What changed in Sintx Technologies, Inc.'s 10-K — 2023 vs 2024
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Paragraph-level year-over-year comparison of Sintx Technologies, Inc.'s 2023 and 2024 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 2024 report.
+152 added−199 removedSource: 10-K (2025-03-19) vs 10-K (2024-03-27)
Top changes in Sintx Technologies, Inc.'s 2024 10-K
152 paragraphs added · 199 removed · 107 edited across 7 sections
- Item 7. Management's Discussion & Analysis+76 / −70 · 39 edited
- Item 1. Business+44 / −76 · 37 edited
- Item 1A. Risk Factors+26 / −47 · 26 edited
- Item 2. Properties+2 / −3 · 2 edited
- Item 3. Legal Proceedings+2 / −1 · 1 edited
Item 1. Business
Business — how the company describes what it does
37 edited+7 added−39 removed181 unchanged
Item 1. Business
Business — how the company describes what it does
37 edited+7 added−39 removed181 unchanged
2023 filing
2024 filing
Biggest changeMembers 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. We also collaborate with a network of leading technical advisors in the design, development and use of our silicon nitride products and product candidates.
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.
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. 16 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 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.
In addition, three (3) U.S. patents (U.S. patent nos. 9,399,309; 9,517,136; and 9,649,197) directed to silicon nitride manufacturing processes were licensed to CTL Medical under an irrevocable, fully paid-up, worldwide license for a ten-year term with CTL Medical also having a Right of First Negotiation to acquire these patents if SINTX decides to later sell these IP assets to a third party. 13 Our remaining issued patents and pending applications are directed to additional aspects of our products and technologies including, among other things: ● designs for intervertebral fusion devices; ● designs for hip implants; ● designs for coated, variable-density, and thin walled implants; ● designs for knee implants; ● implants with improved antibacterial characteristics; ● implants with improved wear performance and surface functionalization ● antipathogenic, antibacterial, antimicrobial, antifungal, and antiviral compositions, devices, and methods; and ● methods and systems for hot-isostatic pressing laser cladding, laser coating, and laser sintering of silicon nitride.
In addition, three (3) U.S. patents (U.S. patent nos. 9,399,309; 9,517,136; and 9,649,197) directed to silicon nitride manufacturing processes were licensed to CTL Medical under an irrevocable, fully paid-up, worldwide license for a ten-year term with CTL Medical also having a Right of First Negotiation to acquire these patents if SINTX decides to later sell these IP assets to a third party. 12 Our remaining issued patents and pending applications are directed to additional aspects of our products and technologies including, among other things: ● designs for intervertebral fusion devices; ● designs for hip implants; ● designs for coated, variable-density, and thin walled implants; ● designs for knee implants; ● implants with improved antibacterial characteristics; ● implants with improved wear performance and surface functionalization ● antipathogenic, antibacterial, antimicrobial, antifungal, and antiviral compositions, devices, and methods; and ● methods and systems for hot-isostatic pressing laser cladding, laser coating, and laser sintering of silicon nitride.
We are developing products on our own behalf and for third party manufacturers – including CTL – for use as components in spine, total hip and knee joint replacements, as well as dental, foot & ankle, and maxillofacial applications. We believe we can also utilize our silicon nitride technology platform to develop future products in additional medical and non-medical markets.
We are developing products on our own behalf and for third party manufacturers – including CTL – for use as components in spine, total hip and knee joint replacements, as well as dental, foot & ankle, and maxillofacial applications. We believe we can also utilize our silicon nitride technology platform to develop future products in additional medical markets.
These qualities provide surgeons with greater certainty of outcomes with our silicon nitride devices than with other biomaterials, such as PEEK and metals. 8 ● Hard, Strong and Resistant to Fracture. Our silicon nitride is hard, strong and possesses superior resistance to fracture over traditional ceramics and greater strength than polymers currently on the market.
These qualities provide surgeons with greater certainty of outcomes with our silicon nitride devices than with other biomaterials, such as PEEK and metals. ● Hard, Strong and Resistant to Fracture. Our silicon nitride is hard, strong and possesses superior resistance to fracture over traditional ceramics and greater strength than polymers currently on the market.
CE Marking gives companies easier access into not only the European market but also to Asian and Latin American markets, most of whom recognize the CE Mark on medical device as a mark of quality and adhering to international standards of consumer safety, health or environmental requirements. 17 Compliance with Healthcare Laws We must comply with various U.S. federal and state laws, rules and regulations pertaining to healthcare fraud and abuse, including anti-kickback and false claims laws, rules, and regulations, as well as other healthcare laws in connection with the commercialization of our products.
CE Marking gives companies easier access into not only the European market but also to Asian and Latin American markets, most of whom recognize the CE Mark on medical device as a mark of quality and adhering to international standards of consumer safety, health or environmental requirements. 16 Compliance with Healthcare Laws We must comply with various U.S. federal and state laws, rules and regulations pertaining to healthcare fraud and abuse, including anti-kickback and false claims laws, rules, and regulations, as well as other healthcare laws in connection with the commercialization of our products.
If we fail to track and report as required by these laws or to otherwise comply with these laws, we could be subject to the penalty provisions of the pertinent state and federal authorities. 19 Clinical research is heavily regulated by FDA regulations for the protection of human subjects (21 C.F.R. 50 and 56) and also the regulations of the U.S Department of Health and Human Services, or the Common Rule (45 C.F.R 46).
If we fail to track and report as required by these laws or to otherwise comply with these laws, we could be subject to the penalty provisions of the pertinent state and federal authorities. 18 Clinical research is heavily regulated by FDA regulations for the protection of human subjects (21 C.F.R. 50 and 56) and also the regulations of the U.S Department of Health and Human Services, or the Common Rule (45 C.F.R 46).
Our 31,000 square foot corporate facility includes an 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.
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.
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.
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.
These developments are ongoing, and we cannot predict the effects they will have on our business. 18 The federal False Claims Act imposes liability on any person that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal healthcare program.
These developments are ongoing, and we cannot predict the effects they will have on our business. 17 The federal False Claims Act imposes liability on any person that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal healthcare program.
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. 12 With respect to PCT application serial no.
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.
This powder can then be utilized to produce composites or coatings. ● Composites of Silicon Nitride and PEEK and PEKK. We have demonstrated in the laboratory 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 and PEKK and that the ensuing composite material maintains the bioactive properties of silicon nitride.
We have several partnerships exploring opportunities in face masks, filters, wound care, and coatings. 10 Market Opportunity Biomedical We believe our silicon nitride biomaterial technology platform provides us with numerous competitive advantages in the biomaterials market.
