{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-032270","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2026-10-07T13:00:12+00:00","discovered_at":"2026-10-07T13:01:00.283621+00:00","generated_at":"2026-10-12T15:58:38.190021+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"BioCardia to present CardiAMP HF II trial design at HFSA; FDA says trial may support approval","bullets":["Poster titled \"Cardiac Delivery of Autologous Minimally Processed Cell Therapy in HFrEF: Multicenter, Double Blind RCT (CardiAMP HF II)\" to be presented at HFSA 2026 in Phoenix, Oct 9-12, 2026.","Study objective: determine efficacy of high-dose autologous cell treatment for ischemic HFrEF patients on guideline-directed medical therapy but with elevated biomarkers of heart stress.","FDA approved Category B designation for CardiAMP cell therapy system in three trials; FDA recently agreed ongoing CardiAMP HF II may support approval.","CEO Peter Altman said the company is advancing the confirmatory CardiAMP HF II trial with world-class centers and has parallel regulatory submissions with FDA and Japan's PMDA."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-032270","json":"https://secwatch.observer/filing/0001437749-26-032270.json","markdown":"https://secwatch.observer/filing/0001437749-26-032270.md","text":"https://secwatch.observer/filing/0001437749-26-032270.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774926032270/0001437749-26-032270-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774926032270/bcda20261007_8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T15:58:38.190021+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"}