UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 15, 2025 SINTX Technologies, Inc. (Exact name of registrant as specified in its charter) Delaware 001-33624 84-1375299 (State or other jurisdiction of incorporation) Registrant's telephone number, including area code: (801) 839-3500 (Former name or former address, if changed since last repo ...

Core Insights - SINTX Technologies is undergoing a disciplined transformation to focus on high-growth medical applications of silicon nitride, aiming for sustainable value creation [2][3] Operational Progress - The company is transitioning from a diversified industrial-ceramics business to a pure-play medical device innovator, targeting large clinical needs in infection resistance and tissue healing [3] - Recent initiatives include improved financial positioning, operational streamlining, and strengthened governance with a reconstituted Board of Directors [4][5][6] Financial Position - As of March 31, 2025, SINTX reported $6.5 million in cash, nearly doubling from $3.6 million at year-end 2024 [8] - The company reduced operating cash burn from $2.7 million in Q1 2024 to $1.3 million in Q1 2025 due to cost optimization efforts [8] - A recent $5 million private placement in February 2025 supports strategic initiatives, with potential to raise an additional $5 million from warrant exercises [8] Strategic Focus Areas - SINTX is strategically aligned around orthopedic implants, spinal fusion devices, dental products, and medical textiles, including wound care and surgical masks [7] - The company is actively developing new R&D programs targeting implantable and antipathogenic products, with ongoing partnerships and licensing discussions with leading medical OEMs [8]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-33624 SINTX Technologies, Inc. (Exact name of registrant as specified in its charter) DELAWARE 84-1375299 (State or other jurisdiction (IRS Employer of incorporat ...

Company Overview - SINTX Technologies has established itself as a leader in advanced ceramics, focusing on biomedical applications with a strong emphasis on silicon nitride, which has been successfully used in spinal implants since 2008[27]. - The company aims to leverage its competitive strengths to become a leading advanced ceramic company in the biomedical sector[45]. - The company aims to become a leading advanced ceramics company, focusing on silicon nitride medical devices, claiming to be the sole provider of such products in the U.S. with FDA clearance for spinal fusion devices[46]. Manufacturing and Technology - The company operates a 31,000 square foot FDA registered and ISO 13485:2016 certified manufacturing facility, ensuring control over the quality and availability of its silicon nitride products[33]. - The manufacturing facility spans 19,000 square feet and is certified under ISO 13485:2016, allowing rapid design and production of silicon nitride products while maintaining quality control[46]. - The company has received three NIH grants to develop 3D printed silicon nitride/polymer implantable medical devices, indicating a commitment to innovation in manufacturing technologies[46]. - The company is advancing AI-designed 3D printing capabilities for custom medical implants, integrating silicon nitride with PEEK to enhance biocompatibility and mechanical performance[37][39]. Product Features and Market Demand - SINTX's silicon nitride exhibits superior properties compared to traditional biomaterials, with a flexural strength over five times that of PEEK and compressive strength over twenty times that of PEEK, enhancing its suitability for long-term human implantation[36]. - The silicon nitride products have demonstrated antibacterial properties, with live bacteria counts being 8 to 30 times lower compared to PEEK, significantly reducing the risk of infection[36]. - The demand for personalized implants is increasing, with regulatory pathways for custom devices being more streamlined, allowing for quicker market entry[38]. - The company is exploring new markets for its silicon nitride, including antipathogenic applications, particularly in products like face masks and filters[29]. Research and Development - SINTX has published over 130 peer-reviewed studies validating the safety and efficacy of its silicon nitride products, supporting its product development strategy[43]. - The company is focused on developing products with anti-pathogenic properties, including those that inactivate the SARS-CoV-2 virus, showcasing its commitment to addressing current health challenges[46][47]. - The company is developing new manufacturing technologies and product candidates, including ceramic armor products, to expand its product lines[131]. Financial Performance - The company incurred a net loss of $11.0 million and $8.3 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $281.7 million as of December 31, 2024[118]. - Cash used in operations was $8.6 million and $14.1 million for the years ended December 31, 2024 and 2023, respectively[118]. - Product revenue for the year ended December 31, 2024, was $1,246,000, a 2% increase from $1,226,000 in 2023[220]. - Grant and contract revenue increased by $240,000, or 17%, from $1,401,000 in 2023 to $1,641,000 in 2024[220]. - Total revenue rose by $260,000, or 10%, from $2,627,000 in 2023 to $2,887,000 in 2024[220]. - Gross profit increased by $233,000, or 13%, from $1,843,000 in 2023 to $2,076,000 in 2024[220]. - Research and development expenses decreased by $3,512,000, or 40%, from $8,713,000 in 2023 to $5,201,000 in 2024[220]. - General and administrative expenses decreased by $225,000, or 5%, from $4,222,000 in 2023 to $3,997,000 in 2024[220]. - Operating expenses totaled $16,123,000 in 2024, an increase of $922,000, or 6%, from $15,201,000 in 2023[220]. Regulatory Environment - Medical devices in the U.S. require either 510(k) clearance or PMA approval before marketing, with the FDA aiming to review 510(k) submissions within 90 days[81]. - The PMA process is more complex and can take several years, requiring extensive data to demonstrate safety and effectiveness, with a first action decision typically within 180 days of filing[84]. - The FDA may classify a new device as Class III if it is not deemed substantially equivalent to a predicate device, necessitating a PMA submission[82]. - The European Union has unified regulations for medical devices, allowing for CE Marking, which certifies compliance with applicable directives[89]. - Notified Bodies in the EU are responsible for assessing conformity for medium and higher risk devices, which is necessary for commercial distribution[90]. Competitive Landscape - The company competes with major players like Medtronic and Stryker, which have greater resources, emphasizing the need for innovative product development to maintain competitiveness[76]. - The orthopedic market is highly competitive, with major players like Medtronic and Stryker dominating, posing challenges for the company[123]. Risks and Challenges - The company may face challenges in obtaining third-party reimbursement for its products, which could significantly reduce potential revenues[101]. - Medicare's reimbursement policies, including DRGs and APCs, may not adequately cover the costs associated with the company's products, affecting their market acceptance[102]. - The company is exposed to risks related to capital resources, including the need for additional financing to support product development and commercialization efforts[113]. - The company may face adverse changes in payment rates from third-party payors, which could negatively impact marketing and sales of its products[106]. - The company is dependent on its senior management and engineering teams, and any loss could materially affect business operations and financial condition[144]. - Cybersecurity risks could expose the company to data loss and litigation, harming its reputation and increasing expenses[146]. - The company may face significant costs and management distraction due to potential product liability claims, which could exceed its insurance coverage[190]. Strategic Partnerships and Collaborations - The company has developed strong collaborations with surgeons and university laboratories, collecting clinical data that supports the efficacy of its silicon nitride products[46]. - The company has licensed certain patents to CTL Medical under a ten-year agreement, indicating strategic partnerships to enhance its market position[71]. - The company has entered into agreements with orthopedic surgeons for product development, which may lead to claims regarding royalty entitlements[183]. Future Outlook - The company anticipates growth in the medical device market driven by new technologies, favorable demographics, and market expansion into underserved regions like South America and Asia[50]. - The company anticipates requiring substantial future capital to continue operations, conduct research and development, and establish marketing and sales capabilities[113]. - The company expects to incur additional research and development costs as it continues to develop new medical devices and other products[218].