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.
Therefore, the payment that a hospital would receive for a particular hospital visit would not typically take into account the cost of our products. 20 Medicare has established a number of DRGs for inpatient procedures that involve the use of products similar to ours.
Therefore, the payment that a hospital would receive for a particular hospital visit would not typically take into account the cost of our products. 19 Medicare has established a number of DRGs for inpatient procedures that involve the use of products similar to ours.
We have engaged academic and commercial partners to assist us in developing this technology and have received NIH grants to assist in advancing this work. This composite material would allow the straightforward machinability of complex spine and CMF devices that would be more challenging to manufacture from silicon nitride alone. ● Silicon Nitride Coating.
We have engaged academic and commercial partners to assist us in developing this technology and have received NIH grants to assist in advancing this work. This composite material would allow the straightforward 3D printing of complex spine and CMF devices that would be more challenging to manufacture from silicon nitride alone. ● Silicon Nitride Coating.
Special 510(k)s are typically processed within 30 days of receipt. 15 The PMA process is more complex, costly and time consuming than the 510(k) clearance procedure.
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.
We manufacture interbody spinal fusion devices for CTL Amedica and have approximately 4 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 3 years remaining of a 10-year exclusive right to continue to manufacture them for CTL Amedica.
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.
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.
Failure to obtain favorable negotiated prices with hospitals or healthcare facilities could adversely affect sales of our products. 21 Employees As of March 1, 2024, we had 43 employees. We believe that our success will depend, in part, on our ability to attract and retain qualified personnel.
Failure to obtain favorable negotiated prices with hospitals or healthcare facilities could adversely affect sales of our products. 20 Employees As of March 1, 2025, we had 20 employees. We believe that our success will depend, in part, on our ability to attract and retain qualified personnel.
We believe that the main drivers for growth within the orthopedic biomaterials market are the following: ● Introduction of New Technologies. Better performing and longer-lasting biomaterials, improved diagnostics, and advances in surgical procedures allow for surgical intervention earlier in the continuum of care and better outcomes for patients.
We believe that the main drivers for growth within the medical device markets are the following: ● Introduction of New Technologies. Better performing and longer-lasting biomaterials, improved diagnostics, and advances in surgical procedures allow for surgical intervention earlier in the continuum of care and better outcomes for patients.
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 US, Europe, Brazil, and Taiwan.
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.
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 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.
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.
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.
We believe we are the only company that designs, develops, manufactures and sells medical grade silicon nitride-based products. Due to its key characteristics, we believe our silicon nitride enables us to offer new and transformative products across multiple medical specialties.
Due to its key characteristics, we believe our silicon nitride enables us to offer new and transformative products across multiple medical specialties.
SA, Dilatometry, UV-VIS and FTIR transmission, haze and clarity. 9 Our Competitive Strengths We believe we can use our silicon nitride technology platform to become a leading advanced ceramic company and have the following principal competitive strengths: ● Sole Provider of Silicon Nitride Medical Devices.
Our Competitive Strengths We believe we can use our silicon nitride technology platform to become a leading advanced ceramic company and have the following principal competitive strengths: ● Sole Provider of Silicon Nitride Medical Devices. We believe we are the only company that designs, develops, manufactures and sells medical grade silicon nitride-based products.
We anticipate that these and other orthopedic companies and OEMs will seek to introduce new biomaterials and products that compete with ours. 14 Our main competitors in the technical ceramics market segment include CoorsTek, Kyocera, and Saint Gobain. Our main competitors in the antipathogenic market segment include BactiGuard and MicroBan.
We anticipate that these and other orthopedic companies and OEMs will seek to introduce new biomaterials and products that compete with ours. 13 Our main competitors in the antipathogenic market segment include BactiGuard and MicroBan. Competition within our industries is primarily based on technology, innovation, product quality, and product awareness and acceptance by customers.
Silicon nitride, an advanced ceramic, is lightweight, resistant to fracture and strong, and is used in many demanding mechanical, thermal and wear applications, such as in space shuttle bearings, jet engine components, and body armor. 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.
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 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.
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.
Competition within our industries is primarily based on technology, innovation, product quality, and product awareness and acceptance by customers. Our principal competitors have substantially greater financial, technical and marketing resources, as well as significantly greater manufacturing capabilities than we do, and they may succeed in developing products that render our products and product candidates non-competitive.
Our principal competitors have substantially greater financial, technical and marketing resources, as well as significantly greater manufacturing capabilities than we do, and they may succeed in developing products that render our products and product candidates non-competitive. Our ability to compete successfully will depend upon our ability to develop innovative products with advanced performance features.
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. ● Favorable and Changing Demographics.
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 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. Our first issued patent expired in 2016, with the last of these patents expiring in 2039.
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 have made advancements in our processes – including the purchase of new manufacturing equipment – which we have leveraged to develop new porous and textured implants. In 2021, SINTX purchased new equipment for its research and development team to develop new composite products of silicon nitride with rigid polymers and fabrics.
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 anticipate that demand for biomaterials and the associated medical devices will increase as the applications in which biomaterials are used are introduced to and become more widely accepted in underserved countries, such as Brazil and China. We also expect to introduce our products into established markets such as Australia and Japan.
We anticipate that demand for biomaterials and the associated medical devices will increase as the applications in which biomaterials are used are introduced to and become more widely accepted in underserved countries, such as South America and Asia. 10 Intellectual Property We rely on a combination of patents, trademarks, trade secrets, nondisclosure agreements, proprietary information ownership agreements and other intellectual property measures to protect our intellectual property rights.
These surgeons have supported us in collecting clinical data on silicon nitride and on reporting the successful patient outcomes they have observed. We also have long standing relations with university laboratories in Japan and the US and participate in a European consortium on silicon nitride. ● Highly Experienced Management and Technical Advisory Team.
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.
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 additional commercial opportunities outside of the medical device market. We have pursued the development of non-medical uses for our silicon nitride since selling the retail spine business in 2018.
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.
As a result, we believe our silicon nitride products will have lower revision rates and fewer complications than comparable metal and traditional oxide ceramic products. ● High Dielectric Breakdown. Our silicon nitride has electrical properties that make it well suited for aerospace engine ignitor applications.
As a result, we believe our silicon nitride products will have lower revision rates and fewer complications than comparable metal and traditional oxide ceramic products. We are leveraging our proprietary Silicon Nitride (SiN) and Polyether Ether Ketone (PEEK) formulation to advance AI designed 3D printing capabilities for Custom and Patient-Specific medical implants.
