On December 19, 2024, Humacyte, Inc. announced that the U.S. Food and Drug Administration (FDA) granted full approval for SYMVESS (acellular tissue engineered vessel-tyod). SYMVESS is indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and autologous vein graft is not feasible.
This approval marks a significant milestone for Humacyte, positioning SYMVESS as a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit. The BLA included positive results from the V005 pivotal Phase 2/3 clinical study and real-world evidence from wartime injuries in Ukraine.
Clinical testing demonstrated high rates of patency, or blood flow, and low rates of amputation and infection with SYMVESS. The product offers an off-the-shelf solution, eliminating the need for invasive vein harvesting procedures in trauma patients.
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