{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-017222","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2026-05-15T12:05:59+00:00","discovered_at":"2026-05-15T12:10:00.409457+00:00","generated_at":"2026-05-15T12:12:15.904965+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"BioCardia Q1 net loss $2.3M; PMDA determines CardiAMP safety/efficacy likely sufficient for Japan approval","bullets":["Net loss $2.3M in Q1 2026 vs $2.7M in Q1 2025; cash $951k as of March 31, 2026.","PMDA Formal Clinical Consultation determined clinical safety and efficacy likely sufficient for market clearance; alignment on foreign data.","FDA expressed no safety concerns, benefits intriguing; confirmed PMA pathway; recommended continuing CardiAMP HF II confirmatory trial.","FDA agreed on two Helix clearance pathways; milestones: Euro PCR presentation Q2 2026, Japan Shonin submission Q4 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-017222","json":"https://secwatch.observer/filing/0001437749-26-017222.json","markdown":"https://secwatch.observer/filing/0001437749-26-017222.md","text":"https://secwatch.observer/filing/0001437749-26-017222.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774926017222/0001437749-26-017222-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774926017222/bcda20260515_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T12:12:15.904965+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"}