{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-019653","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2026-06-05T12:00:10+00:00","discovered_at":"2026-06-05T12:05:00.413457+00:00","generated_at":"2026-06-05T12:05:37.423586+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"BioCardia: FDA confirms CardiAMP HF II trial may support PMA for HFrEF therapy","bullets":["FDA CBER Q-Sub meeting minutes confirm ongoing CardiAMP HF II trial may support Premarket Approval (PMA) for market clearance.","PMA is the most rigorous FDA device marketing application; previously FDA typically required two trials for large indications like HFrEF.","FDA had previously determined CardiAMP Cell Therapy System safe, enabling CMS reimbursement in trial.","Over 1 million U.S. ischemic HFrEF patients could potentially benefit from CardiAMP Cell Therapy.","Company plans to complete U.S. trial for PMA and submit for regulatory approval in Japan with a post-marketing study."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-019653","json":"https://secwatch.observer/filing/0001437749-26-019653.json","markdown":"https://secwatch.observer/filing/0001437749-26-019653.md","text":"https://secwatch.observer/filing/0001437749-26-019653.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774926019653/0001437749-26-019653-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774926019653/bcda20260605d_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T12:05:37.423586+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"}