{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-013987","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2025-05-01T23:59:59+00:00","discovered_at":"2026-05-14T18:02:51.848747+00:00","generated_at":"2026-05-23T01:45:16.040041+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"BioCardia announces first patient enrolled in Phase 3 CardiAMP HF II heart failure trial","bullets":["First patient enrolled in Phase 3 randomized, double-blind, placebo-controlled CardiAMP HF II trial at BayCare Morton Plant Hospital in Clearwater, Florida.","250-patient multicenter study targeting ischemic HFrEF patients with elevated NTproBNP; composite primary endpoint includes death, nonfatal MACE, and quality of life.","Company preparing regulatory submissions in Japan and the USA based on prior CardiAMP HF, TAC-HFT, and TABMMI trial data.","Advances include cell population analysis at screening to define treatment doses and use of FDA-approved Morph DNA steerable catheter."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-013987","json":"https://secwatch.observer/filing/0001437749-25-013987.json","markdown":"https://secwatch.observer/filing/0001437749-25-013987.md","text":"https://secwatch.observer/filing/0001437749-25-013987.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774925013987/0001437749-25-013987-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774925013987/bcda20250501_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T01:45:16.040041+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"}