comply with the requirements of relevant directives will be entitled to bear CE Conformity Marking, indicating that the device conforms to the essential requirements of the applicable directives and, accordingly, can be commercially distributed throughout the European Union. Actual implementation of these directives, however, may vary on a country-by-country basis. The CE Mark is a mandatory conformity mark on medical devices distributed and sold in the European Union and certifies that a medical device has met applicable requirements.

~~The method of assessing conformity varies, but~~In ~~normally involves a combination of self-assessment by~~ the ~~manufacturer~~European ~~and~~Union ~~a third-party assessment by a~~ (“~~Notified Body.~~EU” ~~Notified Bodies are independent testing houses~~), ~~laboratories,~~medical ordevices ~~product~~are ~~certifiers~~regulated ~~authorized~~under byRegulation ~~the~~(EU) ~~European~~2017/745 ~~Union~~on ~~member~~medical ~~states~~devices ~~to perform~~(“EU ~~the required conformity assessment tasks~~MDR”), ~~such as quality system audits and device compliance testing. An assessment by a Notified~~ ~~Body~~which ~~based~~establishes ~~within the European Union is required in order for~~ a ~~manufacturer~~harmonized toregulatory ~~distribute~~framework ~~the~~across ~~product commercially throughout~~ the ~~European Union.~~27 ~~Medium~~EU ~~and~~Member ~~higher risk devices require the intervention of a Notified Body which will be responsible for auditing the manufacturer’s quality system~~States. ~~The~~Under ~~Notified Body will also determine whether or not~~ the ~~product~~MDR, conforms to the requirements of the applicable directives. Devices that meet the applicable requirements of E.U. law and have undergone the appropriate conformity assessment routes will be granted CE “certification.” The CE Mark is mandatory for medical devices ~~sold~~are ~~not~~classified ~~only~~by ~~within~~risk ~~the countries of the European Union~~(Class ~~but~~I, ~~more generally within most of Europe. As many of the European standards are converging with international standards~~IIa, ~~the~~IIb ~~CE Mark is often used on medical devices manufactured~~ and ~~sold outside of Europe (notably in Asia that exports many manufactured products to Europe~~III)., ~~CE Marking gives companies easier access into not only the European market but also to Asian~~ and ~~Latin~~manufacturers ~~American~~must ~~markets,~~demonstrate ~~most of~~compliance ~~whom~~with ~~recognize~~ the CEGeneral ~~Mark~~Safety ~~on medical device as a mark of quality~~ and ~~adhering~~Performance toRequirements ~~international~~set ~~standards~~forth ~~of consumer safety, health~~in orthe ~~environmental requirements~~regulation.

Except for certain low-risk devices, manufacturers must engage a designated Notified Body to assess conformity, including review of the manufacturer’s quality management system and technical documentation, which may include clinical evaluation data. Upon successful completion of the conformity assessment process, the manufacturer issues a Declaration of Conformity and affixes the CE marking, which permits commercial distribution throughout the EU. The MDR imposes significant pre- and post-market obligations, including clinical evaluation, post-market surveillance, vigilance reporting, and registration requirements. The transition to the MDR has increased regulatory scrutiny and compliance costs, and limited Notified Body capacity may affect review timelines.

Manufacturers established outside the EU must appoint an authorized representative within the EU.

United Kingdom and Other European Markets

Following the United Kingdom’s withdrawal from the EU, Great Britain is regulated separately by the Medicines and Healthcare products Regulatory Agency (MHRA) and generally requires UKCA marking, subject to transitional arrangements. Northern Ireland continues to follow EU MDR requirements. Switzerland and certain other European countries maintain regulatory systems that are broadly aligned with EU requirements but may impose additional local obligations, including appointment of local representatives and registration requirements.

Other International Markets

Other jurisdictions, including Canada, Japan, China, Brazil and others, maintain independent regulatory approval processes that typically require submission of technical documentation, evidence of quality system compliance, and, in some cases, local testing or clinical data. Although some countries may consider prior approvals or certifications, such as CE marking, manufacturers must independently comply with applicable local regulatory requirements.

Failure to obtain or maintain required international approvals or certifications could restrict our ability to market our products in those jurisdictions.

Compliance with Healthcare Laws

WeOur operations ~~must~~are ~~comply~~subject ~~with~~to ~~various~~numerous ~~U.S.~~ federal and state healthcare laws, ~~rules~~ and regulations ~~pertaining~~that togovern ~~healthcare~~ fraud and abuse, ~~including anti-kickback and false claims laws~~transparency, ~~rules~~privacy, ~~and~~ ~~regulations~~security, asand ~~well~~interactions aswith ~~other~~ healthcare ~~laws in connection with the commercialization of our products~~professionals. ~~Fraud~~These ~~and abuse~~ laws are interpreted broadly and enforced ~~aggressively~~ by ~~various~~federal ~~state~~ and ~~federal~~state ~~agencies~~authorities, including the U.S. Department of Justice (“DOJ”), the U.S. ~~Office of Inspector General for the~~ Department of Health and Human Services ~~and~~Office ~~various~~of Inspector General (“HHS-OIG”), and state ~~agencies~~attorneys general.

We have entered into ~~agreements~~arrangements with certain surgeons ~~for~~and ~~assistance~~other ~~with~~healthcare ~~the~~professionals, ~~design~~including ofconsulting, ~~our~~product ~~products~~development, ~~some~~royalty, and ofother ~~whom~~compensation wearrangements. ~~anticipate~~Some ~~may~~of ~~make~~these ~~referrals~~individuals tomay usorder or ~~order~~use our products., ~~A majority~~and ofsome ~~these~~may ~~agreements~~hold ~~contain~~equity ~~provisions~~interests ~~for~~in ~~the~~our company. ~~payments~~Such ofrelationships ~~royalties.~~are Insubject ~~addition,~~to ~~some~~scrutiny ~~surgeons~~under ~~currently~~applicable ~~own~~fraud ~~shares~~and ofabuse ~~our stock~~laws. We ~~have~~structure ~~structured~~ these ~~transactions~~arrangements ~~with~~to ~~the intention of complying~~ comply with ~~all~~ applicable ~~laws~~legal requirements, including ~~fraud~~fair ~~and~~market ~~abuse,~~value ~~data privacy~~ and ~~security,~~commercial ~~and~~reasonableness ~~transparency~~standards ~~laws.~~and ~~Despite~~policies ~~this~~intended ~~intention,~~to ~~there~~avoid payments ~~can be no assurance~~ that aare ~~particular~~tied ~~government agency or court would determine our practices~~ to bethe involume ~~full~~or ~~compliance~~value ~~with~~of ~~such laws~~referrals. WeHowever, ~~could~~these belaws ~~materially~~are ~~impacted~~complex ifand ~~regulatory~~fact-specific, orand ~~enforcement agencies~~there orcan ~~courts interpret our financial arrangements with surgeons to~~ be inno ~~violation of healthcare laws, including, without limitation,~~assurance ~~fraud~~that ~~and~~regulatory ~~abuse,~~authorities ~~data~~would ~~privacy~~not ~~and~~challenge ~~security,~~our ~~or transparency laws~~arrangements.

The ~~U.S.~~ federal Anti-Kickback Statute prohibits ~~persons,~~ ~~including a medical device manufacturer (or a party acting on its behalf), from~~ knowingly orand willfully ~~soliciting~~offering, ~~receiving~~paying, ~~offering~~ ~~or paying remuneration~~soliciting, ~~directly~~ or ~~indirectly,~~receiving inremuneration ~~exchange for or~~ to induce ~~either the referral of an individual for a service~~ or reward ~~product~~referrals ~~or the purchasing, ordering, arranging~~ for, oritems ~~recommending the ordering of, any service~~ or ~~product~~services ~~for~~reimbursable ~~which payment may be made~~ by ~~Medicare, Medicaid or any other~~ federal healthcare ~~program~~programs. ~~This~~The statute ~~has been interpreted to apply to arrangements between medical device manufacturers on one hand and healthcare providers on the other. The term “remuneration”~~ is ~~not defined in the federal Anti-Kickback Statute and has been~~ broadly interpreted ~~to include anything of value~~, ~~such as cash payments, gifts or gift certificates, discounts, waiver of payments, credit arrangements, ownership interests, the furnishing of services, supplies or equipment,~~ and ~~the provision of anything at less than its fair market value. Courts have broadly interpreted the scope of the law, holding that~~compliance itwith may be violated if merely “one purpose” of an arrangement is to induce referrals, irrespective of the existence of other legitimate purposes. The Anti-Kickback Statute prohibits many arrangements and practices that are lawful in businesses outside of the healthcare industry. Although there are a number of statutory ~~exemptions~~exceptions ~~and~~or regulatory safe harbors ~~protecting~~is ~~certain~~voluntary ~~business~~but ~~arrangements from~~often ~~prosecution, the exemptions and safe harbors are drawn~~ narrowly, ~~and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exemption or safe harbor~~construed. ~~Our~~Violations ~~practices~~ may ~~not~~result in ~~all~~ ~~cases~~criminal meet all of the criteria for safe harbor protection from federal Anti-Kickback Statute liability. The reach of the Anti-Kickback Statute was broadened by the enacted Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Affordability Reconciliation Act of 2010penalties, ~~collectively, the Affordable Care Act or ACA, which, among other things, amends the intent requirement of~~ the federal Anti-Kickback Statute such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. In addition, the ACA provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act (discussed below) or the civil monetary penalties ~~statute~~, ~~which~~exclusion ~~imposes~~from ~~fines against any person who is determined to have presented or caused to be presented claims to a~~ federal healthcare ~~program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent. In addition to the federal Anti-Kickback Statute~~programs, ~~many~~ ~~states~~and ~~have~~liability ~~their~~under ~~own anti-kickback laws. Often, these laws closely follow~~ the ~~language of the~~ federal ~~law,~~False ~~although~~Claims ~~they do not always have the same scope, exceptions, safe harbors or sanctions~~Act. In some states, these anti-kickback laws apply not only to payments made by government healthcare programs but also to payments made by other third-party payors, including commercial insurance companies.

~~Sales, marketing, consulting, and advisory arrangements~~The ~~between~~federal ~~medical~~False ~~device~~Claims ~~manufacturers~~Act ~~and~~imposes ~~sales~~liability ~~agents~~on ~~and~~persons ~~physicians~~who ~~are~~knowingly ~~subject to the Anti-Kickback Statute and other fraud and abuse laws. Government officials have focused recent enforcement efforts on~~submit, ~~among~~or ~~other~~cause ~~things,~~ the ~~sales~~submission ~~and marketing activities~~ of ~~healthcare companies~~, ~~including~~false ~~medical device manufacturers, and have brought cases against individuals~~ or ~~entities~~fraudulent ~~whose~~claims ~~personnel allegedly offered~~for ~~unlawful~~payment ~~inducements~~ to ~~potential~~federal orhealthcare ~~existing customers in an attempt to procure their business~~programs. WeThe ~~expect~~statute ~~these~~permits ~~activities~~private towhistleblowers ~~continue~~ to bebring aactions ~~focus~~on ofbehalf ~~government enforcement efforts. Settlements~~ of ~~these~~the ~~cases~~government byand ~~healthcare~~share in ~~companies~~any ~~have~~recovery. ~~involved~~Claims ~~significant~~arising ~~fines~~from ~~and penalties~~alleged ~~and~~kickbacks, inimproper ~~some~~marketing ~~instances~~practices, ~~criminal~~or ~~plea~~other ~~agreements.~~regulatory Weviolations ~~are~~may ~~also~~give ~~aware~~rise ~~of governmental investigations of some of the largest orthopedic~~to ~~device~~liability. ~~companies~~Many ~~reportedly~~states ~~focusing~~have onenacted ~~consulting~~similar fraud and ~~service~~abuse ~~agreements between these companies~~ and ~~orthopedic~~false ~~surgeons.~~claims ~~These~~laws ~~developments are~~that ~~ongoing,~~may ~~and~~apply weto ~~cannot~~claims ~~predict~~submitted ~~the~~to ~~effects~~commercial ~~they~~payors as ~~will~~well ~~have~~as ongovernment ~~our business~~programs.

We are also subject to federal and state transparency laws. The federal Physician Payments Sunshine Act requires medical device manufacturers to report certain payments and other transfers of value to physicians, teaching hospitals, and certain non-physician practitioners, as well as certain ownership and investment interests. Various states impose additional reporting, marketing compliance, or gift restriction requirements.

Our business may involve the receipt or processing of health-related information, and we are subject to applicable federal and state privacy and data security laws. To the extent we act as a “business associate” under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), we are directly subject to HIPAA’s privacy, security, and breach notification requirements. In addition, numerous states have enacted consumer privacy and data protection laws that impose obligations regarding the collection, use, storage, and protection of personal information. Outside the United States, we may be subject to foreign data protection laws, including the European Union’s General Data Protection Regulation (“GDPR”).

Clinical research activities are subject to FDA regulations governing investigational devices and the protection of human subjects, including requirements for informed consent and Institutional Review Board oversight, as well as applicable international regulations where studies are conducted.

If our operations are found to violate any applicable healthcare, fraud and abuse, transparency, privacy, or other regulatory requirements, we could be subject to significant civil or criminal penalties, exclusion from participation in federal healthcare programs, corporate integrity obligations, reputational harm, and other sanctions, which could materially and adversely affect our business, financial condition, and results of operations.

The federal False Claims Act imposes liability on any person that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal healthcare program. The qui tam provisions of the False Claims Act allow a private individual to bring civil actions on behalf of the federal government alleging that the defendant has submitted a false claim, or has caused such a claim to be submitted, to the federal government, and to share in any monetary recovery. There are many potential bases for liability under the False Claims Act. Liability arises, primarily, when a person knowingly submits, or causes another to submit, a false claim for reimbursement to the federal government. The False Claims Act has been used to assert liability on the basis of inadequate care, kickbacks, and other improper referrals, and allegations as to misrepresentations with respect to the services rendered. Qui tam actions have increased significantly in recent years, causing greater numbers of healthcare companies, including medical device manufacturers, to defend false claim actions, pay damages and penalties, or be excluded from participation in Medicare, Medicaid or other federal or state healthcare programs as a result of investigations arising out of such actions. In addition, various states have enacted similar laws analogous to the False Claims Act. Many of these state laws apply where a claim is submitted to any third-party payor and not merely a federal healthcare program. We are unable to predict whether we would be subject to actions under the False Claims Act or a similar state law, or the impact of such actions. However, the cost of defending such claims, as well as any sanctions imposed, could adversely affect our financial performance. The Health Insurance Portability and Accountability Act of 1996, or HIPAA, also created several new federal crimes, including healthcare fraud and false statements relating to healthcare matters. The healthcare fraud statute prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors. The false statements statute prohibits knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false, fictitious, or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items, or services.

In addition, we may be subject to, or our marketing or research activities may be limited by, data privacy and security regulation by both the federal government and the states in which we conduct our business. For example, HIPAA and its implementing regulations established uniform federal standards for certain “covered entities” (healthcare providers, health plans and healthcare clearinghouses) governing the conduct of certain electronic healthcare transactions and protecting the security and privacy of protected health information. The American Recovery and Reinvestment Act of 2009, commonly referred to as the economic stimulus package, included expansion of HIPAA’s privacy and security standards called the Health Information Technology for Economic and Clinical Health Act, or HITECH, which became effective on February 17, 2010. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates”—independent contractors or agents of covered entities that create, receive, maintain, or transmit protected health information in connection with providing a service for or on behalf of a covered entity. HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. These laws also require the reporting of breaches of protected health information to affected individuals, regulators and in some cases, local or national media. HIPAA and HITECH impose strict limits on our physician collaborators’ ability to use and disclose patient information on our behalf.

There are also an increasing number of state “sunshine” laws that require manufacturers to provide reports to state governments on pricing and marketing information. Several states have enacted legislation requiring medical device companies to, among other things, establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales and marketing activities, and to prohibit or limit certain other sales and marketing practices. In addition, a federal law known as the Physician Payments Sunshine Act, now requires medical device manufacturers to track and report to the federal government certain payments and other transfers of value made to physicians and teaching hospitals and ownership or investment interests held by physicians and their immediate family members. The first reporting period covered only payments or transfers of value made and ownership or investment interests held by physicians and their immediate family members from August 1, 2013 to December 31, 2013. The federal government disclosed the reported information on a publicly available website beginning in September 2014. For calendar year 2014, the Physician Payments Sunshine Act will require medical device manufacturers to report payments and transfers of values made and ownership or investment interests held by physicians and their immediate family members for the full calendar year. These laws may adversely affect our sales, marketing, and other activities by imposing administrative and compliance burdens on us. If we fail to track and report as required by these laws or to otherwise comply with these laws, we could be subject to the penalty provisions of the pertinent state and federal authorities.

Clinical research is heavily regulated by FDA regulations for the protection of human subjects (21 C.F.R. 50 and 56) and also the regulations of the U.S Department of Health and Human Services, or the Common Rule (45 C.F.R 46). Both FDA human subject regulations and the Common Rule impose restrictions on the involvement of human subjects in clinical research and require, among other things, the balancing of the risks and benefits of research, the documented informed consent of research participants, initial and ongoing review of research by an IRB. Similar regulations govern research conducted in foreign countries. Compliance with human subject protection regulations is costly and time consuming. Failure to comply could substantially and adversely impact our research program and the development of our products.

Because of the breadth of these laws and the narrowness of available statutory and regulatory exemptions, it is possible that some of our business activities could be subject to challenge under one or more of such laws. If our operations are found to be in violation of any of the federal and state laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including criminal and significant civil monetary penalties, damages, fines, imprisonment, exclusion from participation in government healthcare programs, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of pre-marketing product clearances and approvals, private “qui tam” actions brought by individual whistleblowers in the name of the government or refusal to allow us to enter into supply contracts, including government contracts, and the curtailment or restructuring of our operations. Public disclosure of privacy and data security violations could cause significant reputational harm. Any of these events could adversely affect our ability to operate our business and our results of operations. To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws, implementation of corporate compliance programs, as well as laws and regulations requiring transparency of pricing and marketing information and governing the privacy and security of health information, such as the E.U.’s Directive 95/46 on the Protection of Individuals with regard to the Processing of Personal Data, or the Data Directive, and the wide variety of national laws implementing the Data Directive.

Third-Party Reimbursement

~~Because~~Our products ~~our~~are ~~customers~~purchased ~~typically~~primarily ~~receive~~by ~~payment directly from~~ hospitals and surgical centers, werather dothan ~~not anticipate relying~~ directly onby ~~payment for any of our products from~~ third-party ~~payors,~~ ~~such as Medicare, Medicaid, private insurers, and managed care companies~~payors. However, ~~our~~the ~~business will be affected by policies~~commercial ~~administered~~success ~~by federal and state healthcare programs, such as Medicare and Medicaid, as well as private third-party payors, which often follow the policies~~ of ~~the state and federal healthcare programs. For example,~~ our ~~business~~products ~~will~~depends bein ~~indirectly~~significant ~~impacted~~part byon the ~~ability~~ availability of ~~a hospital or medical facility to obtain~~ coverage and ~~third-party~~ reimbursement for procedures ~~performed using our products. Many hospitals and clinics~~ in ~~the~~which United States belong to group purchasing organizations (that typically incentivize their hospital members to make a relatively large proportion of purchases from a limited number of vendors of similar products that have contracted to offer discounted prices). Such contracts often include exceptions for purchasing certain innovative new technologies, however. Accordingly, the commercial success of our ~~products may also depend to some extent on our ability to either negotiate favorable purchase contracts~~devices ~~with~~are ~~key group purchasing organizations or persuade hospitals and clinics to purchase our product “off contract.” These third-party payors may deny reimbursement if they determine that a device~~ used ~~in a procedure was not medically necessary; was not used in accordance with cost-effective treatment methods, as determined by the third-party payor; or was used for an unapproved use~~. AHospitals ~~national~~and orphysicians ~~local coverage~~are ~~decision~~unlikely ~~denying~~to ~~Medicare~~utilize ~~coverage for one or more of~~ our products ~~could result in private insurers and other third party payors also denying coverage. Even~~ if ~~favorable coverage and~~ reimbursement ~~status is attained~~ for ~~our products, less favorable coverage policies and reimbursement rates may be implemented in~~ the ~~future.~~applicable ~~The~~procedures ~~cost~~is ~~containment measures that third-party payors and providers are instituting,~~insufficient both within the United States and abroad, could significantly reduce our potential revenues from the sale of our products and any product candidates. We cannot provide any assurances that we will be able to ~~obtain~~cover ~~and~~associated ~~maintain third party coverage or adequate reimbursement for our products and product candidates in whole or in part~~costs.

~~For inpatient and outpatient procedures, including~~In ~~those~~the ~~that~~United ~~will involve use of our products~~States, Medicare ~~and~~reimburses ~~many~~inpatient ~~other~~hospital ~~third-party~~services ~~payors~~under in the ~~United~~Inpatient ~~States~~Prospective ~~reimburse~~Payment ~~hospitals~~System ~~at a~~(“IPPS”), ~~prospectively~~which ~~determined~~utilizes ~~amount. This amount is generally based on one or more~~ diagnosis -related groups, or (“DRGs”), ~~associated~~and ~~with~~outpatient ~~the patient’s~~hospital ~~condition~~services ~~for~~under ~~inpatient~~the ~~treatment~~Outpatient ~~and~~Prospective ~~generally~~Payment System ~~based~~(“OPPS”), onwhich utilizes ambulatory payment classifications, or (“APCs~~, associated with the procedures performed as an outpatient at an ambulation surgicenter~~”). ~~Each~~Ambulatory ~~DRG~~surgical orcenters ~~APC~~are reimbursed isunder ~~associated with~~ a ~~level~~separate ofprospective payment ~~and~~system. ~~may be~~These ~~adjusted~~payment ~~from~~systems ~~time~~generally toprovide ~~time,~~predetermined ~~usually~~amounts ~~annually. Prospective payments are~~ intended to cover facility ~~most of the non-physician hospital~~ costs ~~incurred~~ inassociated ~~connection~~ with ~~the~~a ~~applicable~~procedure, ~~diagnosis~~including ~~and~~implantable ~~related procedures~~devices. ~~Implant~~Payment ~~products,~~amounts ~~such~~are asestablished ~~those~~without weregard ~~plan~~ to ~~sell, represent part of~~ the ~~total procedure costs while labor, hospital room and board, and other supplies and services represent the balance of those~~cost ~~costs. However, the prospective payment amounts are typically set independently~~ of a particular ~~hospital~~manufacturer’s ~~actual~~product, ~~costs associated with treating a particular patient~~ and ~~implanting~~hospitals abear ~~device. Therefore,~~ the ~~payment~~risk ~~that~~if adevice ~~hospital~~costs ~~would~~exceed ~~receive for a particular hospital visit would not typically take into account the cost of our products~~reimbursement.

19Coverage determinations may be made at the national or local level, and both governmental and private payors may deny or restrict coverage if a procedure is determined to be not medically necessary, not cost-effective, or inconsistent with applicable labeling or standards of care. Changes in coverage policies, reimbursement methodologies, payment rates, or site-of-service rules may adversely affect hospital purchasing decisions and utilization of our products. Private payors frequently adopt policies consistent with Medicare coverage and payment determinations.

~~Medicare~~Hospitals often ~~has~~participate ~~established~~in agroup ~~number~~purchasing oforganizations ~~DRGs~~(“GPOs”), ~~for inpatient~~which ~~procedures~~negotiate ~~that~~pricing ~~involve~~arrangements ~~the~~with ~~use of products similar to ours~~manufacturers. ~~Although~~Our ability ~~Medicare has authority~~ to ~~create~~secure ~~special~~favorable ~~DRGs~~contractual ~~for~~arrangements ~~hospital services~~with ~~that~~GPOs, ~~more properly reflect the actual costs of expensive~~ or ~~new-technology~~to ~~devices~~compete ~~implanted~~effectively asoutside ~~part~~ of asuch ~~procedure~~arrangements, itmay ~~has declined~~affect ~~to do so in the past, and we do not expect that it will do so with respect to~~ our ~~current products and product candidates. Medicare’s~~ ~~DRG~~market ~~and~~access ~~APC classifications may have implications outside of Medicare, as many other U.S. third-party payors often use Medicare DRGs~~ and ~~APCs for purposes of determining reimbursement~~pricing.

~~We believe that orthopedic implants generally~~Federal ~~have~~and ~~been~~state ~~well~~healthcare ~~received~~programs byand ~~third-party~~commercial payors ~~because~~continue ~~of the ability of these implants~~ to ~~greatly~~implement ~~reduce long~~cost-~~term~~containment ~~healthcare costs for patients with degenerative joint disease. However~~measures, ~~coverage~~including ~~and~~value-based ~~reimbursement policies vary from payor to payor and are subject to change.~~purchasing ~~As discussed above~~initiatives, ~~hospitals~~bundled ~~that~~payment ~~purchase~~programs, ~~medical~~and ~~devices~~other ~~for~~payment ~~treatment~~models ofdesigned ~~their patients generally rely on third-party payors~~ to ~~reimburse all~~control orhealthcare ~~part of the costs and fees associated with the procedures performed with these devices~~spending. ~~Both~~These ~~government~~measures ~~and~~may ~~private third-party~~increase ~~coverage~~pricing ~~and~~pressure ~~reimbursement~~on ~~levels are critical to new product acceptance. Neither~~ hospitals ~~nor~~and, ~~surgeons~~in ~~are~~turn, ~~likely~~on tomedical ~~use~~device ~~our products if they do not receive reimbursement for the procedures adequate to cover the cost of our products~~suppliers.

~~While it is expected that hospitals will be able~~Outside tothe ~~obtain~~United ~~coverage for procedures using our products~~States, ~~the~~reimbursement ~~level~~systems ofvary ~~payment~~by ~~available~~jurisdiction toand ~~them~~frequently ~~for~~involve ~~such~~government-established ~~procedures~~pricing ~~may~~controls, ~~change over time.~~health ~~State~~technology ~~and federal healthcare programs~~assessments, ~~such~~or ascentralized ~~Medicare~~procurement ~~and~~processes. ~~Medicaid,~~In ~~closely~~many ~~regulate provider payment levels and have sought to contain~~countries, ~~and~~ ~~sometimes~~hospitals ~~reduce, payment levels. Commercial insurers~~ and ~~managed~~healthcare ~~care~~facilities ~~plans~~operate ~~frequently~~within ~~follow government payment policies and are~~budget ~~likewise~~constraints ~~interested~~that inmay ~~controlling~~limit ~~increases in~~ the ~~cost~~adoption of ~~medical~~new ~~care.~~or ~~These third~~higher-~~party~~cost ~~payors~~technologies. ~~may~~We ~~deny~~cannot ~~payment~~assure ~~if they determine~~ that afavorable ~~procedure was not medically necessary~~coverage, ~~a device used in a procedure was not used in accordance with cost-effective treatment methods~~reimbursement, ~~as determined by the third-party payor,~~ or ~~was~~pricing ~~used~~will ~~for~~be anavailable ~~unapproved~~in ~~use.~~any ~~Further~~market, ~~beginning January 1, 2021~~ and ~~over~~adverse ~~the~~changes ~~course of a three-year period, CMS will eliminate the inpatient only list for Medicare which will result~~ in ~~all~~reimbursement ~~spine~~policies ~~procedures~~could ~~being~~materially ~~payable in~~affect ~~the~~our ~~outpatient~~business, ~~setting. Reimbursement levels in the hospital outpatient and ASC settings are typically lower than for the hospital~~financial ~~inpatient~~condition, ~~setting~~ and ~~may~~results ~~not be adequate to cover the cost~~ of ~~innovative and novel medical devices~~operations.

In addition, some payors are adopting pay-for-performance programs that differentiate payments to healthcare providers based on the achievement of documented quality-of-care metrics, cost efficiencies, or patient outcomes. These programs are intended to provide incentives to providers to find ways to deliver the same or better results while consuming fewer resources. As a result of these programs, and related payor efforts to reduce payment levels, hospitals and other providers are seeking ways to reduce their costs, including the amounts they pay to medical device suppliers. Adverse changes in payment rates by payors to hospitals could adversely impact our ability to market and sell our products and negatively affect our financial performance.18

In international markets, healthcare payment systems vary significantly by country and many countries have instituted price ceilings on specific product lines. There can be no assurance that our products will be considered cost-effective by third-party payors, that reimbursement will be available or, if available, that the third-party payors’ reimbursement policies will not adversely affect our ability to sell our products profitably.

Member countries of the European Union offer various combinations of centrally financed healthcare systems and private health insurance systems. The relative importance of government and private systems varies from country to country. Governments may influence the price of medical devices through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems under which products may be marketed only once a reimbursement price has been agreed upon. Some of these countries may require, as condition of obtaining reimbursement or pricing approval, the completion of clinical trials that compare the cost-effectiveness of a particular product candidate to currently available therapies. Some E.U. member states allow companies to fix their own prices for devices but monitor and control company profits. The choice of devices is subject to constraints imposed by the availability of funds within the purchasing institution. Medical devices are most commonly sold to hospitals or healthcare facilities at a price set by negotiation between the buyer and the seller. A contract to purchase products may result from an individual initiative or as a result of a competitive bidding process. In either case, the purchaser pays the supplier, and payment terms vary widely throughout the European Union. Failure to obtain favorable negotiated prices with hospitals or healthcare facilities could adversely affect sales of our products.

Employees

As of ~~March~~December 131, 2025, we had 2032 employees. We believe that our success will depend, in part, on our ability to attract and retain qualified personnel. We have never experienced a work stoppage due to labor difficulties, and believe ~~that~~ our employee relations ~~with~~to ~~our~~be ~~employees are~~ good. None of our employees are represented by labor unions. We strive toward having a diverse team of employees and are committed to equality, inclusion and workplace diversity.

ITEM 1A.

RISK FACTORS

In addition to the other information contained in this Annual Report, the following risk factors should be considered carefully in evaluating our company. Our business, financial condition, liquidity or results of operations could be materially adversely affected by any of these risks.

Risks Related to Our Capital Resources and Impairments

We will require additional financing and our failure to obtain additional funding would force us to delay, reduce or eliminate our product development programs or commercialization efforts.

We currently have limited committed sources of capital, and we have limited liquidity. Our cash and cash equivalents as of December 31, ~~2024~~2025 were ~~was~~ $34.61 million. In ~~February~~October 2025, ~~we closed~~ the ~~public~~Company ~~offering~~entered ofinto ~~$5.0~~an ~~million~~At ofThe ~~units~~Market ~~consisting~~Offering ofAgreement to sell shares of its common stock, ~~Pre-funded~~from time ~~Warrants~~to time, ~~and~~through ~~common~~an ~~stock~~“at ~~purchase~~the ~~warrants~~market offering” or “ATM” program, ~~resulting~~ inhaving ~~net~~an ~~proceeds~~aggregate tooffering usprice of ~~approximately~~ $36.4 million. WeThere ~~expect~~is ~~our~~presently ~~current~~$6.0 ~~cash~~million ~~and~~available ~~cash~~capacity ~~equivalents~~under ~~will be sufficient to fund our operations through~~ the ~~second quarter of 2026~~ATM. We will require substantial future capital in order to continue ~~to continue~~ operating our business, conduct the research and development and regulatory clearance and approval activities necessary to bring our products to market, and to establish effective marketing and sales capabilities. Our existing capital resources are not sufficient to enable us to fund the completion of the development and commercialization of all of our product candidates.

We cannot determine with certainty the duration and completion costs of the current or future development and commercialization of our product candidates ~~for spinal fusion, joint replacement and coated metals~~ or if, when, or to what extent we will generate revenues from the commercialization and sale of any of these product ~~candidates~~ candidates for which we obtain regulatory approval. We may never succeed in achieving regulatory approval for certain or all of these product candidates. The duration, costs and timing of clinical trials and development of our spinal fusion, joint replacement and coated metal product candidates will depend on a variety of factors, including:

	●	the scope, rate of progress, and expense of our ongoing, as well as any additional, clinical trials and other research and development activities;

	●	future clinical trial results we may choose to conduct;

	●	potential changes in government regulation; and

	●	the timing and receipt of any regulatory approvals.

A change in the outcome of any of these variables with respect to the development of ~~spinal~~our ~~fusion, joint replacement or coated metal~~ product candidates could mean a significant change in the costs and timing associated with the development of these product candidates.

In addition, if adequate funds to develop our product candidates are not available on a timely basis, we may terminate or delay the development of one or more of our product candidates, or delay activities necessary to commercialize our product candidates. Additional funding may not be available to us on acceptable terms, or at all. Any additional equity financing, if available, may not be available on favorable terms and will most likely be dilutive to our current stockholders, and debt financing, if available, may involve more restrictive covenants. Our ability to access capital when needed is not assured and, if not achieved on a timely basis, will materially harm our business, financial condition and results of operations or could cause us to cease operations.

2119

The timing and amount of our future capital requirements will depend on many factors, including:

● the level of sales of our current products and the cost of revenue and sales and marketing; ● the extent of any clinical trials that we will be required to conduct in support of the regulatory clearance of our ~~total~~future ~~hip and knee replacement~~ product candidates; ● the scope, progress, results and cost of our product development efforts; ● the costs, timing and outcomes of regulatory reviews of our product candidates; ● the number and types of products we develop and commercialize; ● the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; and ● the extent and scope of our general and administrative expenses.

Raising additional capital by issuing securities or through debt financings or licensing arrangements will likely cause dilution to existing stockholders, restrict our operations or require us to relinquish proprietary rights.

To the extent ~~that~~the weCompany ~~raise~~raises additional capital through the ~~sale~~issuance of equity or convertible debt securities, ~~your~~existing ~~ownership~~stockholders may ~~interest~~experience ~~will~~dilution ~~likely~~in betheir ~~diluted,~~ownership ~~and~~interests. In addition, the terms of any such securities may include liquidation, conversion, dividend, or other ~~preferences~~preferential rights that are senior to or otherwise adversely affect ~~your~~the rights asof aholders ~~stockholder~~of the Company’s common stock. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or products or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability to achieve our product development and commercialization goals and have a material adverse effect on our business, financial condition and results of operations.

Risks Related to Our Business and Strategy

We have incurred net losses since our inception and anticipate that we will continue to incur ~~substantial~~ net losses for the foreseeable future. We may never achieve or sustain profitability.

We have incurred substantial net losses since our inception. For the years ended December 31, ~~2024~~2025 and ~~2023~~2024, we incurred a net loss of $1110.04 million and $811.30 million, respectively, and used cash in operations of $8.6 million and $148.16 million, respectively. We have an accumulated deficit of $~~281~~292.71 million and $~~270~~281.7 million as of December 31, ~~2024~~2025 and ~~2023~~2024, respectively. Our losses have resulted principally from costs incurred in connection with our sales and marketing activities, research and development activities, manufacturing activities, general and administrative expenses associated with our operations, impairments on intangible assets and property and equipment, interest expense, loss on extinguishment of debt and offering costs. Even if we are successful in launching new products into the market, we ~~expect~~may to continue to incur ~~substantial~~ losses for the foreseeable future as we continue to manufacture products for CTL Medical and other OEM customers and invest in research and ~~develop~~development and ~~seek~~ regulatory approvals for our product candidates. While we are focused on improving margins and controlling costs and believe our new product initiatives may improve our operating results over time, we cannot predict when, or if, we will achieve profitability.

2220

If sales revenue from any of our products or product candidates that receive marketing clearance from the FDA or other regulatory body is insufficient, if we are unable to develop and commercialize any of our product candidates, or if our product development is delayed, we may never become profitable. Even if we do become profitable, we may be unable to sustain or increase our profitability on a quarterly or annual basis.

Our success depends on our ability to successfully commercialize advanced ceramic products for biomedical, and antipathogenic applications, which to date have experienced only limited market acceptance.

We believe we are the first and only company to use silicon nitride in medical applications. To date, however, we have had limited acceptance of our silicon nitride-based products ~~and prior to the disposition of our spine implant business to CTL, our product revenue was derived substantially from our non-silicon nitride products~~. In order to succeed in our goal of becoming a leading advanced ceramics company, we must increase market awareness of our silicon nitride interbody fusion products, including our spinal fusion ~~products~~implants inand ~~conjunction~~foot ~~with~~and ~~CTL,~~ankle wedge systems, and develop and launch new biomedical, industrial, and antipathogenic products. If we fail in any of these endeavors or experience delays in pursuing them, we will not generate revenues as planned and will need to curtail operations or seek additional financing earlier than otherwise anticipated.

Our ~~current~~ biomedical products ~~and our future products~~ may not beachieve ~~accepted~~market byacceptance ~~hospitals~~or ~~and~~commercial ~~surgeons and may not become commercially successful~~success.