We believe that our versatile silicon nitride manufacturing expertise positions us favorably to introduce new and innovative devices in the medical and non-medical fields. In June 2022, we acquired Technology Assessment and Transfer, Inc. (TA&T), a nearly 40-year-old business with a mission to transition advanced materials and process technologies from a laboratory environment to commercial products and services.
We believe that our versatile silicon nitride manufacturing expertise positions us favorably to introduce new and innovative devices in the medical and non-medical fields. Antipathogenic Applications: Today, there is a global need to improve protection against pathogens in everyday life.
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ITEM 1. BUSINESS Overview – SINTX Technologies SINTX Technologies is an advanced ceramics company formed in December 1996, focused on providing solutions in a variety of biomedical, technical, and antipathogenic applications.
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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.
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TA&T has supplied ceramics for use in several biomedical applications. These products were made via 3D printing and include components for surgical instruments as well as conceptual and prototype dental implants. Technical Applications: It is our belief that our silicon nitride has the best combination of mechanical, thermal, and electrical properties of any technical ceramic material.
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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.
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It is a high-performance technical ceramic with high strength, toughness, and hardness, and is extremely resistant to thermal shock and impact. It is also an electrically insulating ceramic material. Typically, it is used in applications where high load-bearing capacity, thermal stability, and wear resistance are required.
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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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We have obtained AS9100D certification and ITAR registration to facilitate entry into the aerospace and protective armor markets. We entered the ceramic armor market through the purchase of assets from B4C, LLC and a technology partnership with Precision Ceramics USA.
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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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We will develop and manufacture high-performance ceramics for personnel, aircraft, and vehicle armor including a 100% Boron Carbide material for ultimate lightweight performance in ballistic applications, and a composite material made of Boron Carbide and Silicon Carbide for exceptional multi-hit performance against ballistic threats.
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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 have signed a 10-year lease at a building near our headquarters in Salt Lake City, Utah to house development and manufacturing activities for SINTX Armor. TA&T’s primary area of expertise is material processing and fabrication know-how for a broad spectrum of monolithic ceramic, ceramic composite, and coating materials.
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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.
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Primary technologies include Additive Manufacturing (3D Printing) of ceramics and metals, low-cost fabrication of fiber reinforced ceramic matrix composites (CMCs) and refractory chemical vapor deposited (CVD) coatings, transparent ceramics for ballistic armor and optical applications, and magnetron sputtered (PVD) coatings for lubrication, wear resistance and environmental barrier coatings for CMCs.
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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.
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TA&T also provides a host of services that include 3D printing, PVD-CVD coatings, material processing-CMCs, CIP, PS, HP, HIP, and material characterization for powders and finished parts-TGA/DSC, PSD. SA, Dilatometry, UV-VIS and FTIR transmission, haze and clarity. Antipathogenic Applications: Today, there is a global need to improve protection against pathogens in everyday life.
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Silicon nitride is a chemical compound comprised of the element’s silicon and nitrogen, with the chemical formula Si 3 N 4 .
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Other Advanced Ceramic Products Ceramic Armor In 2021, SINTX entered the ceramic armor market through the purchase of assets from B4C, LLC, Dayton, Ohio, and a technology partnership with Precision Ceramics USA. SINTX operates its armor business through its wholly owned subsidiary SINTX Armor, Inc.
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SINTX will develop and manufacture high-performance ceramics for personnel, aircraft, and vehicle armor including a 100% boron carbide material for ultimate lightweight performance in ballistic applications, and a composite material made of boron carbide and silicon carbide for exceptional multi-hit performance against ballistic threats.
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The demand for ceramic armor has been propelled in the defense industries and is increasingly being used in the manufacturing of vests, backpacks, and vehicle panels for military applications. Since its introduction during the Vietnam War, ceramic armor has developed into a modern solution for defeating ballistic threats.
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Armor solutions utilizing ceramics are commonly used to protect vehicles, personnel, aircraft, and marine vessels due to their light weight and high hardness. Boron carbide has additional uses including wear components – such as nozzles – and as a neutron absorber in nuclear reactors. SINTX is pursuing opportunities in these market segments as well.
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We have signed a 10-year lease at a building near our headquarters in Salt Lake City, Utah to house development and manufacturing activities for SINTX Armor. The Company has relocated the B4C assets from Dayton into this facility and has made necessary upgrades to the facility infrastructure to operate the equipment.
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A furnace used for our SINTX Armor manufacturing operations overheated and is no longer functional. We have been informed by our insurance carrier that a covered loss has occurred, and coverage is available for the Company’s claim submitted with respect to the sintering furnace that overheated at SINTX Armor in October 2023.
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The Company will be replacing the damaged furnace and expects the repaired furnace to be up and running in the 4th quarter 2024. Company management continues to work with third parties to temporarily outsource the sintering process.
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Technology Assessment and Transfer (“TA&T”) TA&T’s primary area of expertise is material processing and fabrication know-how for a broad spectrum of monolithic ceramic, ceramic composite, and coating materials.
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Primary technologies include Additive Manufacturing (3D Printing) of ceramics and metals, low-cost fabrication of fiber reinforced ceramic matrix composites (CMCs) and refractory chemical vapor deposited (CVD) coatings, transparent ceramics for ballistic armor and optical applications, and magnetron sputtered (PVD) coatings for lubrication, wear resistance and environmental barrier coatings for CMCs.
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TA&T also provides a host of services that include 3D printing, PVD-CVD coatings, material processing-CMCs, CIP, PS, HP, HIP, and material characterization for powders and finished parts-TGA/DSC, PSD.
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We have signed a 10-year lease at a building near its headquarters in Salt Lake City, Utah to house development and manufacturing activities for SINTX Armor. TA&T operates out of two facilities in Millersville, MD totaling 15,840 square feet.
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Subsequent to December 31, 2023 we entered into an amended lease agreement reducing this area to 13,560 square feet. ● Extensive Network of Scientific Collaborators. We have developed strong, multi-year, collaborative relationships with surgeons who have used our products.
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In 2019, we became ITAR-registered and obtained AS9100D certification of our quality management system. We have hired experienced business development employees to identify new markets and applications for our materials and develop commercial relationships. We made the first shipments of non-medical products in our history in 2020, and several of these have transitioned from prototype to regular production orders.
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The launch of SINTX Armor will generate revenue from new products. The acquisition of TA&T brings revenue from multiple markets that we have previously not participated in ● Develop new silicon nitride manufacturing technologies. Our current manufacturing process has allowed us to successfully produce spinal implants for over 10 years.
