{"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","discovered_at":"2026-05-14T18:03:30.647646+00:00","generated_at":"2026-06-07T14:20:13.721588+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Humacyte files BLA for HAV in vascular trauma; data shows superior patency and lower amputation vs synthetic grafts","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001818382-23-000177","json":"https://secwatch.observer/filing/0001818382-23-000177.json","markdown":"https://secwatch.observer/filing/0001818382-23-000177.md","text":"https://secwatch.observer/filing/0001818382-23-000177.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T14:20:13.721588+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}