Sintx Technologies, Inc.

Overview – SINTX Technologies

SINTX Technologies is an advanced ceramics company formed in December 1996 that develops, manufactures, and commercializes silicon nitride biomaterials, composites, devices, and related technologies for medical and other high-value applications. SINTX provides biomedical solutions for medical devices specializing in silicon nitride (Si₃N₄) for musculoskeletal and antipathogenic applications. We also manufacture parts made from silicon nitride for customers in the electrical, aerospace and other industrial sectors. SINTX is a global leader in the research, development, and manufacturing of silicon nitride, and its products have been implanted in humans since 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. More recently, in October 2025, SINTX received U.S. Food and Drug Administration (FDA) 510(k) clearance for the SiNAPTIC® Foot & Ankle Osteotomy Wedge System, enabling SINTX’s commercial entry into reconstructive foot and ankle surgery in the United States. These next-generation implants blend advanced biomaterials science with surgical precision and are designed to elevate 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 30,764 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 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:

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.

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:

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 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. While demand for patient-matched implants continues to increase, regulatory pathways vary depending on device classification and intended use. Many patient-specific devices are reviewed under traditional 510(k), De Novo, or PMA pathways, depending on risk classification. Although FDA provides guidance regarding additive manufacturing and patient-matched devices, regulatory requirements remain substantial and may require extensive validation and, in some cases, clinical data. The Custom Device Exemption is available only in limited circumstances and is not applicable to 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 may reduce hospital stays and operative times related to traditional custom implant manufacturing. It may also lower the costs associated with revision surgeries and improve patient satisfaction scores.

Physicians may benefit from implants designed to match patient anatomy and incorporate radiolucent materials, which can assist with intraoperative visualization using standard imaging modalities. Silicon nitride has been studied for its material properties, including surface characteristics that may inhibit bacterial adhesion under laboratory conditions. However, clinical outcomes, recovery times, and complication rates depend on numerous factors, including patient condition and surgical technique, and the Company makes no guarantee of improved outcomes relative to other available materials.

With our 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 independent third parties have conducted biocompatibility, biomechanical, in vitro, and in vivo testing of our silicon nitride composition to support regulatory submissions for certain of our devices. Additional testing has been performed on specific products and product candidates. Findings from laboratory, animal, and limited human clinical investigations have been described in peer-reviewed publications and scientific 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. While these studies contribute to the scientific understanding of silicon nitride as a biomaterial, regulatory clearance and market adoption depend on multiple factors, including demonstration of safety and performance for specific indications and 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:

Our Strategy

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

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 2 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:

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

We have 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. Patent Nos. 9,051,639 and US 9,517,136 expire in 2032 and 2034, respectively.

We have been issued U.S. Patent No. 10,806,831 and U.S. Patent No. 11,738,122 both directed to antipathogenic implants which expire in 2037 and 2039, respectively.

We also have been issued U.S. Patent No. 11,192,787; U.S. Patent No. 11,591,217; and U.S. Patent No. 12,017,912 directed to antipathogenic devices which all expire in 2038.

We have been issued U.S. Patent No. 9,353,010 directed to alumina-zirconia ceramic implants which expires in 2034.

We have been issued U.S. Patent No. 9,353,012 directed to charge-compensating dopant stabilized alumina-zirconia ceramic implants which expires in 2034.

We have been issued U.S. Patent No. 9,399,309 directed to directed to methods for threading a ceramic material which expires in 2034.

We have been issued U.S. Patent No. 9,925,295 directed to improved ceramic and/or glass materials which expires in 2032.

We have been issued U.S. Patent No. 11,672,252 directed to antifungal composites which expires in 2040.

We have been issued U.S. Patent No. 11,844,344 directed to rapid inactivation of SARS-CoV-2 which expires in 2039.

We have been issued U.S. Patent No. 11,850,214 directed to antiviral compositions and devices which expires in 2038.

We have been issued U.S. Patent No. 11,857,001 directed to antipathogenic face mask which expires in 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 have pending national stage application in 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 have a pending national stage application in Mexico to seek patent protection for our proprietary technologies in that country. We also have a separate issued patent in the 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 have pending national stage applications in China 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 have a pending national stage application in Mexico to seek patent protection for our proprietary technologies in that 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 India 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 have a pending national stage application in Mexico to seek patent protection for our proprietary technologies in 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 have pending national stage application in Mexico to seek patent protection for our proprietary technologies in that 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:

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 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 labeling, establishment 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 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. While many 510(k) submissions do not require clinical data, FDA may require clinical or other additional data depending on the nature of the device, its technological characteristics, and associated risks. The FDA’s review timelines are governed by performance goals established under the Medical Device User Fee Amendments (“MDUFA”), which include target timeframes 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 or pursue the De Novo classification pathway, which provides a process for certain novel low- to moderate-risk devices for which no legally marketed 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 may require submission of a new 510(k); however, certain modifications may be eligible for review under FDA’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 process associated with the cleared device can serve as the basis for clearing the application. Under the Special 510(k) Program, a manufacturer may rely on design control activities and risk 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 subject to MDUFA performance goals and may vary depending on the complexity of 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 under MDUFA, which establish target timeframes for review and 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 applicable quality system regulations, including the QMSR once effective, either of which could extend the 180-day response target. 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 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:

