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What changed in Sintx Technologies, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Sintx Technologies, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+318 added−391 removedSource: 10-K (2026-03-20) vs 10-K (2025-03-19)

Top changes in Sintx Technologies, Inc.'s 2025 10-K

318 paragraphs added · 391 removed · 158 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

69 edited+52 added−95 removed61 unchanged
Biggest changeWe also have long standing relations with university laboratories in Japan and the US 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, launching of new silicon nitride products into multiple industries.
Biggest changeMembers of our management team have extensive experience in silicon nitride, ceramics, research and development, manufacturing and operations, product development, and launching 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.
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.
We believe surgical options using better performing and longer-lasting biomaterials will gain acceptance among surgeons and 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.
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 Billion per year. The mycotoxins produced by these plant fungi have an overall negative impact on human health and longevity.
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 per year. The mycotoxins produced by these plant fungi have an overall negative impact on human health and longevity.
We currently produce silicon nitride for use in our commercial products and product candidates in the following forms: ● 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.
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.
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.
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.
SINTX believes that by incorporating its unique composition of silicon nitride antipathogenic powder into products such as face masks, filters, and wound care devices, it is possible to manufacture surfaces that inactivate pathogens, thereby limiting the spread of infection and disease.
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.
Even if a clinical trial is completed, the results may not demonstrate the safety and efficacy 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.
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.
With 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.
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.
Our porous silicon nitride has interconnected pores 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.
Our porous silicon nitride has interconnected pores similar to that of cancellous bone ranging in size between about 90 and 600 microns. This form of silicon nitride can be used for the promotion of bone in-growth and attachment.
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. ● Imaging Compatible.
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.
We manufacture interbody spinal fusion devices for CTL Amedica and have approximately 3 years remaining of a 10-year exclusive right to continue to manufacture them for CTL Amedica.
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 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.
We believe our porous silicon nitride can act as a substitute for the orthobiologics currently used to fill interbody devices 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 and PEKK and that the ensuing composite material maintains the bioactive properties of silicon nitride.
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.
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 value to OEM partners focused on consumer glass-based surface coatings and treatments.
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 may have value to OEM partners focused on consumer glass-based surface coatings and treatments.
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 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.
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.
These include: ● compliance with the QSR, which require manufacturers to follow stringent design, 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. 15 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.
These include: ● compliance with the 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 occur. 15 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.
Applications include medical devices – such as interbody spinal fusion implants – and non-medical such as electrical and aerospace components. ● Porous Silicon Nitride.
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.
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/US2021/056452 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.
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 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.
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. ● Favorable and Changing Demographics.
This innovative material combination integrates the superior biocompatibility, osteointegration, and antimicrobial properties of silicon nitride with the strength, durability, and radiolucency of PEEK, which we believe will lead to next-generation implants that may enhance mechanical performance, reduce infection risks, and improve imaging compatibility. ● Favorable and Changing Demographics.
We believe that to have a competitive advantage, we must continue to develop and maintain the proprietary aspects of our technologies. We have fifteen issued U.S. patents, twelve issued foreign patents, fifteen pending U.S. non-provisional patent applications, eighty-one pending foreign applications and one pending PCT patent application.
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.
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, either of which could extend the 180-day response target.
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.
Unless an exemption applies, a new medical device will require either prior 510(k) clearance or approval of a premarket approval application, or PMA, before it can be marketed in the United States.
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.
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.
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.
Our first issued patent expired in 2016, with the last of these patents expiring in 2039. We have three U.S. patents directed to articulating implants using our high-strength, high toughness doped silicon nitride solid ceramic. These issued patents, which include US 7,666,229; US 9,051,639; and US 9,517,136 will expire in November 2023, September 2032, and March 2034, respectively.
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.
PCT/US2021/038364 directed to antipathogenic devices and methods thereof 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. 11 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. 11 With respect to PCT application serial no.
If the PMA is complete, the FDA will file the PMA. The FDA is subject to performance goal review times for PMAs and may issue a decision letter as a first action on a PMA within 180 days of filing, but if it has questions, it will likely issue a first major deficiency letter within 150 days of filing.
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.
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 of medical devices are subject to foreign government regulations, which vary substantially from country to country.
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.
PCT/US2021/014725 directed to antifungal composites and methods 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. 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.
We see specific opportunities in markets such as foot and ankle, dental, maxillofacial, and arthroplasty. ● Develop new products with anti-pathogenic properties, including inactivation of the SARS-CoV-2 virus, utilizing our silicon nitride technology.
We see specific opportunities in markets such as foot and ankle, dental, maxillofacial, and arthroplasty. ● Develop new products with antipathogenic properties, including inactivation of the SARS-CoV-2 virus, utilizing our silicon nitride technology. We have conducted tests which have identified and verified the antipathogenic properties of our silicon nitride powders, fully dense components, and silicon nitride-containing composites.
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 infection of any biomaterial implants is always a concern.
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.
PCT/US2021/028975 directed to methods for laser coating of silicon nitride on a metal substrate, 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.
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.
In addition, with the FDA clearance of our silicon nitride Valeo products, we are the only company to develop and manufacture a ceramic for use in FDA cleared spinal fusion medical devices 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.
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.
PCT/US2021/056461 directed to systems and methods for selective laser sintering of silicon nitride and metal composites, 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/US2021/056461 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.
The discovery in 2020 that SINTX silicon nitride inactivates SARS-CoV-2, the virus which causes the disease COVID-19, has opened new markets and applications for our material.
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.
PCT/US2021/062650 directed to nitride based antipathogenic compositions and devices and method of use thereof, 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 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/US2020/037170 directed to methods of surface functionalization of zirconia-toughened alumina with silicon nitride, we entered the national stage in Europe, Australia, Brazil, Canada, China, India, Japan, and Mexico to seek patent protection for our proprietary technologies in those countries. 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/US2021/027270 directed to antiviral compositions and devices and methods of use thereof, 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/US2021/027270 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/US2021/027258 directed to antipathogenic face mask, 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/US2021/027258 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/US2019/048072 directed to antipathogenic devices and methods, we entered the national stage in Europe, Japan, Mexico, Australia, Brazil, Canada, South Korea, China, and India to seek patent protection for our proprietary technologies in those countries. 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.
