SALT LAKE CITY, Utah, Jan. 29, 2026 (GLOBE NEWSWIRE) -- SINTX Technologies, Inc. (NASDAQ: SINT) (“SINTX” or the “Company”), an advanced ceramics and biomaterials company focused on silicon-nitride-based medical technologies, today announced that its management team will present at the Noble Capital Markets Emerging Growth Virtual Equity Conference, to be held February 4–5, 2026. The Company’s participation comes at an important stage in its evolution, following a period of operational restructuring, enhance ...

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].

Revenue Performance - For the three months ended September 30, 2025, product revenue decreased by $0.2 million, or 59%, compared to the same period in 2024, while grant and contract revenue decreased by $0.4 million, or 87%[106]. - For the nine months ended September 30, 2025, product revenue decreased by $0.5 million, or 49%, and grant and contract revenue decreased by $1.1 million, or 86% compared to the same period in 2024[107]. - Total revenue for the three months ended September 30, 2025, was $208,000, a decrease of $591,000, or 74%, and for the nine months, total revenue was $728,000, a decrease of $1.617 million, or 69%[105]. Expenses - Research and development expenses increased by $0.5 million, or 59%, for the three months ended September 30, 2025, primarily due to increased costs related to the Research Agreement[112]. - General and administrative expenses increased by $1.3 million, or 162%, for the three months ended September 30, 2025, primarily due to increased stock-based compensation and headcount-related costs[114]. - Total operating expenses for the three months ended September 30, 2025, were $3.448 million, a decrease of $3.549 million, or 51%, compared to the same period in 2024[105]. Net Loss - The net loss for the three months ended September 30, 2025, was $3.539 million, a decrease of $2.7 million, or 43%, compared to the same period in 2024[105]. - For the nine months ended September 30, 2025, the company incurred a net loss of $8.1 million, compared to a net loss of $9.3 million for the same period in 2024, reflecting a decrease of approximately 12.9%[125]. Cash Flow - Cash used in operating activities decreased to $6.2 million for the nine months ended September 30, 2025, from $7.5 million in the same period of 2024, a reduction of $1.3 million[138]. - Net cash provided by investing activities was $0.955 million during the nine months ended September 30, 2025, compared to a net cash used of $0.204 million in the same period of 2024, an increase of $1.159 million[139]. - Net cash provided by financing activities was $7.9 million for the nine months ended September 30, 2025, down from $9.2 million in the same period of 2024, a decrease of $1.3 million[140]. Strategic Developments - The company 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.[93]. - The company is transitioning away from low-margin OEM technical manufacturing contracts to focus on proprietary silicon nitride-based biomedical devices, which are expected to offer stronger margins[108]. - The company began recognizing commercial revenue from OsseoSculpt™, a next-generation biologic, in Q3 2025, which is anticipated to be a key revenue driver starting in 2026[109]. - The company received FDA 510(k) clearance for a new foot and ankle osteotomy wedge system in October 2025, with revenue expected to begin in the first half of 2026[134]. - The company is focused on advancing its business strategy in the biomedical sector, particularly in developing innovative medical devices using advanced ceramics and biomaterials[128]. Asset Management - The company incurred an impairment charge of approximately $4.6 million related to the write-down of long-lived assets associated with the armor plant, which was shut down in October 2023[132]. - The company entered into an Entity Acquisition Agreement with Tethon Corporation on February 19, 2025, selling all issued shares of TA&T in exchange for the assumption of its liabilities[133]. - The company expects to save approximately $950,000 over the sublease term of the SINTX armor facility, which was leased in October 2025[136]. Accumulated Deficit - The company had an accumulated deficit of $290 million as of September 30, 2025, compared to $282 million as of December 31, 2024[125].

Core Insights - SINTX Technologies has successfully completed clinical evaluations of its product, OsseoSculpt™, leading to early commercial momentum and the first recorded revenue in Q3 2025 [1][3] Product Overview - OsseoSculpt™ features a nanocrystalline HCA surface with a biomimetic pore architecture, enhancing osteoconductive properties and providing a scaffold for bone healing [2] - The product is designed to complement the SINAPTIC® Foot & Ankle Osteotomy Wedge System, which is engineered for stable correction in foot and ankle procedures [4] Commercial Strategy - The company has executed a private label agreement to market OsseoSculpt™ alongside the SINAPTIC wedge system, aiming to streamline the surgical process for healthcare providers [1][3] - Initial orders indicate real-world demand, with a limited release through select design and early-adopter sites [7] Market Positioning - The combination of SINAPTIC wedges and OsseoSculpt™ addresses a critical gap in surgical care, as noted by the positive feedback from design surgeons [3][7] - The broader rollout in the U.S. is planned to align with the availability of the wedge system and surgeon training cycles, targeting Q4 2025 to Q1 2026 [7] Growth Drivers - Key growth drivers include targeted in-service education, case support, and data capture on attach rates, procedure times, and outcomes to support evidence-driven adoption [7]

Core Insights - SINTX Technologies has received FDA approval for its SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking a significant milestone for the company as it enters the U.S. market for foot and ankle reconstruction surgeries [1][2] - The company plans to launch the system in the U.S. commercial market in the first quarter of 2026, leveraging its domestic manufacturing advantages to enhance revenue growth and operational efficiency [1][2] Company Overview - SINTX Technologies is a leader in advanced ceramics, focusing on the application of silicon nitride (Si₃N₄) in the biomedical field [1][4] - The company has been a pioneer in the research and manufacturing of silicon nitride since 2008, with its products already used in human implants [4] Product Details - The SINAPTIC implant system combines proprietary silicon nitride biomaterials with a specially designed sterile single-use instrument kit, aimed at improving surgical efficiency, precision, and repeatability [2] - The system is expected to meet the growing demand for non-metal solutions in orthopedics, enhancing surgical outcomes in the foot and ankle reconstruction sector [2] Market Potential - The global foot and ankle device market is estimated to be between $4.75 billion and $5.4 billion in 2024, presenting a lucrative revenue opportunity for SINTX despite the wedge osteotomy device being a niche segment [2] - Factors such as increasing surgical volumes, the trend towards outpatient surgery centers (ASC), and the use of single-use instruments are expected to drive market growth [2]

Core Insights - Sintx Technologies, Inc. has received FDA 510(k) clearance for the SINAPTIC Foot & Ankle Osteotomy Wedge System, allowing entry into the billion-dollar reconstructive foot and ankle surgery market [1][2] - The system combines SINTX's proprietary silicon nitride biomaterial with surgeon-informed implant designs and a single-use instrument kit, expected to be available in the U.S. market by Q1 2026 [1] Company Strategy - CEO Eric Olson emphasized the potential for meaningful clinical impact and shareholder value through the differentiated biomaterial and surgeon-validated designs in a high-value, procedure-driven market [2] - The stock is currently trading at $4.08, reflecting a 3.53% increase in pre-market hours on the Nasdaq [2]