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

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

Sales of our medical devices outside the United States are subject to the regulatory requirements of each jurisdiction in which the products are marketed. These requirements vary by country and may require additional testing, clinical evidence, quality system documentation, product registration, labeling modifications, and governmental approvals prior to commercialization. Regulatory approval timelines outside the United States may differ from those of the FDA and may be longer or more burdensome.

European Union

In the European Union (“EU”), medical devices are regulated under Regulation (EU) 2017/745 on medical devices (“EU MDR”), which establishes a harmonized regulatory framework across the 27 EU Member States. Under the MDR, devices are classified by risk (Class I, IIa, IIb and III), and manufacturers must demonstrate compliance with the General Safety and Performance Requirements set forth in the 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

Our operations are subject to numerous federal and state healthcare laws and regulations that govern fraud and abuse, transparency, privacy, security, and interactions with healthcare professionals. These laws are interpreted broadly and enforced by federal and state authorities, including the U.S. Department of Justice (“DOJ”), the U.S. Department of Health and Human Services Office of Inspector General (“HHS-OIG”), and state attorneys general.

We have entered into arrangements with certain surgeons and other healthcare professionals, including consulting, product development, royalty, and other compensation arrangements. Some of these individuals may order or use our products, and some may hold equity interests in our company. Such relationships are subject to scrutiny under applicable fraud and abuse laws. We structure these arrangements to comply with applicable legal requirements, including fair market value and commercial reasonableness standards and policies intended to avoid payments that are tied to the volume or value of referrals. However, these laws are complex and fact-specific, and there can be no assurance that regulatory authorities would not challenge our arrangements.

The federal Anti-Kickback Statute prohibits knowingly and willfully offering, paying, soliciting, or receiving remuneration to induce or reward referrals for items or services reimbursable by federal healthcare programs. The statute is broadly interpreted, and compliance with statutory exceptions or regulatory safe harbors is voluntary but often narrowly construed. Violations may result in criminal penalties, civil monetary penalties, exclusion from federal healthcare programs, and liability under the federal False Claims Act.

The federal False Claims Act imposes liability on persons who knowingly submit, or cause the submission of, false or fraudulent claims for payment to federal healthcare programs. The statute permits private whistleblowers to bring actions on behalf of the government and share in any recovery. Claims arising from alleged kickbacks, improper marketing practices, or other regulatory violations may give rise to liability. Many states have enacted similar fraud and abuse and false claims laws that may apply to claims submitted to commercial payors as well as government 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.

Third-Party Reimbursement

Our products are purchased primarily by hospitals and surgical centers rather than directly by third-party payors. However, the commercial success of our products depends in significant part on the availability of coverage and reimbursement for procedures in which our devices are used. Hospitals and physicians are unlikely to utilize our products if reimbursement for the applicable procedures is insufficient to cover associated costs.

In the United States, Medicare reimburses inpatient hospital services under the Inpatient Prospective Payment System (“IPPS”), which utilizes diagnosis-related groups (“DRGs”), and outpatient hospital services under the Outpatient Prospective Payment System (“OPPS”), which utilizes ambulatory payment classifications (“APCs”). Ambulatory surgical centers are reimbursed under a separate prospective payment system. These payment systems generally provide predetermined amounts intended to cover facility costs associated with a procedure, including implantable devices. Payment amounts are established without regard to the cost of a particular manufacturer’s product, and hospitals bear the risk if device costs exceed reimbursement.

Coverage 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.

Hospitals often participate in group purchasing organizations (“GPOs”), which negotiate pricing arrangements with manufacturers. Our ability to secure favorable contractual arrangements with GPOs, or to compete effectively outside of such arrangements, may affect our market access and pricing.

Federal and state healthcare programs and commercial payors continue to implement cost-containment measures, including value-based purchasing initiatives, bundled payment programs, and other payment models designed to control healthcare spending. These measures may increase pricing pressure on hospitals and, in turn, on medical device suppliers.

Outside the United States, reimbursement systems vary by jurisdiction and frequently involve government-established pricing controls, health technology assessments, or centralized procurement processes. In many countries, hospitals and healthcare facilities operate within budget constraints that may limit the adoption of new or higher-cost technologies. We cannot assure that favorable coverage, reimbursement, or pricing will be available in any market, and adverse changes in reimbursement policies could materially affect our business, financial condition, and results of operations.

Employees

As of December 31, 2025, we had 32 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 our employee relations to be 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.