~~With~~ Following the sale of our spine implant business, ~~to CTL~~ we ~~are~~rely ~~now~~in ~~largely~~part ~~dependent~~ on ~~the~~third-party ~~efforts~~distribution ofpartners ~~CTL~~ to ~~sell~~commercialize ~~the~~certain silicon nitride spinal fusion products that we manufacture. ~~and~~If ~~then~~these ~~sell~~partners toare ~~CTL.~~unable ~~If CTL~~to iseffectively ~~not~~market ~~able~~and to sell such products or ~~is unable to~~ increase demand ~~for such products~~, ~~then~~ our revenues ~~will~~would ~~decline.~~be ~~Since~~adversely obtaining regulatory clearance from the FDA for our first silicon nitride spinal fusion products in 2008, we have not been able to obtain significant market share of the interbody spinal fusion market, and CTL may not obtain such market share in the futureaffected. ~~Even if we receive regulatory clearances or approvals for our other product candidates in development, these product candidates may not gain market acceptance among customers.~~

More broadly, our ability to generate meaningful revenue depends on market acceptance of our silicon nitride-based technologies by surgeons, hospitals, and other healthcare providers. Although we received FDA clearance for our first spinal fusion products in 2008, we have not achieved significant market share in the interbody spinal fusion market.

Our newer offerings, including the SiNAPTIC® foot and ankle wedge system, and any future products for which we obtain regulatory clearance or approval, may likewise fail to gain sufficient clinical adoption.

Market acceptance depends on numerous factors, including clinical outcomes, supporting data, reimbursement coverage and levels, pricing, surgeon familiarity, and competition from alternative biomaterials. If our products do not achieve adequate market acceptance, our business, results of operations, and financial condition would be materially adversely affected.

The orthopedic market is highly competitive, and we may not be able to compete effectively against the larger, well-established companies that dominate this market or emerging and small innovative companies that may seek to obtain or increase their share of the market.

The markets for orthopedic products are intensely competitive, and many of our competitors are much larger and have substantially more financial and human resources than we do. Many have long histories and strong reputations within the industry, and a relatively small number of companies dominate these markets. Medtronic, Inc.; DePuy Synthes Companies, a group of Johnson & Johnson companies; Stryker Corporation; Zimmer-Biomet, Inc.; Zimmer Holdings, Inc.; and Smith & Nephew plc, account for a significant number of orthopedic sales worldwide.

These companies enjoy significant competitive advantages over us, including:

	●	broad product offerings, which address the needs of orthopedic surgeons and hospitals in a wide range of procedures;

	●	products that are supported by long-term clinical data;

	●	greater experience in, and resources for, launching, marketing, distributing and selling products, including strong sales forces and established distribution networks;

	●	existing relationships with orthopedic surgeons;

	●	extensive intellectual property portfolios and greater resources for patent protection;

	●	greater financial and other resources for product research and development;

	●	greater experience in obtaining and maintaining FDA and other regulatory clearances and approvals for products and product enhancements;

	●	established manufacturing operations and contract manufacturing relationships;

	●	significantly greater name recognition and widely recognized trademarks; and

	●	established relationships with healthcare providers and payers.

2321

Our products and any product candidates that we may introduce into the market may not enable us to overcome the competitive advantages of these large and dominant orthopedic companies. In addition, even if we successfully introduce additional product candidates incorporating our silicon nitride biomaterial into the market, emerging and small innovative companies may seek to increase their market share and they may eventually possess competitive advantages, which could adversely impact our business. Our competitors may also employ pricing strategies that could adversely affect the pricing of our products ~~and pricing in the spinal fusion and total joint replacement market generally~~.

Moreover, numerous ~~many other~~ companies are ~~seeking~~developing ~~to develop~~and ~~new~~commercializing alternative biomaterials and ~~products~~surface ~~which~~technologies that may compete ~~effectively~~with ~~against~~ our silicon nitride-based products in terms of safety, performance, cost, and ~~price~~clinical acceptance. ~~For~~These ~~example~~include advanced metals, modified polymer ~~Smith~~implants &(such ~~Nephew~~as ~~has~~enhanced ~~developed~~PEEK aformulations), ceramic-coated or oxidized metal devices, ~~known~~additive asmanufacturing ~~Oxinium~~solutions, ~~which~~and ~~may~~other proprietary ~~overcome~~materials designed to improve osseointegration, durability, or antimicrobial properties. For example, certain ofcompetitors have ~~the~~developed ~~limitations~~ceramic-coated ofor treated metal ~~joint replacement~~implants ~~products~~intended ~~and~~to ~~could~~address ~~directly~~limitations associated with traditional metal devices, which may compete directly with our silicon nitride and silicon nitride-coated product ~~candidates~~offerings. Competitive materials and technologies are being advanced not only in spinal applications but also in extremity and other orthopedic segments, including foot and ankle procedures in which our SiNAPTIC® foot and ankle wedge system and potential future extremity products may compete. If competing technologies demonstrate comparable or superior clinical outcomes, are supported by more extensive clinical data, achieve broader surgeon adoption, or are offered at more competitive prices, our ability to gain or maintain market share across our product portfolio could be adversely affected.

The manufacturing process for our silicon nitride products is complex and requires sophisticated state-of-the-art equipment, experienced manufacturing personnel and highly specialized knowledge. If we are unable to manufacture our silicon nitride products on a timely basis consistent with our quality standards, our results of operation will be adversely impacted.

In order to control the quality, cost and availability of our silicon nitride products, we developed our own manufacturing capabilities. We operate a 3130,~~000~~764 square foot facility which is certified under the ISO 13485 medical device manufacturing standard for medical devices and operates under the FDA’s quality systems regulations, or QSRs. All operations, with the exception of raw material production , are performed at this facility.

We are the sole manufacturer of our silicon-nitride based products. Our reliance solely on our internal resources to manufacture our silicon nitride products entails risks to which we would not be subject if we had secondary suppliers for their manufacture, including:

● the inability to meet our product specifications and quality requirements consistently; ● a delay or inability to procure or expand sufficient manufacturing capacity to meet additional demand for our products; ● manufacturing and product quality issues related to the scale-up of manufacturing; ● the inability to produce a sufficient supply of our products to meet product demands; ● the disruption of our manufacturing facility due to equipment failure, natural disaster or failure to retain key personnel; and ● our inability to ensure our compliance with regulations and standards of the FDA, including QSRs, and corresponding state and international regulatory authorities, including the ~~CFDA~~NMPA (China).

2422

Any of these events could lead to a reduction in our product sales, product launch delays, failure to obtain regulatory clearance or approval or impact our ability to successfully sell our products and commercialize our products candidates.

We depend on a limited number of third-party suppliers for key raw materials used in the manufacturing of our silicon nitride products, and the loss of these third-party suppliers or their inability to supply us with adequate raw materials could harm our business.

We rely on a limited number of third-party suppliers for the raw materials required for the production of our silicon nitride products and product candidates. Our dependence on a limited number of third-party suppliers involves several risks, including limited control over pricing, availability, quality, and delivery schedules for raw materials. We have no supply agreements in place with any of our suppliers and cannot be certain that our current suppliers will continue to provide us with the quantities of raw materials that we require or that satisfy our anticipated specifications and quality requirements. Any supply interruption in limited or single sourced raw materials could materially harm our ability to manufacture our products until a new source of supply, if any, could be identified and qualified. We may be unable to find a sufficient alternative supply channel within a reasonable time or on commercially reasonable terms. Any performance failure on the part of our suppliers could delay the production of our silicon nitride products and product candidates and delay the development and commercialization of our product candidates, including limiting supplies necessary for commercial sale, clinical trials and regulatory approvals, which could have a material adverse effect on our business.

In order to be successful, we must expand our available product lines by commercializing new product candidates, but we may not be able to do so in a timely fashion and at expected costs, or at all.

~~Although~~ While we ~~are~~ currently ~~manufacturing~~manufacture silicon nitride ~~interbody~~ spinal fusion implants ~~for~~that ~~CTL,~~are incommercialized ~~order~~through tothird-party bedistribution ~~successful~~arrangements, our welong-term ~~will~~growth ~~need~~depends toon ~~expand~~expanding our product ~~lines~~portfolio toacross ~~include~~orthopedic, ~~other advanced~~extremity, ~~ceramic~~and ~~products~~other ~~for both~~ medical ~~and non-medical~~ applications~~. Therefore~~, weas ~~are developing new manufacturing technologies~~well ~~and~~as ~~new~~selected ~~product~~non-medical ~~candidates including our new ceramic armor products~~markets. ToThis ~~succeed~~includes incontinued ~~our~~ commercialization ~~efforts,~~of weour ~~must~~SiNAPTIC® ~~effectively continue~~foot ~~product development~~ and ~~testing,~~ankle ~~find~~wedge ~~new~~system ~~strategic partners, obtain regulatory clearances~~ and ~~approvals,~~the ~~and enhance our sales~~development ~~and marketing capabilities. Because~~ of ~~these~~additional ~~uncertainties,~~silicon ~~there~~nitride-based isproducts noincorporating ~~assurance that we will succeed in bringing any of~~ our ~~current or~~advanced ~~future~~ceramic ~~product candidates to market~~technologies. If we fail in bringing our product candidates to market, or experience delays in doing so, we will not generate revenues as planned and will need to curtail operations or seek additional financing earlier than otherwise anticipated.

WeTo succeed ~~will~~in ~~depend~~these onefforts, ~~one~~we ormust ~~more~~continue ~~strategic partners~~product todevelopment ~~develop~~and testing, scale and ~~commercialize~~optimize ~~our~~manufacturing ~~biomedical~~processes, obtain necessary regulatory clearances and ~~antipathogenic~~approvals, ~~product~~establish ~~candidates~~or expand distribution and strategic partner relationships, and ifenhance our ~~strategic~~sales ~~partners~~and marketing capabilities. We are ~~unable to~~also ~~execute~~pursuing ~~effectively~~opportunities onin ~~our~~non-medical ~~agreements~~applications, ~~with~~including ~~them~~advanced ceramic armor and other industrial technologies, wewhich ~~may~~involve ~~never~~different ~~become~~market ~~profitable~~dynamics, customer requirements, and competitive landscapes.

WeProduct development ~~are~~and ~~seeking~~commercialization ~~strategic~~involve ~~partners~~substantial totechnical, ~~develop and~~regulatory, ~~commercialize~~financial, ~~our biomedical~~ and ~~antipathogenic~~market ~~product candidates~~risks. We ~~will~~may beencounter ~~reliant~~delays ~~on our strategic partners to develop and commercialize~~in ~~these~~development ~~product candidates~~timelines, ~~although~~increased wecosts, ~~have~~manufacturing ~~not~~challenges, ~~yet~~regulatory ~~entered~~obstacles, ~~into~~or anslower-than-expected ~~agreement~~market ~~with~~adoption. ~~any~~There can ~~strategic partner to develop products and may~~ be ~~unable~~ tono doassurance sothat onany ~~agreeable~~of ~~terms. In order to succeed in~~ our ~~joint~~current ~~commercialization~~or ~~efforts, we and any~~ future ~~partners~~product ~~must~~candidates ~~execute effectively~~will onachieve ~~all~~regulatory ~~elements~~clearance ofor ~~a combined business plan~~approval, ~~including~~be ~~continuing to establish sales and marketing capabilities, manage certified,~~successfully ~~validated and effective commercial-scale manufacturing operations~~commercialized, ~~conduct~~or ~~product~~generate ~~development~~meaningful ~~and testing, and obtain regulatory clearances and approvals for our product candidates~~revenue. If we orare ~~any~~unable ofto ~~our~~successfully ~~strategic~~expand ~~partners~~and ~~fail~~commercialize inour ~~any~~product ~~of these endeavors~~lines, or ~~experience~~if ~~delays~~commercialization inis ~~pursuing them~~delayed, weour ~~will~~revenues ~~not~~and ~~generate~~growth ~~revenues~~prospects aswould ~~planned~~be adversely affected, and ~~will~~we may need to ~~curtail~~reduce operations or seek additional ~~financing~~capital sooner ~~earlier~~ than ~~otherwise~~ anticipated.

25We rely on both strategic partners and our own commercialization capabilities to develop and market our product candidates, and if these efforts are unsuccessful, we may not achieve profitability.

We currently utilize a combination of third-party commercialization arrangements and internal capabilities to develop, manufacture, and market our biomedical and antipathogenic product offerings. For certain product lines, including silicon nitride spinal fusion implants, we rely on distribution or strategic partners for commercialization. At the same time, following our acquisition of the SiNAPTIC® foot and ankle wedge system and related assets, we are undertaking direct commercialization efforts for that product line and may elect to do so for additional products in the future.

Our success will depend on the effectiveness of both these third-party relationships and our internal commercialization infrastructure. Where we rely on strategic partners, we are dependent on their ability to successfully market and distribute our products, manage customer relationships, and allocate sufficient resources to our product lines. Where we pursue commercialization independently, we must continue to build and manage sales and marketing capabilities, establish and maintain effective distribution channels, manage certified and validated commercial-scale manufacturing operations, conduct product development and testing, and obtain and maintain required regulatory clearances and approvals.

There can be no assurance that we will be able to successfully execute on either our partnered or direct commercialization strategies. If our strategic partners fail to perform as expected, if we are unable to effectively build and scale our internal commercialization capabilities, or if we experience delays or increased costs in these efforts, we may not generate revenues as anticipated and may need to curtail operations or seek additional financing sooner than expected.

Building and managing an in-house sales and distribution organization subjects us to significant operational, financial, and execution risks.

In connection with the commercialization of the SiNAPTIC® foot and ankle wedge system and potentially other future products, we are developing internal sales, marketing, and distribution capabilities. Establishing and managing an effective in-house commercial organization requires substantial time, capital, and management resources, and we have limited prior experience operating a direct sales force at scale.

We must recruit, train, and retain experienced sales representatives, including those with established relationships in the foot and ankle and broader orthopedic markets. Competition for qualified sales personnel in the medical device industry is intense, particularly for individuals with existing surgeon relationships and experience calling on hospitals, ambulatory surgery centers, and group purchasing organizations. We may be unable to attract or retain such personnel on acceptable terms, and turnover among sales representatives could disrupt customer relationships and delay revenue growth.

In addition, we may utilize independent distributors in certain territories, which introduces risks related to managing distributor performance, aligning incentives, negotiating pricing and commission structures, and maintaining consistent branding and compliance practices. Distributors may represent competing products and may not prioritize our products. Poor distributor performance or disputes over commercial terms could adversely affect sales.

Direct commercialization also requires us to manage inventory forecasting, warehousing, logistics, instrument tray deployment, and consignment arrangements. Inaccurate demand forecasting, slow inventory turnover, product returns, or obsolescence could result in write-downs and negatively impact gross margins. Furthermore, the need to maintain inventory and instrument sets in the field may increase our working capital requirements and cash burn, particularly during the early stages of market adoption.

If we are unable to effectively build, manage, and scale our internal sales and distribution infrastructure, or if the associated costs exceed our expectations, our commercialization efforts may be delayed or less successful than anticipated, which could materially adversely affect our business, results of operations, financial condition, and liquidity.

Part of our strategy is to establish and develop OEM partnerships and arrangements, which subjects us to various risks.

Because we believe silicon nitride is a superior platform and technology for application in the spine, total joint and other markets and industrial applications, we are establishing OEM partnerships with other companies to replace their materials and products with silicon nitride. Sales of products to OEM customers will expose our business to a number of risks. Sales through OEM partners could be less profitable than direct sales. Sales of our products through multiple channels could also confuse customers and cause the sale of our products to decline. In addition, OEM customers will require that products meet strict standards. Our compliance with these requirements could result in increased development, manufacturing, warranty and administrative costs. A significant increase in these costs could adversely affect our operating results. If we fail to meet OEM specifications on a timely basis, our relationships with our OEM partners may be harmed. Furthermore, we would not control our OEM partners, and they could sell competing products, may not incorporate our technology into their products in a timely manner and may devote insufficient sales efforts to the OEM products.

If hospitals and other healthcare providers are unable to obtain coverage or adequate reimbursement for procedures performed ~~with~~using our medical products, ~~it is unlikely~~ our products ~~will be~~may ~~widely~~not ~~used~~achieve widespread adoption.

~~In the United States, the~~ The commercial success of our ~~spinal~~medical products ~~will depend~~, inincluding ~~part,~~our onsilicon ~~the~~nitride ~~extent~~spinal toimplants, ~~which governmental payers at~~ the ~~federal~~SiNAPTIC® foot and ~~state~~ankle ~~levels,~~wedge ~~including Medicare~~system, and ~~Medicaid,~~any ~~private~~future ~~health~~orthopedic ~~insurers~~or ~~and~~ other ~~third-party~~medical ~~payers~~devices ~~provide coverage for and establish adequate reimbursement levels for procedures utilizing our products. Because~~ we ~~typically~~develop, ~~receive~~depends ~~payment~~in ~~directly~~part ~~from~~on the ~~companies~~availability ~~for~~of ~~whom~~coverage weand ~~manufacture,~~adequate ~~we do not~~reimbursement ~~anticipate~~from ~~relying~~governmental ~~directly~~and onprivate ~~payment from~~ third-party payers ~~for our products~~. ~~However,~~Hospitals ~~hospitals~~ and other healthcare providers that purchase ~~orthopedic~~and ~~products~~use ~~manufactured by us from~~ our ~~customers~~products ~~for~~generally rely ~~treatment~~on ofMedicare, ~~their~~Medicaid, ~~patients~~private ~~generally~~insurers, ~~rely~~and onother ~~third-party~~ payers to ~~pay~~reimburse ~~for~~ all or ~~part~~a portion of the costs ~~and~~of ~~fees~~the ~~associated~~procedures ~~with~~in which our products asare ~~part~~used, oftypically aunder “bundled” ~~rate~~or ~~for~~fixed ~~the~~payment ~~associated procedures~~rates. ~~The~~If ~~existence of~~ coverage ~~and~~is ~~adequate~~unavailable or reimbursement ~~for~~levels ~~our~~are ~~products and the procedures performed with them by government~~insufficient, ~~and~~providers ~~private~~may ~~payers~~be isunwilling ~~critical~~ to ~~market acceptance of our existing and future products. Neither hospitals nor surgeons are likely to~~ use our products ~~if they do not receive adequate reimbursement for the procedures utilizing our products~~.

~~Many~~Coverage and ~~private~~reimbursement ~~payers~~policies ~~currently~~vary ~~base~~among ~~their~~payers ~~reimbursement policies~~and onmay ~~the~~be ~~coverage~~influenced ~~decisions~~by ~~and~~determinations ~~payment~~made ~~amounts determined~~ by the Centers for Medicare ~~and~~& Medicaid Services, or (CMS~~, which administers the Medicare program~~). ~~Others~~Private ~~may~~payers ~~adopt~~frequently ~~different~~follow CMS coverage orand ~~reimbursement~~payment ~~policies for procedures performed with our products~~decisions, ~~while some~~and ~~governmental~~adverse ~~programs,~~determinations ~~such~~at ~~as Medicaid, have reimbursement policies that vary from state to state, some of which may not pay for~~ the ~~procedures~~federal ~~performed with our products in an adequate amount, if at all. A Medicare national~~ or ~~local coverage decision denying coverage~~state ~~for~~level ~~one or more of our products~~ could ~~result~~negatively inaffect ~~private~~reimbursement ~~and~~by other ~~third-party~~ payers. ~~also~~In ~~denying~~addition, ~~coverage for our products. Third-party~~ payers ~~also~~ may deny reimbursement ~~for our products~~ if they determine that a ~~product used in a~~ procedure was not medically necessary, was not ~~used in accordance with~~ cost-effective ~~treatment methods~~, ~~as determined by the third-party payer,~~ or ~~was~~involved ~~used~~a ~~for an unapproved~~ use. ~~Unfavorable~~not ~~coverage~~approved or ~~reimbursement~~cleared ~~decisions~~ by ~~government programs or private payers underscore~~ the ~~uncertainty that our products face in the market and could have a material adverse effect on our business~~FDA.

~~Many~~The U.S. ~~hospitals~~healthcare ~~and~~system ~~clinics~~continues ~~in the United States belong~~ to ~~group~~face ~~purchasing~~significant ~~organizations,~~cost-containment ~~which~~pressures. ~~typically~~Government ~~incentivize~~and ~~their~~private ~~hospital~~payers ~~members~~periodically torevise ~~make~~payment methodologies aand ~~relatively~~may ~~large~~reduce ~~proportion~~reimbursement ~~of purchases~~rates ~~from~~or aimpose ~~limited~~value-based ~~number~~purchasing ofand ~~vendors~~pay-for-performance ofmeasures ~~similar products~~ that ~~have~~increase ~~contracted to offer discounted prices. Such contracts often~~pricing ~~include~~pressure ~~exceptions~~on ~~for~~hospitals ~~purchasing~~and, ~~certain~~indirectly, ~~innovative~~on ~~new~~medical ~~technologies,~~device ~~however~~manufacturers. ~~Accordingly,~~As ~~the~~a ~~commercial~~result, ~~success~~hospitals ofand ~~our~~other ~~products~~providers may ~~also~~ ~~depend~~seek to ~~some~~reduce the ~~extent~~prices onthey ~~our~~pay ~~ability~~for toour ~~either~~products ~~negotiate favorable purchase contracts with key group purchasing organizations and/~~or ~~persuade~~ ~~hospitals~~limit ~~and~~adoption ~~clinics~~of toproducts ~~purchase~~perceived ~~our~~as ~~product~~more ~~“off~~costly ~~contract~~than alternatives.”

~~The healthcare industry in the United States~~Hospitals ~~has experienced a trend toward cost containment as government~~ and ~~private~~clinics ~~payers~~often ~~seek~~participate toin ~~control~~group ~~healthcare~~purchasing ~~costs~~organizations ~~by paying service providers lower rates. While it is expected that hospitals will be able to obtain coverage for procedures using our products~~(GPOs), ~~the~~which ~~level~~negotiate ofpricing ~~payment available~~arrangements towith ~~them~~selected ~~for such procedures may change over time~~vendors. ~~State and federal healthcare programs, such as Medicare and Medicaid, closely~~If ~~regulate~~we ~~provider payment levels and have sought to contain, and sometimes reduce, payment levels. Private payers frequently follow government payment policies and~~ are ~~likewise~~unable ~~interested in controlling increases in the cost of medical care. In addition, some payers are adopting pay-for-performance programs that differentiate payments~~ to ~~healthcare~~secure ~~providers~~contracts ~~based~~with onkey ~~the~~GPOs ~~achievement of documented quality-of-care metrics, cost efficiencies,~~ or ~~patient~~otherwise ~~outcomes.~~persuade ~~These programs are intended to provide incentives to~~ providers to ~~deliver~~purchase the same or better results while consuming fewer resources. As a result of these programs, and related payer efforts to reduce payment levels, hospitals and other providers are seeking ways to reduce their costs, including the amounts they pay to medical device manufacturers. We may not be able to sell our ~~implants~~products ~~profitably~~outside ~~if third-party payers deny or discontinue coverage or reduce their levels~~ of ~~payment~~existing ~~below that which we project~~contracts, ~~or if our production costs increase at a greater rate than payment levels. Adverse changes in payment rates by payers~~ ~~to hospitals could adversely impact~~ our ability to ~~market~~achieve ~~and~~meaningful ~~sell~~market ~~these~~penetration ~~products~~could ~~and~~be ~~negatively~~adversely ~~affect our financial performance~~affected.

26Internationally, reimbursement systems and pricing controls vary by country, and many jurisdictions impose price ceilings or other restrictions on medical devices. Failure to obtain favorable reimbursement or pricing approvals in international markets could limit adoption of our products outside the United States.

InAdverse changes ~~international~~in ~~markets~~coverage, ~~medical~~reimbursement ~~device~~levels, ~~regulatory requirements~~or ~~and~~ healthcare ~~payment systems vary significantly from country to country~~policy, ~~and~~whether ~~many~~in ~~countries~~the ~~have~~United ~~instituted~~States ~~price ceilings on specific product lines. We cannot assure you that our products will be considered cost-effective by international third-party payers, that reimbursement will be available~~ or, ~~if available~~internationally, ~~that~~could ~~the~~materially ~~third-party payers’ reimbursement policies will not~~ adversely ~~affect~~ ~~our~~affect ~~ability to sell~~ our ~~products~~business, ~~profitably.~~results ~~Any failure to receive regulatory or reimbursement approvals would negatively impact market acceptance~~ of ~~our~~operations, ~~products~~and infinancial ~~any international markets in which those approvals are sought~~condition.

There is no assurance that federal or state healthcare reform will not also adversely affect our business and financial results, and we cannot predict how future federal or state legislative, judicial or administrative changes relating to healthcare reform will affect our business.24

A pandemic, epidemic or outbreak of an infectious disease in the United States or elsewhere may adversely affect our business, operations, and financial condition.

AFuture outbreaks ~~significant outbreak in the future~~ of ~~contagious~~ infectious diseases, ~~such~~or asother ~~COVID-19,~~public ~~could~~health ~~result~~emergencies in athe ~~widespread~~United ~~health~~States ~~crisis~~or ~~that~~internationally could ~~adversely~~disrupt ~~affect~~global ~~the~~and domestic economies, ~~and~~ financial markets ~~of many countries~~, ~~resulting~~and inhealthcare ~~an economic downturn~~systems. AsSuch aevents ~~result, our ability to raise additional funds, if necessary,~~ may beresult ~~adversely impacted~~in byreduced ~~risks,~~access ~~or the public perception of the risks, related~~ to ~~the~~capital ~~recent outbreak of COVID-19. Furthermore~~markets, ~~the third parties~~increased wemarket ~~engage~~volatility, orand ~~seek~~constraints toon ~~engage,~~our ~~with~~ability ~~respect~~ to ~~OEM~~raise ~~manufacturing~~additional ~~relationships,~~financing ~~and,~~on ~~for~~acceptable ~~supply and development activities~~terms, ~~may be adversely impacted by risks,~~ or ~~the~~at ~~public perception of the risks, related to the recent outbreak of COVID-19, which may delay OEM relationships, and, product development opportunities, and increase our costs~~all.

Public health crises may also disrupt our operations and those of our suppliers, manufacturers, and distribution partners. Travel restrictions, workforce shortages, quarantines, government-mandated shutdowns, or supply chain interruptions could delay product development, manufacturing, regulatory activities, or commercialization efforts. In addition, hospitals and healthcare providers may postpone elective or non-urgent procedures during periods of healthcare system strain, which could reduce demand for our orthopedic and other medical products.

The extent and duration of any future pandemic or public health emergency and its impact on our business would depend on numerous factors beyond our control, including the severity of the outbreak, governmental responses, and the resilience of global supply chains and healthcare systems. Any such event could materially adversely affect our business, results of operations, financial condition, and liquidity.

Prolonged negative economic conditions in domestic and international markets may adversely affect us, our suppliers, partners and consumers, and could harm our financial position.

There is a risk that one or more of our current suppliers may not continue to operate. Any lender that is obligated to provide funding to us under any future credit agreement with us may not be able to provide funding in a timely manner, or at all, when we require it. The cost of, or lack of, available credit or equity financing could impact our ability to develop sufficient liquidity to maintain or grow our company. These negative changes in domestic and international economic conditions or additional disruptions of either or both of the financial and credit markets may also affect third-party payers and may have a material adverse effect on our business, results of operations, financial condition and liquidity.

In addition, we believe that various demographics and industry-specific trends will help drive growth in our target markets, but these demographics and trends are uncertain. Actual demand for our products could be significantly less than expected if our assumptions regarding these factors prove to be incorrect or do not materialize.

2725

We are dependent on our senior management team, engineering team, and external advisors, and the loss of any of them could harm our business. We may not have sufficient personnel to effectuate our business strategy due to our recent reduction in force.

The members of our current senior management team may not be able to successfully implement our strategy. ~~In addition, we have not entered into employment agreements, other than change-in-control severance agreements, with any of the members of our senior management team.~~ There are no assurances that the ~~services~~ services of any of these individuals will be available to us for any specified period of time. The successful integration of our senior ~~management~~ management team, the loss of members of our senior management team, engineering team and key external advisors, or our inability to attract or retain other qualified personnel or advisors could have a material adverse effect on our business, financial condition and results of operations. We may not have sufficient number of qualified personnel to effectuate our business strategy, which could have a material adverse effect on our business, financial condition and results of operations.

If we experience significant disruptions in our information technology systems, our business, results of operations and financial condition could be adversely affected.

The efficient operation of our business depends on our information technology systems. We rely on our information technology systems to effectively manage our sales and marketing, accounting and financial functions; manufacturing processes; inventory; engineering and product development functions; and our research and development functions. As such, our information technology systems are vulnerable to damage or interruption including from earthquakes, fires, floods and other natural disasters; terrorist attacks and attacks by computer viruses or hackers; power losses; and computer systems, or Internet, telecommunications or data network failures. The failure of our information technology systems to perform as we anticipate or our failure to effectively implement new systems could disrupt our entire operation and could result in decreased sales, increased overhead costs, excess inventory and product shortages, all of which could have a material adverse effect on our reputation, business, results of operations and financial condition.

~~Cyber security~~ Cybersecurity risks and ~~the~~failures ~~failure to maintain the integrity~~ of ~~company,~~our ~~employee~~information ortechnology ~~guest~~systems ~~data~~ could ~~expose~~disrupt usour ~~to data loss~~operations, ~~litigation~~compromise ~~and~~confidential ~~liability~~information, and ~~our reputation~~materially ~~could~~adversely beaffect ~~significantly~~our ~~harmed~~business.

We rely ~~collect and third parties collaborating~~ on ~~our~~ ~~clinical~~information ~~trials~~technology ~~collect~~systems and ~~retain~~digital ~~large~~infrastructure ~~volumes~~to ofoperate ~~data~~our business, including ~~personally~~systems ~~identifiable~~used ~~information~~for ~~regarding~~financial ~~clinical trial~~reporting, ~~participants~~manufacturing ~~and others~~operations, ~~for~~supply ~~business~~chain ~~purposes~~management, ~~including~~inventory ~~for regulatory~~control, ~~research~~sales and ~~development~~distribution ~~and~~activities, ~~commercialization~~research ~~purposes~~and development, and ~~our~~communications ~~collaborators’~~with ~~various information technology systems enter~~customers, ~~process~~suppliers, ~~summarize and report such data. We also maintain personally identifiable information about our~~ employees~~. The integrity and protection of our company~~, ~~employee~~ and ~~clinical~~other ~~data~~third ~~is critical to our business~~parties. We ~~are~~collect, ~~subject to significant security and privacy regulations~~process, ~~as well as requirements imposed by government regulation. Maintaining compliance with these evolving regulations~~ and ~~requirements~~store ~~could~~sensitive ~~be difficult and may increase our expenses. In addition~~information, including aproprietary ~~penetrated~~business ~~or compromised data system or the intentional~~information, ~~inadvertent~~intellectual ~~or negligent release or disclosure of data could result in theft~~property, ~~loss~~ ~~or fraudulent or unlawful use of company,~~ employee ~~or clinical~~ data ~~which could harm our reputation~~, ~~disrupt our operations, or result in remedial~~ and ~~other~~limited ~~costs,~~customer-related ~~fines or lawsuits~~information.

Our systems, and those of our third-party service providers, distributors, and manufacturing partners, may be vulnerable to cybersecurity threats, including unauthorized access, ransomware attacks, phishing schemes, malware, business email compromise, insider misconduct, and other cyber incidents. The frequency and sophistication of cyberattacks have increased in recent years, particularly against healthcare and manufacturing companies.

A successful cyberattack or other security incident could result in the loss, theft, corruption, or unauthorized disclosure of confidential information; disruption of manufacturing or supply chain operations; delays in product development or commercialization; financial loss; and reputational harm. Ransomware or other attacks affecting our manufacturing systems could interrupt production or distribution of our medical products. In addition, a material cybersecurity incident could impair our ability to maintain effective internal control over financial reporting.

We are subject to evolving federal, state, and international data privacy and cybersecurity laws and regulations, as well as contractual obligations with third parties, which require us to safeguard information and, in certain circumstances, provide notice of data breaches. Compliance with these requirements may increase our costs, and any failure to comply could result in regulatory investigations, litigation, fines, or other liabilities.

Although we maintain cybersecurity policies, procedures, and technical safeguards designed to protect our systems and data, these measures may not be sufficient to prevent all incidents. Any significant cybersecurity breach or disruption could materially adversely affect our business, results of operations, financial condition, and liquidity.

Risks Related to Regulatory Approval of Our Products and Other Government Regulations

Contracting with government entities exposes us to additional risks inherent in the government procurement process.

We provide products and services, directly and indirectly, to a variety of domestic government entities, which introduces certain risks, including extended sales and collection cycles, varying governmental budgeting processes and adherence to complex procurement regulations and other government-specific contractual requirements. We have been, are currently and may in the future be subject to audits and investigations relating to our government contracts and any violations could result in various civil and criminal penalties and administrative sanctions, including termination of contracts, payment of fines and suspension or debarment from future government business, as well as harm to our reputation and financial results.

2826

We design, manufacture and service products that incorporate advanced technologies; the introduction of new products and technologies involves risks, and we may not realize the degree or timing of benefits initially anticipated; competition may reduce our revenues and segment share and limit our future opportunities.

We seek to achieve growth through the design, development, production, sale and support of innovative commercial products that incorporate advanced technologies. The product, program and service needs of our customers change and evolve regularly, and we invest substantial amounts in research and development efforts to pursue advancements in a wide range of technologies, products and services. Our ability to realize the anticipated benefits of our technological advancements depends on a variety of factors, including meeting development, production, certification and regulatory approval schedules; receiving regulatory approvals; execution of internal and external performance plans; availability of supplier and internally produced parts and materials; performance of suppliers and subcontractors; availability of supplier and internal facility capacity to perform maintenance, repair and overhaul services on our products; hiring and training of qualified personnel; achieving cost and production efficiencies; identification of emerging technological trends for our target end-customers (such as sustainable technologies, as described below); validation of innovative technologies; risks associated with the development of complex software; the level of customer interest in new technologies and products; and customer acceptance of products we manufacture or that incorporate technologies we develop. In addition, many of our products must adhere to strict regulatory and market-driven safety and performance standards in a variety of jurisdictions. The evolving nature of these standards, along with the long duration of development, production and aftermarket support programs, creates uncertainty regarding program profitability, particularly with our aircraft engine products. Development efforts divert resources from other potential investments in our businesses, and these efforts may not lead to the development of new technologies or products on a timely basis or meet the needs of our customers as fully as competitive offerings. In addition, the industries for our products or products that incorporate our technologies may not develop or grow as we anticipate. We or our customers, suppliers or subcontractors may encounter difficulties in developing and producing new products and services, and may not realize the degree or timing of benefits initially anticipated or may otherwise suffer significant adverse financial consequences. Due to the design complexity of our products or those of our customers or third -party manufacturers that incorporate our products into theirs or our customers’ products, we may experience delays in completing the development and introduction of new products or we may experience the suspension of production after these products enter into service due to safety concerns. Delays and/or suspension of production could result in increased development costs or deflect resources from other projects. We operate in highly competitive industries, and our competitors may have more extensive or more specialized engineering, manufacturing, marketing and servicing capabilities than we do. Our contracts are typically awarded on a competitive basis. Our bids are based upon, among other items, the cost to provide the products and services. To generate an acceptable return on our investment in these contracts, we must be able to accurately estimate our costs to provide the services and deliver the products and to be able to complete the contracts in a timely manner. If we fail to accurately estimate our costs or the time required to complete a contract, the profitability of our contracts may be materially and adversely affected. Furthermore, our competitors, including our customers, may develop competing technologies which gain industry acceptance in advance of or instead of our products, or meet particular in-demand technological needs before us or with technology that is superior to our existing or new technologies. For example, the enhanced focus on climate change has increased demand for more environmentally sustainable products and services, as described below. Our competitors may develop sustainable products or services that are available to our customers before our products or services, or that are adopted more readily than our products or services. In addition, our competitors or customers might develop new technologies or offerings that might cause our existing technologies and offerings to become obsolete or otherwise decrease demand for our offerings. In addition, the possibility exists that competitors or customers will develop aftermarket services and aftermarket parts for our products that attract customers and adversely impact our return on investment on new products. If we are unable to continue to compete successfully against our current or future competitors in our core businesses, we may experience declines in revenues and industry segment share. Any of the foregoing could have a material adverse effect on our competitive position, results of operations, financial condition or liquidity.

Exports and imports of certain of our products are subject to various export control, sanctions and import regulations and may require authorization from regulatory agencies of the U.S. or other countries.

We must comply with various laws and regulations relating to the export and import of products, services and technology from and into the U.S. and other countries having jurisdiction over our operations. In the U.S., these laws and regulations include, among others, the EAR administered by the U.S. Department of Commerce, the ITAR administered by the U.S. Department of State, embargoes and sanctions regulations administered by the U.S. Department of the Treasury, and import regulations administered by the U.S. Department of Homeland Security and the U.S. Department of Justice. Certain of our products, services and technologies have military or strategic applications and we are required to obtain licenses and authorizations from the appropriate U.S. government agencies before selling these products outside of the U.S. or importing these products into the U.S. U.S. foreign policy or foreign policy of other licensing jurisdictions may affect the licensing process or otherwise prevent us from engaging in business dealings with certain individuals, entities or countries. Any failure by us, our customers or our suppliers to comply with these laws and regulations could result in civil or criminal penalties, fines, seizure of our products, adverse publicity, restrictions on our ability to export or import our products, or the suspension or debarment from doing business with the U.S. government. Moreover, any changes in export control, sanctions or import regulations may further restrict the export of our products or services, and the possibility of such changes requires constant monitoring to ensure we remain compliant. Our ability to obtain required licenses and authorizations on a timely basis or at all is subject to risks and uncertainties, including changing U.S. government foreign policies or laws, delays in Congressional action, or geopolitical and other factors. If we are not successful in obtaining or maintaining the necessary licenses or authorizations in a timely manner, our sales relating to those approvals may be prevented or delayed, and revenue and profit previously recognized may be reversed. Any restrictions on the export or import of our products or product lines could have a material adverse effect on our competitive position, results of operations, financial condition or liquidity.

