{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-035408","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2026-11-06T13:30:10+00:00","discovered_at":"2026-11-06T13:35:00.415540+00:00","generated_at":"2026-11-06T13:35:15.327818+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"BioCardia completes PMDA consultation for CardiAMP, advancing toward Japan marketing approval filing","bullets":["BioCardia (NASDAQ: BCDA) completed the PMDA consultation on application materials for its CardiAMP Cell Therapy System for ischemic heart failure in Japan.","CEO Peter Altman said the company is targeting treatment of first patients in Japan and realization of commercial revenues in 2028.","CardiAMP has been evaluated in three clinical trials involving more than 200 patient procedures, including two randomized, double-blind, placebo-controlled trials.","BioCardia cautioned that completion of the consultation does not constitute approval; CardiAMP remains subject to PMDA review and Japanese regulatory requirements.","The announcement came via press release dated November 6, 2026, furnished under Item 8.01 with Exhibit 99.1."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-035408","json":"https://secwatch.observer/filing/0001437749-26-035408.json","markdown":"https://secwatch.observer/filing/0001437749-26-035408.md","text":"https://secwatch.observer/filing/0001437749-26-035408.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774926035408/0001437749-26-035408-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774926035408/bcda20261104_8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-11-06T13:35:15.327818+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"}