{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-24-036648","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2024-12-04T23:59:59+00:00","discovered_at":"2026-05-14T18:03:11.412894+00:00","generated_at":"2026-05-29T09:14:43.386739+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"BioCardia gets positive PMDA consultation; next step after final CardiAMP HF data in Q1 2025","bullets":["Completed consultation with Japan PMDA; PMDA invited next consultation after submission of final 2-year follow-up data.","PMDA remains open to using CardiAMP Heart Failure Trial and prior trials for registration in Japan.","Company anticipates final data from 125-patient CardiAMP HF trial in Q1 2025.","BCDA-01 holds FDA Breakthrough Designation; U.S. trials supported by CMS reimbursement."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-24-036648","json":"https://secwatch.observer/filing/0001437749-24-036648.json","markdown":"https://secwatch.observer/filing/0001437749-24-036648.md","text":"https://secwatch.observer/filing/0001437749-24-036648.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774924036648/0001437749-24-036648-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774924036648/bcda20241204_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T09:14:43.386739+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"}