SINTX Technologies Inc. has agreed to supply OsseoSculpt, a next-generation biologic designed to complement its U.S. Food and Drug Administration 510(k)-cleared SINAPTIC Foot & Ankle Osteotomy Wedge System. The company recorded its first OsseoSculpt commercial sales last quarter.

OsseoSculpt features a nanocrystalline HCA surface with a biomimetic pore architecture that provides an enhanced osteoconductive scaffold. SINTX will market this biologic with its SINAPTIC wedge system to augment bone healing in indicated procedures, providing surgeons with a streamlined solution from a single supplier.

“Pairing our SINAPTIC wedges with a custom-built biologic closes a critical gap at the point of care,” SINTX Technologies Chief Commercial Officer Lisa Marie Del Re stated. “Design-surgeon feedback has been positive, and we recorded Q3 revenue from early evaluations. We expect biologic product utilization will improve the overall economic profile of our wedge portfolio as we scale commercialization.”

The OsseoSculpt supply agreement’s benefits, according to the company, are as follows:

• Accelerates adoption: Offering a ready-to-use biologic with the SINAPTIC wedge system simplifies the procedure stack for surgeons and facilities.
• Validated by key opinion leaders: Several of the SINTX Technologies’ design surgeons have evaluated the product, informing training, positioning, and launch materials.
• Commercial momentum already visible: Initial orders demonstrate real-world demand.

Commercial plan and near-term milestones:

• Limited release now through select design and early-adopter sites.
• Broader U.S. rollout aligned with wedge availability and surgeon training cycles through Q4 2025–Q1 2026.
• Growth drivers include:targeted in-service education, case support, and data capture on attach rate, procedure time, and outcomes for evidence-driven adoption.

The SINAPTIC wedge system, manufactured with silicon nitride (Si₃N₄) biomaterial, is engineered to deliver stable correction in foot and ankle osteotomy procedures. Its design offers precision fit, predictable technique, and compatibility with biologic augmentation, supporting both surgical reproducibility and optimal bone healing. 

Located in Salt Lake City, SINTX Technologies is an advanced ceramics company that develops and commercializes materials, components, and technologies for medical and other high-value applications. SINTX researches, develops, and manufactures silicon nitride, and its products have been implanted in humans since 2008. Through innovation and strategic partnerships, SINTX continues to expand its portfolio across multiple markets.