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].

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]