---
schema_version: "secwatch.filing_event.v1"
accession: "0001818382-23-000177"
form_type: "8-K"
ticker: "HUMA"
cik: "0001818382"
company_name: "Humacyte, Inc."
filed_at: "2023-12-12T23:59:59+00:00"
generated_at: "2026-06-07T14:20:13.721588+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001818382-23-000177
- form_type: 8-K
- ticker: HUMA
- cik: 0001818382
- company_name: Humacyte, Inc.
- filed_at: 2023-12-12T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1818382/000181838223000177/0001818382-23-000177-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1818382/000181838223000177/huma-20231212.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001818382-23-000177
- JSON: https://secwatch.observer/filing/0001818382-23-000177.json
- Plain text: https://secwatch.observer/filing/0001818382-23-000177.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.