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Technical Ceramics We believe there is significant potential for us to leverage our experience and operational discipline with silicon nitride spinal implants and enter non-medical markets for technical ceramics. The excellent mechanical, electrical, and thermal properties of our silicon nitride make it ideal for highly demanding applications in aerospace, welding, and other industrial applications.
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Our AS9100D certification and ITAR registration for the silicon nitride factory have allowed us to obtain orders for aerospace components – initially prototype orders which have now become regular production orders. In January 2024 we announced that we entered into a 10-year, Long-Term Agreement (LTA) with a leading manufacturer of aerospace components and systems.
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Under the LTA, we will manufacture and supply key ceramic aircraft engine components which have been qualified through a rigorous evaluation process. Furthermore, there are few US-based manufacturers of silicon nitride which means there are limited options for those markets that require domestically produced material.
Removed
Since announcing our intent to enter the ceramic armor market in 2021, we have received many inquiries for aircraft, vehicle, and body armor. The war in Ukraine has further increased the worldwide need for ceramic armor.
Removed
Our Salt Lake City armor facility will produce boron carbide and boron carbide/silicon carbide composite armor – materials which are some of the strongest, lightest weight options for ceramic armor. We are developing female-specific torso plates with a partner and expect this market to grow. We also have early-stage relationships with integrators for body armor and aircraft armor.
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The acquisition of TA&T has brought well-established relationships with multiple US government agencies to produce new ceramic materials for leading-edge applications in aerospace and energy. TA&T has wide ranging manufacturing capabilities for ceramic coatings, 3D printed ceramics, and transparent ceramic armor.
Removed
These technologies have been used in over a hundred government research contracts throughout TA&T’s history and are still utilized in the development of novel ceramic-matrix composites. TA&T has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Combat Capabilities Development Command Army Research Laboratory (DEVCOM ARL).
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This partnership is expected to leverage the strengths of both organizations in the areas of ceramic additive manufacturing (ceramic 3D printing) and ceramic matrix composites (CMCs). We believe that we can successfully build on TA&T’s legacy, obtain new government contracts, and leverage its wide range of capabilities with materials and manufacturing technologies to increase revenue from non-government sources.
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Personal Protective Equipment (PPE) We believe that there is the opportunity for significant growth in the personal protective equipment or PPE market for products that are shown to have antiviral properties.
Removed
The Company has demonstrated in controlled research studies the anti-viral properties of its silicon nitride which may be useful in the reduction of the spread of COVID-19 and other pathogens.
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The study results demonstrated that our unique grade of silicon nitride inactivates the SARS-CoV-2 virus within a minute after exposure and has the potential to decrease the risk of viral disease spread on surfaces. Studies have shown that coronavirus spreads between humans when an infected person coughs or sneezes.
Removed
Also, the virus can remain active on a variety of commonly touched surfaces for hours to days. We believe that by incorporating our unique composition of silicon nitride into products such as face masks and personal protective equipment, it is possible to manufacture surfaces that inactivate viral particles, thereby limiting the spread of the disease.
Removed
We envision incorporating our silicon nitride into high-contact surfaces such as medical equipment, screens, countertops, and doorknobs in locations where viral persistence is a concern, such as homes, casinos, and cruise ships. To that effect, we have successfully dispersed and embedded silicon nitride particles into nonwoven and woven fabric fibers.
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Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
26 edited+0 added−21 removed217 unchanged
Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
26 edited+0 added−21 removed217 unchanged
2023 filing
2024 filing
Biggest changeWe 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. 29 Changes in U.S. government defense spending could negatively impact our financial position, results of operations, liquidity and overall business.
Biggest changeWe 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.
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. 24 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. 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.
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. 25 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 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 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. 22 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. 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.
Even if we do become profitable, we may be unable to sustain or increase our profitability on a quarterly or annual basis. Our success depends on our ability to successfully commercialize advanced ceramic products for biomedical, industrial, and antipathogenic applications, which to date have experienced only limited market acceptance.
Even if we do become profitable, we may be unable to sustain or increase our profitability on a quarterly or annual basis. Our success depends on our ability to successfully commercialize advanced ceramic products for biomedical, and antipathogenic applications, which to date have experienced only limited market acceptance.
In addition, if one or more of our clinical trials are delayed, competitors may be able to bring products to market before we do, and the commercial viability of our product candidates could be significantly reduced. 33 Our current and future relationships with third-party payers and current and potential customers in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm administrative burdens and diminished profits and future earnings.
In addition, if one or more of our clinical trials are delayed, competitors may be able to bring products to market before we do, and the commercial viability of our product candidates could be significantly reduced. 31 Our current and future relationships with third-party payers and current and potential customers in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm administrative burdens and diminished profits and future earnings.
If any of the physicians or other healthcare providers or entities with whom we expect to do business, including our collaborators, are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from participation in government healthcare programs, which could also materially affect our business. 34 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.
If any of the physicians or other healthcare providers or entities with whom we expect to do business, including our collaborators, are found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from participation in government healthcare programs, which could also materially affect our business. 32 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.
Even 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. 23 If sales revenue from any of our products or product candidates that receive marketing clearance from the FDA or other regulatory body is insufficient, if we are unable to develop and commercialize any of our product candidates, or if our product development is delayed, we may never become profitable.
Even if we 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.
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. 36 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.
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 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. 38 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. 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.
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. 39 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. 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.
We will receive approval or clearance from the FDA to commercialize products requiring a clinical trial only if we can demonstrate to the satisfaction of the FDA, through well-designed and properly conducted clinical trials, that our product candidates are safe and effective and otherwise meet the appropriate standards required for approval or clearance for specified indications. 32 Clinical trials are complex, expensive, time consuming, uncertain and subject to substantial and unanticipated delays.
We will receive approval or clearance from the FDA to commercialize products requiring a clinical trial only if we can demonstrate to the satisfaction of the FDA, through well-designed and properly conducted clinical trials, that our product candidates are safe and effective and otherwise meet the appropriate standards required for approval or clearance for specified indications. 30 Clinical trials are complex, expensive, time consuming, uncertain and subject to substantial and unanticipated delays.
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. 26 Part of our strategy is to establish and develop OEM partnerships and arrangements, which subjects us to various risks.
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.
Adverse changes in payment rates by payers to hospitals could adversely impact our ability to market and sell these products and negatively affect our financial performance. 27 In international markets, medical device regulatory requirements and healthcare payment systems vary significantly from country to country, and many countries have instituted price ceilings on specific product lines.
