SINTX TECHNOLOGIES RECEIVES FDA CLEARANCE FOR SINAPTIC® FOOT & ANKLE IMPLANT SYSTEM

SALT LAKE CITY, Utah, Oct 21 (Bernama) -- SINTX Technologies, Inc. (NASDAQ: SINT) (“SINTX” or the “Company”), a leader in advanced ceramics specializing in biomedical applications of silicon nitride (Si₃N₄), today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the SINAPTIC® Foot & Ankle Osteotomy Wedge System, enabling SINTX’s commercial entry into reconstructive foot and ankle surgery in the United States. SINTX plans a U.S. commercial launch in Q1 2026, leveraging its U.S.-based manufacturing to drive revenue acceleration and operating efficiency.

The SINAPTIC implant system combines SINTX’s proprietary silicon nitride biomaterial with surgeon-informed implant designs and a planned sterile, single-use instrument kit engineered to enhance surgical efficiency, precision and reproducibility. By combining differentiated material science with practical surgical innovation, the SINAPTIC implant system exemplifies SINTX’s strategy to leverage its unique biomaterials platform into scalable, high-value medical solutions that address unmet clinical needs and drive long-term growth.