2927

Our long-term success depends ~~substantially~~ on our ability to obtain ~~regulatory~~and ~~clearance~~maintain orregulatory ~~approval~~clearances and ~~thereafter~~approvals ~~commercialize~~for our ~~product~~medical ~~candidates;~~products weand ~~cannot~~product candidates, beand ~~certain that~~ we ~~will~~may be ~~able~~unable to do so in a timely manner or at all.

~~The process of obtaining regulatory clearances~~Our ~~or approvals to market a~~ medical device ~~from~~products, ~~the~~including ~~FDA~~our orsilicon ~~similar~~nitride ~~regulatory~~spinal ~~authorities~~implants, ~~outside~~extremity ofproducts ~~the~~such ~~United~~as ~~States~~the ~~can~~SiNAPTIC® befoot ~~costly~~ and ankle ~~time~~wedge ~~consuming~~system, and ~~there~~any ~~can~~future bemedical nodevice ~~assurance~~product ~~that such clearances or approvals will be granted on a timely basis~~candidates, orare atsubject ~~all. The FDA’s 510(k) clearance process generally takes one~~ to ~~six~~extensive ~~months~~regulation ~~from~~by the ~~date~~U.S. ofFood ~~submission,~~and ~~depending~~Drug ~~on whether a special or traditional~~Administration ~~510~~(kFDA) ~~premarket~~and ~~notification~~comparable ~~has~~regulatory ~~been~~authorities ~~submitted,~~outside ~~but~~the ~~can~~United ~~take significantly longer~~States. AnBefore ~~application~~a ~~for~~new ~~premarket~~device ~~approval,~~may ~~or PMA, must~~ be ~~submitted~~commercially tomarketed in the ~~FDA~~United States, ifit ~~the~~generally ~~device~~must ~~cannot~~receive beclearance ~~cleared~~under ~~through~~ the FDA’s 510(k) ~~clearance process or is not exempt from~~ premarket ~~review~~notification ~~by the FDA. The PMA~~ process, ~~almost~~be ~~always~~authorized ~~requires~~through ~~one or more clinical trials and can take two to three years from~~ the ~~date~~De Novo ofclassification ~~filing~~process, or ~~even~~obtain ~~longer.~~approval Inthrough ~~some cases, including in~~ the ~~case~~more ofrigorous ~~our~~premarket ~~interbody~~approval ~~spinal~~(PMA) ~~fusion~~process. ~~devices~~These ~~which~~regulatory ~~incorporate our CSC technology and~~pathways ~~our~~are ~~solid~~costly, ~~silicon nitride femoral head component~~time-consuming, ~~the~~and ~~FDA~~inherently ~~requires clinical data as part of the 510(k) clearance process~~uncertain.

~~It is possible that the FDA could raise questions~~Although ~~about~~many ~~spinal~~orthopedic ~~fusion~~devices ~~products~~are orreviewed ~~other~~under ~~medical device product candidates and could require us to perform additional studies on our products and product candidates. Even if~~ the ~~FDA permits us to use the~~ 510(k) ~~clearance~~ process, ~~we cannot assure you that~~ the FDA ~~will~~may ~~not~~ require ~~either~~ ~~supporting~~additional ~~data~~non-clinical ~~from laboratory tests or studies that we have not conducted~~testing, ~~or substantial supporting~~ clinical data., ~~If we are~~or ~~unable~~other toinformation ~~use the 510(k) clearance process for any of our product candidates, are required~~ to ~~provide~~support ~~clinical~~a ~~data~~submission. orDevices ~~laboratory data~~ that we dobelieve ~~not~~are ~~possess~~eligible tofor ~~support our~~ 510(k) ~~premarket~~clearance ~~notifications~~may ~~for~~instead ~~any~~be ofrequired ~~these product candidates, or otherwise experience delays in obtaining or fail~~ to ~~obtain regulatory clearances,~~ undergo the ~~commercialization~~De ofNovo ~~our product candidates in the United States will be delayed~~ or ~~prevented~~PMA processes, which ~~will~~typically ~~adversely~~involve ~~affect~~greater ~~our~~data ~~ability~~requirements toand ~~generate~~longer ~~additional~~review ~~revenues~~periods. ItIf ~~also~~we ~~may~~seek ~~result~~to inconduct ~~the~~a ~~loss~~clinical study of ~~potential~~a ~~competitive advantages~~significant ~~that~~risk device, we ~~might~~would ~~otherwise~~be ~~attain~~required ~~by bringing our products~~ to ~~market~~obtain ~~earlier than our competitors. Additionally, although the~~ FDA ~~allows~~approval ~~modifications~~of toan beinvestigational ~~made~~device toexemption ~~devices that have received 510~~(kIDE) ~~clearance~~prior ~~with~~to initiating ~~supporting~~such ~~documentation,~~study. ~~the~~Delays ~~FDA~~in ~~may~~preparing ~~disagree with~~or ~~our~~submitting ~~decision~~applications, responding to ~~modify~~FDA ~~our~~requests ~~cleared~~for ~~devices~~additional ~~without~~information, ~~submission~~completing required oftesting, aor ~~new~~obtaining ~~510(k)~~IDE ~~premarket notification~~approval, ~~subjecting~~if ~~us to potential product recall~~required, ~~field~~could ~~alerts~~delay ~~and~~or ~~corrective~~prevent ~~actions.~~commercialization ~~Any~~ of ~~these~~our ~~contingencies~~product ~~could~~candidates ~~adversely~~or ~~affect~~modifications to ~~our~~existing ~~business~~products.

~~Similar~~Even after toa ~~our~~device ~~compliance~~receives ~~with~~clearance ~~U.S.~~or ~~regulatory requirements~~approval, we ~~must~~remain ~~obtain~~subject ~~and~~to ~~comply~~ongoing ~~with~~regulatory ~~international~~ requirements, inincluding ~~order~~compliance towith ~~market~~the ~~and~~FDA’s Quality ~~sell~~System ~~our~~Regulation ~~products~~(which ~~outside~~will oftransition to the ~~United States~~Quality ~~and~~Management weSystem ~~may~~Regulation ~~only~~(QMSR)), ~~promote~~labeling and ~~market~~promotional ~~our products~~restrictions, medical ifdevice ~~approved~~reporting obligations, aspost-market ~~permitted~~surveillance, byand ~~applicable~~FDA ~~regulatory authorities~~inspections. ~~There~~The isFDA nomay ~~guarantee that~~disagree wewith ~~will~~our ~~receive~~determination ~~the~~that a ~~necessary~~modification ~~regulatory~~to ~~approvals~~a ~~for~~cleared ~~our~~device ~~product~~does ~~candidates~~not ~~either~~require ~~inside~~a ~~the~~new ~~United~~premarket ~~States~~submission, orwhich ~~internationally. If~~could ~~our~~result ~~product~~in ~~candidates~~enforcement doactions ~~not~~such ~~receive~~as ~~necessary~~warning letters, ~~regulatory approvals~~fines, ~~our~~product ~~business~~recalls, ~~could~~operating berestrictions, ~~materially~~or ~~and~~other ~~adversely~~corrective ~~affected~~measures.

~~The~~We are ~~safety~~also ofsubject ~~our~~to ~~products~~regulatory isrequirements ~~not~~in ~~yet~~international ~~supported~~markets, including under the European Union Medical Device Regulation (EU byMDR) ~~long~~and other jurisdiction-~~term~~specific frameworks. Approval processes, documentation standards, clinical ~~data~~evidence requirements, and ~~they~~timelines vary ~~may~~by ~~prove~~jurisdiction, and regulatory approvals or certifications in one country do not ensure approval in another. Failure to beobtain or ~~less~~maintain ~~safe~~required regulatory authorizations in the United States or internationally, or significant delays in doing so, could prevent or delay commercialization of our products, increase our costs, and ~~effective~~materially ~~than~~adversely affect our ~~laboratory~~business, ~~data~~results ~~indicate~~of operations, and financial condition.

WeThe safety ~~obtained~~and ~~FDA~~effectiveness ~~clearance for each~~ of our ~~spinal fusion~~ products ~~that~~are we currently manufacture for CTL Medical, and we have sought and intend to seek FDA clearance or approval through the FDA’s 510(k) or PMA process and, where applicable, CE marking for our product candidates. The 510(k) clearance process is based on the FDA’s agreement that a new product candidate is substantially equivalent to an already marketed product for which a PMA was not ~~required.~~supported ~~While~~by ~~most~~long-term ~~510(k) premarket notifications do not require~~ clinical data ~~for clearance~~, ~~the~~and ~~FDA~~they may ~~request~~prove ~~that~~to ~~such data~~ be ~~provided.~~less ~~Long-term~~safe ~~clinical data~~ or ~~marketing experience obtained after clearance may indicate that our products cause unexpected~~effective ~~complications~~than ~~or other unforeseen negative effects. If this happens, we could be subject to the withdrawal of~~ our ~~marketing~~preclinical ~~clearance and~~testing ~~other enforcement sanctions by the FDA~~ or ~~other~~limited ~~regulatory~~clinical ~~authority,~~experience product recalls, significant legal liability, significant negative publicity, damage to our reputation and a dramatic reduction in our ability to sell our products, any one of which would have a material adverse effect on our business, financial condition and results of operationsindicate.

We have ~~may~~received beFDA ~~required~~clearance tofor ~~conduct~~our ~~clinical trials~~silicon tonitride ~~support~~spinal ~~regulatory~~implants ~~approval~~and offor ~~some~~the ofSiNAPTIC® ~~our~~foot ~~product~~and ~~candidates.~~ankle Wewedge ~~have~~system, ~~little~~and ~~experience~~we ~~conducting~~may seek ~~clinical~~additional ~~trials,~~regulatory ~~they~~clearances ~~may proceed~~or ~~more~~approvals ~~slowly~~for ~~than~~future ~~anticipated,~~medical ~~and~~device weproducts. ~~cannot~~Devices becleared ~~certain~~through ~~that~~the ~~our~~FDA’s ~~product~~510(k) process ~~candidates~~are ~~will~~generally berequired ~~shown~~to demonstrate substantial equivalence to bea ~~safe~~legally marketed predicate device and ~~effective~~often ~~for~~are supported ~~human~~primarily ~~use~~by bench testing, biocompatibility data, and other non-clinical information, rather than extensive long-term clinical trial data.

InAs a ~~order~~result, ~~to commercialize~~ our ~~product~~currently ~~candidates in~~marketed ~~the~~products ~~United~~and ~~States,~~any wefuture ~~must~~product ~~submit~~candidates amay ~~PMA~~not ~~for~~have ~~some~~been ofevaluated ~~these~~in ~~product~~long-term ~~candidates,~~clinical ~~which~~studies prior ~~will~~to ~~require~~commercialization. usPost-market tosurveillance, ~~conduct~~published clinical ~~trials.~~experience, ~~We also~~or ~~plan~~additional tostudies ~~provide~~conducted ~~the~~by ~~FDA~~us ~~with~~or ~~clinical~~third ~~trial~~parties may ~~data~~identify topreviously ~~support~~unrecognized ~~some~~adverse ofevents, ~~our~~complications, ~~510(k)~~or ~~premarket~~performance ~~notifications~~limitations. WeIf ~~will~~our ~~receive~~products ~~approval or~~are ~~clearance~~shown ~~from the FDA~~ to ~~commercialize~~be ~~products~~less safe ~~requiring~~or aeffective ~~clinical~~than ~~trial~~anticipated, ~~only~~or if wethey ~~can~~are ~~demonstrate~~associated towith ~~the~~unanticipated ~~satisfaction of the FDA~~risks, ~~through~~we ~~well-designed~~could ~~and~~be ~~properly~~subject ~~conducted~~to ~~clinical~~regulatory ~~trials~~enforcement actions, ~~that~~including ~~our~~recalls ~~product~~or ~~candidates~~withdrawal ~~are~~of ~~safe~~marketing ~~and~~authorization, ~~effective~~as ~~and~~well ~~otherwise~~as ~~meet the~~product ~~appropriate~~liability ~~standards~~claims, ~~required~~negative ~~for~~publicity, ~~approval~~reputational harm, orand ~~clearance~~reduced ~~for~~market ~~specified indications~~acceptance.

30Any such developments could materially adversely affect our business, financial condition, and results of operations.

~~Clinical trials are complex, expensive, time~~We ~~consuming,~~may ~~uncertain~~be ~~and~~required ~~subject~~ to ~~substantial~~generate ~~and unanticipated delays. Before we may begin~~ clinical ~~trials, we must submit and obtain approval for an investigational device exemption,~~ or ~~IDE,~~additional ~~that~~supporting ~~describes,~~data ~~among other things, the manufacture of, and controls~~ for, ~~the device~~certain ~~and~~product a complete investigational plan. Clinical trials generally involve a substantial number of patients in a multi-year study. Because we do not have the experience or the infrastructure necessary to conduct clinical trialscandidates, wewhich ~~will~~could ~~have~~increase tocosts ~~hire one or more contract research organizations, or CROs, to conduct trials on our behalf. CRO contract negotiations may be costly~~ and time consuming and we will rely heavily on the CRO to ensure that our trials are conducted in accordance with regulatory and industry standards. We may encounter problems with our clinical trials and any of those problems could cause us or the FDA to suspend those trials or delay ~~the analysis of~~ ~~the data derived from them~~commercialization.

AAlthough our ~~number~~currently ofmarketed ~~events~~medical ordevices ~~factors,~~have ~~including~~been ~~any of~~cleared through the ~~following,~~FDA’s ~~could~~510(k) ~~delay~~process ~~the~~and ~~completion~~we ofdo ~~our~~not currently conduct, nor do we anticipate conducting, large-scale clinical trials infor our existing product lines, the FDA may require clinical data or other additional testing to support future ~~and~~product ~~negatively~~candidates, ~~impact~~new ~~our~~indications, ~~ability~~or significant modifications to ~~obtain~~existing ~~FDA~~devices. ~~approval~~If we seek to conduct a clinical study for a device that presents a significant risk, ~~and~~we would be required to ~~introduce~~obtain ~~our~~FDA ~~product~~approval ~~candidates:~~of an investigational device exemption (IDE) before initiating such study.

●Any requirement ~~failure~~ to ~~obtain~~conduct ~~financing necessary to bear the cost of designing and conducting~~ clinical ~~trials; ● failure to obtain approval from the FDA or foreign regulatory authorities to commence investigational~~ studies; ●could ~~conditions~~increase ~~imposed on us by the FDA or foreign regulatory authorities regarding the scope or design of~~ our ~~clinical~~development ~~trials;~~costs, ●require ~~failure~~additional totime ~~find~~and aresources, ~~qualified~~and ~~CRO~~delay toregulatory clearance ~~conduct our clinical trials~~ or tocommercialization. ~~negotiate~~Clinical astudies, ~~CRO~~if ~~services agreement on favorable terms; ● delays in obtaining or in our maintaining~~ required, ~~approvals~~are ~~from~~subject institutional review boards or other reviewing entities at clinical sites selected for participation in our clinical trials; ● insufficient supply of our product candidates or other materials necessary to ~~conduct~~regulatory ~~our~~oversight ~~clinical~~and ~~trials;~~may ●be ~~difficulties~~affected inby ~~enrolling~~factors ~~patients~~such as instudy ~~our~~design ~~clinical~~requirements, ~~trials;~~patient ●enrollment ~~negative or inconclusive results from clinical trials~~challenges, ordata ~~results that are inconsistent with earlier results~~variability, that necessitate additional clinical studies; ● failure on the part of the CRO to conduct the clinical trial in accordance with regulatory requirements; ● our failure to maintain a successful relationship with the CRO or ~~termination~~adverse ofevents. ~~our~~Even ~~contractual~~limited ~~relationship with the CRO before completion of the~~ clinical ~~trials; ● serious~~ investigations or ~~unexpected~~post-market ~~side~~studies ~~effects~~may ~~experienced~~produce byresults ~~patients~~that ~~in whom our product candidates~~ are ~~implanted;~~unfavorable or ●insufficient ~~failure by any of our third-party contractors or investigators~~ to ~~comply~~support ~~with~~ regulatory ~~requirements~~clearance or ~~meet~~market ~~other contractual obligations in a timely manner~~acceptance.

~~Our~~If we ~~clinical~~are ~~trials~~required ~~may need~~ to beconduct ~~redesigned or~~more ~~may~~extensive ~~not~~clinical beevaluations ~~completed~~than ~~on schedule~~anticipated, or if atthe ~~all.~~results ~~Delays~~of inany ~~our~~required ~~clinical~~studies ~~trials~~are ~~may result in increased development costs for our product candidates~~unfavorable, ~~which could cause~~ our ~~stock price to decline and limit our~~ ability to ~~obtain~~commercialize ~~additional~~new ~~financing. In addition, if one~~ or ~~more~~ ofmodified ~~our~~products ~~clinical~~could ~~trials~~be ~~are~~ delayed, ~~competitors~~or ~~may~~prevented, bewhich ~~able~~could tomaterially ~~bring~~adversely ~~products~~affect toour ~~market~~business, financial ~~before we do~~condition, and ~~the~~results ~~commercial viability~~ of ~~our product candidates could be significantly reduced~~operations.

3128

Our relationships ~~current~~with ~~and~~healthcare ~~future~~providers, ~~relationships~~distributors, ~~with~~ and third-party payers ~~and~~are ~~current and potential customers in the United States and elsewhere may be~~ subject, ~~directly or indirectly,~~ to ~~applicable~~ ~~anti-kickback,~~complex healthcare fraud and abuse, ~~false claims,~~ transparency, and ~~health information~~ privacy ~~and security and other healthcare~~ laws ~~and regulations~~, ~~which~~and noncompliance could ~~expose~~result usin tosignificant ~~criminal sanctions, civil~~ penalties, ~~contractual~~and ~~damages,~~ reputational harm ~~administrative burdens and diminished profits and future earnings~~.

Our sales, ~~current~~marketing, distribution, and ~~future~~other business arrangements with ~~third-party payers~~healthcare ~~and~~providers, ~~current~~hospitals, ~~and~~ambulatory ~~potential~~surgery ~~customers~~centers, distributors (including ~~providers and physicians, as well as~~ physician -owned distributorships ~~or PODs~~), ~~may~~ ~~expose us to broadly applicable fraud~~ and ~~abuse~~other ~~and~~customers ~~other~~are ~~healthcare~~subject ~~laws~~to ~~and~~numerous ~~regulations~~federal, ~~including~~state, ~~without~~and ~~limitation,~~foreign ~~the~~healthcare ~~federal~~laws ~~Anti-Kickback Statute~~ and ~~the~~regulations. ~~federal~~These ~~False~~laws ~~Claims Act, which~~ may ~~constrain~~affect the ~~business~~manner orin ~~financial arrangements and relationships through~~ which we ~~sell~~promote, market, and ~~distribute~~sell our ~~products.~~medical ~~In addition~~devices, weincluding ~~may be subject to transparency laws and patient privacy regulations by U.S. federal and state governments and by governments in foreign jurisdictions in which we conduct~~ our ~~business.~~spinal ~~The applicable federal,~~implants ~~state~~ and ~~foreign~~the ~~healthcare~~SiNAPTIC® ~~laws~~foot and ~~regulations~~ankle ~~that~~wedge ~~may affect our ability to operate include:~~system.

● In the ~~federal~~United ~~Anti-Kickback Statute~~States, ~~which~~these ~~prohibits~~laws include, among ~~other things~~others, ~~persons~~the ~~from~~federal ~~knowingly~~Anti-Kickback ~~and~~Statute, ~~willfully~~which ~~soliciting,~~prohibits offering, ~~receiving~~ or ~~providing~~receiving remuneration~~, directly or indirectly, in cash or in kind,~~ to induce orreferrals ~~reward,~~ or inpurchases ~~return~~reimbursable ~~for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made~~ under federal healthcare programs~~, such as Medicare and Medicaid~~; ~~● federal civil and criminal false claims laws and civil monetary penalty laws, including~~ the federal False Claims Act, which ~~impose~~imposes ~~criminal~~civil and criminal ~~civil~~liability ~~penalties, including civil whistleblower or qui tam actions, against individuals or entities~~ for ~~knowingly~~false ~~presenting,~~ or ~~causing~~fraudulent ~~to be presented, to the federal government, including the Medicare and Medicaid programs,~~ claims for payment ~~that are false or fraudulent or making a false statement~~ to ~~avoid, decrease or conceal an obligation to pay money to~~ the ~~federal~~ government; ~~● the federal Health Insurance Portability and Accountability Act of 1996, or~~ HIPAA, ~~which imposes criminal~~ and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, ~~and their respective implementing regulations,~~ which ~~impose~~establish ~~obligations on covered~~ healthcare ~~providers,~~fraud ~~health plans,~~ offenses and ~~healthcare~~impose clearinghouses, as well as their business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, ~~security~~ and ~~transmission~~security ofrequirements ~~individually~~for ~~identifiable~~protected health information; ●and the Physician Payments Sunshine Act, which requires reporting ~~(i) manufacturers~~ of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS information related to certain “payments or ~~other~~ transfers of value” ~~made~~ to physicians, ~~which is defined to include doctors, dentists, optometrists, podiatrists~~ and ~~chiropractors, and~~ teaching hospitals,. ~~with~~Many ~~data~~states ~~collection beginning on August 1, 2013, (ii) applicable manufacturers~~ and ~~applicable~~foreign ~~group~~jurisdictions ~~purchasing~~have adopted organizations to report annually to CMS ownership and investment interests held in such entities by physicians and their immediate family members, with data collection beginning on August 1, 2013, (iii) manufacturers to submit reports to CMS by March 31, 2014 and the 90th day of each subsequent calendar year, and (iv) disclosure of such information by CMS on a publicly available website beginning in September 2014; and ● analogous ~~state~~fraud and ~~foreign laws and regulations~~abuse, ~~such as state anti-kickback and false claims laws~~transparency, ~~which may apply to sales or marketing arrangements~~ and ~~claims~~data involving healthcare items or services reimbursed by non-governmental third-party payers, including private insurers; state and foreign laws that require medical device companies to comply with the medical device industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require medical device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws governing the privacy ~~and security of health information in certain circumstances~~laws, ~~many~~some of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations may involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to ~~us,~~commercial wepayers ~~may be subject to significant civil, criminal~~ and administrative penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, which could have a material adverse effect on our business. If any of the physicians or other healthcare providers or entities with whom we expect to do business, including our collaborators, are found not to be in compliance with applicable laws, they may be ~~subject~~broader ~~to criminal, civil or administrative sanctions, including exclusions from participation~~ in scope ~~government~~than ~~healthcare~~federal ~~programs, which could also materially affect our business~~requirements.

32These laws are complex and subject to evolving interpretations. Our compliance efforts may require substantial resources, and we cannot assure that our business arrangements, or those of our distributors or customers, will not be challenged by governmental authorities. If our operations or relationships are found to violate applicable laws, we could be subject to significant civil, criminal, or administrative penalties, including fines, damages, exclusion from participation in government healthcare programs, contractual damages, reputational harm, and the restructuring of our operations. Any such action could materially adversely affect our business, results of operations, and financial condition.

Changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns could adversely affect our results of operations and financial condition.

We are subject to taxes by the U.S. federal, state, local and foreign tax authorities, and our tax liabilities will be affected by the allocation of expenses to differing jurisdictions. Our future effective tax rates could be subject to volatility or adversely affected by a number of factors, including:

	●	changes in the valuation of our deferred tax assets and liabilities;

	●	expected timing and amount of the release of any tax valuation allowance;

	●	tax effects of equity-based compensation;

	●	changes in tax laws, regulations or interpretations thereof; or

	●	future earnings being lower than anticipated in jurisdictions where we have lower statutory tax rates and higher than anticipated earnings in jurisdictions where we have higher statutory tax rates.

We may also be subject to audits of our income, sales and other transaction taxes by U.S. federal, state, local and foreign taxing authorities. Outcomes from these audits could have an adverse effect on our operating results and financial condition.

Proposed legislation in the U.S. Congress, including changes in U.S. tax law, and the recently enacted Inflation Reduction Act of 2022 may adversely impact us and the value of common shares, pre-funded warrants, and Warrants.29

Changes in ~~to U.S.~~ tax laws ~~(which~~or ~~changes~~their ~~may~~interpretation ~~have retroactive application)~~ could adversely affect usour orbusiness ~~holders of common shares, pre-funded warrants~~ and ~~Warrants.~~ Inthe ~~recent~~value ~~years,~~of ~~many~~our ~~changes to U~~securities.~~S. federal income tax laws have been proposed and made, and additional changes to U.S. federal income tax laws are likely to continue to occur in the future.~~

~~The~~ U.S. ~~Congress is~~ ~~currently~~federal, ~~considering~~state, ~~numerous~~and ~~items~~foreign oftax ~~legislation~~laws ~~which~~are ~~may~~subject beto ~~enacted~~change, ~~prospectively~~and orsuch ~~with~~changes ~~retroactive effect, which legislation~~ could adversely ~~impact~~affect our financial ~~performance~~condition, ~~and the value~~ results of ~~common shares~~operations, ~~pre-funded~~cash ~~warrants~~flows, and ~~Warrants.~~the ~~Additionally,~~value ~~states in~~of ~~which~~our wesecurities. ~~operate~~Legislative, administrative, or ~~own~~judicial ~~assets~~developments may ~~impose~~modify ~~new~~tax ~~or increased taxes. If enacted~~rates, the ~~most~~availability of ~~the~~tax ~~proposals~~credits ~~would be effective for the current~~ or ~~later~~net ~~years.~~operating ~~The~~loss ~~proposed~~carryforwards, ~~legislation~~the ~~remains~~timing ~~subject~~of toincome ~~change~~recognition, ~~and~~deductibility ~~its impact on us and holders~~ of ~~common shares~~expenses, ~~pre-funded warrants,~~ or other ~~Warrants~~tax isattributes ~~uncertain~~that affect us.

33The Inflation Reduction Act of 2022 introduced significant changes to U.S. corporate taxation, including a 15% minimum tax on adjusted financial statement income for certain large corporations and a 1% excise tax on certain corporate stock repurchases. Although we do not currently expect to be subject to the corporate minimum tax based on our size and financial profile, future changes in our operations, profitability, ownership structure, or applicable law could affect our tax obligations. The stock repurchase excise tax may increase the cost of any future share repurchase transactions, if undertaken.

In addition, ~~the~~states ~~Inflation Reduction Act of 2022 was recently signed into law~~ and ~~includes~~foreign ~~provisions~~jurisdictions ~~that~~may ~~will~~adopt ~~impact~~new ~~the~~or ~~U.S.~~revised ~~federal~~tax ~~income~~laws, ~~taxation~~increase oftax ~~corporations. Among other items~~rates, ~~this~~or ~~legislation~~change ~~includes provisions that will impose a minimum tax on~~ the ~~book~~interpretation ~~income~~ of ~~certain large corporations~~existing ~~and~~laws. anThe ~~excise~~impact ~~tax~~of onany ~~certain corporate stock repurchases that would be imposed on the corporation repurchasing~~ such ~~stock.~~changes It is ~~unclear how~~uncertain ~~this~~and ~~legislation~~could ~~will~~result bein ~~implemented~~increased bytax ~~the~~expense, ~~U.S.~~reduced ~~Department~~cash offlows, ~~the Treasury and we cannot predict how this legislation~~ or ~~any~~additional ~~future~~compliance ~~changes~~costs, inwhich ~~tax~~could ~~laws~~materially ~~might~~adversely affect usour orbusiness ~~holders~~and ofthe ~~common~~value ~~shares,~~of ~~pre-funded~~our ~~warrants or Warrants~~securities.

~~Recently enacted and future legislation~~Changes ~~may~~in ~~increase~~healthcare ~~the~~laws, ~~difficulty~~regulations, and ~~cost~~reimbursement ~~for~~policies usmay toincrease ~~obtain~~our ~~and~~costs, ~~monitor~~delay regulatory ~~approval~~review, orand ~~clearance~~adversely ofaffect ~~our product candidates~~ pricing and ~~affect the~~demand ~~prices we may obtain~~ for our products.

InHealthcare systems in the United States and ~~some~~internationally ~~foreign~~are ~~jurisdictions, there~~subject ~~have~~to ~~been~~ongoing ~~a number of~~ legislative, regulatory, and ~~regulatory~~policy changes ~~and~~intended ~~proposed~~to ~~changes~~control costs, ~~regarding~~expand ~~the~~access, ~~healthcare~~and ~~system~~improve ~~that~~quality. ~~could~~These ~~prevent or~~changes ~~delay~~may ~~clearance~~affect ~~and/or~~the ~~approval~~regulatory ofrequirements applicable to our ~~product~~medical ~~candidates~~devices, ~~restrict~~including our orspinal ~~regulate~~implants ~~post-clearance~~ and ~~post-approval~~extremity ~~activities~~products ~~and~~such ~~affect our~~as ~~ability~~the toSiNAPTIC® ~~profitably~~foot ~~sell~~and ~~our~~ankle ~~products~~wedge ~~and~~system, ~~any~~as ~~product~~well ~~candidates~~as the reimbursement available for ~~which~~procedures wein ~~obtain~~which ~~marketing~~our ~~approval~~products orare ~~clearance~~used.

In ~~addition, FDA regulations and guidance are~~ ~~often~~the ~~revised~~United orStates, ~~reinterpreted by~~ the FDA inperiodically ~~ways~~updates ~~that~~its ~~may~~regulations, ~~significantly~~guidance, ~~affect our business~~ and ~~our~~policies ~~products.~~governing ~~Any~~the ~~new~~premarket ~~regulations~~review, orclearance, and ~~revisions~~approval ~~or reinterpretations~~ of ~~existing~~medical ~~regulations~~devices, ~~may~~including ~~impose~~the ~~additional~~510(k), ~~costs~~De orNovo, ~~lengthen~~and ~~review~~PMA ~~times of our products~~pathways. ~~Delays~~Regulatory ~~in receipt~~expectations ofmay orevolve ~~failure~~with respect to ~~receive~~clinical data ~~regulatory~~requirements, ~~clearances~~cybersecurity, orquality ~~approvals~~systems ~~for~~(including ~~our~~the ~~new~~transition ~~products~~from ~~would~~the ~~have~~Quality aSystem ~~material~~Regulation ~~adverse~~to ~~effect~~the onQuality ~~our~~Management ~~business~~System Regulation), ~~results of operations~~ and ~~financial~~post-market ~~condition~~surveillance. InSuch ~~addition,~~changes ~~the~~could ~~FDA~~increase isthe ~~currently~~time ~~evaluating~~and ~~the~~expense ~~510(k)~~associated ~~process~~with ~~and~~obtaining ~~may~~or ~~make~~maintaining ~~substantial~~regulatory ~~changes~~clearance toor ~~industry~~approval ~~requirements,~~for ~~including~~our ~~which~~products ~~devices~~or ~~are~~modifications ~~eligible~~thereto. ~~for~~In ~~510(k) clearance~~addition, the ~~ability~~FDA toretains ~~rescind~~authority ~~previously granted~~to ~~510(k)~~revisit ~~clearances~~prior ~~and~~clearance determinations ~~additional~~in ~~requirements~~certain ~~that may significantly impact the process~~circumstances.

~~Among~~Healthcare reform ~~policy~~efforts ~~makers~~at ~~and payers in~~ the ~~United States~~federal and ~~elsewhere~~state levels, ~~there~~as iswell ~~significant~~as ~~interest~~initiatives inby ~~promoting~~commercial ~~changes~~payers, inmay ~~healthcare~~reduce ~~systems~~coverage, ~~with~~limit ~~the~~reimbursement, or ~~stated~~increase ~~goals~~pricing ofpressures ~~containing~~on ~~healthcare costs,~~medical ~~improving~~device ~~quality and expanding access~~manufacturers. InValue-based ~~the~~purchasing ~~United States~~programs, ~~the~~bundled ~~medical~~payment ~~device~~models, ~~industry~~and ~~has~~other ~~been~~cost-containment initiatives amay ~~particular~~encourage ~~focus~~hospitals ofand ~~these efforts~~providers ~~and~~to ~~has~~seek ~~been~~lower-cost ~~significantly~~alternatives ~~affected~~or byrestrict ~~major~~adoption ~~legislative~~of ~~initiatives~~new technologies.

WeInternationally, many ~~expect~~countries maintain government-sponsored healthcare systems that ~~other~~regulate ~~state~~pricing, reimbursement, and ~~federal~~market ~~healthcare~~access. The implementation ~~reform~~of ~~measures~~the ~~will~~European beUnion ~~adopted~~Medical inDevice ~~the~~Regulation ~~future,~~(EU ~~any~~MDR) ofhas ~~which~~increased ~~could~~regulatory ~~reduce~~scrutiny ~~the~~and ~~number~~compliance ofcosts, ~~patients~~and ~~with~~pricing ~~coverage~~and orreimbursement controls ~~limit~~in ~~the~~various ~~amounts~~jurisdictions ~~that federal~~may include price caps, mandatory discounts, reference pricing, and ~~state~~other ~~governments~~measures ~~will~~designed ~~pay~~to ~~for~~limit public ~~healthcare~~expenditures. ~~products~~These ~~and~~policies ~~services,~~may ~~which~~reduce ~~could~~the ~~result~~prices inwe ~~reduced~~are ~~demand~~able to obtain for our products, limit patient access, or delay commercialization ~~additional~~in ~~pricing~~certain ~~pressure~~markets.

~~In the European Union and some other international~~Any ~~markets,~~significant ~~the~~changes ~~government~~in ~~provides health care at a low cost to consumers and regulates prices of~~ healthcare ~~products~~laws, ~~patient~~regulations, ~~eligibility~~ or reimbursement ~~levels~~policies tocould ~~control~~increase ~~costs~~our ~~for~~regulatory ~~the government-sponsored health care system. Many countries are reducing their public expenditures~~ and wecompliance ~~expect to see strong efforts to reduce healthcare costs in international markets~~burdens, ~~including patient access restrictions, suspensions~~ on price increases, prospective and possibly retroactive price reductions and other recoupments and increased mandatory discounts or rebates and recoveries of past price increases. These cost control measures could reduce ~~our~~demand ~~revenues.~~for ~~In addition, certain countries set prices by reference to the prices in other countries where~~ our products ~~are marketed. Thus~~, ~~our~~or ~~inability to secure adequate prices in a particular country may not only limit the marketing of our products within that country but may also~~ adversely affect our ~~ability to~~revenues, ~~obtain acceptable prices in other markets. This may create the opportunity for third-party cross border trade or influence our decision to sell or not to sell a product~~profitability, ~~thus adversely affecting our geographic expansion plans~~ and ~~revenues~~growth prospects.

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Risks Related to Our Intellectual Property and Litigation

If the combination of patents, trade secrets and contractual provisions that we rely on to protect our intellectual property is inadequate, our ability to commercialize our products successfully will be harmed, and we may not be able to operate our business profitably.

Our success depends significantly on our ability to protect our proprietary rights to the technologies incorporated in our products. We rely on a combination of patent protection, trade secret laws and nondisclosure, confidentiality and other contractual restrictions to protect our proprietary technology. However, these may not adequately protect our rights or permit us to gain or keep any competitive advantage.

The issuance of a patent is not conclusive as to its scope, validity or enforceability. The scope, validity or enforceability of our issued patents can be challenged in litigation or proceedings before the U.S. Patent and Trademark Office, or the USPTO, or foreign patent offices. In addition, our pending patent applications include claims to numerous important aspects of our products under development that are not currently protected by any of our issued patents. We cannot assure you that any of our pending patent applications will result in the issuance of patents to us. The USPTO or foreign patent offices may deny or require significant narrowing of claims in our pending patent applications. Patents issued as a result of the pending patent applications, if any, may not provide us with significant commercial protection or be issued in a form that is advantageous to us. Proceedings before the USPTO or foreign patent offices could result in adverse decisions as to the priority of our inventions and the narrowing or invalidation of claims in issued patents. The laws of some foreign countries may not protect our intellectual property rights to the same extent as the laws of the United States, if at all.

Our competitors may successfully challenge and invalidate or render unenforceable our issued patents, including any patents that may ~~issue~~be issued in the future, which could prevent or limit our ability to market our products and could limit our ability to stop competitors from marketing products that are substantially equivalent to ours. In addition, competitors may be able to design around our patents or develop products that provide outcomes that are comparable to our products but that are not covered by our patents.

We have also entered into confidentiality and assignment of intellectual property agreements with all of our employees, consultants and advisors as one of the ways we seek to protect our intellectual property and other proprietary technology. However, these agreements may not be enforceable or may not provide meaningful protection for our trade secrets or other proprietary information in the event of unauthorized use or disclosure or other breaches of the agreements.

