{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-033949","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2025-11-10T23:59:59+00:00","discovered_at":"2026-05-14T18:02:42.641833+00:00","generated_at":"2026-05-16T22:51:11.860615+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"BioCardia announces first patient enrolled at Henry Ford Health in Phase 3 CardiAMP HF II trial","bullets":["First patient enrolled at Henry Ford Health in Phase 3 CardiAMP HF II trial for ischemic heart failure with reduced ejection fraction.","Prior CardiAMP HF study showed reduced mortality and major adverse cardiac events in patients with elevated NTproBNP.","Phase 3 is a 250-patient randomized, placebo-controlled confirmatory study using a three-tier composite primary endpoint.","Primary endpoint composite: all-cause death, nonfatal MACE, and validated quality of life measure.","CEO notes ~2 million US and EU patients with NYHA Class II/III symptoms who may benefit."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-033949","json":"https://secwatch.observer/filing/0001437749-25-033949.json","markdown":"https://secwatch.observer/filing/0001437749-25-033949.md","text":"https://secwatch.observer/filing/0001437749-25-033949.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774925033949/0001437749-25-033949-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774925033949/bcda20251110_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T22:51:11.860615+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"}