Adverse changes in payment rates by payers to hospitals could adversely impact our ability to market and sell these products and negatively affect our financial performance. 26 In international markets, medical device regulatory requirements and healthcare payment systems vary significantly from country to country, and many countries have instituted price ceilings on specific product lines.
The proposed legislation remains subject to change, and its impact on us and holders of common shares, pre-funded warrants, or Warrants is uncertain. 35 In addition, the Inflation Reduction Act of 2022 was recently signed into law and includes provisions that will impact the U.S. federal income taxation of corporations.
The proposed legislation remains subject to change, and its impact on us and holders of common shares, pre-funded warrants, or Warrants is uncertain. 33 In addition, the Inflation Reduction Act of 2022 was recently signed into law and includes provisions that will impact the U.S. federal income taxation of corporations.
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. 28 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. 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.
In addition, we may not have sufficient resources to litigate, enforce or defend our intellectual property rights. 37 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. 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.
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.
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.
In addition, if we are unable to continue to meet the legal, regulatory and other requirements related to being a public company, we may not be able to maintain the listing of our common stock on The NASDAQ Capital Market, which would likely have a material adverse effect on the trading price of our common stock. 40 We may not be able to maintain our listing on the NASDAQ Capital Market, which would adversely affect the price and liquidity of our common stock.
In addition, if we are unable to continue to meet the legal, regulatory and other requirements related to being a public company, we may not be able to maintain the listing of our common stock on The NASDAQ Capital Market, which would likely have a material adverse effect on the trading price of our common stock.
We expect our current cash and cash equivalents will be sufficient to fund our operations through the second quarter of 2024.
We expect our current cash and cash equivalents will be sufficient to fund our operations through the second quarter of 2026.
Our cash and cash equivalents as of December 31, 2023 was $3.3 million. In February 2024 we closed the public offering of $4.0 million of units consisting of shares of common stock, Pre-funded Warrants, Class E Warrants and Class F Warrants, resulting in net proceeds to us of approximately $3.7 million.
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.
For the years ended December 31, 2023 and 2022 we incurred a net loss of $8.3 million and $12.0 million, respectively, and used cash in operations of $14.1 million and $10.3 million, respectively. We have an accumulated deficit of $270.7 and $262.5 million as of December 31, 2023 and 2022 respectively.
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.
Any of the foregoing could have a material adverse effect on our competitive position, results of operations, financial condition or liquidity. 30 Exports and imports of certain of our products are subject to various export control, sanctions and import regulations and may require authorization from regulatory agencies of the U.S. or other countries.
Exports and imports of certain of our products are subject to various export control, sanctions and import regulations and may require authorization from regulatory agencies of the U.S. or other countries.
If we are unable to continue to compete successfully against our current or future competitors in our core businesses, we may experience declines in revenues and industry segment share.
If we are unable to continue to compete successfully against our current or future competitors in our core businesses, we may experience declines in revenues and industry segment share. Any of the foregoing could have a material adverse effect on our competitive position, results of operations, financial condition or liquidity.
In addition, if allegations of impropriety were made against us, we could suffer serious reputational harm, which could negatively affect our financial position, results of operations and liquidity. 31 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. 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.
As a small capitalization company, the price of our common shares has been, and is likely to continue to be, highly volatile.
We may not be able to maintain our listing on the NASDAQ Capital Market, which would adversely affect the price and liquidity of our common stock. As a small capitalization company, the price of our common shares has been, and is likely to continue to be, highly volatile.
Removed
U.S. government sales constitute a portion of our consolidated sales. Our U.S. government revenues largely result from contracts awarded under various U.S. government programs, primarily defense-related programs with the U.S. Department of Defense (DoD).
Removed
Changes in U.S. government defense spending for various reasons, including as a result of potential changes in policy positions or priorities, could negatively impact our results of operations, financial condition and liquidity.
Removed
Our programs are subject to U.S. government policies, budget decisions and appropriation processes which are driven by numerous factors including: (1) geopolitical events; (2) macroeconomic conditions; and (3) the ability of the U.S. government to enact relevant legislation, such as appropriations bills.
Removed
In recent years, U.S. government appropriations have been affected by larger U.S. government budgetary issues and related legislation, and the U.S. government has been unable to complete its budget process before the end of its fiscal year, resulting in both governmental shutdowns and congress providing only enough funds for U.S. government agencies to continue operating at prior-year levels.
Removed
Further, if the U.S. government debt ceiling is not raised and the national debt reaches the statutory debt ceiling, the U.S. government could default on its debts.
Removed
As a result, U.S. government defense spending levels are subject to a wide range of outcomes and are difficult to predict beyond the near-term due to numerous factors, including the external threat environment, future governmental priorities and the state of governmental finances.
Removed
Significant changes in U.S. government defense spending or changes in U.S. government priorities, policies and requirements could have a material adverse effect on our results of operations, financial condition and liquidity.
Removed
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.
Removed
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. As a U.S. government contractor, we are subject to risks relating to U.S. government audits, investigations, and disputes.
Removed
We are subject to U.S. government investigations relating to our U.S. government contracts. Such U.S. government investigations often take years to complete and could result in administrative, civil or criminal liabilities, including repayments, fines, treble and other damages, forfeitures, restitution or penalties, or could lead to suspension or debarment of U.S. government contracting or of export privileges.
Removed
For instance, if we or one of our business units were charged with wrongdoing in connection with a U.S. government investigation (including fraud, or violation of certain environmental or export laws, as further described below), the U.S. government could suspend us from bidding on or receiving awards of new U.S. government contracts pending the completion of legal proceedings.
Removed
If convicted or found liable, the U.S. government could fine and debar us from new U.S. government contracting for a period generally not to exceed three years and could void any contracts found to be tainted by fraud.
Removed
We also could suffer reputational harm if allegations of impropriety were made against us, even if such allegations are later determined to be unsubstantiated. Further, our U.S. government contracts are subject to audit.
Removed
An adverse outcome of any audit or investigation could result in civil and criminal penalties and fines, which could negatively impact our results of operations, financial condition and liquidity.
Removed
On October 20, 2023, we received a notice from the Listing Qualifications Department of The NASDAQ Stock Market stating that the bid price of our common stock for the previous 30 consecutive trading days had closed below the minimum $1.00 per share required for continued listing on The NASDAQ Capital Market under NASDAQ Listing Rule 5550(a)(2).
Removed
We had a period of 180 calendar days, or until April 17, 2024, to regain compliance with the rule. If the Company does not regain compliance with Rule 5550(a)(2) by April 17, 2024, the Company may be eligible for additional time.