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.
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.
PCT/US2022/023868 directed to systems and methods for physical vapor deposition silicon nitride coatings having antimicrobial and osteogenic enhancements, 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.
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.
Our 31,000 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.
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.
Modifications to a 510(k)-cleared device frequently require the submission of a traditional 510(k), but modifications meeting certain conditions may be candidates for FDA review under a Special 510(k).
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.
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. We believe that our product development strategy is consistent with the manner in which other biomaterials have been successfully introduced into the market and adopted as the standard of care.
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.
Silicon nitride is a chemical compound comprised of the element’s silicon and nitrogen, with the chemical formula Si 3 N 4 . 7 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.
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. 7 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.
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 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.
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 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. With respect to PCT 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.
SINTX silicon nitride has been shown to be resistant to bacterial colonization and biofilm formation, making it antibacterial. 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.
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.
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, premarket notification and adherence to the QSR.
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.
With respect to PCT application serial no PCT/US2021/028641 directed to methods of silicon nitride laser cladding, 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.
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.
Even when approved, the FDA may limit the indication for which the medical device may be marketed or to whom it may be sold.
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.
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.
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, and new composite products of silicon nitride with rigid polymers and fabrics.
Special 510(k)s are typically processed within 30 days of receipt. 14 The PMA process is more complex, costly and time consuming than the 510(k) clearance procedure.
Review timelines for Special 510(k)s are subject to MDUFA performance goals and may vary depending on the complexity of the submission. 14 The PMA process is more complex, costly and time consuming than the 510(k) clearance procedure.
We have never experienced a work stoppage due to labor difficulties and believe that our relations with our 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.
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.
The demand for personalized implants is growing as surgeons seek optimized solutions tailored to individual patient anatomy, improving surgical outcomes and reducing complications. Additionally, the regulatory pathway for custom and patient-specific medical devices is significantly more streamlined than traditional premarket approval (PMA) or even 510(k) clearance routes.
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.
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 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.
PCT/US2021/027263 directed to systems and methods for rapid inactivation of SARS-CoV2 by silicon nitride, copper, and aluminum 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/US2021/027263 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.
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.
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.
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 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 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.
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.
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.
This facility allows us to 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.
We and a number of independent third parties have conducted extensive biocompatibility, biomechanical, in vivo and in vitro testing on our silicon nitride composition to establish its safety and efficacy in support of regulatory clearance of our biomaterial, products and product candidates. We have also completed additional testing of our silicon nitride products and product candidates.
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.
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.
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 the U.S. and participate in a European consortium on silicon nitride. ● Highly Experienced Management and Technical Advisory Team.
Fraud and abuse laws are interpreted broadly and enforced aggressively by various state and federal agencies, including the U.S. Department of Justice, the U.S. Office of Inspector General for the Department of Health and Human Services and various state agencies.
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.
We have several partnerships exploring opportunities in face masks, filters, wound care, and coatings. 9 Market Opportunity Biomedical We believe our silicon nitride biomaterial technology platform provides us with numerous competitive advantages in the biomaterials market.
Additionally, in 2025, the USPTO issued a Notice of Allowance for our patent application containing method claims covering our antipathogenic fabric technology. 9 Market Opportunity Biomedical We believe our silicon nitride biomaterial technology platform provides us with numerous competitive advantages in the biomaterials market.
A Special 510(k) allows a manufacturer to declare conformance to design controls without providing new data. 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.
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.
ITEM 1. BUSINESS Overview – SINTX Technologies SINTX Technologies is an advanced ceramics company formed in December 1996, focused on providing biomedical solutions for medical devices. We have grown from focusing primarily on the research, development and commercialization of medical devices manufactured with silicon nitride to becoming an advanced ceramics company engaged in diverse fields, including biomedical and antipathogenic applications.
ITEM 1. BUSINESS 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 presently manufacture advanced ceramic powders and components in our manufacturing facilities based in Salt Lake City, Utah. 6 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.
The Company’s products are primarily sold in the United States. 6 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.
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This diversification enables us to focus on our core competencies which are the manufacturing, research, and development of products comprised from advanced ceramic materials. We seek to connect with new customers, partners and manufacturers to help them realize the goal of leveraging our expertise in advanced ceramics to create new, innovative products across these sectors.
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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.
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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.
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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.
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Under the FDA’s existing framework, many patient-matched implants can be commercialized through the Custom Device Exemption (CDE) pathway or through rapid 510(k) clearances, expediting market entry and adoption. The benefits of AI designed 3D-printed SiN/PEEK implants extend across the entire healthcare ecosystem. For hospitals, these implants can reduce hospital stays and operative times related to traditional Custom implant manufacturing.
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SINTX silicon nitride has been shown to be resistant to bacterial colonization and biofilm formation, making it antibacterial.
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It may also lower the costs associated with revision surgeries and improve patient satisfaction scores. 8 Physicians benefit from precision-engineered implants that enhance surgical predictability and performance, minimizing intraoperative adjustments. As well as accurate intraoperative placement of the implants because of radiolucency of SiN/PEEK.
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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.
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Additionally, the Patients may experience better functional outcomes, faster recovery times, and a reduced risk of complications due to the antimicrobial nature of Silicon Nitride and the superior biomechanical properties of the SiN/PEEK composite.
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We are currently evaluating several different coating technologies.
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We also have one U.S. patent related to our CSC technology that are directed to implants that have both a dense load-bearing, or cortical, component and a porous, or cancellous, component, together with a surface coating. The issued patent US 9,649,197 will expire in July 2035. In addition, U.S. Patent No. 10,806,831 directed to antibacterial implants and U.S.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeEven if we are successful in launching new products into the market, we expect to continue to incur substantial losses for the foreseeable future as we continue to manufacture products for CTL Medical and other OEM customers and research and develop and seek regulatory approvals for our product candidates. 22 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.
Biggest changeEven if we are successful in launching new products into the market, we may continue to incur losses for the foreseeable future as we continue to manufacture products for CTL Medical and other OEM customers and invest in research and development and regulatory approvals for our product candidates.
