{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-029547","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2025-09-22T23:59:59+00:00","discovered_at":"2026-05-14T18:02:46.722817+00:00","generated_at":"2026-05-17T06:03:46.866136+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"BioCardia gets positive PMDA preliminary consultation on CardiAMP HF trial for Japan approval","bullets":["Positive preliminary PMDA consultation on CardiAMP Heart Failure Trial data; formal clinical consultation expected by year-end 2025.","PMDA requested clarifications on composite endpoints, statistical power, NTproBNP subgroup risk-benefit, Japan target patient count, and US development status.","BioCardia completing responses to PMDA questions; 178 ischemic HF patients across three trials under review.","Focus on autologous cell therapy for patients with few therapeutic options, per CEO Peter Altman."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-029547","json":"https://secwatch.observer/filing/0001437749-25-029547.json","markdown":"https://secwatch.observer/filing/0001437749-25-029547.md","text":"https://secwatch.observer/filing/0001437749-25-029547.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774925029547/0001437749-25-029547-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774925029547/bcda20250919c_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T06:03:46.866136+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"}