{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-23-022787","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2023-08-09T23:59:59+00:00","discovered_at":"2026-05-14T18:03:37.058431+00:00","generated_at":"2026-06-12T00:05:13.546243+00:00","sec_items":["2.02","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"BioCardia pauses BCDA-01 heart failure trial after DSMB says likely to miss primary endpoint","bullets":["DSMB recommended pause in BCDA-01 Phase III trial for ischemic heart failure after review shows unlikely to meet FS composite endpoint; no safety issues.","Q2 2023 revenue $43K, down from $974K YoY; net loss $3.4M vs $2.5M; net cash used in ops $3.2M vs $2.6M.","BCDA-02 chronic myocardial ischemia trial expects roll-in cohort completion Q4 2023; BCDA-03 allogeneic trial expects first patient Q3 2023.","Japan PMDA formal consultation for BCDA-01 accepted; Helix platform patent granted in Japan and European intention to grant."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-23-022787","json":"https://secwatch.observer/filing/0001437749-23-022787.json","markdown":"https://secwatch.observer/filing/0001437749-23-022787.md","text":"https://secwatch.observer/filing/0001437749-23-022787.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774923022787/0001437749-23-022787-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774923022787/bcda20230808_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-12T00:05:13.546243+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":[{"claim_id":"d0bdf0c8bc26786e6bddce3f8737c85377535658","claim":"BioCardia, Inc. reported financial results for second quarter of 2023.","evidence_excerpt":"today reports financial results for the second quarter of 2023","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/925741/000143774923022787/0001437749-23-022787-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"second quarter of 2023"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}