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.
Risks Related to Our Business and Strategy We have incurred net losses since our inception and anticipate that we will continue to incur net losses for the foreseeable future. We may never achieve or sustain profitability. We have incurred substantial net losses since our inception.
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. 23 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.
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. 21 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.
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. 28 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 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. 26 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.
Any product liability claim brought against us, with or without merit, could result in the increase of our product liability insurance rates or in our inability to secure coverage in the future on commercially reasonable terms, if at all.
Any product liability claim brought against us, with or without merit, could result in 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.
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. 36 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.
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. 32 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.
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. 37 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.
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. 33 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.
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. 27 We are dependent on our senior management team, engineering team, and external advisors, and the loss of any of them could harm our business.
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. 25 We are dependent on our senior management team, engineering team, and external advisors, and the loss of any of them could harm our business.
In addition, we may not have sufficient resources to litigate, enforce or defend our intellectual property rights. 35 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.
In addition, we may not have sufficient resources to litigate, enforce or defend our intellectual property rights. 31 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.
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. 24 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.
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 NMPA (China). 22 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.
Any infringement claim 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.
Any infringement 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.
Our competitors may successfully challenge and invalidate or render unenforceable our issued patents, including any patents that may issue 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.
Our competitors may successfully challenge and invalidate or render unenforceable our issued patents, including any patents that may 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.
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. 21 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 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.
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. 19 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 future 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.
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 for which we obtain regulatory approval.
We cannot determine with certainty the duration and completion costs of the current or future development and commercialization of our product candidates or if, when, or to what extent we will generate revenues from the commercialization and sale of any of these product candidates for which we obtain regulatory approval.
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.
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.
For the years ended December 31, 2024 and 2023 we incurred a net loss of $11.0 million and $8.3 million, respectively, and used cash in operations of $8.6 million and $14.1 million, respectively. We have an accumulated deficit of $281.7 and $270.7 million as of December 31, 2024 and 2023 respectively.
For the years ended December 31, 2025 and 2024, we incurred a net loss of $10.4 million and $11.0 million, respectively, and used cash in operations of $8.6 million and $8.6 million, respectively. We have an accumulated deficit of $292.1 million and $281.7 million as of December 31, 2025 and 2024, respectively.
In order to succeed in our goal of becoming a leading advanced ceramics company, we must increase market awareness of our silicon nitride interbody spinal fusion products in conjunction with CTL, and develop and launch new biomedical, industrial, and antipathogenic 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 implants and foot and ankle wedge systems, and develop and launch new biomedical, industrial, and antipathogenic products.
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.
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.
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.
There is presently $6.0 million available capacity under the ATM. We will require substantial future capital in order 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.
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 Capital Market under the symbol “SINT”.
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.
We must satisfy certain minimum listing maintenance requirements to maintain the NASDAQ Capital Market quotation, including certain governance requirements and a series of financial 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. 38 ITEM 1B.
Currently our common stock is quoted on the Nasdaq Capital Market under the symbol “SINT.” We must satisfy certain minimum listing maintenance requirements to maintain the Nasdaq Capital Market quotation, including certain governance requirements and a series of financial 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. 34
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.
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. 29 Changes in tax laws or their interpretation could adversely affect our business and the value of our securities.
A change in the outcome of any of these variables with respect to the development of spinal 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.
A change in the outcome of any of these variables with respect to the development of our product candidates could mean a significant change in the costs and timing associated with the development of these product candidates.
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.
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.
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 be accepted by hospitals and surgeons and may not become commercially successful.
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 biomedical products may not achieve market acceptance or commercial success.
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. 29 Our long-term success depends substantially on our ability to obtain regulatory clearance or approval and thereafter commercialize our product candidates; we cannot be certain that we will be able to do so in a timely manner or at all.
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. 27 Our long-term success depends on our ability to obtain and maintain regulatory clearances and approvals for our medical products and product candidates, and we may be unable to do so in a timely manner or at all.
The safety of our products is not yet supported by long-term clinical data, and they may prove to be less safe and effective than our laboratory data indicate.
The safety and effectiveness of our products are not supported by long-term clinical data, and they may prove to be less safe or effective than our preclinical testing or limited clinical experience indicate.
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.
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.
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.
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 the Company raises additional capital through the issuance of equity or convertible debt securities, existing stockholders may experience dilution in their ownership interests.
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.
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.
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.
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 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.
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.
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.
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.
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.
If hospitals and other healthcare providers are unable to obtain coverage or adequate reimbursement for procedures performed using our medical products, our products may not achieve widespread adoption.
We operate a 31,000 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.
In order to control the quality, cost and availability of our silicon nitride products, we developed our own manufacturing capabilities. We operate a 30,764 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.
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.
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. There are no assurances that the services of any of these individuals will be available to us for any specified period of time.
This may create the opportunity for third-party cross border trade or influence our decision to sell or not to sell a product, thus adversely affecting our geographic expansion plans and revenues. 34 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.
Any significant changes in healthcare laws, regulations, or reimbursement policies could increase our regulatory and compliance burdens, reduce demand for our products, or adversely affect our revenues, profitability, and growth prospects. 30 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.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we 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 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.
With the sale of our spine implant business to CTL we are now largely dependent on the efforts of CTL to sell the spinal fusion products that we manufacture and then sell to CTL. If CTL is not able to sell such products or is unable to increase demand for such products, then our revenues will decline.
Following the sale of our spine implant business, we rely in part on third-party distribution partners to commercialize certain silicon nitride spinal fusion products that we manufacture. If these partners are unable to effectively market and sell such products or increase demand, our revenues would be adversely affected.
In order to succeed in our joint commercialization efforts, we and any future partners must execute effectively on all elements of a combined business plan, including continuing to establish sales and marketing capabilities, manage certified, validated and effective commercial-scale manufacturing operations, conduct product development and testing, and obtain regulatory clearances and approvals for our product candidates.
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.
To succeed in our commercialization efforts, we must effectively continue product development and testing, find new strategic partners, obtain regulatory clearances and approvals, and enhance our sales and marketing capabilities. Because of these uncertainties, there is no assurance that we will succeed in bringing any of our current or future product candidates to market.