Core Insights - SINTX Technologies announced a new peer-reviewed study demonstrating the biomechanical advantages of silicon nitride in anterior cervical discectomy and fusion (ACDF) procedures [1][2] Group 1: Study Findings - The study, conducted by SRM Institute of Science and Technology in collaboration with SINTX, utilized finite element analysis to compare various cage designs and materials for cervical spine fusion, highlighting silicon nitride's superior biomechanical performance [2] - Key advantages of silicon nitride include reduced implant subsidence, improved load distribution, and enhanced spinal stability [2][6] Group 2: Market Implications - The findings reinforce the unique advantages of silicon nitride over traditional spinal implant materials like PEEK and titanium, indicating a transformative solution for spinal fusion applications [3] - With global spinal fusion procedures projected to exceed $10 billion annually, the integration of silicon nitride into commercial spinal implant systems presents a significant market opportunity for SINTX [3] Group 3: Product Benefits - Silicon nitride exhibits exceptional load-bearing capability, minimizing the risk of implant subsidence, a common complication in spinal fusion surgery [6] - The material provides enhanced stress distribution, reducing the risk of adjacent segment degeneration [6] - Silicon nitride promotes stronger bone fusion due to its osteoconductive and antimicrobial properties, unlike PEEK, which is biologically inert [6] - The radiolucency of silicon nitride allows for better post-surgical imaging and reduces artifacts in MRI and CT scans [6]

Core Insights - Sintx Technologies, Inc. announced the retirement of Dr. Sonny Bal as Chairman of the Board, with Eric Olson, the current CEO, appointed as the new Chairman effective immediately [1][2] Leadership Transition - Dr. Bal has been Chairman since 2015 and has significantly contributed to Sintx's transformation and growth in advanced materials [2] - Eric Olson expressed gratitude for Dr. Bal's leadership and emphasized the company's focus on high-value medical applications and strategic partnerships moving forward [3] - Since becoming CEO in August 2024, Olson has redirected the company towards high-growth opportunities in biomedical and medical device sectors [3] Company Overview - Sintx Technologies specializes in advanced ceramics for medical applications and is a leader in the research and manufacturing of silicon nitride, with products implanted in humans since 2008 [4] - The company has pursued strategic acquisitions and alliances to expand into new markets [4]

