{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-037910","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2025-12-16T23:59:59+00:00","discovered_at":"2026-05-14T18:02:42.642803+00:00","generated_at":"2026-05-16T13:09:18.008328+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"BioCardia advances CardiAMP Cell Therapy to formal PMDA consultation for HFrEF in Japan","bullets":["Completed third preliminary clinical consultation with Japan's PMDA for CardiAMP Cell Therapy (HFrEF).","PMDA will allow BioCardia to proceed to formal clinical consultation; potential path to regulatory filing.","Data from three completed Phase I-III trials show improved survival, reduced MACE, and better heart function vs control.","CEO Peter Altman notes therapy offers a new mechanism of microvascular repair for ischemic HFrEF patients."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-037910","json":"https://secwatch.observer/filing/0001437749-25-037910.json","markdown":"https://secwatch.observer/filing/0001437749-25-037910.md","text":"https://secwatch.observer/filing/0001437749-25-037910.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774925037910/0001437749-25-037910-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774925037910/bcda20251216_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T13:09:18.008328+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"}