Removed
To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary.
Removed
If the Company meets these requirements, the Staff will inform the Company that it has been granted an additional 180 calendar days. However, if it appears to Staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, the Staff will provide notice that its securities will be subject to delisting.
Removed
We intend to actively monitor our bid price and will consider available options to resolve the deficiency and regain compliance with the Nasdaq Listing Rules, including considering whether to conduct a reverse stock split.
Removed
If Nasdaq delists our common stock from trading on its exchange and we are not able to list our securities on another national securities exchange, we expect our securities could be quoted on an over-the-counter market.
Removed
If this were to occur, we could face significant material adverse consequences, including: ● a limited availability of market quotations for our securities; ● reduced liquidity for our securities; ● a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities; ● a limited amount of news and analyst coverage; and ● a decreased ability to issue additional securities or obtain additional financing in the future. 41
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
1 edited+0 added−0 removed9 unchanged
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
1 edited+0 added−0 removed9 unchanged
2023 filing
2024 filing
Biggest changeWe 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 not materially affected our Company, including our business strategy, results of operations, or financial condition.
Biggest changeWe 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.
Item 2. Properties
Properties — owned and leased real estate
2 edited+0 added−1 removed0 unchanged
Item 2. Properties
Properties — owned and leased real estate
2 edited+0 added−1 removed0 unchanged
2023 filing
2024 filing
Biggest changeWe also lease a 10,936 square foot facility located in Salt Lake City, Utah. This facility houses our Armor business. We occupy this facility pursuant to a lease that expires in October 2031.
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.
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 December 2024. Pursuant to the terms of the lease agreement, we may extend the lease for two additional periods of five years each.
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.
Removed
In connection with operation of Maryland based subsidiary Technology Assessments and Transfer, Inc., we have entered into various leases from which we conduct research, development and manufacturing activities. The leases have various expiration dates ranging from July 2023 through April 2025. We believe that our existing facilities are adequate for our current and projected needs for the foreseeable future.
Item 3. Legal Proceedings
Legal Proceedings — active lawsuits and investigations
1 edited+1 added−0 removed0 unchanged
Item 3. Legal Proceedings
Legal Proceedings — active lawsuits and investigations
1 edited+1 added−0 removed0 unchanged
2023 filing
2024 filing
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.
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.
Added
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
1 edited+0 added−0 removed2 unchanged
Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
1 edited+0 added−0 removed2 unchanged
2023 filing
2024 filing
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, 2023, we had approximately 159 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, 2024, we had approximately 163 holders of record of our common stock.
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
39 edited+37 added−31 removed53 unchanged
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
39 edited+37 added−31 removed53 unchanged
2023 filing
2024 filing
Biggest changeResults of Operations Year Ended December 31, 2023 Compared to the Year Ended December 31, 2022 The following table sets forth, for the periods indicated, our results of operations for the years ended December 31, 2023 and 2022 (dollars, in thousands): Year Ended December 31, 2023 2022 $ Change % Change Product revenue $ 1,226 $ 601 $ 625 104 % Grant and contract revenue 1,401 960 441 46 % Total revenue 2,627 1,561 1,066 68 % Costs of revenue 784 265 519 196 % Gross profit 1,843 1,296 547 42 % Operating expenses: Research and development 8,713 6,450 2,263 35 % General and administrative 4,222 3,990 232 6 % Sales and marketing 1,137 1,336 (199 ) -15 % Grant and contract expense 1,129 855 274 32 % Total operating expenses 15,201 12,631 2,570 20 % Loss from operations (13,358 ) (11,335 ) (2,023 ) 18 % Other income (expense), net 5,099 (704 ) 5,803 824 % Net loss before income taxes (8,259 ) (12,039 ) 3,780 -31 % Provision for income taxes - - - - % Net loss $ (8,259 ) $ (12,039 ) $ 3,780 -31 % 46 Product Revenue Total product revenue increased $0.6 million, or 104%, as compared to the same period in 2022.
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.
These revenue sources include coatings, components for aerospace and medical device markets, toll processing services, and government contracts and grants. We generally recognize revenue from sales where control transfers at a point in time as the title and risk of loss passes to the customer, which is at the time the product is shipped.
These revenue sources include coatings, materials, and components for aerospace and medical device markets, toll processing services, and government contracts and grants. We generally recognize revenue from sales where control transfers at a point in time as the title and risk of loss passes to the customer, which is at the time the product is shipped.
However, actual results may differ from those estimates and assumptions that are used to prepare our consolidated financial statements. 50 New Accounting Pronouncement, Not Yet Adopted The Company has reviewed all recently issued, but not yet adopted, accounting standards, in order to determine their effects, if any, on its results of operations, financial position or cash flows.
However, actual results may differ from those estimates and assumptions that are used to prepare our consolidated financial statements. 47 New Accounting Pronouncement, Not Yet Adopted The Company has reviewed all recently issued, but not yet adopted, accounting standards, in order to determine their effects, if any, on its results of operations, financial position or cash flows.
There have been no material changes to those policies for the year ended December 31, 2023. 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, 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.
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, 2023. 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 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.
Critical Accounting Policies and Estimates A summary of our significant accounting policies and estimates is discussed in Management’s Discussion and Analysis of Financial Condition and Results of Operations and in Note 1 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023.
Critical Accounting Policies and Estimates A summary of our significant accounting policies and estimates is discussed in Management’s Discussion and Analysis of Financial Condition and Results of Operations and in Note 1 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024.
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, 2023, 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). 51 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, 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.
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.
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.
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 5-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 of 3-years.
For the years ended December 31, 2023 and 2022, 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, 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.
Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. 52 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. 49 The Company operates in various tax jurisdictions and is subject to audit by various tax authorities.
On February 2, 2024, the Company closed on a public offering of 16,000,000 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 to purchase one share of common stock, and one Class F Warrant with each warrant to purchase one share of common stock.
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.
On February 10, 2023, the Company closed on a public offering of 2,150,000 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.
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.
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, and/or raise additional funds through the capital markets. Whether and when the Company can attain profitability and positive cash flows from operations or obtain additional financing is uncertain.
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.
The increase in cash used for operating activities during 2023 was primarily due to the $2.3 million mentioned above plus changes in the movement of working capital items during 2023 as compared to the same period in 2022 as follows: a $0.4 million increase in cash used in accounts receivable, a $0.3 million increase for inventory, a $0.3 million increase in cash used for prepaids, a $0.2 million increase in cash used in other liabilities, a $0.2 million increase in cash used in accounts payable and accrued liabilities, and a $0.1 million increase in cash used for payments on operating lease liability.