To succeed in these efforts, we must continue product development and testing, scale and optimize manufacturing processes, obtain necessary regulatory clearances and approvals, establish or expand distribution and strategic partner relationships, and enhance our sales and marketing capabilities.
Since 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 future.
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.
A pandemic, epidemic or outbreak of an infectious disease in the United States or elsewhere may adversely affect our business. A significant outbreak in the future of contagious diseases, such as COVID-19, could result in a widespread health crisis that could adversely affect the economies and financial markets of many countries, resulting in an economic downturn.
Adverse changes in coverage, reimbursement levels, or healthcare policy, whether in the United States or internationally, could materially adversely affect our business, results of operations, and financial condition. 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.
If we or any of our strategic partners 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. 25 Part of our strategy is to establish and develop OEM partnerships and arrangements, which subjects us to various risks.
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. 23 Building and managing an in-house sales and distribution organization subjects us to significant operational, financial, and execution risks.
However, hospitals and other healthcare providers that purchase orthopedic products manufactured by us from our customers for treatment of their patients generally rely on third-party payers to pay for all or part of the costs and fees associated with our products as part of a “bundled” rate for the associated procedures.
Hospitals and other healthcare providers that purchase and use our products generally rely on Medicare, Medicaid, private insurers, and other payers to reimburse all or a portion of the costs of the procedures in which our products are used, typically under bundled or fixed payment rates.
In the United States, the commercial success of our spinal products will depend, in part, on the extent to which governmental payers at the federal and state levels, including Medicare and Medicaid, private health insurers and other third-party payers provide coverage for and establish adequate reimbursement levels for procedures utilizing our products.
The commercial success of our medical products, including our silicon nitride spinal implants, the SiNAPTIC® foot and ankle wedge system, and any future orthopedic or other medical devices we develop, depends in part on the availability of coverage and adequate reimbursement from governmental and private third-party payers.
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Our cash and cash equivalents as of December 31, 2024 was $3.6 million. In February 2025 we closed the public offering of $5.0 million of units consisting of shares of common stock, Pre-funded Warrants, and common stock purchase warrants, resulting in net proceeds to us of approximately $3.4 million.
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Our cash and cash equivalents as of December 31, 2025 were $4.1 million. In October 2025, the Company entered into an At The Market Offering Agreement to sell shares of its common stock, from time to time, through an “at the market offering” or “ATM” program, having an aggregate offering price of $6.4 million.
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We expect our current cash and cash equivalents will be sufficient to fund our operations through the second quarter of 2026.
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In addition, the terms of any such securities may include liquidation, conversion, dividend, or other preferential rights that are senior to or otherwise adversely affect the rights of holders of the Company’s common stock.
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To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will likely be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder.
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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. 20 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.
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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.
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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.
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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, many other companies are seeking to develop new biomaterials and products which may compete effectively against our products in terms of performance and price.
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If our products do not achieve adequate market acceptance, our business, results of operations, and financial condition would be materially adversely affected.
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For example, Smith & Nephew has developed a ceramic-coated metal, known as Oxinium, which may overcome certain of the limitations of metal joint replacement products and could directly compete with our silicon nitride and silicon nitride-coated product candidates. 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.
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Moreover, numerous companies are developing and commercializing alternative biomaterials and surface technologies that may compete with our silicon nitride-based products in terms of safety, performance, cost, and clinical acceptance.
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Although we are currently manufacturing silicon nitride interbody spinal fusion implants for CTL, in order to be successful, we will need to expand our product lines to include other advanced ceramic products for both medical and non-medical applications. Therefore, we are developing new manufacturing technologies and new product candidates including our new ceramic armor products.
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These include advanced metals, modified polymer implants (such as enhanced PEEK formulations), ceramic-coated or oxidized metal devices, additive manufacturing solutions, and other proprietary materials designed to improve osseointegration, durability, or antimicrobial properties.
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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.
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For example, certain competitors have developed ceramic-coated or treated metal implants intended to address limitations associated with traditional metal devices, which may compete directly with our silicon nitride and silicon nitride-coated product offerings.
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We will depend on one or more strategic partners to develop and commercialize our biomedical and antipathogenic product candidates, and if our strategic partners are unable to execute effectively on our agreements with them, we may never become profitable. We are seeking strategic partners to develop and commercialize our biomedical and antipathogenic product candidates.
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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.
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We will be reliant on our strategic partners to develop and commercialize these product candidates, although we have not yet entered into an agreement with any strategic partner to develop products and may be unable to do so on agreeable terms.
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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.
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Because we typically receive payment directly from the companies for whom we manufacture, we do not anticipate relying directly on payment from third-party payers for our products.
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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.
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The existence of coverage and adequate reimbursement for our products and the procedures performed with them by government and private payers is 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.
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While we currently manufacture silicon nitride spinal fusion implants that are commercialized through third-party distribution arrangements, our long-term growth depends on expanding our product portfolio across orthopedic, extremity, and other medical applications, as well as selected non-medical markets.
Removed
Many private payers currently base their reimbursement policies on the coverage decisions and payment amounts determined by the Centers for Medicare and Medicaid Services, or CMS, which administers the Medicare program.
Added
This includes continued commercialization of our SiNAPTIC® foot and ankle wedge system and the development of additional silicon nitride-based products incorporating our advanced ceramic technologies.
Removed
Others may adopt different coverage or reimbursement policies for procedures performed with our products, while some governmental programs, such as Medicaid, have reimbursement policies that vary from state to state, some of which may not pay for the procedures performed with our products in an adequate amount, if at all.
Added
We are also pursuing opportunities in non-medical applications, including advanced ceramic armor and other industrial technologies, which involve different market dynamics, customer requirements, and competitive landscapes. Product development and commercialization involve substantial technical, regulatory, financial, and market risks. We may encounter delays in development timelines, increased costs, manufacturing challenges, regulatory obstacles, or slower-than-expected market adoption.
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A Medicare national or local coverage decision denying coverage for one or more of our products could result in private and other third-party payers also denying coverage for our products.
