Clinical milestone, new President appointment, and platform expansion position SINTX for commercial rollout and revenue growth in 2026 SALT LAKE CITY, Utah, March 23, 2026 (GLOBE NEWSWIRE) -- SINTX Technologies, Inc. (NASDAQ: SINT) (“SINTX” or the “Company”), an advanced biomaterials company focused on developing silicon nitride technologies for medical applications, today provided a corporate business update highlighting recent clinical, operational, and leadership milestones that the Company believes posi ...

Product Development and Innovation - SINTX Technologies received FDA 510(k) clearance for the SiNAPTIC® Foot & Ankle Osteotomy Wedge System in October 2025, marking its entry into reconstructive foot and ankle surgery in the U.S.[28] - The company is advancing AI-designed 3D printing capabilities for custom medical implants, integrating silicon nitride with PEEK to enhance biocompatibility and reduce infection risks[39]. - The company is developing new products with antipathogenic properties, including a patent for "Antipathogenic Fibrous Materials" granted in 2025[49]. - The company is focused on expanding its product portfolio across orthopedic, extremity, and other medical applications, including the commercialization of the SiNAPTIC® foot and ankle wedge system[149]. - The company is developing a range of innovative products, including intervertebral fusion devices, hip implants, and implants with improved antibacterial characteristics[89]. Manufacturing and Quality Control - SINTX's manufacturing facility in Salt Lake City is FDA registered and ISO certified, ensuring high-quality production of silicon nitride products[31]. - The company operates a 19,000 square foot manufacturing facility in Salt Lake City, Utah, certified under ISO 13485:2016 for medical devices, allowing full control over the manufacturing process[48]. - The company operates a 30,764 square foot manufacturing facility certified under ISO 13485 and FDA quality systems regulations[145]. Financial Performance and Position - As of December 31, 2025, the company had cash and cash equivalents of $4.1 million and an accumulated deficit of $292.1 million[126][132]. - The company incurred a net loss of $10.4 million for the year ended December 31, 2025, compared to a net loss of $11.0 million for the previous year[132]. - The company has an At The Market Offering Agreement with an aggregate offering price of $6.4 million, with $6.0 million available capacity under the ATM[126]. - The company has incurred substantial losses primarily due to sales and marketing, research and development, and general administrative expenses[132]. - The company acknowledges that prolonged negative economic conditions could adversely affect its financial position and liquidity[170]. Regulatory Compliance and Challenges - Regulatory compliance is critical, with the FDA requiring either 510(k) clearance or PMA approval for new medical devices, which can be a lengthy and complex process[93][97]. - The PMA process requires extensive data to demonstrate safety and effectiveness, and can take several years to complete, with no guarantee of approval[97]. - The transition to the EU MDR has increased regulatory scrutiny and compliance costs, impacting the company's ability to market products in the EU[102][103]. - The company must navigate international regulatory requirements, which vary by jurisdiction and may impose additional testing and documentation burdens[101][106]. - The company is subject to federal and state healthcare laws, including the Anti-Kickback Statute and the False Claims Act, which impose significant compliance obligations[109][111][112]. Market and Competitive Landscape - The orthopedic market is highly competitive, with major players like Medtronic and Johnson & Johnson dominating the market[140]. - The company faces competition from major players in the medical device market, including Medtronic, Johnson & Johnson, Stryker, and Zimmer Biomet, which have greater financial and manufacturing resources[88][91]. - The demand for personalized implants is increasing, and SINTX is well-positioned to meet this need with its innovative solutions tailored to individual patient anatomy[40]. Risks and Uncertainties - The company faces substantial risks in product development and commercialization, including potential delays, increased costs, and regulatory obstacles that could adversely affect revenue and growth prospects[151]. - The company may face delays in product development and commercialization if adequate funding is not secured[126][127]. - Changes in reimbursement policies and coverage determinations may adversely affect hospital purchasing decisions and utilization of the company's products[119][122]. - The company is vulnerable to cybersecurity threats that could disrupt operations and compromise confidential information, potentially leading to financial loss and reputational harm[177]. - The company is subject to evolving data privacy and cybersecurity regulations, which may increase costs and expose it to regulatory investigations and liabilities[178]. Intellectual Property and Legal Matters - The company holds twenty-one issued U.S. patents and ten issued foreign patents, with the last of these patents expiring in 2042[55]. - The company lacks patent protection for the composition of matter for its solid silicon nitride, allowing competitors to create similar formulations[214]. - The medical devices industry is characterized by extensive litigation over intellectual property rights, which could consume substantial resources[221]. - Product liability claims could exceed insurance coverage, significantly harming the company's financial condition[223]. - The company relies on a combination of patent protection and trade secret laws to protect its proprietary technology, which may not be sufficient[208]. Research and Development - The company invests substantial amounts in research and development to pursue advancements in a wide range of technologies, products, and services[181]. - The company has received three NIH grants to develop 3D printed silicon nitride/polymer implantable medical devices[48]. Strategic Partnerships and Collaborations - The company is establishing OEM partnerships to replace existing materials with silicon nitride, which may expose it to risks related to profitability and compliance with strict standards[160]. - The company has entered into agreements with orthopedic surgeons for product development, which may lead to disputes over ownership rights[217].

