FX.co ★ FDA Approves SYMVESS To Treat Extremity Vascular Trauma

Humacyte, Inc. (HUMA) announced on Friday that it has received approval from the Food and Drug Administration (FDA) for SYMVESS, which is approved for use in adults as a vascular conduit for treating extremity arterial injuries.

The company's Biologics License Application (BLA) was supported by successful outcomes from the V005 pivotal Phase 2/3 study. Additionally, substantial real-world evidence was gathered from its application in addressing wartime injuries in Ukraine, as part of a humanitarian aid initiative.

Clinical trials of SYMVESS demonstrated significant patency, indicating effective blood flow, while also reporting minimal rates of amputation and infection.