{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-010967","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2026-04-02T23:59:59+00:00","discovered_at":"2026-05-14T18:02:33.943718+00:00","generated_at":"2026-05-15T07:55:09.664679+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"BioCardia files FDA meeting request for CardiAMP HF accelerated approval; subgroup shows risk reduction","bullets":["Submitted CardiAMP HF clinical study data to FDA; meeting expected Q2 2026 under Breakthrough Designation.","Subgroup with elevated biomarkers showed 47% relative risk reduction in all-cause cardiac death.","Same subgroup had 37% relative risk reduction in non-fatal major adverse cardiac events (stroke, MI, hospitalization).","Quality of life improvements were statistically significant (p=0.04) in the elevated-biomarker subgroup.","Seeking accelerated approval for CardiAMP System in ischemic HFrEF."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-010967","json":"https://secwatch.observer/filing/0001437749-26-010967.json","markdown":"https://secwatch.observer/filing/0001437749-26-010967.md","text":"https://secwatch.observer/filing/0001437749-26-010967.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774926010967/0001437749-26-010967-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774926010967/bcda20260402_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T07:55:09.664679+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"}