SiNtx Technologies, Inc. SINAPTIC Foot & Ankle Osteotomy Wedge System Major clinical milestone marks SINTX’s entry into the foot and ankle reconstruction market and advances commercialization of its silicon nitride biomaterial platform SALT LAKE CITY, Utah, March 19, 2026 (GLOBE NEWSWIRE) -- SINTX Technologies, Inc. (NASDAQ: SINT) (“SINTX” or the “Company”), a leader in advanced ceramic biomaterials and silicon nitride medical device innovation, today announced the successful completion of the first-in- ...

Core Insights - SINTX Technologies has appointed Ryan Elmore as President, effective March 16, 2026, to accelerate revenue opportunities from its SiNERGY™ silicon nitride devices and antipathogenic fibrous material technologies [1][3]. Company Strategy - Mr. Elmore will lead the transition of SINTX from a product-focused medical device manufacturer to a broader biomaterials platform company, leveraging its proprietary silicon nitride expertise and expanding intellectual property portfolio [3][5]. - The company aims to commercialize silicon nitride technologies across various product categories, including sutures, mesh, and wound dressings, while expanding its capabilities to support multiple material forms [4][5]. Leadership Background - Ryan Elmore brings over 15 years of experience in advanced biomaterials and medical device commercialization, previously serving as Core Business Director at Invibio, a division of Victrex plc [2][5]. - His mandate includes implementing a disciplined commercial execution strategy to translate SINTX's platform assets into scalable revenue opportunities [5]. Product Development Focus - SINTX is focused on expanding the adoption of SiNERGY™ SiN/PEEK biocomposites and developing new product formats such as filament, rod, and sheet to support various manufacturing workflows [4][5]. - The company has established itself as a leader in high-performance biomaterials, with thousands of medical devices implanted since 2008 and a strong patent portfolio [8].

Core Insights - SINTX Technologies, Inc. will present at the Noble Capital Markets Emerging Growth Virtual Equity Conference on February 4–5, 2026, marking a significant moment in the company's evolution following operational restructuring and a renewed focus on its core medical technology platforms [1][2]. Company Developments - The company has undergone operational restructuring, enhanced financial discipline, and is focusing on its core medical-technology platforms, which has resulted in a streamlined cost structure and improved visibility into its balance sheet [2]. - SINTX aims to engage with institutional investors at the conference, highlighting its differentiated medtech opportunities [2][4]. Conference Details - During the conference, SINTX management will discuss operational progress and strategic priorities, including the expansion of its silicon nitride biomaterial platform, recent regulatory milestones, and value creation opportunities in orthopedic, spine, and patient-specific applications [3]. - The conference is attended by institutional investors, family offices, and research analysts focused on growth companies, providing SINTX with opportunities for one-on-one meetings and investor discussions [4]. Company Background - SINTX Technologies, based in Salt Lake City, Utah, specializes in silicon nitride-based materials for medical and high-value applications, with its biomaterials having been implanted in humans since 2008 [6].