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There can be no assurance that any of our current or future product candidates will achieve regulatory clearance or approval, be successfully commercialized, or generate meaningful revenue.
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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 used for an unapproved use.
Added
If we are unable to successfully expand and commercialize our product lines, or if commercialization is delayed, our revenues and growth prospects would be adversely affected, and we may need to reduce operations or seek additional capital sooner than anticipated.
Removed
Unfavorable coverage or reimbursement 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.
Added
We 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.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeITEM 1C. CYBERSECURITY Risk Management and Strategy We regularly assess risks from cybersecurity threats, 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.
Biggest changeITEM 1C. CYBERSECURITY Risk Management and Strategy We maintain processes designed to assess, identify, and manage material risks from cybersecurity threats to our information technology systems and data. These processes are integrated into our broader risk management activities and are intended to protect the confidentiality, integrity, and availability of our systems and information.
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To protect our information systems from cybersecurity threats, we use various security tools that are designed to help identify, escalate, investigate, resolve, and recover from security incidents in a timely manner.
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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.
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Our board of directors assesses risks based on probability and potential impact to key business systems and processes as part of our overall risk management program overseen by the board of directors. Risks that are considered high are incorporated into our overall risk management program.
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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.
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We collaborate with third parties to assess the effectiveness of our cybersecurity prevention and response systems and processes and to assist in the identification, verification, and validation of cybersecurity risks, as well as to support associated mitigation plans when necessary.
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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.
Removed
We have also developed a third-party cybersecurity risk management process to conduct due diligence on external entities, including those that perform cybersecurity services. Cybersecurity threats, including those resulting from any previous cybersecurity incidents, have no t materially affected our Company, including our business strategy, results of operations, or financial condition.
Added
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 of Directors has oversight responsibility for risk management, including risks arising from cybersecurity threats.
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Refer to the risk factor captioned “Cyber security risks and the failure to maintain the integrity of company, employee or guest data could expose us to data loss, litigation and liability, and our reputation could be significantly harmed.” in Part I, Item 1A. “Risk Factors” for additional details regarding cybersecurity risks and potential impacts on our business.
Added
The Board receives periodic updates from management regarding cybersecurity matters, including risk exposures, mitigation efforts, and significant developments, as appropriate. 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.
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Governance Our board of directors oversees our risk management process, including as it pertains to cybersecurity risks, which focuses 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.
Added
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.
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Meetings of our board of directors include discussions and presentations from management regarding specific risk areas throughout the year, including, among others, those relating to cybersecurity threats, and reports from management on our enterprise risk profile on an annual basis.
Removed
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 prevention, detection, mitigation, and remediation of cybersecurity incidents.
Removed
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.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeWe also lease a 10,936 square foot facility located in Salt Lake City, Utah. This facility houses our Armor equipment. We occupy this facility pursuant to a lease that expires in October 2031. We believe that our existing facilities are adequate for our current and projected needs for the foreseeable future.
Biggest changeWe also lease a 10,936 square foot facility located in Salt Lake City, Utah. This facility is 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 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 of five years.
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 period of five years.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeITEM 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.
Biggest changeITEM 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.
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MINE SAFETY DISCLOSURES This item does not apply to our business. 39 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeITEM 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 NASDAQ Capital Market under the symbol “SINT”. Holders of Record As of December 31, 2024, we had approximately 163 holders of record of our common stock.
Biggest changeITEM 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 Nasdaq Capital Market under the symbol “SINT.” Holders of Record As of December 31, 2025, we had approximately 164 holders of record of our common stock.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeResults of Operations Year Ended December 31, 2024 Compared to the Year Ended December 31, 2023 The following table sets forth, for the periods indicated, our results of operations for the years ended December 31, 2024 and 2023 (dollars, in thousands): Year Ended December 31, 2024 2023 $ Change % Change Product revenue $ 1,246 $ 1,226 $ 20 2 % Grant and contract revenue 1,641 1,401 240 17 % Total revenue 2,887 2,627 260 10 % Costs of revenue 811 784 27 3 % Gross profit 2,076 1,843 233 13 % Operating expenses: Research and development 5,201 8,713 (3,512 ) -40 % General and administrative 3,997 4,222 (225 ) -5 % Sales and marketing 614 1,137 (523 ) -46 % Armor exit costs 4,602 - 4,602 100 % Reduction in force 407 - 407 100 % Grant and contract expense 1,302 1,129 173 15 % Total operating expenses 16,123 15,201 922 6 % Loss from operations (14,047 ) (13,358 ) (689 ) 5 % Other income (expense), net 3,023 5,099 (2,076 ) -41 % Net loss before income taxes (11,024 ) (8,259 ) (2,765 ) 33 % Provision for income taxes - - - - % Net loss $ (11,024 ) $ (8,259 ) $ (2,765 ) 33 % 42 Product Revenue, Grant and Contract Revenue Total product revenue remained relatively flat when comparing the years ended December 31, 2024 and 2023.
Biggest changeResults of Operations Year Ended December 31, 2025 Compared to the Year Ended December 31, 2024 The following table sets forth, for the periods indicated, our results of operations for the years ended December 31, 2025 and 2024 (dollars, in thousands): Year Ended December 31, 2025 2024 $ Change % Change Product revenue $ 729 $ 1,246 $ (517 ) -41 % Grant and contract revenue 289 1,641 (1,352 ) -82 % Total revenue 1,018 2,887 (1,869 ) -65 % Cost of revenue 557 811 (254 ) -31 % Gross profit 461 2,076 (1,615 ) -78 % Operating expenses: Research and development 4,587 5,201 (614 ) -12 % General and administrative 6,197 3,997 2,200 55 % Sales and marketing 242 614 (372 ) -61 % Armor exit costs - 4,602 (4,602 ) -100 % Reduction in force - 407 (407 ) -100 % Grant and contract expense 156 1,302 (1,146 ) -88 % Total operating expenses 11,182 16,123 (4,941 ) -31 % Loss from operations (10,721 ) (14,047 ) 3,326 -24 % Other income (expense), net 357 3,023 (2,666 ) -88 % Net loss before income taxes (10,364 ) (11,024 ) 660 -6 % Provision for income taxes - - - - % Net loss $ (10,364 ) $ (11,024 ) $ 660 -6 % 38 Revenue Product revenue decreased $0.5 million, or 41%, compared to the same period in 2024.
