{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-009978","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2025-03-31T23:59:59+00:00","discovered_at":"2026-05-14T18:03:06.842306+00:00","generated_at":"2026-05-24T02:47:33.354867+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"BioCardia Phase 3 CardiAMP-HF shows survival benefit, MACCE reduction at 2 years; primary endpoint not met","bullets":["Primary composite efficacy endpoint did not reach statistical significance in overall 115-patient trial.","In all treated patients: 20.9% relative risk reduction in heart death equivalents; 44.6% reduction in non-fatal MACCE.","Patients with elevated NTproBNP (50% of cohort) showed statistically significant composite of survival, MACCE, and QOL.","Treated subgroup (elevated NTproBNP) saw 47% relative risk reduction in heart death equivalents and 10.5-point MLHFQ improvement.","Company plans to discuss results with FDA and PMDA to align on regulatory pathway for this Breakthrough Therapy."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-009978","json":"https://secwatch.observer/filing/0001437749-25-009978.json","markdown":"https://secwatch.observer/filing/0001437749-25-009978.md","text":"https://secwatch.observer/filing/0001437749-25-009978.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774925009978/0001437749-25-009978-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774925009978/bcda20250330_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T02:47:33.354867+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"}