Group 1 - SINTX Technologies, Inc. will present at Sidoti & Company's Year End Virtual Investor Conference on December 10-11, 2025 [1] - The presentation is scheduled for December 10, 2025, at 3:15 P.M. ET [1] - Interested parties can schedule one-on-one meetings with SINTX management by contacting KCSA Strategic Communications [1] Group 2 - SINTX Technologies is headquartered in Salt Lake City, Utah, and specializes in advanced ceramics [3] - The company develops, manufactures, and commercializes silicon nitride biomaterials, composites, devices, and related technologies for medical and high-value applications [3]

Core Insights - SINTX Technologies has signed a supply agreement with Evonik Corporation to produce its proprietary SiN/PEEK composite material, enabling immediate production of AI-assisted patient-specific implants [1][2][3] - The SiN/PEEK material is designed for 3D printing of customized implants, addressing requests from doctors for vertebral body replacement implants for orthopedic and neurosurgical tumor patients [2][3] - The collaboration aims to combine Evonik's polymer manufacturing expertise with SINTX's silicon nitride biomaterials to meet critical clinical needs in trauma, spine, and oncology [2][3] Company Overview - SINTX Technologies, Inc. specializes in advanced ceramic materials, focusing on the development and commercialization of silicon nitride biomaterials and composites for medical applications [7] - The company has a strong patent portfolio and has developed thousands of medical devices since 2008, establishing itself as a leader in high-performance biomaterials [7] - SINTX is preparing to expand its production capabilities and regulatory submissions to address a broader range of indications beyond its current humanitarian focus [3][7] Material Advantages - SiN/PEEK offers superior pathogen-resistant surface properties, osteoconductive support, and enhanced imaging performance compared to standard PEEK [5][3] - The combination of silicon nitride and PEEK aims to provide additional clinical and economic value in complex implant indications [3][5] - The material supports greater design flexibility for patient-specific geometries through AI-assisted additive manufacturing [5][3] Strategic Collaboration - The agreement with Evonik is seen as a significant milestone for SINTX and the field of patient-specific implants, ensuring stable quality, reliable supply, and scalability for future collaborations [2][3] - Evonik's commitment to innovation in medical devices aligns with SINTX's goals to improve patient outcomes through advanced materials [2][3]

Core Insights - SINTX Technologies has signed a supply agreement with Evonik Corporation to manufacture a proprietary silicon nitride–PEEK compound for AI-assisted additive manufacturing of patient-specific implants [1][2][3] - The collaboration aims to leverage Evonik's industrial-scale manufacturing capabilities to produce SiN/PEEK, enabling SINTX to meet immediate physician requests for humanitarian-use vertebral body replacement implants [2][5] - The SiN/PEEK compound is expected to offer advantages over standard PEEK, including antipathogenic surface characteristics, osteogenic potential, and improved visualization for complex surgical procedures [3][4][7] Company Overview - SINTX Technologies specializes in advanced ceramics and biomaterials, focusing on silicon nitride for medical applications, with a strong patent portfolio and U.S.-based manufacturing [9] - The company has a history of thousands of medical devices implanted since 2008 and aims to expand its technology platform through innovation and market diversification [9] Industry Context - The partnership with Evonik is positioned as a significant advancement in the field of patient-specific implants, combining expertise in high-performance polymers with advanced biomaterials [3][4] - The SiN/PEEK compound is designed to support regulatory clearances for both patient-matched and traditionally manufactured implantable devices, indicating a strategic move towards broader market opportunities [2][5]

