SINTX introduced OsseoSculpt, a biologic featuring a nanocrystalline hydroxyapatite surface and a biomimetic pore architecture, to complement its FDA‑cleared SINAPTIC Foot & Ankle Osteotomy Wedge System.
The private‑label agreement allows SINTX to supply OsseoSculpt to surgeons using the SINAPTIC system, streamlining the procedure and potentially improving clinical outcomes. The first commercial revenue from OsseoSculpt was recorded in Q3 2025, marking the company’s first biologic revenue stream.
SINTX’s Q2 2025 revenue was $0.15 million, a decline of 82.4% from the same period a year earlier, and its trailing‑twelve‑month revenue as of October 2025 was $0.95 million, down from previous years. The company’s operating and net margins remain negative, underscoring the financial challenges that the new product launch aims to address.
The SINAPTIC system received FDA 510(k) clearance in October 2025 and is slated for commercial launch in the United States in Q1 2026. OsseoSculpt will be released in a limited initial rollout, with a broader U.S. launch aligned with the wedge’s availability and surgeon training cycles through Q4 2025–Q1 2026.
SINTX’s silicon nitride platform, known for its pro‑osteogenic, bacteriostatic, and hydrophilic properties, underpins both the wedge and the biologic. The company’s acquisition of SiNAPTIC Holdings’ surgical assets in June 2025 and its ongoing exploration of other silicon nitride applications signal a broader platform‑based growth strategy.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.