{"schema_version":"secwatch.filing_event.v1","accession":"0001818382-24-000192","form_type":"8-K","ticker":"HUMA","cik":"0001818382","company_name":"Humacyte, Inc.","filed_at":"2024-10-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.807066+00:00","generated_at":"2026-05-30T09:47:22.631607+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Humacyte ATEV meets Phase 3 co-primary endpoints; superior to AV fistula in hemodialysis","bullets":["ATEV showed functional patency 81.3% at 6 months vs 66.4% for AV fistula; secondary patency 68.3% vs 62.2% at 12 months (joint p=0.0071).","Subgroup analyses: ATEV superior in female (p<0.0001), obese (p=0.0001), and diabetic (p=0.0024) patients for patency rates and hemodialysis duration.","Thrombosis reported in 52.1% of ATEV patients vs 9.1% for AV fistula; 94% of thrombotic events successfully treated.","Infection rates low and similar: 9.1% ATEV vs 9.9% AV fistula.","Phase 3 trial enrolled 242 hemodialysis patients in US; ATEV is investigational and not yet FDA-approved."],"urls":{"canonical":"https://secwatch.observer/filing/0001818382-24-000192","json":"https://secwatch.observer/filing/0001818382-24-000192.json","markdown":"https://secwatch.observer/filing/0001818382-24-000192.md","text":"https://secwatch.observer/filing/0001818382-24-000192.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1818382/000181838224000192/0001818382-24-000192-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1818382/000181838224000192/huma-20241028.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T09:47:22.631607+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"}