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.