There have been no material changes to those policies for the year ended December 31, 2024. 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.
There have been no material changes to those policies for the year ended December 31, 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.
The Company does not employee 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.
The Company does not 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.
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, 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). 48 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.
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, 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). 43 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.
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.
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.
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. 41 Gross Profit Our gross profit measures our product revenue relative to our cost of revenue.
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. 37 Gross Profit Our gross profit measures our product revenue relative to our cost of revenue.
Derivative Liabilities Derivative liabilities include the fair value of instruments such as common stock warrants, preferred stock warrants and convertible features of notes, that are initially recorded at fair value and are required to be re-measured to fair value at each reporting period.
Derivative Liabilities Derivative liabilities include the fair value of instruments such as common stock warrants, preferred stock warrants and convertible features of notes, which are initially recorded at fair value and are required to be re-measured to fair value at each reporting period.
For the years ended December 31, 2024 and 2023, 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.
For the years ended December 31, 2025 and 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.
Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. 49 The Company operates in various tax jurisdictions and is subject to audit by various tax authorities.
Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. 44 The Company operates in various tax jurisdictions and is subject to audit by various tax authorities.
Our existing capital resources are not sufficient to enable us to fund the completion of the development and commercialization of all our product candidates. 43 To date, the 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.
Our existing capital resources are not sufficient to enable us to fund the completion of the development and commercialization of all our product candidates. 39 To date, our 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.
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.
As we transition our focus 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.
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.
The armor plant had not been fully operational since the acquisition of the armor equipment in July 2021 and had been completely shut down since October 2023 due to the malfunctioning of the sintering furnace. In connection with this decision, we incurred an impairment charge of approximately $4.6 million during the year ended December 31, 2024.
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 of 3-years.
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 through 2028.
This increase was primarily attributable to an increase in asset impairment costs at the SINTX Armor facility. Reduction in Force Expenses Reduction in force expenses increased $0.4 million, or 100%, as compared to the same period in 2023. This increase was primarily attributable to payroll expenses related to severance and accrued vacation payouts.
This decrease was attributable to the asset impairment costs at the SINTX Armor facility. Reduction in Force Expenses Reduction in force expenses decreased $0.4 million, or 100%, as compared to the same period in 2024. This decrease was attributable to payroll expenses related to severance and accrued vacation payouts.
For the years ended December 31, 2024 and 2023, the Company incurred a net loss of $11.0 million and $8.3 million, respectively, and used cash in operations of $8.6 million and $14.1 million, respectively. The Company had an accumulated deficit of $281.7 million and $270.7 million as of December 31, 2024 and 2023, respectively.
For the years ended December 31, 2025 and 2024, the Company incurred a net loss of $10.4 million and $11.0 million, respectively, and used cash in operations of $8.6 million and $8.6 million, respectively. The Company had an accumulated deficit of $292.1 million and $281.7 million as of December 31, 2025 and 2024, respectively.
It is anticipated that the Company will continue to generate operating losses and use cash in operations. The Company’s continuation as a going concern is dependent upon its ability to increase sales, decrease expenses and/ raise additional funding. Whether and when the Company can attain profitability and positive cash flows from operations or obtain additional financing is uncertain.
We expect that we will continue to generate operating losses and use cash in operations. Our continuation as a going concern is dependent upon its ability to increase sales, decrease expenses and raise additional funding. It is uncertain when, if ever, we will attain profitability and positive cash flows from operations or obtain additional financing.
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.
Historically engaged in both industrial and biomedical applications, we have prioritized the development and commercialization of innovative medical devices, leveraging our expertise in advanced ceramics and biomaterials. This renewed focus aligns with a commitment to improving patient outcomes through the creation of products designed for surgical, orthopedic, and other specialized medical applications.
Net Cash Provided by Financing Activities Net cash provided by financing activities was $9.1 million during 2024, compared to $11.7 million provided by financing activities during the same period in 2023, a decrease of $2.6 million.
Net Cash Provided by Financing Activities Net cash provided by financing activities was $8.2 million during 2025, compared to $9.1 million provided by financing activities during the same period in 2024, a decrease of $0.9 million.
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.
This decision was part of an ongoing strategic review of our operations aimed at improving operational efficiency and reducing costs. On August 12, 2024, the board of directors 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 our long-term strategic goals.
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.
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.
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.
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 TA&T in exchange for the assumption by Tethon of the outstanding liabilities of TA&T.
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.
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.
The decrease in cash used in investing activities during 2024 was primarily due to a $0.5 million increase in proceeds from notes receivable, offset by $0.2 million increase in purchase of property and equipment.
The increase in cash provided by investing activities during 2025 was primarily due to $0.8 million in proceeds from the acquisition of Sinaptic Surgical, $0.5 million decrease in purchase of property and equipment and $0.3 million increase in proceeds from the sale of property and equipment, partially offset by a $0.5 million decrease in proceeds from notes receivable.
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, 7 years of which remain.
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, through 2028. The Company is currently pursuing other sales opportunities for silicon nitride outside the spinal fusion application.
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.
We are concentrating 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.
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. 50 ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Not applicable.
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. 45
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. 45 On August 8, 2024, the Board of Directors approved a plan to implement a Company-wide reduction in the workforce.
By focusing on partnerships and collaborations with healthcare institutions and industry leaders, we believe that we are positioned to expand our footprint in the medical device sector and drive shareholder value through sustainable, high-impact innovations. On August 8, 2024, the board of directors approved a plan to implement a Company-wide reduction in the workforce.
Net Cash Used in Investing Activities Net cash used in investing activities was $0.2 million during 2024, compared to $0.5 million used in investing activities during the same period in 2023, a decrease of $0.3 million.
Net Cash Provided by (Used in) Investing Activities Net cash provided by investing activities was $0.9 million during 2025, compared to $0.2 million used in investing activities during the same period in 2024, an increase of $1.1 million.