The decrease in cash used for operating activities during 2024 was primarily due to the $3.4 million mentioned above plus changes in the movement of working capital items during 2024 as compared to the same period in 2023 as follows: a $0.9 million decrease in cash used in accounts receivable, a $0.7 million decrease in cash used for prepaids, a $0.6 million decrease for inventory, a $0.4 million decrease in cash used in other liabilities, and a $0.2 million decrease in cash used for payments on operating lease liability, all offset by a $0.7 million increase in cash used in accounts payable and accrued liabilities.
Net Cash Used in Investing Activities Net cash used in investing activities was $0.5 million during 2023, compared to $1.1 million used in investing activities during the same period in 2022, a decrease of $0.6 million.
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.
The increase in the net loss from operations, and related non-cash add backs to the net loss, was $2.3 million from 2023 when compared to 2022.
The decrease in the net loss from operations, and related non-cash add backs to the net loss, was $3.4 million from 2024 when compared to 2023.
In general, our customer does not have rights of return or exchange. We believe our product revenue will increase as we secure opportunities to manufacture third party products with silicon nitride, launch and generate revenue from our ceramic armor products, and as we continue to introduce new products into the market.
In general, our customer does not have rights of return or exchange. We believe our product revenue will increase as we secure opportunities to manufacture third party products with silicon nitride, and as we continue to introduce new products into the market. We derive grant and contract revenue from awards provided by governmental agencies.
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.
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.
Sales and Marketing Expenses Sales and marketing expenses decreased $0.2 million, or -15%, as compared to the same period in 2022. This decrease was primarily attributable to a reduction in employee wages and an overall decrease in costs for outside consulting.
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.
Grant and Contract Expenses Grant and contract expenses increased $0.2 million, or 32%, as compared to the same period in 2022. This increase was primarily attributable to a general increase in grant and contract revenue when compared to the prior year.
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.
On October 17, 2022, the Company completed a rights offering of units consisting of convertible preferred stock and common stock warrants, resulting in gross proceeds to the Company of approximately $4.7 million, after deducting expenses relating to the offering, including dealer-manager fees and expenses, On February 25, 2021, the Company entered into an Equity Distribution Agreement with Maxim Group LLC (“Maxim”), which was subsequently amended on October 12, 2023 (as amended, the “2021 Distribution Agreement”), pursuant to which the Company may sell from time to time, shares of the Company’s common stock having an aggregate offering price of up to $1.1 million through Maxim, as agent.
On October 17, 2022, the Company completed a rights offering of units consisting of convertible preferred stock and common stock warrants, resulting in gross proceeds to the Company of approximately $4.7 million, after deducting expenses relating to the offering, including dealer-manager fees and expenses, On February 25, 2021, the Company entered into an Equity Distribution Agreement (the “ATM Agreement”) with Maxim Group LLC (the “Agent”), as sales agent, as amended on January 10, 2023 and October 12, 2023 , pursuant to which the Company could offer and sell shares of the Company’s common stock, par value $0.01 pershare (the “Shares”), initially up to an aggregate offering price of $15,000,000, from time to time in an at-the-market public offering.
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. For instance, results from an independent study demonstrated the potential anti-viral properties of our silicon nitride.
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.
This increase was primarily attributable to an increase in product revenue and a shift in customer base and product mix. Gross profit increased $0.5 million, or 42%, as compared to the same period in 2022. This increase was primarily attributed to an increase in grant and contract revenue and a shift in product mix to more profitable products.
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.
This increase was primarily attributable to an increase in proceeds from issuance of common stock of $5.1 million, an increase in proceeds from issuance of warrant derivative liabilities of $2.8 million, and a $0.5 million decrease in the payment on debt.
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.
Cash Flows The following table summarizes, for the periods indicated, cash flows from operating, investing and financing activities (in thousands): Year Ended December 31, 2023 2022 Net cash used in operating activities $ (14,115 ) $ (10,263 ) Net cash used in investing activities (501 ) (1,101 ) Net cash provided by financing activities 11,711 3,336 Net cash provided (used) $ (2,905 ) $ (8,028 ) Net Cash Used in Operating Activities Net cash used in operating activities was $14.1 million in 2023, compared to $10.3 million used in 2022, an increase of $3.8 million.
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 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. 53
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.
During the year ended December 31, 2023, the Company grant and contract revenue increased $0.4 million as compared to the same period in 2022. Costs of Revenue and Gross Profit Cost of revenue increased $0.5 million, or 196% as compared to the same period in 2022.
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.
This increase was primarily due to the change in the fair value of the derivative liabilities in the amount of $6.8 million, and a $0.1 million increase in other income offset by a $0.8 million in offering costs on derivative liabilities and a $0.3 million decrease in other income.
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.
For the years ended December 31, 2023 and 2022, the Company incurred a net loss of $8.3 million and $12.0 million, respectively, and used cash in operations of $14.1 million and $10.3 million, respectively.
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.
Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under “Risk Factors” and elsewhere in this Annual Report. 43 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.
Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under “Risk Factors” and elsewhere in this Annual Report.
The decrease in cash used in investing activities during 2023 was primarily due to a $0.9 million purchase of property and equipment, offset by and a $0.3 million increase in cash acquired in acquisition in the prior year.
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.
Net Cash Provided by Financing Activities Net cash provided by financing activities was $11.7 million during 2023, compared to $3.3 million provided by financing activities during the same period in 2022, an increase of $8.4 million.
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.
We derive grant and contract revenue from awards provided by governmental agencies. Cost of Revenue The expenses that are included in cost of revenue include all in-house manufacturing costs for the products we manufacture. 45 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. 41 Gross Profit Our gross profit measures our product revenue relative to our cost of revenue.
General and Administrative Expenses General and administrative expenses increased $0.2 million, or 6%, as compared to the same period in 2022. This increase is primarily due to an increase in costs for investor relations, employee wages, and employee recruitment costs.
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.
Each unit was sold at a public offering price of $0.25. The Class E and Class F Warrants in the units are immediately exercisable at a price of $0.25 per share. The Class E Warrants will expire five years from the date of issuance and the Class F Warrants will expire eighteen months from the date of issuance.
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.
The Company had an accumulated deficit of $270.7 million and $262.5 million as of December 31, 2023 and 2022, respectively. 47 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. 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.