Core Insights - SINTX Technologies, Inc. has sold its wholly-owned subsidiary, Technology Assessment and Transfer (TA&T), to Tethon Corporation, marking a strategic move to enhance financial flexibility and focus on high-growth opportunities in the medical device sector [1][2][3] Financial Impact - The divestment reduces corporate liabilities by $750,000 and lowers annual operating expenses by more than $1.7 million, improving the company's financial position [2][3] Strategic Focus - The sale aligns with SINTX's strategy to concentrate on commercializing bioceramic technologies aimed at improving patient outcomes and enhancing medical implants and devices [2][3] - The company is committed to advancing its proprietary silicon nitride-based technologies, which have been utilized in human implants since 2008, indicating confidence in its core technologies for long-term value creation [3][4]

Core Insights - SINTX Technologies, Inc. has been granted U.S. Patent No. 12,239,761, enhancing its intellectual property portfolio and solidifying its leadership in silicon nitride innovation [1][2][5] - The patent focuses on advancements in silicon nitride material processing and applications, particularly in the biomedical sector, which is crucial for next-generation implant technology [2][3] - The company is the only FDA-registered producer of implantable silicon nitride, with a diverse portfolio aimed at improving implant longevity and patient safety [4][6] Intellectual Property and Innovation - The newly issued patent covers innovative methods for adhering silicon nitride to various biomaterial substrates, improving biocompatibility and infection resistance [3] - SINTX's intellectual property portfolio now includes 17 issued U.S. patents and 84 pending applications worldwide, reflecting its commitment to innovation [5] Market Position and Applications - SINTX is recognized as a global leader in the research, development, and manufacturing of silicon nitride, with products implanted in humans since 2008 [6] - The company's innovations target orthopedic, craniomaxillofacial, dental, and spinal implants, aligning with its mission to enhance patient outcomes and surgical success rates [3][4]

Core Insights - SINTX Technologies has received a Notice of Allowance from the USPTO for its patent application titled "Methods of Silicon Nitride Laser Cladding," highlighting its leadership in biomaterial innovation and strengthening its intellectual property portfolio [1][5] - The patent protects a novel method for laser bonding bioactive silicon nitride to various biomedical implant substrates, enhancing their biological performance through superior osseointegration and bacterial resistance [2][3] - SINTX is the only FDA-registered producer of implantable silicon nitride, with a focus on expanding its technology applications across diverse markets [4][5] Intellectual Property and Innovation - The company now holds 17 issued U.S. patents and 84 pending patent applications globally, reinforcing its position as a leader in advanced ceramics and biomaterial innovation [5] - The newly allowed patent complements a recently granted U.S. Patent (US 12162807), expanding SINTX's capabilities in enhancing traditional implantable device materials [3] Market Position and Strategy - SINTX's advancements in silicon nitride technology open new opportunities in the biomedical field and provide innovative pathways for upgrading existing medical devices [3][4] - The company has been involved in strategic acquisitions and alliances to enter new markets, with manufacturing and R&D facilities located in Utah and Maryland [6]

Core Insights - SINTX Technologies has signed a Joint Development Agreement (JDA) with NED Medical Inc. to develop advanced ceramic-based microspheres for radiotherapeutic applications [1][2] - The collaboration aims to transition the microsphere process from R&D to pilot production, focusing on preclinical testing and regulatory submissions [2][4] Group 1: Partnership Details - The partnership will leverage SINTX's ceramic manufacturing expertise to support NED Medical's preclinical testing and process validation [2] - SINTX has successfully manufactured ceramic-based microspheres containing Yttrium-90 that meet NED Medical's specifications for a TARE device targeting hepatocellular carcinoma [2][3] - The engineered microspheres feature porosity, allowing for future adaptations in targeted chemotherapy and combination therapies [2] Group 2: Strategic Implications - This partnership signifies SINTX's strategic expansion into the high-growth field of radio therapeutics, a market expected to grow significantly in the coming years [4] - SINTX's proprietary ceramic microsphere technology is anticipated to optimize dosing and enhance treatment precision, positioning the company as a leader in targeted radio-therapeutic devices [4][5] - The agreement opens avenues for future collaborations, including scaling production and expanding indications within oncology and musculoskeletal areas [4] Group 3: Leadership and Innovation - The partnership is expected to transform cancer treatment and underscores SINTX's commitment to advancing innovative solutions in oncological therapies [3] - Dr. Ryan Bock, CTO of SINTX, will join NED Medical's Scientific Advisory Board to guide the clinical development of CombiSphere [3]