Sales and Marketing Expenses Sales and marketing expenses decreased $0.5 million, or -46%, as compared to the same period in 2023. This decrease was primarily attributable to a reduction in employee wages and an overall decrease in costs for outside consulting. Armor Exit Costs Armor exit costs increased $4.6 million, or 100%, as compared to the same period in 2023.
Sales and Marketing Expenses Sales and marketing expenses decreased $0.4 million, or 61%, compared to the same period in 2024. This decrease was primarily due to decreases in payroll related costs and outside consulting costs. Armor Exit Costs Armor exit costs decreased $4.6 million, or 100%, compared to the same period in 2024.
This decrease was primarily due to a decrease in the change in the fair value of the derivative liabilities in the amount of $2.8 million, and a $0.1 million increase in gain on disposal of assets offset by $0.8 million in offering costs on derivative liabilities in 2023 with no corresponding amount in 2024.
This decrease was primarily due to a $3.6 million decrease in the change in value of derivative liabilities, partially offset by $0.5 million change in derivative liabilities offering costs, a $0.3 million gain on disposal of property and equipment associated with SINTX Armor, and a $0.1 million increase in interest income.
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. As explained above, the Company sold most intangible assets that had a carrying value, retaining the carrying value of only one trademark asset.
The Company amortizes definite-lived intangible assets on a straight-line basis over their useful lives. The Company recorded no impairment for definite-lived intangible assets during the year ended December 31, 2025. Goodwill Goodwill represents the excess of the purchase price over the fair market value of identifiable net assets.
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.
This charge primarily relates to the write-down of certain long-lived assets associated with the armor plant to their estimated fair value.
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 Net cash used in operating activities $ (8,642 ) $ (14,115 ) Net cash used in investing activities (194 ) (501 ) Net cash provided by financing activities 9,094 11,711 Net cash provided (used) $ 258 $ (2,905 ) 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, a decrease of $5.5 million.
The consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties. 40 Cash Flows The following table summarizes, for the periods indicated, cash flows from operating, investing and financing activities (in thousands): Year Ended December 31, 2025 2024 Net cash used in operating activities $ (8,571 ) $ (8,642 ) Net cash provided by (used in) investing activities 913 (194 ) Net cash provided by financing activities 8,200 9,094 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 2025, compared to $8.6 million used in 2024, remaining consistent year over year.
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.
We continue to seek opportunities to raise additional funding through equity and/or debt financing. However, such funding is not guaranteed and may not be available on favorable terms and may involve restrictive covenants. Any additional equity financing, if available, will most likely be dilutive to its current stockholders.
This decrease was primarily attributable to a decrease in proceeds from issuance of warrant derivative liabilities of $3.3 million, an increase in payments on debt of $0.2 million, offset by a $0.9 million increase in proceeds from issuance of common stock.
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 $3.4 million, and a decrease in proceeds from issuance of common stock and prefunded warrants of $1.7 million, partially offset by increases in proceeds from the exercise of warrants, net of cash fees, and deposit for stock issuance (in other current liabilities) of $3.6 million, proceeds from issuance of common stock in connection with ATM, net of fees of $0.3 million, and proceeds from issuance of warrants in connection with exercise of warrants of $0.2 million.
Off-Balance Sheet Arrangements We do not have any off-balance sheet arrangements, as defined in Item 303(a)(4) of Regulation S-K.
Indebtedness Information with 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. 41 Off-Balance Sheet Arrangements We do not have any off-balance sheet arrangements, as defined in Item 303(a)(4) of Regulation S-K.
This decrease was primarily attributable to a decrease in patent expenses, employee wages, product prototypes, and tooling expenses. General and Administrative Expenses General and administrative expenses decreased $0.2 million, or -5%, as compared to the same period in 2023. This decrease is primarily due to a decrease in employee wages and recruiting expenses.
Research and Development Expenses Research and development expenses decreased $0.6 million, or 12%, compared to the same period in 2024. This decrease was primarily due to a decrease in payroll related costs, patent expenses, prototypes, and outside consulting costs, partially offset by an increase in costs related to a research agreement.
Grant and Contract Expenses Grant and contract expenses increased $0.2 million, or 15%, as compared to the same period in 2023. This increase was primarily attributable to a general increase in grant and contract revenue when compared to the prior year. Other Income (Expense), Net Other income decreased $2.1 million, or -41%, as compared to the same period in 2023.
Grant and Contract Expenses Grant and contract expenses decreased $1.1 million, or 88%, compared to the same period in 2024. This decrease was primarily due to the decrease in grant and contract revenue associated with the sale of the TA&T subsidiary.
Removed
Overview SINTX Technologies is an advanced ceramics company formed in December 1996, focused on providing solutions in a variety of biomedical, technical, and antipathogenic applications. We have grown from focusing primarily on the research, development and commercialization of medical devices manufactured with silicon nitride to becoming an advanced ceramics company engaged in diverse fields, including biomedical, technical and antipathogenic applications.
Added
Overview 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.
Removed
This diversification enables us to focus on our core competencies which are the manufacturing, research, and development of products comprised from advanced ceramic materials for external partners. We seek to connect with new customers, partners and manufacturers to help them realize the goal of leveraging our expertise in advanced ceramics to create new, innovative products across these sectors.
Added
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.
Removed
During the year ended December 31, 2024, the Company grant and contract revenue increased $0.2 million or 17% as compared to the same period in 2023. Costs of Revenue and Gross Profit Cost of revenue remained relatively flat when comparing the years ended December 31, 2024 and 2023.
Added
Grant and contract revenue decreased $1.4 million, or 82%, compared to the same period in 2024. Revenue trends and strategic focus The decrease in total revenue was primarily due to the Company’s ongoing strategic repositioning away from non-core, low-margin OEM technical manufacturing contracts that did not support long-term profitability.
Removed
Gross profit increased $0.2 million, or 13%, as compared to the same period in 2023. This increase was primarily attributed to an increase in grant and contract revenue and a shift in product mix to more profitable products. Research and Development Expenses Research and development expenses decreased $3.5 million, or -40%, as compared to the same period in 2023.