Regulatory Approvals - SINTX received FDA 510(k) clearance for the SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking a significant milestone for commercial entry into reconstructive foot and ankle surgery in the U.S.[6] Financial Performance - Total revenue for Q3 2025 was $208 million, a decrease of 74.0% compared to $799 million in Q3 2024[17]. - Product revenue for the nine months ended September 30, 2025, was $541 million, down 48.7% from $1,054 million in the same period of 2024[17]. - Gross profit for Q3 2025 was $93 million, significantly lower than $589 million in Q3 2024, reflecting a gross margin decline[17]. - The net loss for Q3 2025 was $3,539 million, compared to a net loss of $6,239 million in Q3 2024, indicating an improvement[17]. - The company reported a net loss attributable to common stockholders of $10,258 million for Q3 2025, compared to $6,239 million in Q3 2024[17]. - Basic net loss per share for Q3 2025 was $(1.19), compared to $(6.96) in Q3 2024[17]. - Adjusted EBITDA loss was $2.3 million in Q3 2025, a significant improvement from a loss of $6.1 million in Q3 2024[6]. - Adjusted EBITDA for Q3 2025 was $(2,308) million, an improvement from $(6,085) million in Q3 2024[19]. Operating Expenses - Operating expenses decreased by 51% year-over-year to approximately $3.4 million, leading to an operating loss of $3.4 million compared to $6.4 million in Q3 2024[6]. - Total operating expenses for Q3 2025 were $3,448 million, a decrease of 50.7% from $6,997 million in Q3 2024[17]. - Research and development expenses for Q3 2025 were $1,264 million, up 58.7% from $796 million in Q3 2024[17]. Liquidity and Cash Management - Cash and cash equivalents increased to $6.25 million as of September 30, 2025, up from $3.60 million on December 31, 2024, reflecting improved liquidity management[6]. - SINTX raised an additional $4.3 million in gross proceeds through warrant inducement and common stock warrant exercises, strengthening its liquidity position[6]. Asset and Liability Management - Total assets increased to $11.36 million as of September 30, 2025, compared to $9.41 million on December 31, 2024[15]. - Total liabilities rose to $7.30 million as of September 30, 2025, up from $5.52 million on December 31, 2024[15]. Strategic Initiatives - The company plans to prepare the SINAPTIC wedge system for launch and expand clinical engagement in targeted surgical specialties[7]. - The company executed a sublease of the Armor facility, estimated to save approximately $950,000 in lease costs over the sublease term[6]. Shareholder Information - Weighted average common shares outstanding for Q3 2025 were 2,963,539, significantly higher than 896,305 in Q3 2024[17].

Core Insights - SINTX Technologies, Inc. reported third quarter financial results and provided a business update, focusing on its commercialization plan for infection-resistant silicon nitride devices and polymer composites [1][2]. Business Highlights and Key Milestones - The company received FDA 510(k) clearance for the SINAPTIC Foot & Ankle Osteotomy Wedge System, marking a significant milestone for commercial entry into reconstructive foot and ankle surgery in the U.S. [5][7]. - Initial product revenue was recorded from the OsseoSculpt™ product, a companion biologic to the SINAPTIC wedge portfolio [7]. - SINTX executed a sublease of the Armor facility, projected to save approximately $950,000 in lease costs, aligning resources with medical device priorities [7]. - The company raised an additional $4.3 million through warrant inducement and common stock warrant exercises, strengthening its liquidity [7]. Financial Results - Cash and cash equivalents increased to $6.25 million as of September 30, 2025, compared to $3.60 million on December 31, 2024 [7]. - Total revenue for Q3 2025 was $0.208 million, a decrease from $0.799 million in Q3 2024, primarily due to reduced grant revenue [7]. - Operating expenses were approximately $3.4 million, a 51% decrease year-over-year [7]. - The operating loss was $3.4 million, down from $6.4 million in Q3 2024, while the net loss was $3.5 million, or $1.19 per fully diluted share, compared to a net loss of $6.2 million, or $6.96 per fully diluted share in Q3 2024 [7]. Future Priorities - SINTX plans to prepare the SINAPTIC wedge system for launch, expand clinical engagement in targeted surgical specialties, and leverage its material science into adjacent indications [5]. - The company is also evaluating options for partnering, licensing, and capital formation to enhance market access and shareholder value [5].