In the event a competitor infringes upon any of our patents or other intellectual property rights, enforcing our rights may be difficult, time consuming and expensive, and would divert management’s attention from managing our business. There can be no assurance that we will be successful on the merits in any enforcement effort. In addition, we may not have sufficient resources to litigate, enforce or defend our intellectual property rights.

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We have no patent protection covering the composition of matter for our solid silicon nitride or for all of the components of the process we use for manufacturing our silicon nitride, and competitors may create silicon nitride formulations substantially similar to ours.

Although we have a number of U.S. and foreign patents and pending applications relating to our solid silicon nitride products or product candidates, we have no patent protection either for the composition of matter for our silicon nitride or for the processes of manufacturing solid silicon nitride. As a result, competitors may create silicon nitride formulations substantially similar to ours and use their formulations in products that may compete with our silicon nitride products, provided they do not violate our issued product patents. Although we have, and will continue to develop, significant know-how related to these processes, there can be no assurance that we will be able to maintain this know-how as trade secrets, and competitors may develop or acquire equally valuable or more valuable know-how related to the manufacture of silicon nitride.

We could become subject to intellectual property litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages, prevent us from marketing our commercially available products or product candidates and/or reduce the margins we may realize from our products that we may commercialize.

The medical devices industry is characterized by extensive litigation and administrative proceedings over patent and other intellectual property rights. Whether a product infringes a patent involves complex legal and factual issues, and the determination is often uncertain. There may be existing patents of which we are unaware that our products under development may inadvertently infringe. The likelihood that patent infringement claims may be brought against us increases as the number of participants in the orthopedic market increases and as we achieve more visibility in the marketplace and introduce products to market.

Any infringement ~~claim~~claims against us, even if without merit, may cause us to incur substantial costs, and would place a significant strain on our financial resources, divert the attention of management from our core business, and harm our reputation. In some cases, litigation may be threatened or brought by a patent holding company or other adverse patent owner who has no relevant product revenues and against whom our patents may provide little or no deterrence. If we were found to infringe any patents, we could be required to pay substantial damages, including triple damages if an infringement is found to be willful, and royalties and could be prevented from selling our products unless we obtain a license or are able to redesign our products to avoid infringement. We may not be able to obtain a license enabling us to sell our products on reasonable terms, or at all, and there can be no assurance that we would be able to redesign our products in a way that would not infringe those patents. If we fail to obtain any required licenses or make any necessary changes to our technologies or the products that incorporate them, we may be unable to commercialize one or more of our products or may have to withdraw products from the market, all of which would have a material adverse effect on our business, financial condition and results of operations.

In addition, in order to further our product development efforts, we have entered into agreements with orthopedic surgeons to help us design and develop new products, and we expect to enter into similar agreements in the future. In certain instances, we have agreed to pay such surgeons royalties on sales of products which incorporate their product development contributions. There can be no assurance that surgeons with whom we have entered into such arrangements will not claim to be entitled to a royalty even if we do not believe that such products were developed by cooperative involvement between us and such surgeons. In addition, some of our surgeon advisors are employed by academic or medical institutions or have agreements with other orthopedic companies pursuant to which they have agreed to assign or are under an obligation to assign to those other companies or institutions their rights in inventions which they conceive or develop or help conceive or develop.

There can be no assurance that one or more of these orthopedic companies or institutions will not claim ownership rights to an invention we develop in collaboration with our surgeon advisors or consultants on the basis that an agreement with such orthopedic company or institution gives it ownership rights in the invention or that our surgeon advisors on consultants otherwise have an obligation to assign such inventions to such company or institution. Any such claim against us, even without merit, may cause us to incur substantial costs, and would place a significant strain on our financial resources, divert the attention of management from our core business and harm our reputation.

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We may be subject to damages resulting from claims that we have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition agreements with our competitors or non-solicitation agreements.

Some of our employees were previously employed at other medical device or ceramic companies, including our competitors and potential competitors. Many of our former distributors and potential distributors sell, or in the past have sold, products of our competitors. We may be subject to claims that either we, or these employees or distributors, have inadvertently or otherwise used or disclosed the trade secrets or other proprietary information of our competitors. In addition, we have been and may in the future be subject to claims that we caused an employee or sales agent to break the terms of his or her non-competition agreement or non-solicitation agreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. If we fail in defending such claims, in addition to paying money damages, we may lose valuable intellectual property rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize products, which could have an adverse effect on our business, financial condition and results of operations.

If our advanced ceramic products or our product candidates conflict with the rights of others, we may not be able to manufacture or market our products or product candidates, which could have a material and adverse effect on us.

Our commercial success will depend in part on not infringing the patents or violating the other proprietary rights of third parties. Issued patents held by others may limit our ability to develop commercial products. All issued patents are entitled to a presumption of validity under the laws of the United States. If we need suitable licenses to such patents to permit us to develop or market our product candidates, we may be required to pay significant fees or royalties, and we cannot be certain that we would even be able to obtain such licenses. Competitors or third parties may obtain patents that may cover subject matter we use in developing the technology required to bring our products to market, that we use in producing our products, or that we use in treating patients with our products. We know that others have filed patent applications in various jurisdictions that relate to several areas in which we are developing products. Some of these patent applications have already resulted in patents and some are still pending. If we were found to infringe any of these issued patents or any of the pending patent applications, when and if issued, we may be required to alter our processes or product candidates, pay licensing fees or cease activities. If use of technology incorporated into or used to produce our product candidates is challenged, or if our processes or product candidates conflict with patent rights of others, third parties could bring legal actions against us, in Europe, the United States and elsewhere, claiming damages and seeking to enjoin manufacturing and marketing of the affected products. Additionally, it is not possible to predict with certainty what patent claims may issue from pending applications. In the United States, for example, patent prosecution can proceed in secret prior to issuance of a patent, provided such application is not filed in foreign jurisdiction. For U.S. patent applications that are also filed in foreign jurisdictions, such patent applications will not publish until 18 months from the filing date of the application. As a result, third parties may be able to obtain patents with claims relating to our product candidates which they could attempt to assert against us. Further, as we develop our products, third parties may assert that we infringe the patents currently held or licensed by them, and we cannot predict the outcome of any such action.

There has been extensive litigation in the medical devices industry over patents and other proprietary rights. If we become involved in any litigation, it could consume a substantial portion of our resources, regardless of the outcome of the litigation. If these legal actions are successful, in addition to any potential liability for damages, we could be required to obtain a license, grant cross-licenses and pay substantial royalties in order to continue to manufacture or market the affected products.

We cannot assure you that we would prevail in any legal action or that any license required under a third-party patent would be made available on acceptable terms, or at all. Ultimately, we could be prevented from commercializing a product, or forced to cease some aspect of our business operations, as a result of claims of patent infringement or violation of other intellectual property rights, which could have a material and adverse effect on our business, financial condition and results of operations.

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Risks Related to Potential Litigation from Operating Our Business

We may become subject to potential product liability claims, and we may be required to pay damages that exceed our insurance coverage.

Our business exposes us to potential product liability claims that are inherent in the design, testing, manufacture, sale and distribution of our currently marketed products and each of our product candidates that we are seeking to introduce to the market. The use of orthopedic medical devices can involve significant risks of serious complications, including bleeding, nerve injury, paralysis, infection, and even death. Any product liability claim brought against us, with or without merit, could result in ~~the~~an increase of our product liability insurance rates or in our inability to secure coverage in the future on commercially reasonable terms, if at all. In addition, if our product liability insurance proves to be inadequate to pay a damage award, we may have to pay the excess of this award out of our cash reserves, which could significantly harm our financial condition. If longer-term patient results and experience indicate that our products or any component of a product causes tissue damage, motor impairment or other adverse effects, we could be subject to significant liability. A product liability claim, even one without merit, could harm our reputation in the industry, lead to significant legal fees, and result in the diversion of management’s attention from managing our business.

Any claims relating to our improper handling, storage or disposal of biological or hazardous materials could be time consuming and costly.

Although we do not believe that the manufacture of our silicon nitride or non-silicon nitride products will involve the use of hazardous materials, it is possible that regulatory authorities may disagree or that changes to our manufacturing processes may result in such use. Our business and facilities and those of our suppliers and future suppliers may therefore be subject to foreign, federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of hazardous materials and waste products. We may incur significant expenses in the future relating to any failure to comply with environmental laws. Any such future expenses or liability could have a significant negative impact on our business, financial condition and results of operations.

Risks Related to Public Companies

We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.

We are currently a “smaller reporting company” as defined in the Securities Exchange Act of 1934. Smaller reporting companies are able to provide simplified executive compensation disclosures in their filings, are exempt from the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that independent registered public accounting firms provide an attestation report on the effectiveness of internal control over financial reporting, and have certain other decreased disclosure obligations in their SEC filings, including, among other things, only being required to provide two years of audited financial statements in annual reports. We cannot predict whether investors will find our common stock less attractive because of our reliance on any of these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock, and our stock price may be more volatile.

We incur substantial costs as a result of being a public company and our management expects to devote substantial time to public company compliance programs.

As a public company, we incur significant legal, insurance, accounting and other expenses, including costs associated with public company reporting. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment will result in increased general and administrative expenses and may divert management’s time and attention from product development and commercialization activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to practice, regulatory authorities may initiate legal proceedings against us, and our business may be harmed. These laws and regulations could make it more difficult and costlier for us to obtain director and officer liability insurance for our directors and officers, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult for us to attract and retain qualified executive officers and qualified members of our board of directors, particularly to serve on our audit and compensation committees. In addition, if we are unable to continue to meet the legal, regulatory and other requirements related to being a public company, we may not be able to maintain the listing of our common stock on ~~The~~the ~~NASDAQ~~Nasdaq Capital Market, which would likely have a material adverse effect on the trading price of our common stock.

We may not be able to maintain our listing on the ~~NASDAQ~~Nasdaq Capital Market, which would adversely affect the price and liquidity of our common stock.

As a small capitalization company, the price of our common shares has been, and is likely to continue to be, highly volatile. Any announcements concerning us or our competitors, quarterly variations in operating results, introduction of new products, delays in the introduction of new products or changes in product pricing policies by us or our competitors, acquisition or loss of significant customers, partners and suppliers, changes in earnings estimates or our ratings by analysts, regulatory developments, or fluctuations in the economy or general market conditions, among other factors, could cause the market price of our common shares to fluctuate substantially. There can be no assurance that the market price of our common shares will not decline below its current price or that it will not experience significant fluctuations in the future, including fluctuations that are unrelated to our performance.

Currently our common stock is quoted on the ~~NASDAQ~~Nasdaq Capital Market under the symbol “SINT”.” We must satisfy certain minimum listing ~~maintenance~~ maintenance requirements to maintain the ~~NASDAQ~~Nasdaq Capital Market quotation, including certain governance requirements and a series of financial ~~tests~~ tests relating to stockholders’ equity or net income or market value, public float, number of market makers and stockholder, market capitalization, and maintaining a minimum bid price of $1.00 per share.

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ITEM 1B.

UNRESOLVED STAFF COMMENTS

Not applicable.

ITEM 1C.

CYBERSECURITY

Risk Management and Strategy

We ~~regularly assess risks from cybersecurity~~ ~~threats,~~maintain ~~monitor our information systems for potential vulnerabilities, and test those systems pursuant to our cybersecurity policies,~~ processes, ~~and practices, which are integrated into our overall risk management program. To protect our information systems from cybersecurity threats, we use various security tools that are~~ designed to ~~help~~assess, identify, ~~escalate, investigate, resolve,~~ and ~~recover~~manage ~~from~~material ~~security incidents in a timely manner. Our board of directors assesses~~ risks ~~based~~from oncybersecurity ~~probability~~threats ~~and potential impact~~ to ~~key~~our ~~business~~information technology systems and ~~processes as part of our overall risk management program overseen by the board of directors~~data. ~~Risks~~These ~~that~~processes are ~~considered~~integrated ~~high are incorporated~~ into our ~~overall~~broader risk management ~~program.~~activities ~~We collaborate with third parties to assess the effectiveness of our cybersecurity prevention~~ and ~~response~~are ~~systems~~intended ~~and processes and~~ to ~~assist~~protect in the ~~identification~~confidentiality, ~~verification, and validation of cybersecurity risks, as well~~ ~~as to support associated mitigation plans when necessary. We have also developed a third-party cybersecurity risk management process to conduct due diligence on external entities~~integrity, including those that perform cybersecurity services. Cybersecurity threats, including those resulting from any previous cybersecurity incidents, have not materially affected our Company, including our business strategy, results of operations, or financial condition. Refer to the risk factor captioned “Cyber security risks and ~~the~~availability ~~failure to maintain the integrity~~ of ~~company, employee or guest data could expose us to data loss, litigation and liability, and~~ our ~~reputation~~systems ~~could be significantly harmed.” in Part I, Item 1A. “Risk Factors” for additional details regarding cybersecurity risks~~ and ~~potential~~ ~~impacts on our business~~information.

We rely on information technology systems to support our manufacturing operations, supply chain management, inventory and distribution activities, research and development, financial reporting, and corporate functions. To protect these systems, we implement a range of technical and administrative safeguards, including access controls, network monitoring tools, data backup procedures, incident response protocols, and employee cybersecurity awareness training. We periodically assess our systems for vulnerabilities and engage third-party service providers, as appropriate, to assist in evaluating and strengthening our cybersecurity posture.

We also maintain processes to assess cybersecurity risks associated with certain third-party vendors and service providers that have access to our systems or data. These processes may include due diligence, contractual safeguards, and ongoing oversight, as appropriate based on the nature of the services provided.

As of the date of this Annual Report, we have not identified any cybersecurity incidents that have materially affected, or are reasonably likely to materially affect, our business strategy, results of operations, or financial condition. However, cybersecurity threats are continually evolving, and there can be no assurance that our processes and controls will be sufficient to prevent all incidents. For additional information regarding cybersecurity risks, see Part I, Item 1A. “Risk Factors.”

Governance

Our Board ~~board~~ of ~~directors~~Directors ~~oversees~~has ~~our~~oversight responsibility for risk management ~~process~~, including ~~as it pertains to cybersecurity~~ risks, ~~which~~arising ~~focuses~~from ~~on the most significant risks we face in the short-, intermediate-, and long-term timeframe. Management is responsible for the operational oversight of company-wide~~ cybersecurity ~~strategy, policy, and standards across relevant departments to assess and help prepare us to address cybersecurity risks~~threats. ~~Meetings~~The ofBoard ~~our board of directors~~receives ~~include~~periodic ~~discussions~~updates ~~and presentations~~ from management regarding ~~specific~~cybersecurity ~~risk areas throughout the year~~matters, including, ~~among~~risk ~~others~~exposures, ~~those relating~~mitigation ~~to cybersecurity threats~~efforts, and ~~reports~~significant from management on our enterprise risk profile on an annual basis. The board of directors reviews our cybersecurity risk profile with management on a periodic basis using key performance and/or risk indicators. These key performance indicators are metrics and measurements designed to assess the effectiveness of our cybersecurity program in the preventiondevelopments, ~~detection,~~ ~~mitigation,~~as ~~and remediation of cybersecurity incidents~~appropriate. ~~We take a risk-based approach to cybersecurity and have implemented cybersecurity policies throughout our operations that are designed to address cybersecurity threats and incidents.~~

Management is responsible for the day-to-day management of cybersecurity risk. Members of senior management oversee the Company’s cybersecurity policies, procedures, and controls, coordinate efforts across relevant functional areas, and lead response efforts in the event of a cybersecurity incident. Management reports to the Board on cybersecurity risks and related matters on a periodic basis and would promptly inform the Board of any material cybersecurity incident.

ITEM 2.

PROPERTIES

Our 30,764 square foot corporate office and manufacturing facilities are located in Salt Lake City, Utah. We occupy these facilities pursuant to a lease that expires in October 2031. Pursuant to the terms of the lease agreement, we may extend the lease for one additional ~~periods~~ period of five years.

We also lease a 10,936 square foot facility located in Salt Lake City, Utah. This facility ~~houses~~is ~~our Armor equipment. We occupy this facility~~ pursuant to a lease that expires in October 2031. As of November 2025, this facility is subleased through October 2031.

We believe that our existing facilities are adequate for our current and projected needs for the foreseeable future.

ITEM 3.

LEGAL PROCEEDINGS

We are currently not a party to any material legal proceedings. However, our industry is characterized by frequent claims and litigation, including claims regarding intellectual property and product liability. As a result, we may be subject to various legal proceedings in the future.

ITEM 4.

MINE SAFETY DISCLOSURES

This item does not apply to our business.

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PART II

ITEM 5.

MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITY SECURITIES

Market Information

Our shares of common stock are currently quoted on ~~The~~the ~~NASDAQ~~Nasdaq Capital Market under the symbol “SINT”.”

Holders of Record

As of December 31, ~~2024~~2025, we had approximately ~~163~~ 164 holders of record of our common stock. Because many of our shares of common stock are held by brokers and other institutions on behalf of stockholders, this number is not indicative of the total number of stockholders represented by these stockholders of record.

Dividends

We have not declared or paid dividends to stockholders since inception and do not plan to pay cash dividends in the foreseeable future. We currently intend to retain earnings, if any, to finance our growth.

Issuer Purchases of Equity Securities

None

ITEM 6.

RESERVED

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ITEM 7.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes appearing elsewhere in this Annual Report. This discussion and analysis contain forward-looking statements based upon current beliefs, plans, expectations, intentions and projections that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under “Risk Factors” and elsewhere in this Annual Report.

Overview

SINTX Technologies is an advanced ceramics company formed in December 1996, ~~focused~~that ondevelops, ~~providing~~manufactures, ~~solutions~~and incommercializes asilicon ~~variety~~nitride biomaterials, ~~of biomedical~~composites, ~~technical~~devices, and ~~antipathogenic~~related ~~applications.~~technologies Wefor ~~have grown~~medical ~~from~~and ~~focusing~~other ~~primarily~~high-value onapplications. ~~the~~SINTX ~~research,~~provides ~~development~~biomedical solutions ~~and~~for ~~commercialization of~~ medical devices ~~manufactured~~specializing ~~with~~in silicon nitride to ~~becoming~~(Si₃N₄) anfor ~~advanced~~musculoskeletal ~~ceramics company engaged in diverse fields, including biomedical, technical~~ and antipathogenic applications. ~~This~~We ~~diversification~~also ~~enables~~manufacture usparts tomade ~~focus~~from onsilicon ~~our~~nitride ~~core~~for ~~competencies~~customers ~~which~~in ~~are~~ the ~~manufacturing~~electrical, ~~research,~~aerospace and ~~development~~other ofindustrial ~~products comprised from advanced ceramic materials for external partners~~sectors. WeSINTX ~~seek~~is a toglobal ~~connect~~leader ~~with~~in ~~new~~the ~~customers~~research, ~~partners~~development, and ~~manufacturers~~manufacturing ~~to help~~of ~~them~~silicon ~~realize~~nitride, ~~the~~and ~~goal~~its ofproducts ~~leveraging~~have ~~our~~been ~~expertise~~implanted in ~~advanced~~humans ~~ceramics to create new, innovative products across these sectors~~since 2008.

SINTX Core Business

Components of our Results of Operations

We manage our business within one reportable segment, which is consistent with how our management reviews our business, makes investment and resource allocation decisions and assesses operating performance.

Revenue

Our product revenue is derived from the manufacture and sale of products. These revenue sources include coatings, materials, and components for aerospace and medical device markets, toll processing services, and government contracts and grants. We generally recognize revenue from sales where control transfers at a point in time as the title and risk of loss passes to the customer, which is at the time the product is shipped. In general, our customer does not have rights of return or exchange.

We believe our product revenue will increase as we secure opportunities to manufacture third party products with silicon nitride, and as we continue to introduce new products into the market.

We derive grant and contract revenue from awards provided by governmental agencies. The goal of these grants and contracts is ultimately to develop revenue producing products.

Cost of Revenue

The expenses that are included in cost of revenue include all in-house manufacturing costs for the products we manufacture.

4137

Gross Profit

Our gross profit measures our product revenue relative to our cost of revenue.

Research and Development Expenses

Our research and development costs are expensed as incurred. Research and development costs consist of engineering, product development, clinical trials, test-part manufacturing, testing, developing and validating the manufacturing process, manufacturing, facility and regulatory-related costs. Research and development expenses also include employee compensation, employee and non-employee stock-based compensation, supplies and materials, consultant services, and travel and facilities expenses related to research and development activities.

We expect to incur additional research and development costs as we continue to develop new medical devices, industrial and ceramic armor products, product candidates for antipathogenic applications, and other products which may increase our total research and development expenses.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries, benefits and other related costs, including stock-based compensation for certain members of our executive team and other personnel employed in finance, compliance, administrative, information technology, customer service, executive and human resource departments. General and administrative expenses also include other expenses not part of the other cost categories mentioned above, including facility expenses and professional fees for accounting and legal services.

Results of Operations

Year Ended December 31, ~~2024~~2025 Compared to the Year Ended December 31, ~~2023~~2024

The following table sets forth, for the periods indicated, our results of operations for the years ended December 31, ~~2024~~2025 and ~~2023~~2024 (dollars, in thousands):

	Year Ended December 31,
	2024			2023			$ Change			% Change
	2025			2024			$ Change			% Change
Product revenue	$	~~1,246~~729		$	1,~~226~~246		$	20(517	)		2-41	%
Grant and contract revenue		~~1,641~~289			1,~~401~~641			~~240~~(1,352	)		17-82	%
Total revenue		21,~~887~~018			2,~~627~~887			~~260~~(1,869	)		10-65	%
Costs of revenue		811			784			27			3	%
Cost of revenue		557			811			(254	)		-31	%
Gross profit		~~2,076~~461			12,~~843~~076			~~233~~(1,615	)		13-78	%
Operating expenses:
Research and development		54,~~201~~587			85,~~713~~201			(~~3,512~~614	)		-4012	%
General and administrative		36,~~997~~197			43,~~222~~997			~~(225~~2,200	)		-555	%
Sales and marketing		~~614~~242			~~1,137~~614			(~~523~~372	)		-4661	%
Armor exit costs		~~4,602~~-			-4,602			(4,602	)		-100	%
Reduction in force		~~407~~-			-407			(407	)		-100	%
Grant and contract expense		~~1,302~~156			1,~~129~~302			~~173~~(1,146	)		15-88	%
Total operating expenses		1611,~~123~~182			1516,~~201~~123			~~922~~(4,941	)		6-31	%
Loss from operations		(1410,~~047~~721	)		(1314,~~358~~047	)		~~(689~~3,326	)		5-24	%
Other income (expense), net		~~3,023~~357			53,~~099~~023			(2,~~076~~666	)		-4188	%
Net loss before income taxes		(1110,~~024~~364	)		(811,~~259~~024	)		~~(2,765~~660	)		33-6	%
Provision for income taxes		-			-			-			-	%
Net loss	$	(1110,~~024~~364	)	$	(811,~~259~~024	)	$	~~(2,765~~660	)		33-6	%

4238

~~Product~~ Revenue~~, Grant and Contract Revenue~~

~~Total product~~ Product revenue ~~remained~~decreased ~~relatively~~$0.5 ~~flat when~~million, ~~comparing~~or ~~the years ended December 31~~41%, ~~2024~~compared ~~and~~to ~~2023. During~~ the ~~year~~same ~~ended~~period ~~December~~in ~~31,~~ 2024,. ~~the~~Grant ~~Company grant~~ and contract revenue ~~increased~~ decreased $01.24 million, or 1782% as , compared to the same period in ~~2023~~2024.

~~Costs of~~ Revenue trends and ~~Gross~~strategic ~~Profit~~focus

~~Cost~~The decrease ofin total revenue ~~remained~~was ~~relatively~~primarily ~~flat~~due ~~when comparing~~to the ~~years~~Company’s ~~ended~~ongoing ~~December~~strategic ~~31,~~repositioning ~~2024~~away ~~and~~from ~~2023.~~non-core, ~~Gross~~low-margin ~~profit~~OEM technical ~~increased~~manufacturing ~~$0.2~~contracts ~~million,~~that ordid ~~13%,~~not assupport ~~compared~~long-term toprofitability. ~~the~~This ~~same~~planned ~~period~~reduction in OEM-related revenue is consistent ~~2023.~~with ~~This~~our ~~increase~~corporate ~~was~~shift ~~primarily~~toward ~~attributed~~commercializing toproprietary ansilicon ~~increase~~nitride-based inbiomedical ~~grant~~devices, ~~and~~which ~~contract~~we ~~revenue~~believe ~~and~~offer stronger margins, a ~~shift~~more indefensible ~~product~~competitive ~~mix~~position, toand ~~more~~better ~~profitable products~~long-term value for shareholders.

While this strategic realignment has led to a decline in reported revenue, we believe it is a necessary step in positioning the Company for sustainable growth. During this transitional period, we continue to invest in the development and regulatory advancement of silicon nitride-based orthopedic and surgical implants, as evidenced by the recently received 510(k) clearance for osteotomy wedges used in foot and ankle fusion procedures. Additionally, we entered into a private label agreement to supply OsseoSculpt™, a next-generation biologic designed to complement the foot and ankle osteotomy wedges. We began recognizing commercial revenue from OsseoSculpt™ in the second half of 2025. We believe that these products will serve as key revenue drivers in 2026.

Cost of Revenue and Gross Profit

Cost of revenue decreased $0.3 million, or 31%, compared to the same period in 2024, while gross profit decreased $1.6 million, or 78%, for the same period. These decreases were primarily due to the decrease in revenue mentioned above.

Research and Development Expenses

Research and development expenses decreased $30.5 6 million, or ~~-40~~12%, as compared to the same period in ~~2023~~2024. This decrease was primarily ~~attributable~~due to a decrease in payroll related costs, patent expenses, ~~employee~~ ~~wages~~prototypes, ~~product~~and ~~prototypes~~outside consulting costs, ~~and~~partially ~~tooling~~offset ~~expenses~~by an increase in costs related to a research agreement.

General and Administrative Expenses

General and administrative expenses ~~decreased~~ increased $02.2 million, or -555%, as compared to the same period in ~~2023~~2024. This ~~decrease~~increase is primarily due to aincreased ~~decrease~~stock-based incompensation ~~employee~~and ~~wages~~other ~~and~~headcount ~~recruiting~~related costs, and fees paid to departing members of the board of directors, partially offset by lower legal expenses and outside consulting costs.

Sales and Marketing Expenses

Sales and marketing expenses decreased $0.54 million, or ~~-46~~61%, as compared to the same period in ~~2023~~2024. This decrease was primarily ~~attributable~~due to ~~a reduction~~ decreases in ~~employee~~payroll ~~wages~~related ~~and an overall decrease in~~ costs ~~for~~and outside consulting costs.

Armor Exit Costs

Armor exit costs ~~increased~~decreased $4.6 million, or 100%, as compared to the same period in ~~2023~~2024. This ~~increase~~decrease was ~~primarily~~ attributable to anthe ~~increase in~~ asset impairment costs at the SINTX Armor facility.

Reduction in Force Expenses

Reduction in force expenses ~~increased~~decreased $0.4 million, or 100%, as compared to the same period in ~~2023~~2024. This ~~increase~~decrease was ~~primarily~~ attributable to payroll expenses related to severance and accrued vacation payouts.

Grant and Contract Expenses

Grant and contract expenses ~~increased~~decreased $01.21 million, or 1588%, as compared to the same period in ~~2023~~2024. This ~~increase~~decrease was primarily ~~attributable~~due to athe ~~general increase~~ decrease in grant and contract revenue ~~when~~associated ~~compared~~with tothe sale of the ~~prior~~TA&T ~~year~~subsidiary.

Other Income (Expense), Net

Other income (expense), net decreased $2.17 million, or ~~-41~~88%, as compared to the same period in ~~2023~~2024. This decrease was primarily due to a $3.6 million decrease in the change in ~~the fair~~ value of ~~the~~ derivative liabilities, inpartially ~~the~~offset ~~amount~~by of $20.85 million, ~~and~~change in derivative liabilities offering costs, a $0.13 million ~~increase in~~ gain on disposal of ~~assets~~property ~~offset~~and byequipment ~~$0.8~~associated ~~million~~with inSINTX ~~offering costs~~Armor, onand ~~derivative~~a ~~liabilities~~$0.1 inmillion ~~2023~~increase ~~with no corresponding amount~~ in interest ~~2024~~income.

Liquidity and Capital Resources

The consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern within one year from the date of issuance of these consolidated financial statements.

For the years ended December 31, ~~2024~~2025 and ~~2023~~2024, the Company incurred a net loss of $1110.04 million and $811.30 million, respectively, and used cash in operations of $8.6 million and $148.1 6 million, respectively. The Company had an accumulated deficit of $~~281~~292.71 million and $~~270~~281.7 million as of December 31, ~~2024~~2025 and ~~2023~~2024, respectively. We will require substantial future capital in order to continue operating our business, conduct research and development and regulatory clearance and approval activities necessary to bring our products to market, and to establish effective marketing and sales capabilities. Our existing capital resources are not sufficient to enable us to fund the completion of the development and commercialization of all our product candidates.

4339

To date, ~~the~~our ~~Company’s~~ operations have been principally financed from proceeds from the issuance of preferred and common stock and, to a lesser extent, cash generated from product sales. ItWe isexpect ~~anticipated~~ that ~~the~~we ~~Company~~ will continue to generate operating losses and use cash in operations. ~~The~~Our ~~Company’s~~ continuation as a going concern is dependent upon its ability to increase sales, decrease expenses and/ raise additional funding. ~~Whether and~~It is uncertain when, if ~~the~~ever, ~~Company~~we ~~can~~will attain profitability and positive cash flows from operations or obtain additional financing ~~is uncertain~~.

~~The~~We continue ~~Company~~to isseek ~~actively~~opportunities ~~generating~~to raise additional ~~scientific~~ ~~and~~funding ~~clinical~~through ~~data~~equity toand/or ~~have~~debt itfinancing. ~~published~~However, insuch ~~leading~~funding ~~industry~~is ~~publications.~~not Weguaranteed and ~~believe~~may ~~the~~not ~~publication~~be ofavailable ~~such~~on ~~data~~favorable ~~would~~terms ~~help sales~~and ~~efforts~~may asinvolve ~~the~~restrictive ~~Company~~covenants. ~~approaches~~Any ~~new~~additional ~~prospects.~~equity ~~The~~financing, ~~Company~~if isavailable, ~~also~~will most ~~making~~likely ~~additional~~be ~~changes~~dilutive to ~~the~~its ~~sales~~current ~~strategy,~~stockholders. ~~including a~~If ~~focus~~we onare ~~revenue~~not ~~growth~~able byto ~~expanding~~obtain ~~the~~additional ~~use~~debt ofor ~~silicon~~equity ~~nitride~~financing, inthe ~~other~~impact ~~areas~~on our ~~outside~~company ofand ~~spinal~~business ~~fusion~~will ~~applications~~be material and adverse.

The board ~~Company~~of ~~has~~directors, ~~common~~together ~~stock~~with ~~that~~management, remains focused on advancing our business strategy and focus. Our strategic emphasis is focused ~~publicly~~on utilizing our technology in making advancements in the biomedical sector. Historically engaged in both industrial and biomedical ~~traded~~applications, we have prioritized the development and ~~has~~commercialization ~~been~~of ~~able~~innovative tomedical ~~successfully~~devices, ~~raise~~leveraging ~~capital~~our ~~when~~expertise ~~needed~~in ~~since~~advanced ceramics and biomaterials. This renewed focus aligns with a commitment to improving patient outcomes through the ~~date~~creation of products designed for surgical, orthopedic, and other specialized medical applications. We are concentrating our resources on high-growth areas within the ~~Company’s~~healthcare ~~initial~~sector ~~public~~where ~~offering~~our inproprietary ~~February~~materials and technologies—such as silicon nitride—provide a distinct ~~2014~~competitive advantage due to their unique strength, durability, and biocompatibility.

OnThrough this ~~February 20~~transformation, ~~2025,~~as ~~entered~~demonstrated ~~into~~by athe ~~private placement~~recent ~~transaction~~FDA ~~pursuant to a Securities Purchase Agreement~~ 510(~~the “Purchase Agreement”~~k) ~~with~~clearance ~~certain~~of ~~institutional~~our ~~and accredited~~SiNAPTIC® ~~investors~~Foot ~~for~~& ~~aggregate~~Ankle ~~gross~~Osteotomy ~~proceeds~~Wedge ~~of $5.0 million~~System, our ~~before~~aim ~~deducting~~is ~~fees~~ to ~~the~~deliver ~~placement~~meaningful ~~agent~~innovations ~~and~~to ~~other expenses payable by~~ the ~~Company~~medical ~~in connection with the Private Placement~~community. ~~The~~Our ~~Company~~current ~~intends~~research toand ~~use~~development ~~the~~pipeline ~~net~~is ~~proceeds~~centered ~~from~~on ~~the Private Placement for general~~medical-grade ~~corporate~~devices ~~purposes~~that ~~and~~incorporate ~~working~~antimicrobial ~~capital.~~properties, ~~H.C.~~enhanced ~~Wainwright~~imaging ~~& Co. (“Wainwright”)~~capabilities, ~~acted~~and asdurability ~~the~~under ~~exclusive~~physiological ~~placement agent for the Private Placement~~conditions, which are ~~closed~~critical onfor ~~February~~orthopedic 25implants, ~~2025.~~spinal Asfusion ~~part of the Private Placement~~devices, ~~the~~and ~~Company~~other ~~issued~~surgical ~~(i) 1,171,189 shares of the Company’s common stock, par value $0~~tools.01 ~~per~~As ~~share~~we ~~(“Common~~transition ~~Stock”),~~our ~~(ii)~~focus ~~pre-funded~~away ~~warrants~~from ~~to purchase 278,098~~industrial ~~shares~~applications, ofwe ~~Common~~anticipate ~~Stock~~this ~~(the~~strategic ~~“Pre-Funded~~shift ~~Warrants”)~~will ~~with~~enable anus ~~exercise price of $0.0001 per share, and (iii) warrants~~ to ~~purchase 1,449,287~~better ~~shares~~serve ~~of Common Stock (~~the ~~“Common~~medical ~~Warrants~~sector,” ~~together~~address ~~with~~critical ~~the~~unmet ~~Pre-Funded Warrants~~needs, ~~the “Warrants”)~~and ~~(the~~position ~~Warrants,~~SINTX ~~together~~as ~~with~~a ~~the~~leading ~~Shares~~provider ~~and~~in ~~Warrant Shares (as defined below),~~ the ~~“Securities”)~~medical ~~with~~device ~~an exercise price of $3~~market.32 ~~per~~By ~~share.~~focusing ~~The~~on ~~purchase~~partnerships ~~price per share of Common Stock~~ and ~~the~~collaborations ~~associated~~with ~~Common~~healthcare ~~Warrant was $3.45~~ institutions and ~~the~~industry ~~purchase~~leaders, ~~price~~we ~~per Pre-Funded~~believe ~~Warrant~~that ~~and~~we ~~associated~~are ~~Common~~positioned ~~Warrant~~to ~~was~~expand ~~$3.4499.~~our ~~The~~footprint ~~Common~~in ~~Warrants~~the ~~are~~medical ~~exercisable~~device ~~immediately~~sector and ~~expire~~drive ~~five-and~~shareholder ~~one-half~~value ~~years~~through ~~from~~sustainable, ~~issuance. The Pre~~high-~~Funded~~impact ~~Warrants are exercisable immediately and terminate when exercised in full~~innovations.