Research and Development Expenses Research and development expenses increased $2.3 million, or 35%, as compared to the same period in 2022. This increase was primarily attributable to an increase in patent expenses, employee wages, product prototypes, and costs of operations associated with opening the SINTX Armor facility and the acquisition of TA&T.
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.
Gross proceeds, before deducting placement agent fees and other offering expenses, are approximately $4.0 million.
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.
Removed
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 US, Europe, Brazil, and Taiwan.
Added
We will require substantial future capital in order to continue operating our business, conduct research and development and regulatory clearance and approval activities necessary to bring our products to market, and to establish effective marketing and sales capabilities.
Removed
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.
Added
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.
Removed
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.
Added
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.
Removed
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.
Added
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.
Removed
As a human implant material, silicon nitride offers bone ingrowth, resistance to bacterial and viral infection, ease of diagnostic imaging, resistance to corrosion, and superior strength and fracture resistance, all of which claims are validated in our large and growing inventory of peer-reviewed, published literature reports.
Added
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.
Removed
We believe that our versatile silicon nitride manufacturing expertise positions us favorably to introduce new and innovative devices in the medical and non-medical fields. In June 2022, we acquired Technology Assessment and Transfer, Inc. (TA&T), a nearly 40-year-old business with a mission to transition advanced materials and process technologies from a laboratory environment to commercial products and services.
Added
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.
Removed
TA&T has supplied ceramics for use in several biomedical applications. These products were made via 3D printing and include components for surgical instruments as well as conceptual and prototype dental implants. Technical Applications: It is our belief that our silicon nitride has the best combination of mechanical, thermal, and electrical properties of any technical ceramic material.
Added
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).
Removed
It is a high-performance technical ceramic with high strength, toughness, and hardness, and is extremely resistant to thermal shock and impact. It is also an electrically insulating ceramic material. Typically, it is used in applications where high load-bearing capacity, thermal stability, and wear resistance are required.
Added
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.
Removed
We have obtained AS9100D certification and ITAR registration to facilitate entry into the aerospace and protective armor markets. We entered the ceramic armor market through the purchase of assets from B4C, LLC and a technology partnership with Precision Ceramics USA.
Added
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”).
Removed
We will develop and manufacture high-performance ceramics for personnel, aircraft, and vehicle armor including a 100% Boron Carbide material for ultimate lightweight performance in ballistic applications, and a composite material made of Boron Carbide and Silicon Carbide for exceptional multi-hit performance against ballistic threats.
Added
On March 22, 2024, the company suspended sales under the ATM Agreement and terminated the continuous offering. On July 11, 2024, the Company filed a Prospectus Supplement with the SEC adjusting the amount available for sale under the ATM Agreement to $3.1 million and shortly thereafter begin offering and selling Shares under the ATM Agreement to the public.
Removed
We have signed a 10-year lease at a building near our headquarters in Salt Lake City, Utah to house development and manufacturing activities for SINTX Armor. 44 TA&T’s primary area of expertise is material processing and fabrication know-how for a broad spectrum of monolithic ceramic, ceramic composite, and coating materials.
Added
During the year ended December 31, 2024, 602,357 Shares were sold under the ATM Agreement for gross proceeds of approximately $3.7 million.
Removed
Primary technologies include Additive Manufacturing (3D Printing) of ceramics and metals, low-cost fabrication of fiber reinforced ceramic matrix composites (CMCs) and refractory chemical vapor deposited (CVD) coatings, transparent ceramics for ballistic armor and optical applications, and magnetron sputtered (PVD) coatings for lubrication, wear resistance and environmental barrier coatings for CMCs.
Added
Because the Company is subject to General Instruction I.B.6 of Form S-3, it is restricted from selling securities in a public primary offering with a value exceeding one-third of its public float (the market value of our common stock held by our non-affiliates) in any 12-month period so long as its public float remains below $75.0 million.
Removed
TA&T also provides a host of services that include 3D printing, PVD-CVD coatings, material processing-CMCs, CIP, PS, HP, HIP, and material characterization for powders and finished parts-TGA/DSC, PSD. SA, Dilatometry, UV-VIS and FTIR transmission, haze and clarity. Antipathogenic Applications: Today, there is a global need to improve protection against pathogens in everyday life.
Added
As of December 31, 2024, there was no capacity to offer and sell Shares under the ATM Agreement.
Removed
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.
Added
On June 11, 2024, the Company received formal notice from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company has evidenced compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).
Removed
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. We presently manufacture advanced ceramic powders and components in our manufacturing facilities based in Salt Lake City, Utah and Millersville, Maryland.
Added
The Company remains subject to a “Mandatory Panel Monitor,” as that term is defined in Listing Rule 5815(d)(4)(B), for a period of one year from June 11, 2024.
Removed
Other Income (Expense), Net Other income (expenses) increased $5.8 million, or 824%, as compared to the same period in 2022.
Added
If, within the one-year period, the Company fails to satisfy the minimum $1.00 closing bid price threshold for 30 consecutive business days, Nasdaq will issue a delist determination rather than provide the Company with a grace period to regain compliance with the Bid Price Rule.
Removed
We believe that we may be able to apply our silicon nitride powder to personal protection products, such as face masks, gowns and gloves, resulting in inactivation of viruses that come into contact with the items.
Added
In that event, the Company would have the opportunity to request a new hearing to address the deficiency. We are actively seeking opportunities to raise additional equity and/or debt financing. However, such funding is not guaranteed and may not be available to the Company on favorable or acceptable terms and may involve significant restrictive covenants.
Removed
Subject to the terms and conditions of the 2021 Distribution Agreement, as amended, Maxim will use its commercially reasonable efforts to sell the shares from time to time, based on our instructions.
Added
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.
Removed
Under the 2021 Distribution Agreement, Maxim may sell the Shares by any method permitted by law deemed to be an “at-the-market” offering (the “ATM”) as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), including, without limitation, sales made directly on the Nasdaq Capital Market.
Added
The Board of Directors, together with management, is performing an ongoing evaluation of the Company’s business strategy and focus. On August 1, 2024, the board of directors appointed Eric Olson to the office of Chief Executive Officer and President to lead the evaluation process. The Company has implemented a change in strategic emphasis to advancements in the medical device sector.
Removed
We have no obligation to sell any shares under the ATM and may at any time suspend offers under the 2021 Distribution Agreement.
Added
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.
Removed
The Offering will terminate upon the earlier of (i) the sale of shares having an aggregate offering price of $15.0 million, (ii) the termination by either Maxim or the Company upon the provision of fifteen (15) days written notice, or (iii) February 25, 2025.
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