Added
This planned reduction in OEM-related revenue is consistent with our corporate shift toward commercializing proprietary silicon nitride-based biomedical devices, which we believe offer stronger margins, a more defensible competitive position, and better long-term value for shareholders.
Removed
The Company is actively generating additional scientific and clinical data to have it published in leading industry publications. We believe the publication of such data would help sales efforts as the Company approaches new prospects.
Added
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.
Removed
The Company is also making additional changes to the sales strategy, including a focus on revenue growth by expanding the use of silicon nitride in other areas outside of spinal fusion applications.
Added
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.
Removed
The Company has common stock that is publicly traded and has been able to successfully raise capital when needed since the date of the Company’s initial public offering in February 2014.
Added
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.
Removed
On February 20, 2025, entered into a private placement transaction pursuant to a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional and accredited investors for aggregate gross proceeds of $5.0 million, before deducting fees to the placement agent and other expenses payable by the Company in connection with the Private Placement.
Added
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.
Removed
The Company intends to use the net proceeds from the Private Placement for general corporate purposes and working capital. H.C. Wainwright & Co. (“Wainwright”), acted as the exclusive placement agent for the Private Placement, which closed on February 25, 2025.
Added
General and Administrative Expenses General and administrative expenses increased $2.2 million, or 55%, compared to the same period in 2024. This increase is primarily due to increased stock-based compensation and other headcount related costs, and fees paid to departing members of the board of directors, partially offset by lower legal expenses and outside consulting costs.
Removed
As part of the Private Placement, the Company issued (i) 1,171,189 shares of the Company’s common stock, par value $0.01 per share (“Common Stock”), (ii) pre-funded warrants to purchase 278,098 shares of Common Stock (the “Pre-Funded Warrants”) with an exercise price of $0.0001 per share, and (iii) warrants to purchase 1,449,287 shares of Common Stock (the “Common Warrants,” together with the Pre-Funded Warrants, the “Warrants”) (the Warrants, together with the Shares and Warrant Shares (as defined below), the “Securities”) with an exercise price of $3.32 per share.
Added
Other Income (Expense), Net Other income (expense), net decreased $2.7 million, or 88%, compared to the same period in 2024.
Removed
The purchase price per share of Common Stock and the associated Common Warrant was $3.45 and the purchase price per Pre-Funded Warrant and associated Common Warrant was $3.4499. The Common Warrants are exercisable immediately and expire five-and one-half years from issuance. The Pre-Funded Warrants are exercisable immediately and terminate when exercised in full.
Added
If we are not able to obtain additional debt or equity financing, the impact on our company and business will be material and adverse. The board of directors, together with management, remains focused on advancing our business strategy and focus. Our strategic emphasis is focused on utilizing our technology in making advancements in the biomedical sector.
Removed
On February 2, 2024, the Company closed on a public offering of 80,000 units, with each unit consisting of one share of its common stock, or one pre-funded warrant to purchase 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.
Added
Through this transformation, as demonstrated by the recent FDA 510(k) clearance of our SiNAPTIC® Foot & Ankle Osteotomy Wedge System, our aim is to deliver meaningful innovations to the medical community.
Removed
Each unit was sold at a public offering price of $50.00 resulting in gross proceeds to the Company of $4 million before deducting offering fees and expenses. The Class E and Class F Warrants were immediately exercisable at a price of $50.00 per share.
Added
In 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.
Removed
The Class E Warrants expire five years from the date of issuance and the Class F Warrants expire eighteen months from the date of issuance.
Added
In October 2025, we entered into the 2025 ATM Agreement to sell shares of its common stock from time to time, through an “at the market offering” program, having an aggregate offering price of $6.4 million was filed with the SEC. As of December 31, 2025, there is $6.0 million remaining balance on the 2025 ATM Agreement.
Removed
Of the $4.0 million of gross proceeds, approximately $0.6 million were allocated to common stock and prefunded 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).
Added
In October 2025, we entered into a sublease agreement to lease the SINTX armor facility to a third party, which is expected to save the Company approximately $1.0 million over the sublease term.
Removed
On February 10, 2023, the Company closed on a public offering of 10,750 units, with each unit consisting of one share of common stock, or one pre-funded warrant to purchase one share of its common stock, one Class C Warrant to purchase one share of common stock, and one half of one Class D Warrant with each whole Class D Warrant entitling the holder to purchase one share of common stock.
Added
While management has implemented plans intended to mitigate these conditions, we have concluded that substantial doubt exists about the Company’s ability to continue as a going concern for 12 months from the date these consolidated financial statements are issued.
Removed
Gross proceeds, before deducting offering expenses, totaled approximately $12.0 million.
Added
Related-Party Transactions Information with respect to our related party transactions may be found in Note 14 to the consolidated financial statements included in Part II, Item 8 of this Annual Report, which is incorporated by reference.
Removed
Of the $12.0 million of gross proceeds, approximately $5.4 million were allocated to common stock and prefunded warrants ($4.8 million net of offering costs) and approximately $6.7 million were allocated to derivative liabilities (with approximately $0.7 million of cash offering costs and $0.1 million of agent warrant offering costs recorded as derivative expense).
Added
However, actual results may differ from those estimates and assumptions that are used to prepare our consolidated financial statements. 42 New Accounting Pronouncements Information with respect to new accounting pronouncements may be found in Note 1 to the consolidated financial statements included in Part II, Item 8 of this Annual Report, which is incorporated by reference.
Removed
On March 26, 2024, the Company closed on a public offering of 142,000 shares of the Company’s common stock, (the “March 26 Offering”). Each Share was sold at a public offering price of $9.40.
Added
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.
Removed
The aggregate proceeds to the Company from the March 26 Offering were approximately $1.3 million before deducting placement agent fees and other estimated offering expenses payable by the Company. 44 On April 5, 2024, the Company closed on a public offering of 358,000 shares of the Company’s common stock, (the “April 5 Offering”).
Added
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.
Removed
Each Share was sold at a public offering price of $4.20. The aggregate proceeds to the Company from the April 5 Offering were approximately $1.5 million before deducting placement agent fees and other offering expenses payable by the Company.
Added
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.

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