On August ~~February 2~~8, 2024, the ~~Company~~board ~~closed on a public offering~~ of ~~80,000~~directors ~~units,~~approved ~~with~~a ~~each~~plan ~~unit consisting of one share of its common stock, or one pre-funded warrant~~ to ~~purchase~~implement one share of its common stock, one Class E Warrant with each warrant entitled to purchase one share of common stock, and one Class F Warrant with each warrant entitled to purchase one share of common stock. Each unit was sold at a ~~public~~Company-wide ~~offering~~reduction ~~price of $50.00 resulting~~ in ~~gross~~ ~~proceeds to~~ the ~~Company of $4 million before deducting offering fees and expenses~~workforce. ~~The~~This ~~Class~~decision Ewas ~~and Class F Warrants were immediately~~part ~~exercisable at a price~~ of ~~$50.00~~an ~~per~~ongoing ~~share.~~strategic ~~The~~review ~~Class E Warrants expire five years from the date~~ of ~~issuance~~our ~~and~~operations ~~the~~aimed ~~Class~~at Fimproving ~~Warrants expire~~operational ~~eighteen~~efficiency ~~months from the date of issuance. Of the $4.0 million of gross proceeds, approximately $0.6 million were allocated to common stock~~ and ~~prefunded~~reducing ~~warrants ($0.5 million net of offering~~ costs~~) and approximately $3~~.~~4 million were allocated to derivative liabilities (with approximately $0.5 million of cash offering costs and $0.1 million of agent warrant offering costs recorded as derivative expense).~~

On August ~~February 10~~12, ~~2023~~2024, the ~~Company~~board ~~closed on a public offering~~ of ~~10,750~~directors ~~units,~~approved ~~with~~a ~~each~~plan ~~unit~~to ~~consisting~~cease ofefforts ~~one~~to ~~share~~make ofthe ~~common~~armor ~~stock,~~plant oroperational. ~~one~~This ~~pre-funded~~decision ~~warrant~~was made to ~~purchase~~streamline ~~one~~operations ~~share of~~and ~~its~~focus ~~common~~on ~~stock,~~core ~~one~~business ~~Class~~areas Cthat ~~Warrant~~align towith ~~purchase~~our ~~one~~long-term ~~share~~strategic ofgoals. ~~common~~The ~~stock,~~armor ~~and~~plant ~~one~~had ~~half~~not ofbeen fully ~~one~~operational ~~Class~~since Dthe ~~Warrant~~acquisition ~~with~~of ~~each whole Class D Warrant entitling~~ the ~~holder~~armor toequipment ~~purchase~~in ~~one~~July ~~share~~2021 ofand ~~common~~had ~~stock.~~been ~~Gross~~completely ~~proceeds,~~shut ~~before~~down ~~deducting~~since ~~offering~~October ~~expenses,~~2023 ~~totaled approximately~~due ~~$12.0~~to ~~million. Of~~ the ~~$12.0~~malfunctioning ~~million~~ of ~~gross~~the ~~proceeds,~~sintering ~~approximately $5~~furnace.4 ~~million~~In ~~were~~connection ~~allocated~~with tothis ~~common~~decision, ~~stock~~we ~~and~~incurred ~~prefunded~~an ~~warrants ($4.8~~impairment ~~million~~charge ~~net~~ of ~~offering costs) and~~ approximately $64.7 6 million ~~were~~during ~~allocated~~the toyear ~~derivative~~ended ~~liabilities~~December ~~(with~~31, ~~approximately $0~~2024.~~7 million~~ ofThis ~~cash~~charge ~~offering~~primarily ~~costs~~relates ~~and~~to ~~$0.1~~the ~~million~~write-down of ~~agent~~certain ~~warrant~~long-lived ~~offering~~assets ~~costs~~associated with ~~recorded~~the asarmor ~~derivative~~plant ~~expense)~~to their estimated fair value.

On February ~~March 26~~19, ~~2024~~2025, ~~the~~we ~~Company~~entered ~~closed~~into onan aEntity ~~public offering~~Acquisition ofAgreement ~~142,000 shares of the Company’s common stock,~~ (the “~~March 26 Offering~~Agreement”). ~~Each~~with ~~Share~~Tethon ~~was~~Corporation ~~sold at a public~~(“Tethon”), ~~offering~~pursuant ~~price~~to ofwhich ~~$9.40.~~the ~~The~~Company ~~aggregate~~sold ~~proceeds~~ to ~~the~~Tethon ~~Company~~all ~~from~~of the ~~March~~issued 26and ~~Offering~~outstanding ~~were~~shares ~~approximately~~of ~~$1.3~~TA&T ~~million~~in ~~before~~exchange ~~deducting placement~~for ~~agent~~the ~~fees~~assumption ~~and~~by ~~other~~Tethon of ~~estimated~~the ~~offering~~outstanding ~~expenses~~liabilities ~~payable~~of ~~by the Company~~TA&T.

44In October 2025, we received FDA 510(k) clearance for a new foot and ankle osteotomy wedge system, enabling SINTX’s commercial entry into reconstructive foot and ankle surgery in the United States. Revenue is expected to begin during the first half of 2026.

OnIn October ~~April 5~~2025, ~~2024,~~we ~~the~~entered ~~Company~~into ~~closed~~the on2025 aATM ~~public offering~~Agreement ofto ~~358,000~~sell shares of ~~the~~its ~~Company’s~~ common stock from time to time, ~~(the~~through an “~~April~~at 5the ~~Offering~~market offering”). ~~Each~~program, ~~Share~~having ~~was~~an ~~sold~~aggregate ~~at a public~~ offering price of $46.~~20.~~4 ~~The~~million ~~aggregate~~was ~~proceeds~~filed towith the ~~Company~~SEC. ~~from~~As ~~the~~of ~~April~~December 531, ~~Offering~~2025, ~~were~~there ~~approximately~~ is $16.50 million ~~before~~remaining ~~deducting placement~~balance ~~agent~~on ~~fees~~the ~~and~~2025 ~~other~~ATM ~~offering expenses payable by the Company~~Agreement.

On In October 172025, ~~2022,~~we ~~the~~entered ~~Company~~into ~~completed~~ a ~~rights~~ ~~offering~~sublease ofagreement ~~units~~to ~~consisting~~lease ofthe ~~convertible~~SINTX ~~preferred~~armor ~~stock~~facility ~~and~~to ~~common~~a ~~stock~~third ~~warrants~~party, ~~resulting~~which inis ~~gross~~expected ~~proceeds~~ to save the Company of approximately $41.70 million, ~~after~~over ~~deducting expenses relating to~~ the ~~offering,~~sublease ~~including dealer-manager fees and expenses,~~term.

OnWhile ~~February~~management ~~25,~~has ~~2021,~~implemented ~~the~~plans ~~Company~~intended ~~entered~~to ~~into an~~mitigate ~~Equity~~these ~~Distribution~~conditions, ~~Agreement~~we ~~(the~~have ~~“ATM~~concluded ~~Agreement”)~~that ~~with~~substantial doubt ~~Maxim~~exists ~~Group~~about ~~LLC (~~the ~~“Agent”),~~Company’s asability ~~sales~~to ~~agent,~~continue as ~~amended~~ ona ~~January~~going ~~10,~~concern ~~2023~~for ~~and October~~ 12, ~~2023~~months ,from ~~pursuant to which~~ the ~~Company~~date ~~could~~these ~~offer~~consolidated ~~and sell shares of the Company’s common~~financial ~~stock,~~statements ~~par~~are ~~value $0~~issued.01 ~~pershare~~The ~~(the~~consolidated ~~“Shares”),~~financial ~~initially~~statements updo tonot aninclude ~~aggregate~~any ~~offering~~adjustments ~~price~~that ofmight ~~$15,000,000,~~result from ~~time to time in an at-~~the~~-market~~ ~~public~~outcome ~~offering~~of these uncertainties.

On March 22, 2024, the company suspended sales under the ATM Agreement and terminated the continuous offering. On July 11, 2024, the Company filed a Prospectus Supplement with the SEC adjusting the amount available for sale under the ATM Agreement to $3.1 million and shortly thereafter begin offering and selling Shares under the ATM Agreement to the public. During the year ended December 31, 2024, 602,357 Shares were sold under the ATM Agreement for gross proceeds of approximately $3.7 million. Because the Company is subject to General Instruction I.B.6 of Form S-3, it is restricted from selling securities in a public primary offering with a value exceeding one-third of its public float (the market value of our common stock held by our non-affiliates) in any 12-month period so long as its public float remains below $75.0 million. As of December 31, 2024, there was no capacity to offer and sell Shares under the ATM Agreement.40

On June 11, 2024, the Company received formal notice from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company has evidenced compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”). The Company remains subject to a “Mandatory Panel Monitor,” as that term is defined in Listing Rule 5815(d)(4)(B), for a period of one year from June 11, 2024. If, within the one-year period, the Company fails to satisfy the minimum $1.00 closing bid price threshold for 30 consecutive business days, Nasdaq will issue a delist determination rather than provide the Company with a grace period to regain compliance with the Bid Price Rule. In that event, the Company would have the opportunity to request a new hearing to address the deficiency.

We are actively seeking opportunities to raise additional equity and/or debt financing. However, such funding is not guaranteed and may not be available to the Company on favorable or acceptable terms and may involve significant restrictive covenants. Any additional equity financing, if available to the Company, will most likely be dilutive to its current stockholders. If the Company is not able to obtain additional debt or equity financing on a timely basis, the impact on the Company will be material and adverse.

The Board of Directors, together with management, is performing an ongoing evaluation of the Company’s business strategy and focus. On August 1, 2024, the board of directors appointed Eric Olson to the office of Chief Executive Officer and President to lead the evaluation process.

The Company has implemented a change in strategic emphasis to advancements in the medical device sector. Historically engaged in both industrial and biomedical applications, SINTX is prioritizing the development and commercialization of innovative medical devices, leveraging our expertise in advanced ceramics and biomaterials. Such a renewed focus would align with a commitment to improving patient outcomes through the creation of products designed for surgical, orthopedic, and other specialized medical applications. We would concentrate our resources on high-growth areas within the healthcare sector where our proprietary materials and technologies—such as silicon nitride—provide a distinct competitive advantage due to their unique strength, durability, and biocompatibility.

Through this transformation, SINTX’s aim would be to deliver meaningful innovations to the medical community. Our current research and development pipeline is centered on medical-grade devices that incorporate antimicrobial properties, enhanced imaging capabilities, and durability under physiological conditions, which are critical for orthopedic implants, spinal fusion devices, and other surgical tools. If we transition away from industrial applications, we anticipate this strategic shift will enable us to better serve the medical sector, address critical unmet needs, and position SINTX as a leading provider in the medical device market. By focusing on partnerships and collaborations with healthcare institutions and industry leaders, SINTX is positioned to expand its footprint in the medical device sector and drive shareholder value through sustainable, high-impact innovations, however, such a transition has not been approved by the Board of Directors, nor can such approval or successful transition be assured.

On August 8, 2024, the Board of Directors approved a plan to implement a Company-wide reduction in the workforce. This decision is part of the Company’s ongoing strategic review of its operations aimed at improving operational efficiency and reducing costs. The reduction in force reduced the number of employees of the Company from 40 to 23. During the year ended December 31, 2024, the Company recorded expenses of approximately $407,000 associated with the reduction in workforce.

On August 12, 2024, the Board of Directors of the Company approved a plan to cease efforts to make the armor plant operational. This decision was made to streamline operations and focus on core business areas that align with the Company’s long-term strategic goals. The armor plant has not been fully operational since the acquisition of the armor equipment in July 2021 and has been completely shut down since October 2023 due to the malfunctioning of the sintering furnace. In connection with this decision the Company incurred an impairment charge of approximately $4.6 million during the year ended December 31, 2024. This charge primarily relates to the write-down of certain long-lived assets associated with the armor plant to their estimated fair value.

The Company’s insurance carrier has determined that a covered loss occurred when the sintering furnace malfunctioned, and coverage is available for the Company’s repair of the sintering furnace. However, the Company’s efforts to fully repair the damaged furnace continue to be delayed. Management will work with the insurance company to continue to fund the repair of the furnace. When the furnace is fully repaired, management intends to sell the furnace, and related equipment, to a third party. However, the full repair and sale of the furnace, and related equipment, cannot be assured. Therefore, in the calculation of the $4.6 million impairment charge, management has assumed no proceeds will be received from a potential sale of the furnace and related equipment.

Sale of TA&T

On February 19, 2025, we entered into an Entity Acquisition Agreement (the “Agreement”) with Tethon Corporation (“Tethon”), pursuant to which the Company sold to Tethon all of the issued and outstanding shares of Technology Assessment and Transfer, Inc. (“TA&T”), a wholly owned subsidiary of the Company, in exchange for the assumption by Tethon of the outstanding liabilities of TA&T (the “Sale”).

Based on the decrease in expenditures from the reduction in force, sale of TA&T and the increase in cash on February 20, 2025, SINTX management has determined that there is no uncertainty of the Company’s ability to continue as a going concern through at least March 19, 2026 and further analysis of this matter is not deemed necessary for the year ended December 31, 2024.

Cash Flows

The following table summarizes, for the periods indicated, cash flows from operating, investing and financing activities (in thousands):

	Year Ended December 31,
	2024			2023
	2025			2024
Net cash used in operating activities	$	(8,~~642~~571	)	$	(148,~~115~~642	)
Net cash used in investing activities		(194	)		(501	)
Net cash provided by (used in) investing activities		913			(194	)
Net cash provided by financing activities		98,~~094~~200			119,~~711~~094
Net cash provided (used)	$	258		$	(2,905	)
Net increase in cash and cash equivalents	$	542		$	258

Net Cash Used in Operating Activities

Net cash used in operating activities was $8.6 ~~million~~ ~~in 2024, compared to $14.1~~ million ~~used~~ in ~~2023~~2025, ~~a decrease of $5.5 million. The decrease in the net loss from operations, and related non-cash add backs to the net loss, was $3.4 million from 2024 when~~ compared to ~~2023. The decrease in cash used for operating activities during 2024 was primarily due to the~~ $38.4 million mentioned above plus changes in the movement of working capital items during 2024 as compared to the same period in 2023 as follows: a $0.9 million decrease in cash used in accounts receivable, a $0.7 million decrease in cash used for prepaids, a $0.6 million ~~decrease for inventory, a $0.4 million decrease in cash~~ used in ~~other liabilities~~2024, ~~and~~remaining aconsistent ~~$0.2 million~~year ~~decrease~~over ~~in cash used for payments on operating lease liability, all offset by a $0~~year.~~7 million increase in cash used in accounts payable and accrued liabilities.~~

Net Cash Provided by (Used in) Investing Activities

Net cash ~~used~~provided inby investing activities was $0.2 9 million during ~~2024~~2025, compared to $0.52 million used in investing activities during the same period in ~~2023~~2024, aan ~~decrease~~increase of $01.31 million. The ~~decrease~~increase in cash ~~used~~provided inby investing activities during ~~2024~~2025 was primarily due to a $0.58 million ~~increase~~ in proceeds from ~~notes~~the ~~receivable~~acquisition of Sinaptic Surgical, ~~offset~~ by$0.5 million decrease in purchase of property and equipment and $0.23 million increase in ~~purchase~~proceeds from the sale of property and equipment, partially offset by a $0.5 million decrease in proceeds from notes receivable.

Net Cash Provided by Financing Activities

Net cash provided by financing activities was $98.12 million during ~~2024~~2025, compared to $119.71 million provided by financing activities during the same period in ~~2023~~2024, a decrease of $20.6 9 million. ~~This~~The $0.9 million decrease to net cash provided by financing activities was primarily attributable to a decrease in proceeds from issuance of warrant derivative liabilities of $3.34 million, an ~~increase~~and a decrease in ~~payments~~proceeds onfrom issuance ~~debt~~of common stock and prefunded warrants of $01.27 million, partially offset by aincreases in proceeds from the exercise of warrants, net of cash fees, and deposit for stock issuance (in other current liabilities) of $03.96 million, ~~increase~~proceeds from issuance of common stock in connection with ATM, net of fees of $0.3 million, and proceeds from issuance of ~~common~~warrants ~~stock~~in connection with exercise of warrants of $0.2 million.

Indebtedness

~~Business~~Information with ~~Loan~~respect to our indebtedness may be found in Note 7 to the consolidated financial statements included in Part II, Item 8 of this Annual Report, which is incorporated by reference.

On July 20, 2021, TA&T, entered into a Loan Authorization and Agreement in the amount of approximately $350,000 (the “Business Loan”). The Company made a one-time $35,000 buy down payment when acquiring the loan. The Business Loan bore interest at a rate of 3.75% per annum. The Business Loan was secured by a general security interest in all of the assets of TA&T. The Business Loan contained other standard provisions that are customary of loans of this type. The business loan was paid in full during the first quarter of 2024 and there was no outstanding balance at December 31, 2024.41

Insurance Premium Finance Arrangements

In March 2024, in connection with securing Director and Officer professional liability insurance, the Company entered into a Premium Finance Arrangement to extend the premium payment out for a period of 10 months. The Company paid a total of $40,000 up front toward the insurance premium and financed approximately $238,000. The Company will make 10 equal payments under the terms of the Premium Finance Agreement. The Premium Finance Agreement bears interest at an annual percentage rate of 8.510%. The Director and Officer professional liability insurance debt was paid in full during the fourth quarter of 2024 and there was no outstanding balance at December 31, 2024.

In June 2024, in connection with securing commercial liability insurance, the Company entered into a Premium Finance Arrangement to extend the premium payment out for a period of 10 months. The Company paid a total of $26,000 up front toward the insurance premium and financed approximately $117,000. The Company will make 10 equal payments under the terms of the Premium Finance Agreement. The Premium Finance Agreement bears interest at an annual percentage rate of 8.75%. As of December 31, 2024, there was an outstanding balance of $32,000.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements, as defined in Item 303(a)(4) of Regulation S-K.

Related-Party Transactions

~~We have not entered~~Information ~~into~~with ~~any~~respect ~~transactions since January 1, 2021~~ to ~~which~~our werelated ~~have been a~~ party, intransactions ~~which~~may ~~the~~be ~~amount~~found ~~involved~~ in ~~the~~Note ~~transaction~~14 ~~exceeded~~to the ~~lesser~~ ofconsolidated ~~$120,000~~financial orstatements ~~one~~included ~~percent of the average of our total assets at year-end for the last two completed fiscal years, and~~ in ~~which any~~Part ~~of our directors~~II, ~~executive~~Item ~~officers~~8 ~~or, to our knowledge, beneficial owners~~ of ~~more than 5% of our common stock, on an as converted~~this ~~basis,~~Annual ~~or any member of the immediate family of any of the foregoing persons had or will have a direct or indirect material interest~~Report, ~~other~~ ~~than~~which ~~equity~~is ~~and~~incorporated ~~other~~by ~~compensation, termination, change in control and other arrangements~~reference.

Indemnification Agreements: We have entered into indemnification agreements with each of our executive officers and directors that require us to indemnify such persons against any and all expenses, including judgments, fines or penalties, attorney’s fees, witness fees or other professional fees and related disbursements and other out-of-pocket costs incurred, in connection with any action, suit, arbitration, alternative dispute resolution mechanism, investigation, inquiry or administrative hearing, whether threatened, pending or completed, to which any such person may be made a party by reason of the fact that such person is or was a director, officer, employee or agent of our company, provided that such director or officer acted in good faith and in a manner that the director or officer reasonably believed to be in, or not opposed to, our best interests. The indemnification agreements also set forth procedures that will apply in the event of a claim for indemnification thereunder. We believe that these provisions and agreements are necessary to attract and retain qualified persons as directors and officers.

Seasonality and Backlog

Our business is generally not seasonal in nature. The majority of our product revenue is derived from the manufacture and sale of spinal fusion products, used in the treatment of spine disorders, to CTL Medical. We also retained CTL Medical to act as our exclusive broker to offer for sale, and sell, our manufacturing services to third party developers of spinal implants and spinal devices that incorporate silicon nitride technology, which has a remaining term ofthrough ~~3-years~~2028. CTL Medical’s sales generally consist of products that are in stock with them or maintained at hospitals or with their sales distributors. Accordingly, we do not have a backlog of sales orders.

Critical Accounting Policies and Estimates

A summary of our significant accounting policies and estimates is discussed in Management’s Discussion and Analysis of Financial Condition and Results of Operations and in Note 1 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024. There have been no material changes to those policies for the year ended December 31, ~~2024~~2025. The preparation of the consolidated financial statements in accordance with U.S. generally accepted accounting principles requires us to make judgments, estimates and assumptions regarding uncertainties that affect the reported amounts of assets and liabilities. Significant areas of uncertainty that require judgments, estimates and assumptions include the accounting for income taxes and other contingencies as well as valuation of derivative liabilities, asset impairment and collectability of accounts receivable. We use historical and other information that we consider to be relevant to make these judgments and estimates. However, actual results may differ from those estimates and assumptions that are used to prepare our consolidated financial statements.

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New Accounting ~~Pronouncement, Not Yet Adopted~~Pronouncements

~~The Company has reviewed all recently issued,~~Information ~~but~~with ~~not~~respect ~~yet~~to ~~adopted,~~new accounting ~~standards,~~pronouncements inmay ~~order~~be tofound ~~determine~~in ~~their~~Note ~~effects,~~1 ifto ~~any,~~the onconsolidated ~~its results of operations,~~ financial ~~position or~~statements ~~cash~~included ~~flows.~~in ~~Based~~Part ~~on that review~~II, ~~the~~Item ~~Company~~8 ~~believes~~of ~~that~~this Annual noReport, ~~other~~which ~~pronouncements~~is ~~will~~incorporated ~~have~~by ~~a significant effect on its financial statements upon adoption~~reference.

Revenue Recognition

The Company derives its product revenue primarily from the sale of aerospace components and spinal fusion products, used in the treatment of spine disorders to CTL Medical, with whom the Company has a 10-year exclusive sales agreement in place, 7through ~~years of which remain~~2028. The Company is currently pursuing other sales opportunities for silicon nitride outside the spinal fusion application. The sale of the Company’s products has a single performance obligation and revenue is recognized at the time the product is shipped to the customer. In general, the Company’s customers do not have any rights of return or exchange.

Revenue is recognized when control of the goods or services promised under the contract is transferred to the customer either at a point in time (e.g., upon delivery) or over time (e.g., as performed under the contract). The Company accounts for a contract when it has approval and commitment from both parties, the rights and payment terms of the parties are identified, the contract has commercial substance and collectability of consideration is probable. Contracts are reviewed to determine whether there is one or multiple performance obligations. A performance obligation is a promise to transfer a distinct good or service to a customer and represents the unit of accounting for revenue recognition. For contracts with multiple performance obligations, the expected consideration, or the transaction price, is allocated to each performance obligation identified in the contract based on the relative standalone selling price of each performance obligation. Revenue is then recognized for the transaction price allocated to the performance obligation when control of the promised goods or services underlying the performance obligation is transferred. Contract consideration is not adjusted for the effects of a significant financing component when, at contract inception, the period between when control transfers and when the customer will pay for that good or service is one year or less. Contact modifications that provide for additional distinct goods or services at the standalone selling price are treated as separate contracts. The transaction price for our contracts reflects our estimate of returns, rebates and discounts, which historically have not been significant. Amounts billed to customers for shipping and handling are included in the transaction price and generally are not treated as separate performance obligations as these costs fulfill a promise to transfer the product to the customer. The Company does not ~~employee~~employ salespeople to actively seek additional customers; there are no incremental costs for obtaining customers that need to be capitalized.

Account and Other Receivables and Allowance for Credit Losses Doubtful Accounts

Financial assets, which potentially subject the Company to credit losses, consist primarily of receivables. We measure expected credit losses of financial assets based on historical loss and other information available to management using type of receivable (commercial, grants or contracts, retainage, or other) and different aging categories (less than 90 days past due, over 90 days past due, over 180 days past due, and financially troubled customers). These expected credit losses are recorded to an allowance for credit losses valuation account that is deducted from receivables to present the net amount expected to be collected on the financial asset on the consolidated balance sheet. Management believes that the historical loss information it has compiled is a reasonable basis on which to determine expected credit losses for trade receivables held as of December 31, ~~2024~~2025, because the composition of the trade receivables as of that date is consistent with that used in developing the historical credit-loss percentages (i.e., the similar risk characteristics of its customers and its lending practices have not changed significantly over time).

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Inventories

Inventories are stated at the lower of cost or net realizable value, with cost for manufactured inventory determined under the standard costs, which approximate actual costs, determined on the first-in first-out (“FIFO”) method. Manufactured inventory consists of raw material, direct labor and manufacturing overhead cost components. The Company reviews the carrying value of inventory on a periodic basis for excess or obsolete items, and records any write-down as a cost of revenue, as necessary.

Long Lived Intangible Assets

The Company evaluates the carrying value of intangibles when events or changes in circumstances indicate that the carrying value may not be recoverable. Factors the Company considers important which could trigger an impairment review include, but are not limited to, significant under-performance relative to historical or projected future operating results, significant changes in the manner of its use of acquired assets or its overall business strategy, and significant industry or economic trends. The Company amortizes definite-lived intangible assets on a straight-line basis over their useful lives. The Company recorded no impairment ~~loss~~ for definite-lived intangible assets during the year ended December 31, ~~2024~~2025. ~~As explained above, the Company sold most intangible assets that had a carrying value, retaining the carrying value of only one trademark asset.~~

Goodwill

Goodwill represents the excess of the purchase price over the fair market value of identifiable net assets. Goodwill is not amortized, but rather is tested at the reporting unit level at least annually for impairment or more frequently if triggering events or changes in circumstances indicate impairment. Initially, qualitative factors are considered to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. Some of these qualitative factors may include macroeconomic conditions, industry and market considerations, a change in financial performance, entity-specific events, a sustained decrease in share price, and consideration of the difference between the fair value and carrying amount of a reporting unit as determined in the most recent quantitative assessment. If, through this qualitative assessment, the conclusion is made that it is more likely than not that a reporting unit’s fair value is less than its carrying amount, a quantitative impairment analysis is performed. This analysis involves estimating the fair value of a reporting unit using widely accepted valuation methodologies including the income and market approaches, which requires the use of estimates and assumptions. These estimates and assumptions include revenue growth rates, discount rates, and determination of appropriate comparable entities. If the fair value of the reporting unit is less than its carrying amount, an impairment loss is recognized in an amount equal to the excess of the carrying amount over the fair value of the reporting unit, not to exceed the carrying amount of the goodwill. The Company recorded no impairment for goodwill during the year ended December 31, 2025.

Property and Equipment

Property and equipment, including leasehold improvements, are stated at cost, less accumulated depreciation and amortization. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets, which range from three to five years. Leasehold improvements are amortized over the shorter of their estimated useful lives or the related lease term, generally five years.

The Company reviews the carrying value of the Company’s property and equipment that are held and used in the Company’s operations for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of these assets is determined based upon expected undiscounted future net cash flows from the operations to which the assets relate, utilizing management’s best estimate, assumptions, and projections at the time. If the carrying value is determined to be unrecoverable from future operating cash flows, the asset is deemed impaired, and an impairment charge would be recognized to the extent the carrying value exceeded the estimated fair value of the asset. The Company estimates the fair value of assets based on the estimated future discounted cash flows of the asset.

Income Taxes

The Company recognizes deferred tax assets and liabilities for the future tax consequences attributable to the differences between the financial statement carrying value of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates in effect for the fiscal year in which those temporary differences are expected to be recovered or settled. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.

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The Company operates in various tax jurisdictions and is subject to audit by various tax authorities. The Company provides for tax contingencies whenever it is deemed probable that a tax asset has been impaired, or a tax liability has been incurred for events such as tax claims or changes in tax laws. Tax contingencies are based upon their technical merits relative tax law and the specific facts and circumstances as of each reporting period. Changes in facts and circumstances could result in material changes to the amounts recorded for such tax contingencies.

The Company recognizes uncertain income tax positions taken on income tax returns at the largest amount that is more-likely than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained.

The Company’s policy for recording interest and penalties associated with uncertain tax positions is to record such items as a component of our income tax provision. For the years ended December 31, ~~2024~~2025 and ~~2023~~2024, the Company did not record any material interest income, interest expense or penalties related to uncertain tax positions or the settlement of audits for prior periods.

Stock-Based Compensation

The Company measures stock-based compensation expense related to employee stock-based awards based on the estimated fair value of the awards as determined on the date of grant and is recognized as expense over the remaining requisite service period. The Company utilizes the Black-Scholes-Merton option pricing model to estimate the fair value of employee stock options. The Black-Scholes-Merton model requires the input of highly subjective and complex assumptions, including the estimated fair value of the Company’s common stock on the date of grant, the expected term of the stock option, and the expected volatility of the Company’s common stock over the period equal to the expected term of the grant. The Company estimates forfeitures at the date of grant and revises the estimates, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company accounts for stock options to purchase shares of stock that are issued to non-employees based on the estimated fair value of such instruments using the Black-Scholes-Merton option pricing model.

Derivative Liabilities

Derivative liabilities include the fair value of instruments such as common stock warrants, preferred stock warrants and convertible features of notes, ~~that~~which are initially recorded at fair value and are required to be re-measured to fair value at each reporting period. The change in fair value of the instruments is recognized as a component of other income (expense) in the Company’s consolidated statements of operations until the instruments settle, expire or are no longer classified as derivative liabilities. The Company estimates the fair value of these instruments using the Black-Scholes-Merton or Monte-Carlo valuation models depending on the complexity of the underlying instrument. The significant assumptions used in estimating the fair value include the exercise price, volatility of the stock underlying the instrument, risk-free interest rate, estimated fair value of the stock underlying the instrument and the estimated life of the instrument.

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ITEM 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

ITEM 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Financial Statements

The consolidated financial statements of the Company appear at the end of this Annual Report beginning with the index to Financial Statements on page F-1 (see Part IV, Item 15 “Financial Statements”), and are incorporated herein.

ITEM 9.

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

None.

ITEM 9A.

CONTROLS AND PROCEDURES

(a) Disclosure Controls and Procedures

We maintain disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934 (the “Exchange Act”), that are designed to ensure that information required to be disclosed in the reports filed or submitted under the Exchange Act, is recorded, processed, summarized, and reported within the time periods specified by the Commission’s rules and forms. Disclosure controls and procedures include controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act are properly recorded, processed, summarized and reported within the time periods required by the Commission’s rules and forms.

We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer (~~principal~~Principal ~~executive~~Executive ~~officer~~Officer) and ~~principal~~Chief ~~financial officer~~Financial Officer (Principal Financial and Accounting Officer), of the effectiveness of the design and operation of these disclosure controls and procedures, as such term is defined in Exchange Act Rule 13a-15(e), as of December 31, ~~2024~~ 2025. Based on this evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, ~~2024~~2025, the end of the period covered by this Annual Report on Form 10-K.

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(b) Management’s Report on Internal Control over Financial Reporting

Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act.

Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness of internal control over financial reporting to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Our internal control over financial reporting is designed to provide reasonable assurance of achieving its objectives as specified above. Management does not expect, however, that our internal control over financial reporting will prevent or detect all error and fraud. Any control system, no matter how well designed and operated, is based upon certain assumptions and can provide only reasonable, not absolute, assurance that its objectives will be met. Further, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected.

Management, including our Chief Executive Officer and Chief Financial Officer, has assessed the effectiveness of our internal control over financial reporting as of December 31, ~~2024~~2025. In making our assessment of the effectiveness of internal control over financial reporting, management used the criteria set forth in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”).

As defined in SEC Regulation S-X, a material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis. Based on this assessment, management determined that, as of December 31, ~~2024~~2025, the Company’s internal control over financial reporting was effective.

There were no changes in our internal control over financial reporting that occurred during ~~2024~~2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

ITEM 9B.

OTHER INFORMATION

During the three months ended December 31, ~~2024~~2025, none of our directors or officers adopted or terminated a “Rule 10-b5-1 trading arrangement” or “non-Rule 10-b5-1 trading arrangement” as each term is identified in Item 408 of Regulation S-K.

ITEM 9C.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

None.

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PART III

ITEM 10.

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Directors

The following table sets forth the names, ages, and positions with SINTX for each of our directors.

Name	Age	Positions
B. Sonny Bal, M.D.	62	Chairman of the Board of Directors
Eric Olson	62	CEO and Chairman of the Board of Directors
David W. Truetzel	68	Director
Jay Moyes	72	Director
Jeffrey S. White	71	Director
Robert Mitchell	63	Director
Eric A. Stookey	54	Director
Chris Lyons	56	Director
Mark Froimson, M.D.	64	Director
Mark Anderson	62	Director
Eric Olson	61	Director, President and Chief Executive Officer
Gregg Honigblum	63	Director

Our Board is divided into three classes (Class I, Class II and Class III) with staggered three-year terms. Directors in each class are elected to serve for three-year staggered terms that expire in successive years. Officers serve at the discretion of our Board. The following is information on the business experience of each director now serving and a discussion of the qualifications, attributes and skills that led to the Board of Directors’ conclusion that each one is qualified to serve as a director.

The following is a brief summary of the background of each of our directors:

Class I ~~III~~Director ~~Directors—~~– continuing ~~directors~~ director with a term expiring at the ~~2026~~2027 annual meeting of ~~stockholder~~stockholders.

B.Eric Olson, ~~Sonny~~age ~~Bal~~62, ~~M.D.~~was appointed to the board of directors in November 2024 and has served onas ~~our~~Chief ~~Board of~~Executive ~~Directors~~Officer since ~~February 2012~~August 1, 2024. Prior to being appointed as ~~Chairman~~Chief ofExecutive ~~our~~Officer, ~~Board~~from ofJune ~~Directors~~2022 ~~since~~to August ~~2014.~~2024, DrMr. ~~Bal~~Olson ~~was~~served aas ~~tenured~~Founder, ~~Professor~~Chief ~~in Orthopaedic~~Executive ~~Surgery~~Officer atand ~~the~~Board ~~University~~Member of ~~Missouri~~Foresite Innovations, ~~Columbia~~LLC, ~~and~~a ~~has~~private anhealthcare ~~extensive~~innovation ~~history~~and ofdevelopment ~~research~~holding ~~into~~company. ~~silicon~~From ~~nitride~~January 2016 ~~ceramics~~to June 2022, Mr. HeOlson was ~~Adjunct Professor~~the offounder, ~~Material~~President, ~~Sciences~~Chief atExecutive ~~Missouri~~Officer ~~Science~~ and ~~Technology~~Board ~~University~~Member atof ~~Rolla.~~Predictive DrBiotech, Inc., ~~Bal~~which developed isthe afirst ~~member~~human ofstem ~~the~~cell ~~American~~and ~~Academy~~tissue ~~of Orthopaedic~~product ~~Surgeons,~~(HCT/P) derived from the ~~American~~perinatal ~~Association~~tissue. ofPrior ~~Hip~~to ~~and~~joining ~~Knee~~Predictive ~~Surgeons~~Biotech, Mr. ~~and~~Olson was the ~~International~~President ~~Society~~and ofChief ~~Technology~~Executive inOfficer ~~Arthroplasty~~for Cupertino based Skeletal Kinetics from December 2014 to January 2016. This ~~Dr.~~Colson ~~Bal~~& ~~received~~Associates ~~his~~company ~~M.D.~~developed ~~degree~~and ~~from~~commercialized ~~Cornell~~synthetic ~~University~~bone substitute products for Orthopedic and anSpinal Mapplications.~~B.A.~~ From ~~from~~February ~~Northwestern~~2012 ~~University~~to September 2014, Mr. Olson served as Chief Executive Officer and President and a ~~J.D.~~member ~~from~~of the ~~University~~board of ~~Missouri,~~directors ~~and~~of aSINTX PhTechnologies (formerly Amedica Corporation).D Mr. Olson began his career with London-based Smith & Nephew and has worked in ~~Engineering~~Senior ~~from~~Sales ~~the~~and ~~Kyoto~~Marketing ~~Institute~~leadership roles with Johnson & Johnson, Medtronic and Wright Medical. He earned Bachelor of ~~Technology~~Science Degrees in ~~Japan.~~Behavioral WeScience ~~believe~~and ~~that~~Health ~~Dr.~~Administration ~~Bal’s~~from ~~breadth~~The University of ~~experience~~Utah and ~~scientific~~ ~~expertise~~completed ina ~~silicon~~Master’s ~~nitride~~level ~~qualifies~~Hospital ~~him~~Administration Internship toProgram ~~serve~~at asthe ~~our~~same ~~Chairman.~~institution

5348

~~Jeffrey S~~Jay M. ~~White~~Moyes, ~~has~~age ~~served~~72, onwas ~~our~~appointed ~~Board of~~to ~~Directors~~the ~~since~~board ~~January~~of ~~2014.~~directors ~~From~~in ~~January~~April ~~2013~~2025. toSince ~~2018~~April 2012, Mr. ~~White~~Moyes has also served ason ~~Principal~~the atboard of ~~Medtech~~directors ~~Advisory~~of ~~Group~~Puma ~~LLC~~Biotechnology, Inc., a ~~firm~~public hebiopharmaceutical ~~founded that~~company ~~advises~~with ~~early~~a focus on the development and ~~mid-stage~~commercialization ~~medical~~of innovative ~~technology~~products ~~firms.~~to Inenhance ~~that~~cancer ~~capacity~~care. Mr. ~~White~~Moyes has ~~consulted~~been ~~MiMedx~~a ~~Group~~member of the board of directors of Biocardia, Inc., ~~the~~a ~~leading~~public ~~amniotic~~cardiovascular ~~tissue~~regenerative ~~and~~medicine ~~allograft~~company, ~~regenerative~~since ~~biomaterials~~January ~~firm~~2011. ~~since~~Mr. ~~mid~~Moyes served as the Chief Financial Officer of Sera Prognostics, Inc., a public commercial-~~2015~~stage biotechnology company focused on improving maternal and ~~served~~neonatal ashealth ~~Vice~~through ~~President~~innovative biomarker approaches, ~~Product~~from March ~~Management~~2020 ~~Strategies~~to atJune ~~MiMedix~~2023. Mr. ~~White~~Moyes previously served as a ~~director~~member of ~~Residency~~the ~~Select~~board ~~LLC~~of directors of Achieve Life Sciences, Inc., a public specialty pharmaceutical company, ~~which~~from ~~offers~~August ~~psychometric~~2017 ~~assessment~~to May 2023; Predictive Technology Group, ~~training~~Inc., a public molecular diagnostics and ~~compliance~~regenerative ~~products~~medicine company, from February 2019 to ~~medical~~December ~~and~~2019; ~~surgical~~Osiris ~~residency~~Therapeutics, ~~programs~~Inc., ~~Mr.~~a ~~White~~public ~~also~~bio-surgery ~~served~~company, infrom ~~2014~~May ~~and~~2006 ~~2015~~until asDecember 2017; ~~President~~ and ~~director~~Amedica ofCorporation ~~Liventa~~(now ~~Bioscience LLC~~SINTX Technologies, Inc.), a ~~provider~~public oforthopedic ~~specialty~~implant ~~amniotic~~company, ~~tissue~~from ~~allografts~~November ~~for~~2012 ~~use~~to inAugust ~~surgical~~2014. He ~~and~~served ~~wound~~as ~~care~~Chief ~~applications~~Financial Officer of Amedica from October 2013 to August 2014. From May ~~2006~~2008 tothrough ~~December~~July ~~2012 he~~2009, Mr. Moyes served as Chief ~~Global~~Financial ~~Director~~Officer of ~~Business~~XDx ~~Development~~(now ~~for~~CareDx), ~~Synthes~~ Inc., a ~~global~~privately ~~orthopedic~~held ~~firm~~molecular diagnostics company. Prior to that, ~~was~~Mr. ~~acquired~~Moyes byserved ~~Johnson~~as Chief Financial Officer of Myriad Genetics, Inc., a public healthcare diagnostics company, from June 1996 until November 2007, and ~~Johnson~~as inits ~~2012~~Vice President of Finance from July 1993 until May 1996. From 1991 to 1993, Mr. ~~White~~Moyes ~~has~~ served as ~~Chief~~Vice ~~Executive~~President ~~Officer~~of Finance and~~/or~~ ~~co-founder~~Chief Financial Officer of ~~several~~Genmark, ~~start-up~~Inc., ~~surgical~~a ~~device~~privately ~~firms~~held ~~and~~genetics ~~has~~company. ~~previously held~~Mr. ~~executive~~Moyes ~~level~~held various positions atwith ~~United~~the ~~States~~accounting ~~Surgical~~firm ~~Corporation,~~of ~~now~~KPMG LLP ~~part~~from of1979 ~~Medtronic.~~through Mr1991. ~~White~~He holds an M.B.A. from the University of Utah, a B.SA. in ~~Biology~~economics from ~~Union~~Weber State University, and is formerly ~~College~~a inCertified ~~Schenectady~~Public NYAccountant. WeMr. ~~believe~~Moyes ~~that~~also served as a member of the Board of Trustees of the Utah Life Science Association from 1999 through 2006. Mr. ~~White’s~~Moyes ~~experience~~was nominated to serve as ana ~~executive~~director because his extensive background in finance and ~~founder~~accounting and his experience in the context of ~~medical~~the ~~device~~life ~~companies~~sciences ~~qualifies~~ industry enable him to ~~serve~~make onsignificant ~~our~~contributions ~~Board~~to ofthe ~~Directors~~Board.

