SALT LAKE CITY, Utah, Dec. 08, 2025 (GLOBE NEWSWIRE) -- SINTX Technologies, Inc. (NASDAQ: SINT) (“SINTX” or the “Company”), today announced that management will be presenting at Sidoti & Company’s Year End Virtual Investor Conference, held December 10-11, 2025. Sidoti's Year End Virtual Investor ConferenceDates: December 10-11, 2025Presentation Date and Time: Wednesday, December 10, 2025 at 3:15 P.M. ETWebcast: https://sidoti.zoom.us/webinar/register/WN_O_OnAvXpQki63dk_9JbUYw To schedule a one-on-one meetin ...

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]

Core Insights - SINTX Technologies has received FDA 510(k) clearance for the SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking its entry into the reconstructive foot and ankle surgery market in the U.S. with a planned commercial launch in Q1 2026 [1][3] - The global foot & ankle device market is estimated to be approximately $4.75–$5.4 billion in 2024, with SINTX targeting a significant revenue opportunity through its innovative implant system [3] Company Overview - SINTX Technologies specializes in advanced ceramics, particularly in the biomedical applications of silicon nitride (Si₃N₄), and has been a leader in this field since 2008 [5] - The SINAPTIC implant system integrates proprietary silicon nitride biomaterial with surgeon-informed designs and a sterile, single-use instrument kit to enhance surgical efficiency and outcomes [2][3] Market Positioning - The SINAPTIC system is positioned to meet the growing demand for non-metal solutions in orthopedics, aiming to improve surgical outcomes through the proven performance of silicon nitride [3] - The company anticipates that the combination of procedure growth, migration to Ambulatory Surgery Centers (ASC), and single-use instrumentation will create a compelling revenue opportunity in the foot and ankle device market [3] Product Features - The silicon nitride material used in the SINAPTIC system offers unique benefits, including superior protein absorption, osteointegration, bacteriostatic properties, hydrophilicity, and enhanced visibility in imaging compared to traditional metal implants [7]