{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-011992","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2025-04-15T23:59:59+00:00","discovered_at":"2026-05-14T18:02:51.848344+00:00","generated_at":"2026-05-23T15:15:49.194176+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"BioCardia CardiALLO heart failure trial passes DSMB review; no safety issues","bullets":["DSMB recommends study continue as designed after 30-day safety review of 20M-cell dosing cohort.","No treatment-emergent major adverse cardiac events or immune reactions observed.","Company plans to enroll 39 participants in the US for Phase 1/2 CardiALLO-HF trial.","CEO cites potential for nondilutive funding and partnering, and future pivotal trial in USA, Japan.","High-dose arm targets patients with active inflammation, at least 2x effective dose of prior MSC studies."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-011992","json":"https://secwatch.observer/filing/0001437749-25-011992.json","markdown":"https://secwatch.observer/filing/0001437749-25-011992.md","text":"https://secwatch.observer/filing/0001437749-25-011992.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774925011992/0001437749-25-011992-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774925011992/bcda20250415_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T15:15:49.194176+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"}