Class II Directors —– continuing ~~directors~~ director with a term expiring at the ~~2025~~2028 annual meeting of stockholders.

~~David~~Robert D. WMitchell, age 63, was appointed to our board of directors in April 2025. ~~Truetzel~~Since March 1, 2018, he has served on ~~our~~the ~~Board~~board of directors of ~~Directors~~Conavi ~~since~~Medical ~~our~~Corp., ~~acquisition~~a ofpublic US(TSX), ~~Spine~~commercial stage medical device company focused on designing, ~~Inc.~~manufacturing, inand ~~September~~marketing imaging ~~2010~~technologies to guide common minimally invasive cardiovascular procedures and is currently their chairperson of the HR and Governance Committee. Since August 2021, Mr. ~~Truetzel~~Mitchell has ~~been~~served as Executive Chairman of the Board of Directors for Life Seal Vascular Inc, a privately held medical device company pioneering solutions to revolutionize endovascular intervention. Mr. Mitchell is a general partner since January 2024 in NLP Ventures LLC. Since January 2022 he has also served as a General Partner in FF20 Ventures, an early-stage venture capital fund. Since March 2018 he has served as Chairman and founder of ~~Augury~~RDM ~~Capital~~Enterprises, ~~Partners~~LLC. From December 2010 to 2018, Mr. Mitchell served as President of Endologix, Inc., a ~~private~~public ~~equity~~company ~~fund~~focused ~~that~~on ~~invests~~the indevelopment, ~~life~~manufacture, ~~sciences~~and commercialization of innovative medical devices for the treatment of aortic disorders. Mr. Mitchell served as President and ~~information~~Chief ~~technology~~Executive ~~companies~~Officer of Nellix, ~~which~~Inc. hefrom February ~~co-founded~~2008 until its acquisition of by Endologix in ~~2006~~December 2010. From November 2006 to February 2008, Mr. ~~Truetzel~~Mitchell isserved as Executive Vice President and Chief Operating Officer of AngioDynamics, Inc., a ~~director~~publicly-held medical device company. From 2005 to 2006, Mr. Mitchell served as Chairman, President and Chief Executive Officer of ~~Enterprise~~Millimed ~~Bank~~Holdings, Inc., ~~Bonfyre~~a privately-held medical device company based in Roskilde, ~~LLC~~Denmark. From 2004 to 2005, aMr. ~~provider~~Mitchell served as Vice President of ~~enterprise~~Worldwide ~~technology~~Sales ~~management~~for ~~solutions~~Align Technology, ~~Paranet~~Inc., ~~LLC~~a publicly-held company. From 1987 to 2004, anMr. ITMitchell ~~services~~held various positions with Cook Incorporated, a privately-held medical device company, including ~~provider~~Vice President and ~~ScholarPath~~Director, ~~Inc.~~Global anSales ~~educational~~and ~~software~~Marketing ~~platform~~for various business units including diagnostic and interventional, endovascular, critical care. Mr. ~~Truetzel~~Mitchell holds a B.S. ~~in Business Administration~~ from ~~Saint~~the ~~Louis~~ University of Utah and an M.B.A. from ~~The~~Indiana ~~Wharton~~Wesleyan ~~School~~University. WeMr. ~~believe~~Mitchell ~~that~~was nominated ~~Mr.~~to ~~Truetzel’s~~serve ~~financial~~as a director because his extensive background and ~~managerial~~experience ~~expertise~~in ~~qualify~~the ~~him~~context of the life sciences industry enable him to ~~serve~~make onsignificant ~~our~~contributions ~~Board~~to ofthe ~~Directors~~Board.

~~Eric~~Chris Lyons, A.age ~~Stookey~~56, has served on our ~~Board~~ board of ~~Directors~~directors since ~~October~~April ~~2014~~2025. Since January 2024, Mr. ~~Stookey~~Lyons has served as ~~Chief~~a ~~Operating~~partner ~~Officer~~with BiotechExec, a provider of ~~Osteoremedies,~~executive ~~LLC~~management ~~since~~services ~~March~~and offractional ~~2015.~~executive ~~From~~placement ~~October~~for medical device, biotech, diagnostics ~~2011~~and ~~until~~digital ~~August~~health ~~2014~~companies. Additionally, since January 2018, Mr. ~~Stookey~~Lyons has served as the ~~President~~chief ofexecutive ~~the~~officer ~~Extremities-Biologics~~for ~~division~~Southern atMetrics Consulting ~~Wright~~where ~~Medical~~he ~~Group~~advises ~~Inc~~emerging medtech companies on commercialization and successful exits. Mr. ~~Stookey also~~Lyons ~~served~~worked infor ~~various~~Medtronic ~~other marketing~~ Spine and ~~sales~~Biologics, ~~positions~~from atFebruary ~~Wright~~2005 ~~Medical~~to ~~Group~~January ~~Inc.~~2018 ~~since~~in ~~1995~~various roles, including asDirector ~~the~~Global ~~Senior~~Business ~~Vice~~Development ~~President and~~for ~~Chief~~10 ~~Commercial~~years, ~~Officer~~as ~~from~~Director of ~~January~~International ~~2010~~Biologic ~~to November 2011~~Marketing, asand ~~the~~Senior ~~Vice~~Product ~~President~~Manager ~~North~~– ~~American~~International ~~Sales~~Biologics. ~~from~~Prior ~~2007~~ to ~~January~~joining ~~2010~~Medtronic, as ~~the~~Mr. ~~Vice~~Lyons worked ~~President~~for USSmith ~~Sales~~& ~~from~~Nephew ~~2005~~for to16 ~~2007,~~years asin ~~the~~various ~~Senior~~roles ~~Director~~including ofClinical Therapies Sales, ~~Central Region~~Representative, ~~from~~Group ~~2003~~Manager toOrthopedic Navigation ~~2005~~ and asGroup ~~the~~Product ~~Director of~~Manager. ~~Marketing~~Mr. ~~for~~Lyons ~~Large~~holds ~~Joint~~a ~~Reconstruction~~BBA, ~~Products~~Marketing & Sales from ~~2001~~Fogelman toCollege ~~2003.~~of ~~Mr.~~Business ~~Stookey~~& ~~earned~~Economics, University ~~his~~of MMemphis.B Mr.A. ~~from~~Lyons ~~Christian~~was ~~Brothers~~nominated ~~University and~~to ~~his~~serve ~~B.S.~~as ina ~~Business~~director ~~from~~because ~~the~~his ~~Indiana~~extensive ~~University~~background ~~School~~and ofexperience ~~Business.~~in Wethe ~~believe~~context of ~~that~~the ~~Mr.~~medical ~~Stookey’s~~device industry ~~and~~enable ~~executive leadership experience qualifies~~ him to ~~serve~~make onsignificant ~~our~~contributions ~~Board~~to ofthe ~~Directors~~Board.

Class III IDirectors ~~Director~~- — continuing ~~director~~ directors with a term expiring at the ~~2027~~2026 annual meeting of stockholders.

Mark ~~Froimson~~ Anderson, ~~M.D.~~age ~~has~~62, ~~served~~was onappointed to our ~~Board~~ board of ~~Directors~~directors ~~since~~in ~~February~~April ~~2019~~2025. ~~Dr.~~Since ~~Froimson~~May is2022, ~~currently~~Mr. aAnderson ~~Principal~~has atserved ~~Riverside~~as ~~Health Advisors,~~ a ~~consulting~~consultant in ~~company~~the ~~that provides~~medical ~~strategic~~device ~~advice~~industry. ~~and~~From ~~services~~June 1991 to ~~health~~April ~~care~~2022, ~~executive leaders~~Mr. ~~Dr.~~Anderson ~~Froimson~~ served asin ~~the~~various ~~President~~roles ofwith ~~the~~Boston ~~American~~Scientific, ~~Association of~~a ~~Hip~~public ~~and~~medical device ~~Knee~~company, ~~Surgeons~~including ~~from~~Regional ~~March 2017 to March 2018. Previously~~Manager, heArea ~~was the Executive~~ Vice President and ~~Chief~~Sales ~~Clinical~~Director. ~~Officer~~Mr. ~~of Trinity~~Anderson ~~Health,~~is a ~~major~~seasoned ~~national~~executive ~~non-profit~~with ~~Catholic~~over ~~healthcare~~35 years ~~system~~in ~~comprising~~the 93medical ~~hospitals~~device ~~in 22 states~~industry. ~~Prior~~His toexperience ~~his executive leadership position~~ at ~~Trinity~~Boston ~~Health,~~Scientific ~~Dr.~~crossed ~~Froimson~~four ~~was~~divisions ~~President~~Cardiology, ~~and~~Watchman, ~~Chief Executive Officer of Euclid Hospital~~Endoscopy, aand Corporate ~~Cleveland Clinic Hospital~~Contracts. ~~Dr. Froimson~~Additionally, ~~served~~he asmanaged ~~a staff surgeon in~~ the ~~Department~~#1 ofcustomer ~~Orthopedic~~for ~~Surgery~~Boston atScientific ~~the~~(HCA ~~Cleveland~~Healthcare) ~~Clinic~~ for ~~over~~nearly 169 years,. ~~during~~Mr. ~~which time~~Anderson heis ~~held~~recognized afor ~~variety~~building ofhigh-performing ~~leadership positions~~teams, ~~including~~expanding ~~President~~global ~~of the professional staff~~markets, ~~Vice Chair of the Orthopedic~~ and ~~Rheumatologic Institute,~~scaling ~~and~~businesses ~~member~~with ofa ~~the~~strong ~~board~~commercial ~~of governors~~ and ~~board of trustees~~clinical focus. DrMr. ~~Froimson~~Anderson ~~also~~holds ~~serves~~a onBBA, ~~the~~Finance ~~board~~from ofThe ~~directors~~University of ~~Pacira~~Texas ~~Biosciences, Inc.,~~at ~~a publicly traded company on the NASDAQ Stock Market~~Austin. DrMr. ~~Froimson~~Anderson ~~received~~was anominated ~~B.S.~~to inserve ~~philosophy~~as ~~from~~a ~~Princeton~~director ~~University, an~~because ~~M.D.~~his ~~from~~extensive ~~Tulane~~background ~~University~~and ~~School~~experience ofin ~~Medicine~~the ~~and~~context anof ~~MBA~~the ~~from~~medical ~~the~~device ~~Weatherhead~~industry ~~School~~enable ofhim ~~Business~~to atmake ~~Case~~significant ~~Western~~contributions ~~Reserve~~to the ~~University~~Board.

~~Eric~~Gregg Honigblum, ~~Olson~~age 63, has served as the Company’s Chief ~~Executive~~Investment Officer ~~and President~~ since ~~August~~May ~~2024 and as a member of the Board of Directors since November 2024~~2025. Prior to ~~being appointed~~serving as the Company’s Chief ~~Executive~~Investment Officer ~~and President~~, ~~from June 2022 to August 2024,~~ Mr. ~~Olson,~~Honigblum ~~age 61,~~ served as ~~Founder,~~the Company’s Chief ~~Executive~~ Strategy Officer ~~and~~from ~~Board~~November ~~Member~~2024 ofto ~~Foresite~~May ~~Innovations, LLC, a private healthcare innovation and development holding company~~2025. From ~~January~~December ~~2016~~2023 to ~~June~~November ~~2022~~2024, Mr. ~~Olson~~Honigblum ~~was~~served ~~the~~as ~~founder,~~a ~~President,~~Managing ~~Chief~~Director ~~Executive~~for ~~Officer~~FNEX ~~and Board Member of Predictive Biotech~~Capital, ~~Inc.~~LLC, ~~which developed~~a ~~the~~global ~~first~~leader ~~human~~in ~~stem~~Private ~~cell~~Securities transaction and ~~tissue~~investment ~~product~~banking. ~~(HCT/P)~~From ~~derived~~June ~~from~~2021 ~~the perinatal tissue. Prior~~ to ~~joining~~December ~~Predictive~~2023 ~~Biotech,~~ Mr. ~~Olson~~Honigblum ~~was~~served ~~the~~as ~~President~~a ~~and~~Managing ~~Chief~~Director ~~Executive Officer~~ for ~~Cupertino~~Westlake ~~based~~Securities, ~~Skeletal~~an ~~Kinetics~~investment banking ~~from~~firm ~~December~~focused ~~2014~~on togrowth, ~~January~~merger ~~2016.~~and ~~This Colson~~acquisitions, ~~& Associates company developed~~ and ~~commercialized~~capital ~~synthetic~~raising ~~bone~~services ~~substitute products~~ for ~~Orthopedic~~middle ~~and~~market ~~Spinal applications~~companies. From ~~February~~August ~~2012~~2016 to December ~~September~~2023 ~~2014,~~ Mr. ~~Olson~~Honigblum ~~served~~was asa ~~Chief~~co-founder ~~Executive Officer~~ and ~~President~~Director ~~and~~for aHealthGrowth ~~member~~Capital, ofLLC ~~the~~specializing ~~board~~in ofproviding ~~directors~~capital, strategic ofadvisory ~~SINTX~~services, ~~Technologies (formerly Amedica Corporation). Mr. Olson began his career with London-based Smith & Nephew~~ and ~~has~~a ~~worked in~~Group ~~Senior~~Purchasing ~~Sales~~Organization ~~and~~Platform ~~Marketing leadership roles~~ with ~~Johnson~~large &wholesale ~~Johnson,~~pharmaceutical ~~Medtronic and Wright Medical~~distributors. He earned ~~Bachelor~~a Bachelor of ~~Science Degrees~~Arts degree in ~~Behavioral~~Economics ~~Science and Health Administration~~ from ~~The~~the University of ~~Utah~~Texas ~~and~~at ~~completed~~Austin. aMr. ~~Master’s~~Honigblum ~~level~~holds ~~Hospital~~Series ~~Administration Internship~~7, ~~Program~~24, atand ~~the~~63 ~~same~~securities ~~institution~~licenses.

5449

Executive Officers

Our current executive officers and their respective ages and positions are as follows:

Name	Age	Position
Eric Olson.	61	President and Chief Executive Officer, Principal Financial Officer
Eric Olson	62	Chief Executive Officer
Gregg Homigblum	62	Chief Strategy Officer
Ryan Elmore	51	President
Gregg Honigblum	63	Chief Investment Officer and Director
Kevin Trask	41	Chief Financial Officer

The following is a brief summary of the background of each of our executive officers.

Eric Olson has served as the Company’s Chief Executive Officer ~~and President~~ since August 2024 and as a member of the Board of Directors since November 2024. Prior to being appointed as Chief Executive Officer ~~and President~~, from June 2022 to August 2024, Mr. Olson, age 6162, served as Founder, Chief ~~Executive~~ Executive Officer and Board Member of Foresite Innovations, LLC, a private healthcare innovation and development holding company. From ~~January~~ January 2016 to June 2022, Mr. Olson was the founder, President, Chief Executive Officer and Board Member of Predictive Biotech, Inc., ~~which~~ which developed the first human stem cell and tissue product (HCT/P) derived from the perinatal tissue. Prior to joining Predictive Biotech, Mr. Olson was the President and Chief Executive Officer for Cupertino based Skeletal Kinetics from December 2014 to January 2016. This Colson & Associates company developed and commercialized synthetic bone substitute products for Orthopedic and Spinal applications. From February 2012 to September 2014, Mr. Olson served as Chief Executive Officer and President and a member of the board of directors of SINTX Technologies (formerly Amedica Corporation). Mr. Olson began his career with London-based Smith & Nephew and has worked in Senior Sales and Marketing leadership roles with Johnson & Johnson, Medtronic and Wright Medical. He earned Bachelor of Science Degrees in Behavioral Science and Health Administration from The University of Utah and completed a Master’s level Hospital Administration Internship Program at the same institution.

~~Gregg~~Ryan Elmore ~~Honigblum~~ has served as ~~the~~President ~~Company’s Chief~~of ~~Strategy~~SINTX ~~Officer~~Technologies, Inc. since ~~November~~March ~~2024~~16, 2026. ~~Prior~~Mr. toElmore ~~being~~reports ~~appointed~~to asthe Chief ~~Strategy~~Executive Officer, ~~from~~and is ~~December~~responsible ~~2023~~for toexecution ~~November~~of ~~2024~~the ~~Mr. Honigblum~~Company’s ~~served~~business asand aoperational ~~Managing~~strategy, ~~Director~~including ~~for~~innovation, ~~FNEX Capital~~commercialization, ~~LLC~~business development, aand global ~~leader~~expansion inof ~~Private~~SiNERGY, ~~Securities~~the ~~transaction~~Company’s ~~and~~proprietary ~~investment~~implantable-grade ~~banking. From~~silicon ~~June~~nitride ~~2021~~biomaterial platform. Prior to ~~December~~joining ~~2023~~SINTX, Mr. ~~Honigblum~~Elmore served asin avarious ~~Managing~~leadership ~~Director~~roles ~~for~~at ~~Westlake Securities~~Invibio, ana ~~investment~~division ~~banking~~of ~~firm~~Victrex ~~focused on growth~~plc, ~~merger~~a ~~and~~global ~~acquisitions,~~manufacturer ~~and~~of high-performance ~~capital~~biomaterials ~~raising~~and ~~services~~polymers ~~for~~used ~~middle~~in ~~market~~medical ~~companies~~device applications. ~~From~~Most ~~August~~recently, ~~2016~~from toSeptember ~~December~~2021 ~~2023~~to ~~Mr.~~March ~~Honigblum~~2026, he ~~was~~served aas ~~co-founder~~Core ~~and~~Business Director, where he was responsible for ~~HealthGrowth~~leadership ~~Capital,~~of ~~LLC~~the ~~specializing~~Victrex inBiomaterials ~~providing~~business ~~capital,~~across three strategic segments ~~advisory~~including ~~services~~Musculoskeletal, Cardiovascular, and aPharmaceutical ~~Group Purchasing~~markets. ~~Organization~~From ~~Platform~~October ~~with~~2010 ~~large~~to ~~wholesale~~November ~~pharmaceutical~~2021, ~~distributors~~Mr. HeElmore ~~earned~~served as aInvibio ~~Bachelor~~Global Head of ~~Arts~~Sales, ~~degree~~with inresponsibility ~~Economics~~for ~~from~~international commercial strategy, channel management, contracts administration ~~the~~and ~~University~~sales execution across all continents including facilitation of ~~Texas~~high atgrowth ~~Austin~~markets in Asia. Mr. ~~Honigblum~~Elmore holds ~~Series~~a 7,B.S. ~~24,~~In ~~and~~Mechanical Engineering 63with ~~securities~~sub-specialization ~~licenses~~through certification in Biomedical Engineering from the University of South Florida.

Gregg Honigblum has served as the Company’s Chief Investment Officer since May 2025. Prior to serving as the Company’s Chief Investment Officer, Mr. Honigblum served as the Company’s Chief Strategy Officer from November 2024 to May 2025. From December 2023 to November 2024, Mr. Honigblum served as a Managing Director for FNEX Capital, LLC, a global leader in Private Securities transaction and investment banking. From June 2021 to December 2023 Mr. Honigblum served as a Managing Director for Westlake Securities, an investment banking firm focused on growth, merger and acquisitions, and capital raising services for middle market companies. From August 2016 to December 2023, Mr. Honigblum was a co-founder and Director for HealthGrowth Capital, LLC specializing in providing capital, strategic advisory services, and a Group Purchasing Organization Platform with large wholesale pharmaceutical distributors. He earned a Bachelor of Arts degree in Economics from the University of Texas at Austin. Mr. Honigblum holds Series 7, 24, and 63 securities licenses.

Kevin Trask has served as the Company’s Chief Financial Officer since September 2025. Prior to being appointed as the Company’s Chief Financial Officer, Mr. Trask served as the Company’s Corporate Controller from May 2025 to September 2025. From May 2024 to May 2025, he served as Corporate Controller at USANA Health Sciences, Inc., a global publicly traded company. From October 2022 to May 2024, Mr. Trask served as the Head of Finance and Accounting at an early-stage private consumer goods company. From June 2021 to October 2022, Mr. Trask served as the Director of Accounting at Quotient Technologies, Inc, a publicly traded company. Prior to Quotient, Mr. Trask held multiple, progressive accounting and finance management positions at global publicly traded companies. He began his career in public accounting, providing assurance services to both large and small private and public companies. Mr. Trask holds a B.S. in Accounting from California State Polytechnic University and is an actively licensed CPA.

Arrangements between Officers and Directors

To our knowledge, there is no arrangement or understanding between any of our officers and any other person, including directors, pursuant to which the officer was selected to serve as an officer.

5550

Family Relationships

None of our directors are related by blood, marriage, or adoption to any other director, executive officer, or other key employees.

Other Directorships

With the exception of DrMr. ~~Froimson~~Moyes, who is also on the board of directors of ~~Pacira~~Puma ~~Biosciences~~Biotechnology, Inc. and Biocardia, aInc., both SEC public reporting ~~company~~ companies, none of the directors of the Company are also directors of issuers with a class of securities registered under Section 12 of the Exchange Act (or which otherwise are required to file periodic reports under the Exchange Act).

Other Involvement in Certain Legal Proceedings

None of our directors or executive officers has been involved in any bankruptcy or criminal proceedings (other than traffic and other minor offenses) or been subject to any of the items set forth under Item 401(f) of Regulation S-K, nor have there been any judgments or injunctions brought against any of our directors or executive officers during the last ten years that we consider material to the evaluation of the ability and integrity of any director or executive officer.

The Board and Committees

Our Board of Directors has ~~five~~six members., ~~The~~ namely, the Chairman of the Board, ~~and~~Eric Olson, who also serves as our Chief Executive Officer, B.and Gregg ~~Sonny Bal~~Honigblum, ~~MD,~~who ~~PhD,~~also isserves aas ~~member~~our ofChief ~~the~~Investment ~~Board~~Officer, and isfour ~~a full~~non-~~time~~ employee ~~of SINTX.~~directors ~~David~~Jay ~~W. Truetzel~~Moyes, ~~Eric~~Mark ~~A. Stookey~~Anderson, ~~Jeffrey~~Robert ~~S. White,~~ Mitchell and ~~Mark~~Chris ~~Froimson~~Lyons ~~are~~(the “non-employee directors,”). ~~and~~The ~~the~~ Board has determined that ~~these~~the ~~persons~~non-employee directors (who constitute a majority of the Board) are “independent directors” under the criteria set forth in Rule 5605(a)(2) of the Nasdaq Listing Rules. The Board met ~~forty~~eight (408) times during the year ended December 31, ~~2024~~2025. All directors attended more than seventy-five percent (75%) of the meetings of the Board and committee meetings of which such director was a member held during ~~2024~~ 2025.

In accordance with our restated Certificate of Incorporation, our Board of Directors is divided into three classes with staggered three-year terms. At each annual meeting of stockholders, the successors to the directors whose terms then expire will be elected to serve until the third annual meeting following such election. Our directors are divided among the three classes as follows:

● The Class I directors are ~~Mark~~Eric ~~Froimson~~Olson and ~~Eric~~Jay ~~Olsen~~Moyes, and their terms will expire at the 2027 annual meeting of stockholders ~~to be held in 2027~~. ● The Class II directors are ~~David~~Robert W.Mitchell ~~Truetzel~~ and ~~Eric~~Chris ~~A. Stookey~~Lyons, and their terms will expire at the ~~2025~~2028 annual meeting of stockholders. ● The Class III directors are B.Gregg ~~Sonny~~Honigblum ~~Bal, M.D.~~ and ~~Jeffrey~~Mark ~~S. White~~Anderson, and their terms will expire at the annual meeting of stockholders to be held in 2026.

Any additional directorships resulting from an increase in the number of directors will be distributed among the three classes so that, as nearly as possible, each class will consist of one-third of the directors.

Our Board of Directors has three permanent committees: the Audit Committee, the Compensation Committee, and the Corporate Governance and Nominating Committee. The written charters for these committees are on our website at https://irinvestors.sintx.com/corporate-governance/documents-charters. Our Board of Directors may from time to time establish other standing committees. In addition, from time to time, special committees may be established under the direction of our Board of Directors when necessary to address specific issues.

5651

The following table sets forth a description of the three permanent Board committees and the chairpersons and members of those committees, all of whom are independent directors:

Committee Independent Chairman Independent Members Audit Committee ~~David~~Jay W.Moyes ~~Truetzel~~Mark ~~Eric~~Anderson A.Robert ~~Stookey~~Mitchell ~~Jeffrey~~Chris S.Lyons ~~White~~ Compensation Committee ~~Jeffrey~~Mark S.Anderson ~~White~~Jay ~~David~~Moyes W.Robert ~~Truetzel~~Mitchell ~~Eric~~Chris A.Lyons ~~Stookey~~Nominating ~~Governance~~ and ~~Nominating~~Governance Committee ~~Eric~~Robert A.Mitchell ~~Stookey~~Jay ~~Jeffrey~~Moyes S.Mark ~~White~~Anderson ~~David~~Chris ~~W. Truetzel~~Lyons

~~Corporate~~Nominating and Governance ~~and Nominating~~ Committee

The Nominating ~~Corporate~~and Governance ~~and Nominating~~ Committee is currently comprised of the following members: ~~Eric~~Robert A.Mitchell ~~Stookey~~ (Chairman), ~~David~~Jay W.Moyes, ~~Truetzel~~Mark Anderson and ~~Jeffrey~~Chris ~~S White~~Lyons. Among other items, the ~~Corporate~~Nominating ~~Governance~~ and ~~Nominating~~Governance Committee is tasked by the Board to: (1) identify individuals qualified to serve as members of the Board and, recommend individuals to be nominated by the Board for election by the stockholders or to be appointed by the Board to fill vacancies consistent with the criteria approved by the Board; (2) develop and periodically evaluate and recommend changes to SINTX’s Corporate Governance Guidelines and Code of Ethics, and to review the Company’s policies and programs that relate to matters of corporate responsibility, including public issues of significance to the Company and its stakeholders; and (3) oversee an annual evaluation of the performance of the Board. The Board has determined that each of the members of the ~~Corporate~~Nominating and Governance ~~and Nominating~~ Committee is “independent” under the standard set forth in Rule 5605(a)(2) of the Nasdaq Listing Rules. The Nominating ~~Corporate~~and Governance ~~and Nominating~~ Committee did not meet as a separate committee in ~~2024~~2025, but rather, because the committee is comprised of all three independent directors, governance matters were addressed as necessary in meetings of the Board. The ~~Corporate~~Nominating ~~Governance~~ and ~~Nominating~~Governance Committee operates under a written charter adopted by the Board of Directors, which sets forth the responsibilities and powers delegated by the Board to the ~~Corporate~~Nominating ~~Governance~~ and ~~Nominating~~Governance Committee.

Board Nominations

In considering Board candidates, the Board seeks individuals of proven judgment and competence who have strong reputations in their respective fields. Although we do not have a formal diversity policy, the Board considers such factors as experience, education, employment history, special talents or personal attributes, anticipated participation in Board activities, and geographic and diversity factors. The process for identifying and evaluating nominees would include detailed consideration of the recommendations and opinions of members of our Board, our executive officers, and our stockholders. There would be no difference in the process of evaluation of candidates recommended by a stockholder and those recommended by other sources.

The Nominating and Governance Committee has adopted a policy and procedures for shareholders to recommend nominees to the Company’s Board. The Committee will only consider qualified proposed nominees that meet the qualification standards set forth on Appendix A to the Committee’s charter available on the Company’s website at www.SINTX.com. Pursuant to the policy, only shareholders who meet minimum percentage ownership requirements as established by the Board may make recommendations for consideration by the Committee. At this time, the Board has set a minimum percentage ownership of 5% of the Company’s issued and outstanding shares of common stock for a period of at least one year. To make recommendations, a shareholder must submit the recommendation in writing by mail, courier or personal delivery to: Corporate Secretary, SINTX Technologies, Inc., 1885 West 2100 South, Salt Lake City, UT 84119. For each annual meeting the Committee will consider only one proposed nominee from each shareholder or shareholder group (within the meaning of Regulation 13D under the Exchange Act).

The recommendation must set forth (1) the name, address, including telephone number, of the recommending shareholder or shareholder group; (2) the number of the Company’s shares of common stock held by such shareholder and proof of ownership if the shareholder is not a holder of record; and (3) a statement that the shareholder has a good faith intention of holding the shares through the record date of the Company’s next annual meeting. For shareholder groups this information must be submitted for each shareholder in the group.

5752

The recommendation must set forth in relation to the proposed nominee being recommended by the shareholder: (1) the information required by Items 401, 403 and 404 of Regulation S-K under the Exchange Act, (2) any material relationships or agreements between the proposed nominee and the recommending shareholder or the Company’s competitors, customers, labor unions or other persons with special interests in the Company; (3) a statement regarding the qualifications of the proposed nominee to serve on the Board; (4) a statement that the proposed nominee can fairly represent the interests of all shareholders of the Company; and (5) a signed consent by the proposed nominee to being interviewed by the Nominating and Governance Committee.

Recommendations must be made not later than 120 calendar days prior to the first anniversary of the date of the proxy statement for the prior annual meeting of shareholders. In the event that the date of the annual meeting of shareholders for the current year is more than 30 days following the first anniversary date of the annual meeting of shareholders for the prior year, the submission of a recommendation will be considered timely if it is submitted not earlier than the close of business on the 120 days prior to such annual meeting and not later than the close of business on the later of 90 days prior to such annual meeting or the close of business 10 days following the day on which public announcement of the date of such meeting is first made by the Company.

Audit Committee

We have a standing Audit Committee and audit committee charter, which complies with Rule 10A-3 of the Exchange Act, and the requirements of the Nasdaq Listing Rules. Our Audit Committee was established in accordance with Section 3(a)(58)(A) of the Exchange Act. The Audit Committee is currently comprised of the following members: ~~David~~Jay W.Moyes ~~Truetzel~~ (Chairman), ~~Eric~~Mark A.Anderson, ~~Stookey~~Robert Mitchell and ~~Jeffrey~~Chris ~~S White~~Lyons. The Audit Committee provides oversight for financial reporting matters, internal controls, and compliance with the Company’s financial policies, and meets with its auditors when appropriate. The Audit Committee ~~did~~met ~~not~~two ~~meet~~(2) times as a separate committee in ~~2024~~2025, ~~but~~as ~~rather,~~well addressing ~~because~~other ~~the~~ committee ~~is comprised of all three independent directors, committee~~ matters ~~were addressed~~ as necessary in meetings of the Board. The Board has determined that ~~David~~Jay W.Moyes ~~Truetzel~~ is an “audit committee financial expert” within the meaning of Item 407(d)(5) of Regulation S-K. Further, the Board has determined that each member of ~~David~~the W.Audit ~~Truetzel,~~Committee ~~Jeffrey~~is ~~S. White and Eric A. Stookey are~~ “independent” under the standard set forth in Rule 5605(a)(2) of the Nasdaq Listing Rules. The Audit Committee operates under a written charter adopted by the Board of Directors, which sets forth the responsibilities and powers delegated by the Board to the Audit Committee.

Compensation Committee

The Compensation Committee of the Board is comprised of the following members: ~~Jeffrey~~Mark S.Anderson ~~White,~~ (Chairman), ~~David~~Jay W.Moyes, ~~Truetzel~~Robert Mitchell and ~~Eric A~~Chris Lyons. ~~Stookey.~~ The Board has determined that each member of ~~David~~the W.Compensation ~~Truetzel,~~Committee ~~Jeffrey~~is ~~S. White and Eric A. Stookey are~~ “independent” under the standard set forth in in Rule 5605(a)(2) of the Nasdaq Listing Rules. The Compensation Committee recommends to the Board for determination compensation of our executive officers, including the chief executive officer, and addresses salary and benefit matters for other key personnel and ~~employees~~ employees of the Company. The Compensation Committee met ~~one~~two ~~time~~(2) times as a separate committee in ~~2024~~2025, ~~additionally,~~as ~~because~~well ~~the committee~~addressing isother ~~comprised of all three independent directors,~~ committee matters ~~were addressed~~ as necessary in meetings of the Board. The Compensation Committee operates under a written charter adopted by the Board of Directors, which sets forth the responsibilities and powers delegated by the Board to the Compensation Committee.

Code of Business Conduct

The Board has adopted a Code of Business Conduct that applies to all of our employees, officers and directors, including those officers responsible for financial reporting. The code of business conduct is available on our website at https://irinvestors.sintx.com/corporate-governance/documents-charters. We intend to disclose any amendments to the code or any waivers of its requirements on our website.

The Bylaws of the Company provide that no contract or transaction between SINTX and one or more of its directors or officers, or between SINTX and any other corporation, firm, association, or other organization in which one or more of its directors or officers are financially interested, shall be void or voidable solely for this reason, or solely because the director or officer is present at or participates in the meeting of the Board of Directors or committee that authorizes or approves the contract or transaction, or because their votes are counted for such purpose, provided that:

	●	the material facts as to his, her, or their relationship or interest as to the contract or transaction are disclosed or are known to the Board of Directors or the committee and noted in the minutes, and the Board of Directors or committee authorizes the contract or transaction in good faith by the affirmative vote of a majority of disinterested directors, even though the disinterested directors are less than a quorum;

	●	the material facts as to his, her, or their relationship or interest as to the contract or transaction are disclosed or are known to the stockholders entitled to vote thereon and the contract or transaction is specifically approved in good faith by vote of the stockholders; or

	●	the contract or transaction is fair as to SINTX as of the time it is authorized, approved or ratified by the Board of Directors, a committee thereof, or the stockholders.

5853

ITEM 11.

EXECUTIVE COMPENSATION

The following discussion relates to the compensation of our “named executive officers.”

Summary Compensation Table

The following table sets forth information about certain compensation awarded or paid to our named executive officers for the ~~2024~~2025 and ~~2023~~ 2024 fiscal years.

Name and Principal Position	Year		~~Salary~~	Salary		~~Bonus~~	Bonus		~~Non-Equity Incentive Plan Compensation~~	Non-Equity Incentive Plan Compensation		~~Stock Awards~~	Stock Awards		~~Option Awards~~	Option Awards		~~All Other Comp (1)~~	All Other Comp (1)		~~Total Compensation~~	Total Compensation
Eric Olson	2024		$	135,962		$	25,000		$	-		$	-		$	-		$	33,632		$	194,594
Eric Olson (2)		2025		$	366,346		$	120,000		$	-		$	512,650		$	-		$	55,014		$	1,054,010
Chief Executive Officer	~~2023~~	2024	$	-$	135,962	$	-$	25,000	$	-$	-	$	-$	-	$	-$	-	$	-$	33,632	$	-$	194,594
B. Sonny Bal	2024		$	253,788		$	7,222		$	-		$	7,716		$	19,622		$	152,303		$	440,651
Gregg Honigblum (3)		2025		$	321,442		$	97,000		$	-		$	501,700		$	-		$	52,830		$	972,972
Chief Executive Officer	2023		$	412,692		$	36,750		$	-		$	14,772		$	61,367		$	11,730		$	537,312
Chief Investment Officer
David O’Brien	2024		$	220,769		$	5,510		$	-		$	3,443		$	9,821		$	130,281		$	369,824
Kevin Trask (4)		2025		$	169,231		$	25,000		$	-		$	363,320		$	-		$	4,953		$	562,504
Chief Operating Officer	2023		$	367,308		$	23,681		$	-		$	9,405		$	41,735		$	11,474		$	453,602
Chief Financial Officer

(1) Amount reflects matching of 401(k) contributions paid by us, severance, vacation payouts, housing expenses, and commuting expenses, unless otherwise noted.

