Humacyte files BLA for HAV in vascular trauma; data shows superior patency and lower amputation vs synthetic grafts

Humacyte, Inc.

BLA submitted to FDA seeking approval of Human Acellular Vessel (HAV) for urgent arterial repair in extremity vascular trauma.
Supported by V005 Phase 2/3 trial: 90.2% 30-day secondary patency (vs 78.9% synthetic), 9.8% amputation (vs 24.3%), 2.0% infection (vs 8.4%).
Ukraine humanitarian program (V017) data: 93.8% patency, zero amputations, zero infections; integrated analysis showed 91.5% patency, 4.5% amputation, 0.9% infection.
Priority Review requested; FDA has RMAT designation and DoD priority for military trauma; 60-day filing review period.

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