Synchron COMMAND EFS completed with 6/6 patients meeting primary safety endpoint — pivotal trial targeting 2026
Summary
Synchron completed its COMMAND Early Feasibility Study with all 6 of 6 patients meeting the primary safety endpoint — the strongest possible feasibility trial result and the foundation for FDA Pre-Market Approval application. The COMMAND study evaluated the Stentrode endovascular BCI for assistive communication in ALS and high-level SCI patients across 8 US medical centers. Synchron is now planning a pivotal trial targeting 2026 enrollment across 4+ US sites, which if successful would provide the data for FDA PMA submission.
Why it matters
6/6 EFS safety endpoint is the highest possible result — it eliminates any remaining doubt about Stentrode safety at the feasibility scale and provides the cleanest possible foundation for a pivotal trial application. Synchron is now the BCI company closest to FDA PMA approval for a chronically implanted communication device — ahead of even Neuralink, whose PRIME trial is still in IDE feasibility phase.
Want the full NeurotechMag Pro intelligence database?
Access 800+ papers, trials, patents, funding rounds and news items — updated daily.
Start free trial