	(1)	Amount reflects matching of 401(k) contributions paid by us, severance, vacation payouts, housing expenses, and commuting expenses, unless otherwise noted.
	(2)	Mr. Olson has served as the Chief Executive Officer since August 2024.
	(3)	Mr. Honigblum has served as the Chief Investment Officer since May 2025, and served as the Chief Strategy Officer from November 2024 to May 2025.
	(4)	Mr. Trask has served as the Chief Financial Officer since September 2025.

Narrative Disclosure to Summary Compensation Table. ~~We do not have written employment agreements with any of our executive officers. All of our executive officers serve on an at-will basis.~~ The base salaries for our named executive officers were determined by our compensation committee after reviewing a number of factors, including: the responsibilities associated with the position, the seniority of the executive’s position, the base salary level in prior years, and our financial position; and for executive officers other than our Chief Executive Officer, recommendations made by our Chief Executive Officer. The Board, on an annual basis, adopts an executive bonus payment plan that is designed to provide executive officers with annual incentive compensation based on the achievement of certain pre-established performance objectives. By utilizing a combination of objective and subjective performance factors critical to our success, this program incentivizes our executive officers to achieve results that benefit them and the Company. Performance factors include the achievement of predetermined ~~financial~~ financial performance objectives, adherence to financial discipline measures and achievement of business development, product development and long-term business stability. The Board may modify or re-weight the objectives during the course of the fiscal year, if necessary, to reflect changes in our business plan.

59Employment Agreements

On May 5, 2025, the Company entered into new Executive Employment Agreements with Eric Olson, Chief Executive Officer and President, and Gregg Honigblum, Chief Investment Officer (each, an “Executive”), which superseded and replaced their prior employment and change-in-control agreements.

Each agreement provides for an initial two-year term beginning May 5, 2025, with automatic one-year renewals unless either party provides at least 90 days’ prior written notice of non-renewal.

Base Salary and Annual Bonus

Pursuant to his employment agreement, Mr. Olson receives an annual base salary of $375,000, subject to annual review by the Compensation Committee. Mr. Olson is eligible for an annual target cash bonus opportunity equal to 40% of his base salary, based on performance criteria established by the Compensation Committee.

Pursuant to his employment agreement, Mr. Honigblum receives an annual base salary of $325,000, subject to annual review by the Compensation Committee. Mr. Honigblum is eligible for an annual target cash bonus opportunity equal to 35% of his base salary.

Annual bonuses are generally earned based on continued employment through the last day of the applicable fiscal year and are payable no later than March 15 of the following year.

Equity Awards

In connection with entering into their employment agreements, each of Mr. Olson and Mr. Honigblum was granted 55,000 restricted stock units (“RSUs”) effective May 2, 2025. Under the original terms of the awards:

	●	25% of the RSUs vested immediately upon grant; and
	●	The remaining 75% were scheduled to vest in equal annual installments on May 2, 2026, May 2, 2027, and May 2, 2028, subject to continued service.

In November 2025, the Board of Directors approved the acceleration of vesting of all unvested RSUs granted in May 2025 to the Company’s executives. As a result, all remaining unvested RSUs held by Messrs. Olson and Honigblum became fully vested during fiscal 2025. The incremental compensation expense associated with such acceleration is reflected in the “Stock Awards” column of the Summary Compensation Table for 2025.

All equity awards are subject to the terms of the Company’s Equity Incentive Plan and applicable award agreements.

Severance and Change-in-Control Provisions

Each Executive’s employment agreement provides for severance benefits upon certain terminations of employment.

If the Executive’s employment is terminated by the Company without “Cause” or by the Executive for “Good Reason” (each as defined in the applicable employment agreement), the Executive is entitled to:

	●	Accrued but unpaid salary and earned benefits;
	●	A lump sum cash payment equal to one times the sum of (i) base salary and (ii) the greater of the target annual bonus for the year of termination or the average annual bonus for the prior three completed years (subject to specified assumptions if fewer than three years of bonus history exist); and
	●	Payment of certain continued health benefit amounts for up to twelve months.

If such termination occurs within one year following (or six months prior to) a Change in Control, the Executive is entitled to enhanced severance consisting of:

	●	A prorated annual bonus for the year of termination;
	●	A lump sum payment equal to three times the sum of (i) base salary and (ii) the greater of target annual bonus for the year of termination or the highest annual bonus paid in the preceding three years; and
	●	Continued health benefit payments for up to thirty-six months.

Severance payments are conditioned upon the Executive’s execution and non-revocation of a general mutual release of claims.

The agreements also contain customary definitions of “Cause,” “Good Reason,” and “Change in Control,” as well as provisions addressing indemnification, directors’ and officers’ insurance coverage, Section 409A compliance, and excise tax cutback under Section 280G of the Internal Revenue Code.

Other Compensation and Benefits

Each Executive is eligible to participate in employee benefit plans made available to senior executives, including health and welfare plans, 401(k) participation, and paid time off. The amounts reflected in the “All Other Compensation” column of the Summary Compensation Table include Company 401(k) matching contributions and other benefits described in footnote (1) to the table.

Outstanding Equity Awards at Fiscal Year-End

The following table shows information regarding equity awards held by our named executive officers as of December 31, ~~2024~~2025:

	Number of Securities Underlying Unexercised Options (#)(1)					Option Exercise		Option Expiration		Number of Restricted Stock Units that have not vested				Market value of shares or units of stock that have not vested ($)
	Number of Securities Underlying Unexercised Options (#)					Option Exercise		Option Expiration				Number of Restricted Stock Units that have not vested (1)				Market value of shares or units of stock that have not vested ($)
Name	Exercisable		Unexercisable			Price		Date
Sonny Bal		3		-	(2)	$	9,400	4/21/2030			-			$	-
Eric Olson		-		-		$	-		-				826			$	6,408
		4		-	(3)		38,600	3/2/2031			-				-
		-		-			-		-				60,000				231,600
		4		-	(4)		9,800	1/26/2032			-				-
Gregg Honigblum		-		-		$	-		-				826			$	3,188
		-		-			-		-		12		58,000		42		223,880
											-				-
Kevin Trask		-		-		$	-		-				40,000			$	154,400
David O’Brien		3		-	(5)		9,400	4/21/2030			-				-
		3		-	(6)		38,600	3/2/2031			-				-
		3		-	(7)		9,800	1/26/2032			-				-
		-		-			-				8				27

	(1)	The options have not been, and may never be, exercised, and actual gains, if any, on exercise will depend on the value of the shares of common stock on the date of exercise.
	(2)	28% of the stock option vests on the one-year anniversary of the date of the grant and 3% per month thereafter.
	(3)	28% of the stock option vests on the one-year anniversary of the date of the grant and 3% per month thereafter.
	(4)	28% of the stock option vests on the one-year anniversary of the date of the grant and 3% per month thereafter.
	(5)	28% of the stock option vests on the one-year anniversary of the date of the grant and 3% per month thereafter.
	(6)	28% of the stock option vests on the one-year anniversary of the date of the grant and 3% per month thereafter.
	(7)	28% of the stock option vests on the one-year anniversary of the date of the grant and 3% per month thereafter.

401(k) Plan

We offer our executive officers, including our named executive officers, retirement benefits, including participation in our tax-qualified profit -sharing plan that includes a “cash-or-deferred” (or 401(k)) feature in the same manner as other employees. The plan is intended to satisfy the requirements of Section 401 of the Internal Revenue Code. Our employees may elect to reduce their current compensation by up to the statutorily prescribed annual limit and have a like amount contributed to the plan. In addition, we may make discretionary and/or matching contributions to the plan in amounts determined annually by our Board. We currently ~~elect to~~ match the contributions of our employees who participate in our 401(k) plan as follows: a match of 100% on the first 3% of compensation contributed by a plan participant and a match of 50% on amounts above 3%, up to 5%, of compensation contributed by a plan participant.

Potential Payments upon Termination or Change in Control

We have ~~had~~ entered into certain agreements and maintained certain plans that may have required us to make certain payments and/or provide certain benefits to the executive officers named in the Summary Compensation Table in the event of a termination of employment or change in control.

The ~~Company also entered into a Change of~~ ~~Control~~following ~~Agreement~~summarizes (the ~~“Change~~material ofterms ~~Control Agreement”) with Mr. Olson. Among other things, the Change in Control Agreement provides that upon the consummation~~ of ~~a change in control, all outstanding options, restricted stock and other such rights held by~~ the ~~executive~~severance ~~will fully vest. Additionally, if a change in control occurs~~ and ~~at any time during the one-year period following the~~ change in control ~~(i)~~provisions weapplicable ~~or our successor terminate the executive’s employment other than for cause (but not including termination due~~ to ~~the~~Mr. ~~executive’s~~Olson ~~death~~ or ~~disability)~~Mr. orHonigblum ~~(ii) the executive terminates his employment for good~~pursuant ~~reason, then such executive has the right~~ to ~~receive~~their ~~(i)~~respective ~~payment~~employment ~~consisting~~agreements ofin aeffect ~~lump~~as ~~sum payment equal to one times his highest annual salary with us during the preceding three-year period, including the year~~ of ~~such~~December ~~termination and including bonus payments (measured on a fiscal year basis)~~31, ~~but~~2025. ~~not~~The ~~including any reimbursements and~~ amounts ~~attributable~~payable todepend ~~stock~~on ~~options and other non-cash compensation and (ii) continued health insurance coverage under~~ the ~~Company’s~~circumstances ~~health plan for a period~~ of ~~12 months following~~ termination~~. “Change in control” is defined in the Change of Control Agreement as occurring upon: (i) any~~ ~~“person” (as such term is used in Sections 13(d)~~ and ~~14(d)~~satisfaction of ~~the~~certain ~~Securities Exchange Act of 1934~~conditions, asincluding ~~amended) becoming~~ the ~~“beneficial~~execution ~~owner”~~and ~~(as defined in Rule 13d~~non-3revocation ~~under the Exchange Act), directly or indirectly,~~ of securities representing 50% or more of the total voting power represented by our then outstanding voting securities (excluding securities held by us or our affiliates or any of our employee benefit plans) pursuant to a ~~transaction~~general orrelease ~~a series~~ of ~~related~~claims ~~transactions which our board did not approve; (ii) a merger or consolidation of our company, other than a merger or consolidation which would result~~ in ~~our~~ ~~voting~~favor ~~securities outstanding immediately prior thereto continuing to represent at least 50%~~ of the total voting securities or such surviving entity or parent of such corporation outstanding immediately after such merger or consolidation; (iii) the approval by our stockholders of an agreement for the sale or disposition of all or substantially all of our assets; (iv) or a change in the composition of the Board of Directors whereby individuals who were members of the Board of Directors immediately prior to the agreement cease to constitute a majority of the Board of Directors. As defined in the agreements, “cause” means: (i) the executive’s commission of a felony (other than through vicarious liability or through a motor vehicle offense); (ii) the executive’s intentional misconduct that causes material harm to the Company, provided that such misconduct is not rectifiable or remains uncorrected after written notice and a 30-day cure period; (iii) the commission by the executive of an act of fraud, embezzlement or misappropriation of funds; (iv) a material breach by the executive of any material provision of any agreement to which the executive and we are party, which breach is not cured within 30 days after our delivery to the executive of written notice of such breach; or (v) the executive’s refusal to carry out a lawful written directive from our board. “Good reason” as defined in the agreements means, without the executive’s consent: (i) a change in the principal location at which the executive performs his duties to a new work location that is at least 500 miles from the prior location; or (ii) a material change in the executive’s compensation, authority, functions, duties or responsibilities, which would cause his position with us to become of less responsibility, importance or scope than his prior position, provided, however, that such material change is not in connection with the termination of the executive’s employment with us for any reason.

~~In the event that an officer entitled to receive~~Termination orWithout ~~receives~~Cause ~~payment~~ or ~~benefit~~for ~~under~~Good ~~the~~Reason ~~Change~~(Not in ~~Control~~Connection ~~Agreements described above, or under any other plan, agreement or arrangement~~ with ~~us, or any person whose action results in~~ a ~~change~~Change in control or any other person affiliated with us and it is determined that the total amount of payments will be subject to excise tax under Section 4999 of the Internal Revenue Code, or any similar successor provisions, we will be obligated to pay such officer a “gross up” payment to cover all taxes, including any excise tax and any interest or penalties imposed with respect to such taxes due to such payment. Under the Agreement, Mr. Olson’s receipt of such severance payments is subject to his execution and delivery of a general release of claims in favor of the Company. Control)

If the employment of Mr. Olson or Mr. Honigblum is terminated by the Company without “Cause” or by the executive for “Good Reason” (each as defined in the applicable employment agreement), and such termination is not in connection with a Change in Control, the executive would be entitled to:

●	Accrued but unpaid base salary and any earned but unpaid bonus;
●	A lump sum cash severance payment equal to one times the sum of:
		○	the executive’s then-current annual base salary; and
		○	the greater of (i) the target annual bonus for the year of termination or (ii) the average annual bonus earned for the three most recently completed fiscal years (subject to adjustment if fewer than three years of bonus history exist); and
●	Payment or reimbursement of the employer portion of COBRA premiums for up to twelve (12) months following termination.

Equity awards would be treated in accordance with the applicable equity incentive plan and award agreements.

Termination in Connection with a Change in Control

If the executive’s employment is terminated by the Company without Cause or by the executive for Good Reason within one year following, or six months prior to, a Change in Control (as defined in the employment agreement), the executive would be entitled to enhanced severance benefits consisting of:

●	Accrued but unpaid base salary and any earned but unpaid bonus;
●	A prorated annual bonus for the fiscal year of termination;
●	A lump sum cash payment equal to three times the sum of:
		○	the executive’s then-current annual base salary; and
		○	the greater of (i) the target annual bonus for the year of termination or (ii) the highest annual bonus earned during the preceding three fiscal years; and
●	Payment or reimbursement of the employer portion of COBRA premiums for up to thirty-six (36) months.

The employment agreements include a “best net” excise tax provision under Section 280G of the Internal Revenue Code, pursuant to which payments may be reduced if such reduction would result in a greater after-tax benefit to the executive.

Termination for Cause, Death, Disability, or Voluntary Resignation Without Good Reason

If the executive’s employment is terminated:

	●	By the Company for Cause,
	●	By the executive without Good Reason, or
	●	As a result of death or disability, the executive (or his estate) would be entitled only to accrued but unpaid base salary and any earned but unpaid bonus through the date of termination, and any vested benefits under applicable plans.

Equity Awards

Equity awards, if any, will be governed by the terms of the applicable equity incentive plan and award agreements.

Code of Business Conduct Violations

It is our policy under our Code of Business Conduct to take appropriate action against any executive officer whose actions are found to violate the Code or any other policy of SINTX. Disciplinary actions may include immediate termination of employment and, where SINTX has suffered a loss, pursuing its remedies against the executive officer responsible. SINTX will cooperate fully with the appropriate authorities where laws have been violated.

Role of the Board in Risk Oversight

~~Risk~~Our Board isof ~~inherent~~Directors ~~with~~has ~~every~~overall ~~business,~~responsibility ~~and~~for ~~how well~~risk aoversight. ~~business~~The ~~manages~~Board oversees the Company’s risk ~~can~~management ~~ultimately~~framework, ~~determine~~including strategic, ~~its~~operational, ~~success~~financial, regulatory, compliance, information technology security, and governance risks. Management is responsible for the day-to-day identification, assessment, and management of ~~the~~ risks ~~that~~ weand ~~face,~~reports ~~while~~regularly ~~our~~to the Board ~~of Directors, as a whole~~ and ~~through~~ its committees, ~~has~~regarding significant ~~responsibility~~risk ~~for~~exposures ~~the~~and ~~oversight~~mitigation ~~of risk management~~efforts. In ~~its~~The ~~risk oversight role, our~~ Board ofadministers ~~Directors~~its isoversight ~~responsible~~function ~~for~~both ~~satisfying~~directly ~~itself~~and ~~that~~through ~~the~~its ~~risk management processes designed and~~standing ~~implemented~~committees, byin ~~management~~accordance ~~are~~with ~~adequate~~their ~~and~~respective ~~functioning as designed~~charters.

~~Our Board of Directors does not have a standing~~The ~~risk~~Audit ~~management~~Committee ~~committee,~~assists ~~but rather administers this oversight function directly through our Board of Directors as a whole, as well as through various standing committees of~~ the Board ofin ~~Directors~~overseeing ~~that address~~ risks ~~inherent~~relating into ~~their~~financial ~~respective areas of oversight. In particular~~reporting, ~~our~~internal ~~Board~~control ofover ~~Directors~~financial isreporting, ~~responsible~~accounting policies, ~~for~~liquidity, ~~monitoring~~legal and ~~assessing~~regulatory ~~strategic risk exposure~~compliance, ~~including a determination of the nature~~ and ~~level~~related ofparty ~~risk appropriate for us~~transactions. ~~Our~~Consistent ~~Audit~~with ~~Committee~~its ~~has~~charter, the ~~responsibility~~Audit ~~to consider and discuss our major financial~~Committee ~~risk~~also ~~exposures~~oversees ~~and~~matters ~~the~~relating ~~steps~~to ~~our~~information ~~management~~technology ~~has~~security ~~taken to monitor~~ and control ~~these exposures, including guidelines~~ and ~~policies~~receives toperiodic ~~govern the~~reports ~~process~~from ~~by which risk assessment and~~ management ~~is undertaken. The Audit Committee also monitors oversight of the performance of~~regarding ~~our~~compliance ~~internal~~processes ~~audit function. Our Corporate Governance~~ and Nominating Committee monitors the effectiveness of our corporate governance guidelines, including whether they are successful in preventing illegal or improper liability-creating conduct. Our Compensation Committee assesses and monitors whether any of our compensation policies and programs have the potential to encourage excessive risk~~-taking~~ ~~or promote behaviors contra to our Code of Business Conduct~~exposures.

61The Compensation Committee oversees risks relating to executive and employee compensation policies and practices. As provided in its charter, the Compensation Committee reviews compensation programs to determine whether such policies and practices create risks that are reasonably likely to have a material adverse effect on the Company and evaluates whether incentive structures appropriately align management interests with long-term stockholder value.

The Nominating and Governance Committee oversees risks relating to corporate governance, Board composition and independence, succession planning for the Chief Executive Officer (in coordination with the Compensation Committee), and the implementation and monitoring of the Company’s Code of Business Conduct and Ethics. The Committee also oversees compliance with Nasdaq listing standards and applicable governance requirements.

While each committee focuses on specific risk areas within its mandate, the full Board receives reports from its committees and considers significant risks in the context of the Company’s overall business strategy and long-term objectives.

Board Compensation

The following table shows the total compensation paid or accrued during the fiscal year ended December 31, ~~2024~~2025 to each of our non-employee directors.

Name	Fees Earned or Paid in Cash ($)		Stock Awards ($)		Option Awards ($)(611)		Total ($)
Sonny Bal (1)	$	16,667	$	-	$	-	$	16,667
Jay Moyes (1)	$	54,250	$	-	$	112,640	$	166,890
David W. Truetzel (2)		120,000		-		-		120,000
Robert Mitchell (2)		44,563		-		112,640		157,203
Jeffrey S. White (3)		40,000		-		-		40,000
Chris Lyons (3)		44,563		-		112,640		157,203
Eric A. Stookey (4)		40,000		-		-		40,000
Mark Anderson (4)		44,563		-		112,640		157,203
Mark Froimson (5)	$	40,000	$	-	$	-	$	40,000
Sonny Bal (5)(10)		50,000		-		31,100		81,100
David Truetzel (6)(10)		150,000		-		31,100		181,100
Jeffrey White (7)(10)		50,000		-		31,100		81,100
Eric Stookey (8)(10)		50,000		-		31,100		81,100
Mark Froimson (9)(10)	$	50,000	$	-	$	31,100	$	81,100

	(1)	As of December 31, ~~2024~~2025, Mr. ~~Bal~~Moyes had 1530,000 option awards outstanding.
	(2)	As of December 31, ~~2024~~2025, Mr. ~~Truetzel~~Mitchell had 530,000 option awards outstanding.
	(3)	As of December 31, ~~2024~~2025, Mr. ~~White~~Lyons had 530,000 option awards outstanding.
	(4)	As of December 31, ~~2024~~2025, Mr. ~~Stookey~~Anderson had 530,000 option awards outstanding.
	(5)	As of December 31, ~~2024~~2025, Mr. ~~Froimson~~Bal had 410,000 option awards outstanding.
	(6)	~~The~~As amounts in this column do not reflect compensation actually received by our non-employee directors nor do they reflect the actual value that will be recognized by the non-employee directors. Instead, the amounts reflect the aggregate grant date fair value computed in accordance with Accounting Standards Codification (“ASC”) 718 of ~~awards of stock options made to non-employee directors for the fiscal year ended~~ December 31, ~~2024~~2025, ~~but excludes an estimate for forfeitures~~Mr. ~~The~~Truetzel ~~fair~~had ~~value~~10,000 ~~of each~~ option ~~award~~awards ~~is estimated on the date of grant using the Black-Scholes option-pricing model~~outstanding.
	(7)	As of December 31, 2025, Mr. White had 10,000 option awards outstanding.
	(8)	As of December 31, 2025, Mr. Stookey had 10,000 option awards outstanding.
	(9)	As of December 31, 2025, Mr. Froimson had 10,000 option awards outstanding.
	(10)	Tenure on the Board of Directors ended April 2025.
	(11)	The amounts in this column do not reflect compensation actually received by our non-employee directors nor do they reflect the actual value that will be recognized by the non-employee directors. Instead, the amounts reflect the aggregate grant date fair value computed in accordance with Accounting Standards Codification (“ASC”) 718 of awards of stock options made to non-employee directors for the fiscal year ended December 31, 2025, but excludes an estimate for forfeitures. The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model.

The following compensation schedule sets forth calendar year 2026 compensation for non-employee directors (paid on a ~~quarterly~~monthly basis) as approved by the Board:

● Annual ~~Retainer~~retainer of $4065,000 paid in 12 equal monthly installments of $35,~~333~~417 each; ● $1Additionally,~~000~~ ~~for~~an ~~each~~annual ~~board~~retainer ~~and~~of ~~committee~~$26,000 ~~meeting~~to ~~attended~~the inchair ~~person;~~of ●the ~~$500~~Audit ~~for~~Committee ~~each~~and ~~board~~annual ~~and~~retainer ~~committee~~of ~~meeting~~$9,750 ~~attended~~for ~~via~~chairpersons ~~telephone~~of orall other ~~remote~~committees ~~medium;~~of ~~and~~the Board; ● Reimbursement of reasonable expenses as supported by documentation and receipts.

A new Board appointee receives an option award ~~of 400 stock options~~ upon appointment. Further, each non-employee member of the Board is awarded an option ~~grant for 150 stock options~~ award on an annual basis.

The chair of the Audit Committee is paid an annual retainer of $120,000 payable in monthly increments of $10,000 each.

Equity Compensation Plan Information

The following table sets forth information as of December 31, ~~2024~~2025 relating to all of our equity compensation plans:

Plan Category	(a) Number of Securities to be Issued upon Exercise of Outstanding Options, Warrants and Rights			(b) Weighted- average Exercise Price of Outstanding Options, Warrants and Rights			(c) Number of Securities Remaining Available for Future Issuance under Equity Compensation Plans (Excluding Securities Referenced in Column (a))
Equity compensation plans approved by stockholders		72592,359	(1)	$	~~19,546~~6.65	(2)		~~333~~102,~~706~~325
Equity compensation plans not approved by Stockholders		-			-			-
Total		72592,359	(1)	$	~~19,546~~6.65	(2)		~~333~~102,~~706~~325

(1)	Includes options outstanding under our 2020 Equity Incentive Plan and 2025 Equity Incentive Plan.
(2)	Represents weighted-average exercise price per share of common stock acquirable upon exercise of outstanding stock options.

6258

~~2020~~ Equity Incentive Plan

~~The 2020 Plan provides for the grant of nonqualified~~2025 ~~stock~~Equity ~~options,~~Incentive incentive stock options, restricted stock, restricted stock units, stock appreciation rights (SARs), and performance share awards to employees, officers, consultants, advisors, non-employee directors and independent contractors designated by either the board of directors of the Company or if so authorized by the board of directors, the Compensation Committee (the “Committee”) of the Board of Directors. Under the 2020 Plan, the maximum number of shares of common stock which may be issued, subject to adjustment as described below, is 333,745 shares of common stock, which includes 25 shares that were forfeited or reacquired by the Company due to termination or cancellation of the awards and are now part of the total number of shares of common stock permitted to be granted under the 2020 Plan. For stock options and SARs, the aggregate number of shares with respect to which such awards are exercisable, rather than the number of shares actually issued upon exercise, will be counted against the number of shares available for awards under the 2020 Plan. If awards under the 2020 Plan expire or otherwise terminate without being exercised, the shares not acquired pursuant to such awards again become available for issuance under the 2020 Plan in accordance with its terms. However, under the following circumstances, shares will not again be available for issuance under the 2020 Plan: (i) shares unissued due to a “net exercise” of a stock option, (ii) any shares withheld, or shares tendered to satisfy tax withholding obligations with respect to a stock option or SAR, (iii) shares covered by a SAR that is not settled in shares upon exercise and (iv) shares repurchased using stock option exercise proceeds.

The 2025 Equity Incentive Plan (the “2025 Plan”), as approved by the Company’s shareholders on September 4, 2025, provides for the grant of stock options (including incentive stock options and nonqualified stock options), stock appreciation rights (“SARs”), restricted stock, restricted stock units, performance awards, and other stock-based awards to employees, officers, non-employee directors, consultants, and other service providers selected by the Compensation Committee of the Board of Directors (the “Committee”) or, if applicable, the Board of Directors.

Share Reserve

The maximum number of shares of common stock available for issuance under the 2025 Plan is 700,000 shares, plus any shares that become available in connection with the cancellation or forfeiture of awards issued under the Company’s 2020 Equity Incentive Plan. The number of shares available for issuance under the Plan is subject to adjustment for stock splits, recapitalizations, and other customary capital structure changes. Beginning January 1, 2026, and on each January 1 thereafter for ten years, the number of shares available under the 2025 Plan will automatically increase by the lesser of (i) 10% of the Company’s outstanding shares (calculated on a fully diluted basis as described in the Plan) as of the preceding December 31, or (ii) such lesser number of shares as determined by the Board of Directors . The Board may elect to provide for no increase for any year.

Share Counting and Recycling

Shares subject to awards under the 2025 Plan count against the share reserve only to the extent they are actually issued and delivered. Shares forfeited, cancelled, or returned to the Company may again become available for issuance under the Plan in accordance with its terms. Shares withheld or tendered to satisfy tax withholding obligations or exercise price requirements are treated in accordance with the Plan’s share counting provisions. Awards granted in connection with corporate acquisitions or mergers that qualify under Nasdaq Listing Rule 5635 do not count against the share reserve. No further awards may be granted under the Company’s 2020 Equity Incentive Plan.

Administration

The 2025 ~~2020~~ Plan is ~~to be~~ administered by the Compensation Committee, which must consist of at least two directors meeting applicable independence orrequirements inunder ~~the~~Nasdaq ~~board~~and Rule 16b-3 of ~~director’s~~the ~~sole~~Exchange ~~discretion~~Act. The Committee has broad authority to interpret the Plan, bydetermine eligibility, select recipients, establish award terms and conditions, accelerate vesting, and adopt administrative rules. The Committee may delegate certain authority consistent with the ~~board~~terms of ~~directors~~the Plan and applicable law. The Plan prohibits repricing of stock options or cash buyouts of underwater options without shareholder approval in accordance with Nasdaq Listing Rule 5635.

Subject to the express provisions of the 2020 Plan, the Committee has authority to administer and interpret the 2020 Plan, including the authority to determine who is eligible to participate in the 2020 Plan and to whom and when awards are granted under the 2020 Plan, to grant awards, to determine the number of shares of common stock subject to awards and the exercise or purchase price of such shares under an award, to establish and verify the extent of satisfaction of any performance criteria applicable to awards, to prescribe and amend the terms of the agreements evidencing awards made under the 2020 Plan, and to make other determinations deemed necessary or advisable for the administration of the 2020 Plan.Options

~~Eligibility~~Options granted under the 2025 Plan may be either incentive stock options or nonqualified stock options. The exercise price of any option may not be less than 100% of the fair market value of the Company’s common stock on the grant date (subject to limited exceptions for corporate transactions). Options may not have a term longer than ten years (or five years in the case of certain 10% stockholders receiving incentive stock options).

~~Participants under the 2020 Plan are limited~~Change toin ~~employees, officers, non-employee directors, and consultants providing services to the Company, or any person to whom an offer of employment or engagement with the Company is extended.~~Control

~~Transferability~~The 2025 Plan includes provisions governing the treatment of awards in the event of a Change in Control, as defined in the Plan. In general:

~~Generally,~~● noIf ~~award~~awards ~~(other~~are ~~than~~assumed ~~fully~~or ~~vested and~~substituted ~~unrestricted~~by ~~shares)~~the ~~and~~successor noentity, ~~right~~accelerated ~~under~~vesting ~~any~~may ~~such~~occur ~~award~~upon ~~shall~~certain bequalifying ~~transferable~~terminations byfollowing athe ~~participant~~Change ~~other~~in ~~than~~Control. by● ~~will~~If awards are not assumed or bysubstituted, ~~the~~outstanding ~~laws~~awards ~~of descent~~may ~~and~~accelerate ~~distribution,~~or ~~and~~be nocancelled ~~award~~in (exchange for cash or other ~~than~~consideration, ~~fully~~as ~~vested~~determined ~~and~~by ~~unrestricted~~the ~~shares)~~Committee. or● ~~right~~The ~~under~~Committee ~~any~~has ~~such~~discretion ~~award~~to ~~may~~determine beappropriate ~~pledged~~adjustments in connection with mergers, ~~alienated,~~ ~~attached~~asset sales, or ~~otherwise~~similar ~~encumbered~~transactions.

Corporate Transactions

In the event of any Change-in-Control Event (as defined in the 2020 Plan), reorganization, merger, consolidation, split-up, spin-off, combination, plan of arrangement, take-over bid or tender offer, repurchase or exchange of common stock or other securities of the Company or any other similar corporate transaction or event involving the Company, all outstanding options and SARs shall become immediately exercisable with respect to 100% of the shares subject to such options or SARs, and/or the restricted period shall expire immediately with respect to 100% of the outstanding shares of restricted stock awards or restricted stock units. Further, with respect to performance share awards and cash awards, in the event of a Change-in-Control, all performance goals or other vesting criteria will be deemed achieved at 100% of target levels and all other terms and conditions will be deemed met.

Amendment and Termination

NoThe Board ~~awards~~of Directors may beamend, ~~granted~~suspend, ~~pursuant~~or toterminate the ~~2020~~ 2025 Plan ~~after~~at ~~the~~any ~~ten-year~~time, ~~anniversary~~subject ofto ~~the~~shareholder ~~effective~~approval ~~date~~where ofrequired ~~the~~by ~~2020~~applicable law, ~~Plan~~tax ~~which~~rules, ifor ~~the~~Nasdaq ~~shareholders~~listing ~~approve~~standards. ~~the~~No amendment ~~and~~may ~~restatement of~~materially impair outstanding awards without the ~~2020~~consent ~~Plan~~of the affected participant, ~~will~~except beas ~~April~~provided ~~21,~~in ~~2030~~the Plan.

~~The~~No awards ~~Committee~~ may ~~amend,~~be ~~modify~~granted orunder ~~terminate an outstanding award, provided, however, that, except as expressly provided in~~ the ~~2020~~2025 Plan, ~~the~~after ~~Committee may not, without~~ the ~~participant’s consent,~~tenth ~~amend,~~anniversary ~~modify or terminate an outstanding award unless it determines that the action would not adversely alter or impair the terms or conditions~~ of ~~such~~its ~~award.~~shareholder However, the Committee reserves the right to reprice any previously granted “underwater” option or SAR by (i) lowering the exercise price, (ii) canceling the underwater option or SAR and granting a substitute award, or (iii) repurchasing the underwater option or SARapproval.

6359

ITEM 12.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The following table sets forth certain information regarding the beneficial ownership of our common stock as of March 1, ~~2025~~2026 by:

	●	each of our current directors;

	●	each of our executive officers; and

	●	all of our directors and executive officers as a group;

	●	each stockholder known by us to own beneficially more than 5% of our Common Stock.

Beneficial ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to the securities. Shares of common stock that may be acquired by an individual or group within 60 days of March 1, ~~2025~~2026, pursuant to the exercise or vesting of options or warrants or conversion of convertible promissory notes, are deemed to be outstanding for the purpose of computing the percentage ownership of such individual or group, but are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person shown in the table. Percentage of shares beneficially owned is based on 24,~~515~~004,~~179~~699 shares issued and outstanding on March 1, ~~2025~~2026.

Except as indicated in footnotes to this table, we believe that the stockholders named in this table have sole voting and investment power with respect to all shares of common stock shown to be beneficially owned by them, based on information provided to us by such stockholders. The address for each director and executive officer listed is: c/o SINTX Technologies, Inc., 1885 West 2100 South, Salt Lake City, Utah 84119.

	Shares Beneficially Owned
Name and Address of Beneficial Owner	Number		Percentage
Five Percent Stockholders**:
Sinaptic Holdings, LLC (1)		281,450		6.9	%
Medtech Ceramics, LP (2)		400,069		9.9	%
Kevin Patrick Murphy (3)		356,350		8.6	%
Directors and Named Executive Officers:
Eric Olson (4)		134,553		3.3	%
Gregg Honigblum (5)		233,680		5.8	%
Kevin Trask (6)		57,566		1.4	%
Jay Moyes (7)		34,000		*
Robert Mitchell (8)		30,000		*
Chris Lyons (9)		38,292		*
Mark Anderson (10)		48,000		1.2	%
All executive officers and directors as a group (7 persons)		576,091		13.7	%

		Shares Beneficially Owned
	*	Indicates ownership of less than 1% of the outstanding shares of the Company’s common stock.
Name and Address of Beneficial Owner		Number		Percentage
	**	Based solely on information stated in Schedule 13G/A filings.
Five Percent Stockholders:
none
Directors and Named Executive Officers:
B. Sonny Bal, M.D. (1)			22		*
David W. Truetzel (2)			5		*
Jeffrey S. White (3)			5		*
Eric A. Stookey (4)			5		*
David O’Brien (5)			22		*
Mark Froimson, M.D. (6)			4		*
All executive officers and directors as a group (6 persons)			63		*

* Indicates ownership of less than 1% of the outstanding shares of the Company’s common stock.

(1)	Represents 216,450 shares of common stock, and warrants to purchase 65,000 shares of common stock that are currently exercisable within 60 days of March 1, 2026.

(2)	Medtech Ceramics holds (a) 370,384 shares of common stock, (b) prefunded warrants to purchase 129,170 shares of common stock, (c) 760,881 warrants to purchase 760,881 shares of common stock, and (d) 507,254 shares of common stock underlying previously owned warrants. The Common Warrants, pre-funded warrants, and shares of common stock underlying previously owned warrants beneficially owned by MedTech Ceramics, LP, are subject to 9.99% Beneficial Ownership Limitation. The number of shares beneficially owned by Medtech Ceramics set forth in the table above reflects the application of such 9.99% Beneficial Ownership Limitation.

(3)	Represents 225,914 shares of common stock and common stock purchase warrants to purchase 130,436 shares of common stock.

(4)	Represents 99,553 shares of common stock and 35,000 RSUs that will vest within 60 days of March 1, 2026.

(5)	Represents 204,180 shares of common stock and 29,500 RSUs that will vest within 60 days of March 1, 2026.

(6)	Represents 35,566 shares of common stock and 22,000 RSUs that will vest within 60 days of March 1, 2026.

(7)	Represents 4,000 shares of common stock, and options to purchase 30,000 shares of common stock that are currently exercisable within 60 days of March 1, 2026.

(8)	Represents options to purchase 30,000 shares of common stock that are currently exercisable within 60 days of March 1, 2026.

(9)	Represents options to purchase 30,000 shares of common stock that are currently exercisable within 60 days of March 1, 2026.

(10)	Represents 18,000 shares of common stock, and options to purchase 30,000 shares of common stock that are currently exercisable within 60 days of March 1, 2026.

