SINTX revenue falls 65% on OEM exit; FDA clears foot/ankle wedge; going concern returns

Filed March 20, 2026 · Period ending December 31, 2025 · Compared to 10-K Mar 19, 2025 · ~1 min read

Key Changes

• high

  Revenue dropped 65% to $1.0M as company exited low-margin OEM contracts. Management frames this as strategic repositioning toward proprietary devices, but transition has not yet replaced lost revenue.

  MD&A: Revenue verify on EDGAR →
• high

  FDA cleared SiNAPTIC foot/ankle wedge system in October 2025, enabling commercial entry into reconstructive foot/ankle surgery—first product outside spinal fusion.

  Business: FDA Clearance verify on EDGAR →
• high

  Going concern doubt reinstated after prior year's removal. Cash at $4.1M with $6.0M ATM capacity remaining, but no explicit runway projection provided.

  MD&A: Liquidity verify on EDGAR →