(RTTNews) - Humacyte, Inc. (HUMA), Friday said that the Food and Drug Administration or FDA has granted approval for SYMVESS for use in adults as a vascular conduit for extremity arterial injury.
Humacyte's Biologics License Application (BLA) included positive results from the V005 pivotal Phase 2/3 study, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid program.
In clinical testing SYMVESS was observed to have high rates of patency, or blood flow, and low rates of amputation and infection.
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