(1)	Represents 7 shares of Common Stock and options to purchase 15 shares of Common Stock that are currently exercisable within 60 days of March 1, 2025.
(2)	Represents options to purchase 5 shares of Common Stock that are currently exercisable within 60 days of March 1, 2025.
(3)	Represents options to purchase 5 shares of Common Stock that are currently exercisable within 60 days of March 1, 2025.
(4)	Represents options to purchase 5 shares of Common Stock that are currently exercisable within 60 days of March 1, 2025.
(5)	Represents 7 shares of Common Stock, and options to purchase 15 shares of Common Stock that are currently exercisable within 60 days of March 1, 2025
(6)	Represents options to purchase 4 shares of Common Stock that are currently exercisable within 60 days of March 1, 2025.

ITEM 13.

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

Transactions with Related Persons

WeDuring the year ended December 31, 2025, the Company entered into a Research Collaboration Agreement (“Research Agreement”) with a company that is majority owned by a shareholder of the Company. The Company paid $500,000 to fund the Research Agreement. As of December 31, 2025, there was no remaining balance. Other than the Research Agreement, we have not entered into any transactions since ~~January~~ January 1, ~~2024~~2025 to which we have been a party, in which the amount involved in the transaction exceeded the lesser of $120,000 or one ~~percent~~ percent of the average of our total assets at year-end for the last two completed fiscal years, and in which any of our directors, executive officers or, to our knowledge, beneficial owners of more than 5% of our common stock, on an as converted basis, or any member of the immediate family of any of the foregoing persons had or will have a direct or indirect material interest, other than equity and other compensation, termination, change in control and other arrangements, which are described above under “Executive and Director Compensation.”

Policy for Review of Related Party Transactions

WeThe Company ~~have~~has adopted a written policy for the review ofand ~~transactions with~~approval of related ~~persons~~party transactions, as ~~set~~reflected ~~forth~~ in ~~our~~the Audit Committee Charter and the Company’s internal governance practices. The policy ~~requires~~applies ~~review,~~to ~~approval or ratification of all~~ transactions in which wethe ~~are~~Company is a participant and in which any ~~of our directors~~director, executive ~~officers~~officer, ~~shareholders~~holder ~~holding~~of more than 5% five percent of ~~our~~the Company’s outstanding common stock, anany immediate family member of ~~any of~~ the foregoing persons, or any other person ~~who~~determined by the Board ~~determines may~~of beDirectors ~~considered~~ to be a related person, has a direct or indirect material interest, and which ~~meet~~are ~~the~~required ~~threshold~~to ~~requirements~~be ~~set~~disclosed ~~forth in~~pursuant to Item 404 of Regulation S-K ~~under the Exchange Act (typically $120,000 or more in value)~~. ~~All related party transactions must be reported for review by the Audit Committee pursuant to the Audit Committee’s charter.~~

~~In reviewing and approving such transactions,~~Under the ~~Audit Committee shall obtain~~policy, orrelated ~~shall~~party ~~direct~~transactions ~~management~~subject to ~~obtain~~Item on404 ~~its~~are ~~behalf,~~required ~~all~~to ~~information~~be ~~that~~submitted to the Audit Committee ~~believes~~for review and approval toor, beif ~~relevant~~appropriate, ~~and~~ratification. ~~important~~In toreviewing a ~~review~~proposed oftransaction, the ~~transaction~~Audit ~~prior~~Committee toconsiders ~~its~~all ~~approval.~~relevant ~~Following~~facts ~~receipt~~and ofcircumstances available to it, including the ~~necessary~~nature ~~information,~~of ~~a discussion~~the ~~shall~~related beperson’s ~~held~~interest ofin the ~~relevant~~transaction, ~~factors~~the ifmaterial ~~deemed~~terms toof bethe ~~necessary~~transaction, and bywhether the ~~Audit~~transaction ~~Committee~~is ~~prior~~on toterms ~~approval.~~comparable Noto ~~related~~those ~~party transaction~~that ~~shall~~could be ~~entered~~obtained ~~into~~in ~~prior~~arm’s-length todealings ~~the~~with ~~completion~~an ofunrelated ~~these procedures~~third party.

~~Following its review, the~~ The Audit Committee determines whether ~~these~~the ~~transactions~~transaction ~~are~~is ~~in,~~fair orto ~~not~~and ~~inconsistent~~in ~~with,~~ the best interests of the Company and its stockholders,. ~~taking~~No ~~into consideration~~related ~~whether~~party ~~they~~transaction ~~are~~subject ~~on terms no less favorable~~ to the ~~Company~~policy ~~than~~may ~~those~~be ~~available~~entered ~~with~~into ~~other~~without ~~parties~~prior review and approval of the ~~related~~Audit ~~person’s~~Committee, ~~interest~~unless pre-approval is not practicable, in which case the transaction will be submitted for ratification as promptly as reasonably practicable.

~~Our~~All related ~~policy~~party ~~for review of~~ transactions ~~with~~disclosed ~~related persons was followed~~ in ~~all~~this ofAnnual ~~the~~Report ~~transactions~~were ~~set~~reviewed ~~forth above~~ and ~~all~~approved, ~~such~~or ~~transactions~~ratified, ~~were~~by ~~reviewed~~the ~~and~~Audit ~~approved~~Committee in accordance ~~with~~ ~~our~~with ~~policy~~the ~~for~~Company’s ~~review~~related ofparty ~~transactions~~transaction ~~with related persons~~policy.

Director Independence

Information regarding the independence of directors is disclosed above under Item 10 under the heading “The Board and Committees” and incorporated herein by reference.

ITEM 14.

PRINCIPAL ACCOUNTANT FEES AND SERVICES

The aggregate fees and expenses incurred from our principal accounting firm, Tanner ~~LLC~~LLP, for fiscal years ended December 31, ~~2024~~2025 and ~~2023~~2024, were as follows (in thousands):

	Year Ended December 31 , 2024		Year Ended December 31, 2023
	Year Ended December 31, 2025		Year Ended December 31, 2024
Audit fees	$	~~247~~208,~~382~~118	$	~~209~~247,~~666~~382
Audit related fees		~~109~~42,~~238~~399		~~150~~109,~~253~~238
Total Fees	$	~~356~~250,~~620~~517	$	~~359~~356,~~919~~620

Each of the permitted non-audit services has been pre-approved by the Audit Committee or the Audit Committee’s Chairman pursuant to delegated authority by the Audit Committee, other than de minimus non-audit services for which the pre-approval requirements are waived in accordance with the rules and regulations of the Securities and Exchange Commission.

Audit Fees

Consist of fees billed for professional services rendered for the audit of our financial statements and review of interim consolidated financial statements included in quarterly reports and services that are normally provided by the principal accountants in connection with statutory and regulatory filings or engagements.

Audit Related Fees

Consist of fees billed for assurance and related services that are reasonably related to the performance of the audit or review of our consolidated financial statements (i.e. consents and comfort letters associated with offerings) and are not reported under “Audit Fees”.”

Policy for Approval of Audit and Permitted Non-Audit Services

The Audit Committee charter provides that the Audit Committee will pre-approve audit services and non-audit services to be provided by our independent auditors before the accountant is engaged to render these services. The Audit Committee may consult with management in the decision-making process, but may not delegate this authority to management. The Audit Committee may delegate its authority to pre-approve services to one or more committee members, provided that the designees present the pre-approvals to the full committee at the next committee meeting.

PART IV

ITEM 15.

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

Reference is made to the Index to Consolidated Financial Statements beginning on Page F-1 hereof.

(1)

Financial Statements. The following consolidated financial statements and the notes thereto, and the Report of Independent Registered Public Accounting Firm are incorporated by reference as provided in Item 8 of this report:

Report of Independent Registered Public Accounting Firm	F-2
Consolidated Balance Sheets as of December 31, 2024 and 2023	F-3
Consolidated Balance Sheets as of December 31, 2025 and 2024	F-3
Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023	F-4
Consolidated Statements of Operations for the Years Ended December 31, 2025 and 2024	F-4
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2024 and 2023	F-5
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2025 and 2024	F-5
Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023	F-6
Consolidated Statements of Cash Flows for the Years Ended December 31, 2025 and 2024	F-6
Notes to Consolidated Financial Statements	F-7

(2)

Consolidated Financial Statement Schedules

Consolidated Financial Statement Schedules have been omitted because they are either not required or not applicable, or because the information required to be presented is included in the consolidated financial statements or the notes thereto included in this Annual Report.

(3)

Exhibits

The exhibits listed on the accompanying Exhibit Index are filed or incorporated by reference as part of this Annual Report and such Exhibit Index is incorporated by reference.

Exhibit Number	Exhibit Description	Filed with this Report	Incorporated by Reference herein from Form or Schedule	Filing Date	SEC File/Reg. Number
2.1	Asset Purchase Agreement by and among Amedica Corporation, CTL Corporation and US Spine Inc. dated as of September 5, 2018		Form 8-K (Exhibit 2.1)	10/5/18	001-33624
2.2+†	Asset Purchase Agreement by and among SINTX Technologies, Inc. and B4C, LLC, dated July 20, 2021.		Form 8-K (Exhibit 2.1)	7/26/21	001-33624
2.3†	Stock Purchase Agreement		Form 8-K (Exhibit 2.1)	7/6/22	001-33624
2.3	Entity Acquisition Agreement between the Company and Tethon Corporation dated February 19, 2025		Form 8-K (Exhibit 1.1)	2/20/25	001-33624
3.1	Restated Certificate of Incorporation of the Registrant		Form 8-K (Exhibit 3.1)	2/20/14	001-33624
3.1.1	Certificate of Amendment to the Restated Certificate of Incorporation of SINTX Corporation		Form 8-K (Exhibit 3.1)	1/22/16	001-33624
3.1.2	Certificate of Amendment to the Restated Certificate of Incorporation of SINTX Corporation		Form 8-K (Exhibit 3.1)	11/16/17	001-33624
3.1.3	Certificate of Designation of Series B Preferred Stock		Form 8-K (Exhibit 3.1)	5/15/18	001-33624
3.1.4	Certificate of Amendment to the Restated Certificate of Incorporation		Form 8-K (Exhibit 3.1)	11/02/18	001-33624
3.1.5	Certificate of Amendment to the Restated Certificate of Incorporation of SINTX Technologies, Inc.		Form 8-K (Exhibit 3.1)	7/26/19	001-33624
3.1.6	Certificate of Designation of Series C Preferred Stock		Form 8-K (Exhibit 3.1)	2/07/20	001-33624
3.1.7	Certificate of Designation of Series D Preferred Stock		Form 8-K (Exhibit 3.1)	10/17/22	001-33624
3.1.8	Certificate of Designation of Series E Preferred Stock		Form 8-K (Exhibit 3.1)	10/28/22	001-33624
3.1.9	Certificate of Amendment to the Restated Certificate of Incorporation of Sintx Technologies, Inc.		Form 8-K (Exhibit 3.1)	12/19/22	001-33624
3.1.10	Certificate of Amendment to the Restated Certificate of Incorporation of Sintx Technologies, Inc.		Form 8-K (Exhibit 3.1)	5/23/24	001-33624
3.2	Amended and Restated Bylaws of SINTX Technologies, Inc.		Form 8-K (Exhibit 3.1)	10/01/21	001-33624
4.1	Form of Common Stock Certificate of the Registrant		Amendment No. 3 to Form S-1 (Exhibit 4.1)	1/29/14	333-192232

6863

Exhibit Number	Exhibit Description	Filed with this Report	Incorporated by Reference herein from Form or Schedule	Filing Date	SEC File/Reg. Number
4.2	Form of ~~Common~~Warrant Agency Agreement between Amedica Corporation and American Stock ~~Warrant~~Transfer and Trust Company, LLC, dated February 6, 2020		Form S8-K (Exhibit 10.1/A)	12/1507/20	~~333~~001-~~234438~~33624
4.3	~~Form~~Dealer ofManager ~~Warrant~~Warrants ~~Agency~~issued ~~Agreement~~to ~~between~~Maxim ~~Amedica~~Group ~~Corporation and American Stock Transfer and Trust Company,~~ LLC, ~~dated~~on ~~February~~October 617, ~~2020~~2022		Form 8-K (Exhibit 104.1)	210/0717/2022	001-33624
4.4	~~Warrant~~Dealer ~~Issued~~Manager Warrants issued to ~~Maxim~~Ascendiant ~~Group~~Capital Markets, LLC on ~~February~~October 617, ~~2020~~2022		Form 8-K (Exhibit 4.12)	210/0717/2022	001-33624
4.5	~~Warrant~~Form ~~Issued~~of toClass ~~Ascendiant~~A ~~Capital Markets, LLC on February 6, 2020~~Warrant		Form 8-K (Exhibit 4.23)	210/0717/2022	001-33624
4.6	Form of ~~Indenture~~Class B Warrant		Form S8-3K (Exhibit 4.24)	310/2517/1922	~~333~~001-~~230492~~33624
4.7	~~Dealer~~Form ~~Manager~~of ~~Warrants~~Class ~~issued~~C ~~to Maxim Group LLC on October 17, 2022~~Warrant		Form 8S-K1 (Exhibit 4.113)	102/177/2223	~~001~~333-~~33624~~269475
4.8	~~Dealer~~Form ~~Manager~~of ~~Warrants~~Pre-Funded ~~issued to Ascendiant Capital Markets, LLC on October 17, 2022~~Warrant		Form 8S-K1 (Exhibit 4.214)	102/176/2223	~~001~~333-~~33624~~269475
4.9	Form of Class AD Warrant		Form 8S-K1 (Exhibit 4.315)	102/177/2223	~~001~~333-~~33624~~269475
4.10	Form of ~~Class~~Placement BAgent Warrant		Form 8S-K1 (Exhibit 4.416)	102/176/2223	~~001~~333-~~33624~~269475
4.11	~~Form~~Warrant ofAgency ~~Class C Warrant~~Agreement		Form S8-1K (Exhibit 4.135)	2/79/23	~~333~~001-~~269475~~33624
4.12	Form of Pre-Funded Warrant		Form S8-1K (Exhibit 4.141)	2/62/2324	~~333~~001-~~269475~~33624
4.13	Form of Class DE Warrant		Form S8-1K (Exhibit 4.152)	2/72/2324	~~333~~001-~~269475~~33624
4.14	Form of ~~Placement~~Class ~~Agent~~F Warrant		Form S8-1K (Exhibit 4.163)	2/62/2324	~~333~~001-~~269475~~33624
4.15	~~Warrant~~Form ~~Agency~~of ~~Agreement~~Placement Agent Warrant		Form 8-K (Exhibit 4.54)	2/92/2324	001-33624
4.16	Form of ~~Pre-Funded~~ Warrant Agency Agreement		Form 8-K (Exhibit 4.15)	2/2/24	001-33624
4.17	Form of ~~Class~~Senior EIndenture, ~~Warrant~~to be entered into between the Registrant and the trustee designated therein		Form 8S-K3 (Exhibit 4.214)	210/212/2423	~~001~~333-~~33624~~274951
4.18	Form of ~~Class~~Subordinated FIndenture, ~~Warrant~~to be entered into between the Registrant and the trustee designated therein		Form 8S-K3 (Exhibit 4.316)	210/212/2423	~~001~~333-~~33624~~274951
4.19	~~Form~~Description of ~~Placement~~Registrant’s ~~Agent Warrant~~Securities	X	~~Form 8-K (Exhibit 4.4)~~	~~2/2/24~~	~~001-33624~~
4.20	Form of ~~Warrant~~Pre-Funded ~~Agency Agreement~~Warrant		Form 8-K (Exhibit 4.51)	2/226/2425	001-33624
4.21	Form of ~~Senior~~Common ~~Indenture, to be entered into between the Registrant and the trustee designated therein~~Warrant		Form S8-3K (Exhibit 4.142)	102/1226/2325	~~333~~001-~~274951~~33624
4.22	Form of ~~Subordinated~~Placement ~~Indenture,~~Agent ~~to be entered into between the Registrant and the trustee designated therein~~Warrant		Form S8-3K (Exhibit 4.163)	102/1226/2325	~~333~~001-~~274951~~33624
4.23	~~Description~~Form of ~~Registrant’s Securities~~Warrant	X	Form 8-K (Exhibit 4.1)	6/27/25	001-33624
10.1	Centrepointe Business Park Lease Agreement Net by and between the Registrant and Centrepointe Properties, LLC, dated as of April 21, 2009		Form S-1 (Exhibit 10.10)	11/8/13	333-192232
10.2	First Addendum to Centrepointe Business Park Lease Agreement Net by and between the Registrant and Centrepointe Properties, LLC, dated as of January 31, 2012		Form S-1 (Exhibit 10.11)	11/8/13	333-192232
10.3	Form of ~~Change~~Indemnification ofAgreement ~~Control~~by Agreement*and between the Registrant and its officers and directors		Amendment No. 2 Form 8S-K1 (Exhibit 10.114)	712/2220/1513	~~001~~333-~~33624~~192232
10.4	Form of Indemnification Agreement by and between the Registrant and its officers and directors		Amendment No. 2 Form S-1 (Exhibit 10.14)	12/20/13	333-192232

6964

Exhibit Number	Exhibit Description	Filed with this Report	Incorporated by Reference herein from Form or Schedule	Filing Date	SEC File/Reg. Number
10.5	Exchange Agreement dated April 4, 2016, by and among SINTX Corporation and Riverside Merchant Partners, LLC		Form 8-K (Exhibit 10.2)	4/05/16	001-33624
10.4	Amendment to Centrepointe Business Park Lease Agreement, dated June 7, 2019, between SINTX Technologies, Inc. and Centrepointe Properties, LLC.		Form 8-K (Exhibit 10.1)	6/10/19	001-33624
10.6	Form of Warrant Amendment Agreement		Form S-1 (Exhibit 10.26)	4/26/18	333-223032
10.5	Promissory Note issued by CTL Corporation in favor of Amedica Corporation dated as of October 1, 2018.		Form 8-K (Exhibit 10.1)	10/5/18	001-33624
10.7	Amendment to Centrepointe Business Park Lease Agreement, dated June 7, 2019, between SINTX Technologies, Inc. and Centrepointe Properties, LLC.		Form 8-K (Exhibit 10.1)	6/10/19	001-33624
10.6	Security Agreement between Amedica Corporation and CTL Corporation dated as of October 1, 2018.		Form 8-K (Exhibit 10.2)	10/5/18	001-33624
10.8	Promissory Note issued by CTL Corporation in favor of Amedica Corporation dated as of October 1, 2018.		Form 8-K (Exhibit 10.1)	10/5/18	001-33624
10.7	Guaranty between Amedica Corporation and Daniel Chon dated as of October 1, 2018.		Form 8-K (Exhibit 10.3)	10/5/18	001-33624
10.9	Security Agreement between Amedica Corporation and CTL Corporation dated as of October 1, 2018.		Form 8-K (Exhibit 10.2)	10/5/18	001-33624
10.8	ROFN Security Agreement between Amedica Corporation and CTL Corporation dated as of October 1, 2018.		From 8-K (Exhibit 10.4)	10/5/18	001-33624
10.10	Guaranty between Amedica Corporation and Daniel Chon dated as of October 1, 2018.		Form 8-K (Exhibit 10.3)	10/5/18	001-33624
10.9	2025 Equity Incentive Plan*		Form 8-K (Exhibit 10.1)	9/5/25	001-33624
10.11	ROFN Security Agreement between Amedica Corporation and CTL Corporation dated as of October 1, 2018.		From 8-K (Exhibit 10.4)	10/5/18	001-33624
10.10	2020 Equity Incentive Plan*		Defn 14a Proxy Statement	7/10/2020	001-33624
10.12	Promissory Note, dated April 28, 2020 between SINTX Technologies, Inc. and First State Community Bank.		Form 8-K (Exhibit 10.1)	4/30/20	001-33624
10.11	Form of Warrant Agency Agreement between SINTX Technologies, Inc. and American Stock Transfer & Trust Company, LLC		Form 8-K (Exhibit 10.1)	10/17/22	001-33624
10.13	Form of Share Purchase Agreement		Form 8-K (Exhibit 99.1)	6/29/20	001-33624
10.12	Form of Securities Purchase Agreement		Form 8-K (Exhibit 10.1)	2/9/23	001-33624
10.14	Placement Agency Agreement		Form 8-K (Exhibit 99.2)	6/29/20	001-33624
10.13	Form of Placement Agent Agreement		Form S-1 (Exhibit 10.25)	2/6/23	333-269475
10.15	Form of Share Purchase Agreement		Form 8-K (Exhibit 99.1)	7/20/20	001-33624
10.14	Form of Securities Purchase Agreement		Form 8-K (Exhibit 10.1)	2/2/24	001-33624
10.16	Placement Agency Agreement		Form 8-K (Exhibit 99.2)	7/20/20	001-33624
10.15	Form of Placement Agency Agreement		Form 8-K (Exhibit 10.2)	2/2/24	001-33624
10.17	Form of Share Purchase Agreement		Form 8-K (Exhibit 99.1)	8/6/20	001-33624
10.16	Form of Stock Purchase Agreement		Form 8-K (Exhibit 10.1)	3/26/24	001-33624
10.18	Placement Agency Agreement		Form 8-K (Exhibit 99.2)	8/6/20	001-33624
10.17	Form of Placement Agency Agreement		Form 8-K (Exhibit 10.2)	3/26/24	001-33624
10.19	Form of Indenture		Form S-3 (Exhibit 4.18)	10/2/20	333-249267
10.18	Form of Stock Purchase Agreement		Form 8-K (Exhibit 10.1)	4/4/24	001-33624
10.20	Equity Distribution Agreement, dated as of February 25, 2021, by and between SINTX Technologies, Inc. and Maxim Group LLC		Form 8-K (Exhibit 10.1)	2/26/20	001-33624
10.19	Form of Placement Agency Agreement		Form 8-K (Exhibit 10.2)	4/4/24	001-33624
10.21	2020 Equity Incentive Plan		Defn 14a Proxy Statement	7/10/2020	001-33624
10.20	Form of Asset Purchase Agreement		Form 8-K (Exhibit 10.1)	6/27/25	001-33624
10.22	Form of Warrant Agency Agreement between SINTX Technologies, Inc. and American Stock Transfer & Trust Company, LLC		Form 8-K (Exhibit 10.1)	10/17/22	001-33624
10.20.1	Amendment No. 1 to Asset Purchase Agreement		Form 8-K (Exhibit 10.1.1)	6/27/25	001-33624
10.23	Amendment to Equity Distribution Agreement, dated as of January 10, 2023 by and between SINTX Technologies, Inc., and Maxim Group LLC		Form 8-K (Exhibit 10.1)	1/13/23
10.21	Executive Employment Agreement with Eric Olson, dated May 5, 2025*	X
10.24	Form of Securities Purchase Agreement		Form 8-K (Exhibit 10.1)	2/9/23	001-33624
10.22	Executive Employment Agreement with Gregg Honigblum, dated May 5, 2025*	X
10.25	Form of Placement Agent Agreement		Form S-1 (Exhibit 10.25)	2/6/23	333-269475
10.23	Form of Purchase Agreement		Form 8-K (Exhibit 10.1)	2/26/25	001-33624
10.26	Form of Securities Purchase Agreement		Form 8-K (Exhibit 10.1)	2/2/24	001-33624
10.24	Form of Registration Rights Agreement		Form 8-K (Exhibit 10.2)	2/26/25	001-33624
10.27	Form of Placement Agency Agreement		Form 8-K (Exhibit 10.2)	2/2/24	001-33624
10.25	Form of Inducement Letter		Form 8-K (Exhibit 10.1)	9/9/25	001-33624
10.28	Form of Stock Purchase Agreement		Form 8-K (Exhibit 10.1)	3/26/24	001-33624
10.26	Form of New Warrant		Form 8-K (exhibit 10.2)	9/9/25	001-33624
10.29	Form of Placement Agency Agreement		Form 8-K (Exhibit 10.2)	3/26/24	001-33624
10.27	Form of Placement Agent Warrant		Form 8-K (exhibit 10.3)	9/9/25	001-33624
10.30	Form of Stock Purchase Agreement		Form 8-K (Exhibit 10.1)	4/4/24	001-33624
10.28	Form of Additional Placement Agent Warrant		Form 8-K (Exhibit 10.4)	9/9/25	001-33624
10.31	Form of Placement Agency Agreement		Form 8-K (Exhibit 10.2)	4/4/24	001-33624
10.29	At The Market Offering Agreement, dated October 3, 2025, by and between the Company and H.C. Wainwright & Co., LLC		Form 8-K (Exhibit 10.1)	10/3/25	001-33624
10.30	Executive Employment Agreement with Ryan Elmore, dated February 6, 2026*		Form 8-K (Exhibit 10.1)	2/18/26	001-33624

7065

Exhibit Number	Exhibit Description	Filed with this Report	Incorporated by Reference herein from Form or Schedule	Filing Date	SEC File/Reg. Number
19	Insider Trading Policy	X	Form 10-K (Exhibit 19)	3/19/25	001-33624
21.1	List of Subsidiaries	X
23.1	Consent of Independent Registered Public Accounting Firm, Tanner LLC	X
31.1	Certification of Chief Executive Officer	X
31.2	Certification of Principal Financial Officer	X
32	Certification pursuant to Section 906 of the Sarbanes Oxley Act of 2002 (furnished herewith)	X
97	SINTX Technologies, Inc. Clawback Policy		Form 10-K (Exhibit 97)	3/27/24	001-33624
101 SCH	Inline XBRL Taxonomy Extension Schema Document (A)	X
101.CAL	Inline XBRL Taxonomy Extension Calculation Linkbase Document (A)	X
101.DEF	Inline XBRL Taxonomy Extension Definition Linkbase Document (A)	X
101.LAB	Inline XBRL Taxonomy Extension Label Linkbase Document (A)	X
101.PRE	Inline XBRL Taxonomy Extension Presentation Linkbase Document (A)	X
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

*	Management contract of compensatory plan or arrangement
+	Schedules and exhibits to this Exhibit have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request.
†	A portion of this Exhibit has been omitted as it contains information that (i) is not material and (ii) would be competitively harmful if publicly disclosed.

(A)	XBRL (Extensible Business Reporting Language) information is furnished and not filed for purposes of Section 11 and 12 of the Securities Act of 1933 and Section 18 of the Securities Exchange Act of 1934.

ITEM 16.	FORM 10-K SUMMARY

	None.

7166

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

		SINTX Technologies, Inc.
	Date: March 19, 2025	/s/ Eric Olson
	Date: March 20, 2026	/s/ Eric Olson
		Eric Olson
		Chief Executive Officer
		Chief Executive Officer and Chairman of the Board of Directors
		(Principal Executive Officer and Principal Financial Officer)

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

	Date: March 19, 2025	/s/ Eric Olson
	Date: March 20, 2026	/s/ Eric Olson
		Eric Olson., Director
		Eric Olson
	Date: March 19, 2025	/s/ B. Sonny Bal
		Chief Executive Officer and Chairman of the Board of Directors
		B. Sonny Bal, M.D., Director
		(Principal Executive Officer)
	Date: March 19, 2025	/s/ David W. Truetzel
	Date: March 20, 2026	/s/ Kevin Trask
		David W. Truetzel, Director
		Kevin Trask
	Date: March 19, 2025	/s/ Jeffrey S. White
		Chief Financial Officer
		Jeffrey S. White, Director
		(Principal Financial Officer)
	Date: March 19, 2025	/s/ Eric A. Stookey
	Date: March 20, 2026	/s/ Jay Moyes
		Eric A. Stookey, Director
		Jay Moyes
	Date: March 19, 2025	/s/ Mark Froimson
		Director
		Mark Froimson, M.D., Director
	Date: March 20, 2026	/s/ Robert Mitchell
		Robert Mitchell
		Director
	Date: March 20, 2026	/s/ Mark Anderson
		Mark Anderson
		Director
	Date: March 20, 2026	/s/ Chris Lyons
		Chris Lyons
		Director
	Date: March 20, 2026	/s/ Gregg Honigblum
		Gregg Honigblum
		Director

7267

As of and For the Years ended December 31, 2024 and 2023
As of and For the Years Ended December 31, 2025 and 2024
Report of Independent Registered Public Accounting Firm (PCAOB ID 270)	F-2
Consolidated Balance Sheets	F-3
Consolidated Statements of Operations	F-4
Consolidated Statements of Stockholders’ Equity	F-5
Consolidated Statements of Cash Flows	F-6
Notes to Consolidated Financial Statements	F-7

F-1

Report of Independent Registered Public Accounting Firm

Board of Directors and Stockholders of

SINTX Technologies, Inc.

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheets of SINTX Technologies, Inc. and subsidiaries (the “Company”) as as of December 31, ~~2024~~2025 and ~~2023~~2024, the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, ~~2024~~2025, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, ~~2024~~2025 and ~~2023~~2024, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, ~~2024~~2025, in conformity with accounting principles generally accepted in the United States of America.

Going Concern

The financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has recurring losses from operations and negative operating cash flows and needs to obtain additional financing to finance its operations. These issues raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matter

The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the account or disclosure to which it relates.

Warrants classified as Derivative Liabilities Valuation

As described in Note 1 to the financial statements, the Company initially records warrants classified as derivative liabilities at fair value and is required to re-measure the fair value each reporting period. The Company estimates the fair value of these instruments using Monte-Carlo valuation models. The significant assumptions used in estimating the fair value include the exercise price, volatility of the stock underlying the instrument, risk-free interest rate, estimated fair value of the stock underlying the instrument and the estimated life of the instrument.

We obtained an understanding and evaluated the design and implementation of controls over the Company’s process for calculating the fair values of the warrants classified as derivative liabilities, including controls over management’s review of the significant assumptions described above.

To test the estimated fair value of the warrants classified as derivative liabilities, we performed audit procedures that included, among others, assessing methodologies and testing the significant assumptions discussed above as well as the underlying data used by the Company in its analysis, and evaluating management’s specialist.

/s/ TANNER ~~LLC~~LLP (PCAOB ID 270) We have served as the Company’s auditors since 2017 Lehi, Utah March 1820, ~~2025~~2026

F-2

SINTX Technologies, Inc.

Consolidated Balance Sheets

(in thousands, except share and per share data)

	2024			2023
	2025			2024
	As of December 31,
	2024			2023
	2025			2024
Assets
Current assets:
Cash and cash equivalents	$	34,~~598~~140		$	3,~~340~~598
Account and other receivables, net of allowance totaling 61 and 72 respectively		196			685
Account and other receivables, net of allowance totaling $2.4 and $61.0 respectively		178			196
Prepaid expenses and other current assets		~~465~~507			~~539~~225
Inventories		~~502~~825			~~888~~502
Other current assets		10			80
Total current assets		5,650			4,521
Total current assets		4,771			5,532
Inventories, net		219			465
Inventories, net		465			333
Property and equipment, net		476			922
Property and equipment, net		922			4,826
Intangible assets, net		142			16
Intangible assets, net		16			21
Goodwill		302			-
Operating lease right of use asset		32,~~159~~458			43,~~094~~159
Other long-term assets		80259			~~559~~330
Total assets	$	9,~~413~~506		$	159,~~365~~413
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	~~299~~382		$	~~636~~299
Accrued liabilities		~~986~~422			~~1,404~~986
Current portion of long-term debt		32			46
Debt		7			32
Derivative liabilities		~~208~~827			~~304~~208
Current portion of operating lease liability		~~456~~398			~~512~~456
Other current liabilities		1,697			41
Total current liabilities		13,~~982~~733			21,~~906~~982
Operating lease liability, net of current portion		32,~~537~~844			3,~~687~~537
Total liabilities		56,~~519~~577			65,~~593~~519
Commitments and contingencies		-			-
Stockholders’ equity:
Convertible preferred stock Series B, $0.01 par value, 130,000,000 total shares authorized inclusive of all series of preferred; 19 and 26 shares issued and outstanding of December 31, 2024 and December 31, 2023 respectively.		-			-
Convertible preferred stock Series B, $0.01 par value, 130,000,000 total shares authorized inclusive of all series of preferred; 19 shares issued and outstanding of December 31, 2025 and December 31, 2024.		-			-
Convertible preferred stock Series C, $0.01 par value, 130,000,000 total shares authorized inclusive of all series of preferred; 50 shares issued and outstanding as of both December 31, 2024 and 2023.		-			-
Convertible preferred stock Series C, $0.01 par value, 130,000,000 total shares authorized inclusive of all series of preferred; 50 shares issued and outstanding as of December 31, 2025 and 2024.		-			-
Convertible preferred stock Series D, $0.01 par value, 130,000,000 total shares authorized inclusive of all series of preferred; 180 shares issued and outstanding as of both December 31, 2024 and 2023.		-			-
Convertible preferred stock Series D, $0.01 par value, 130,000,000 total shares authorized inclusive of all series of preferred; 180 shares issued and outstanding as of December 31, 2025 and 2024.		-			-
Preferred stock value		-			-
Convertible preferred stock, value		-			-
Common stock, $0.01 par value, 250,000,000 shares authorized; 1,342,853 and 26,603 shares issued and outstanding as of December 31, 2024 and 2023, respectively.		13			-
Treasury stock, 50,424 shares as of December 31, 2025		(133	)		-
Additional paid-in capital		285,619			279,486
Common stock, $0.01 par value, 250,000,000 shares authorized; 3,970,869 and 1,342,853 shares issued and outstanding as of December 31, 2025 and 2024, respectively.		40			13
Accumulated deficit		(281,738	)		(270,714	)
Additional paid-in capital		295,124			285,619
Total stockholders’ equity		3,894			8,772
Accumulated deficit		(292,102	)		(281,738	)
Total liabilities and stockholders’ equity	$	9,413		$	15,365
Total stockholders’ equity		2,929			3,894
Total liabilities and stockholders’ equity	$	9,506		$	9,413

The accompanying notes are an integral part of these consolidated financial statements.

F-3

SINTX Technologies, Inc.

Consolidated Statements of Operations

(in thousands, except share and per share data)

	2024			2023
	2025			2024
	Years Ended December 31,
	2024			2023
	2025			2024
Product revenue	$	~~1,246~~729		$	1,~~226~~246
Grant and contract revenue		~~1,641~~289			1,~~401~~641
Total revenue		21,~~887~~018			2,~~627~~887
Costs of revenue		811			784
Cost of revenue		557			811
Gross profit		~~2,076~~461			12,~~843~~076
Operating expenses:
Research and development		54,~~201~~587			85,~~713~~201
General and administrative		36,~~997~~197			43,~~222~~997
Sales and marketing		~~614~~242			~~1,137~~614
Armor exit costs		~~4,602~~-			-4,602
Reduction in force		~~407~~-			-407
Grant and contract expenses		~~1,302~~156			1,~~129~~302
Total operating expenses		1611,~~123~~182			1516,~~201~~123
Loss from operations		(1410,~~047~~721	)		(1314,~~358~~047	)
Other income (expenses):
Interest expense		(2952	)		(229	)
Interest income		~~107~~175			~~135~~107
Gain (loss) on the disposal of assets		~~(19~~327	)		17(19	)
Change in fair value of derivative liabilities		~~3,475~~(124	)		53,~~718~~475
Offering costs of derivative liabilities		~~(550~~-	)		(~~786~~550	)
Other income (expense)		3931			1739
Total other income (expense), net		~~3,023~~357			53,~~099~~023
Net loss before income taxes		(1110,~~024~~364	)		(811,~~259~~024	)
Provision for income taxes		-			-
Net loss		(1110,~~024~~364	)		(811,~~259~~024	)
Deemed dividend related to beneficial conversion feature on convertible preferred stock		-			(26	)
Deemed dividend related to warrant inducement		(6,719	)		-
Net loss attributable to common stockholders	$	(1117,~~024~~083	)	$	(811,~~285~~024	)
Net loss per share – basic and diluted
Basic – net loss	$	(143.8774	)	$	(~~442~~14.0887	)
Basic – deemed dividend and accretion of a discount on conversion of preferred stock		-			(1.39	)
Basic – deemed dividend related to warrant inducement		(2.42	)		-
Basic – attributable to common stockholders	$	(146.8716	)	$	(~~443~~14.4787	)
Diluted – net loss	$	(153.1974	)	$	(~~623~~15.2819	)
Diluted - deemed dividend and accretion of a discount on conversion of preferred stock		-			(1.19	)
Diluted - deemed dividend related to warrant inducement		(2.42	)		-
Diluted – attributable to common stockholders	$	(156.1916	)	$	(~~624~~15.4719	)
Weighted average common shares outstanding:
Basic		~~741~~2,~~250~~773,518			18741,~~682~~250
Diluted		~~744~~2,~~782~~773,518			21744,~~786~~782

The accompanying notes are an integral part of these consolidated financial statements.

F-4

SINTX Technologies, Inc.

Consolidated Statements of Stockholders’ Equity

(in thousands, except share data)

	Shares		Amount		Shares		Amount		~~Capital~~Stock		~~Deficit~~Capital			~~Equity~~Deficit			Equity
	Preferred Stock				Common Stock				~~Paid-In~~Treasury		~~Accumulated~~Paid-In			~~Total~~Accumulated			Total
	Shares		Amount		Shares		Amount		~~Capital~~Stock		~~Deficit~~Capital			~~Equity~~Deficit			Equity
Balance as of December 31, 2022		283	$	-		2,711	$	-	$	268,159	$	(262,455	)	$	5,704
Balance as of December 31, 2023		256	$	-		26,603	$	-	$	-	$	279,486		$	(270,714	)	$	8,772
Stock based compensation		-		-

Filing Compare · Sintx Technologies, Inc.