{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-021041","form_type":"8-K","ticker":"BCDA","cik":"0000925741","company_name":"BioCardia, Inc.","filed_at":"2026-06-18T12:00:37+00:00","discovered_at":"2026-06-18T12:05:00.232041+00:00","generated_at":"2026-06-18T12:05:43.855837+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"BioCardia targets Q4 2026 Japan PMDA submission for CardiAMP cell therapy; updates on US trial and pipeline","bullets":["Japan PMDA supports potential approval of CardiAMP for ischemic HFrEF; submission planned for Q4 2026.","Initial Japan target: 20,000 patients; prior cardiac cell therapy reimbursement at $124,000 per procedure.","CardiAMP HF II trial enrolling in US with 4 active centers; FDA may support Premarket Approval.","Helix delivery catheter in discussions with 8 gene/cell therapy programs; allogeneic MSC platform has 2 FDA INDs.","Recent financing closed to fund PMDA submission, US trial enrollment, and partnership discussions."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-021041","json":"https://secwatch.observer/filing/0001437749-26-021041.json","markdown":"https://secwatch.observer/filing/0001437749-26-021041.md","text":"https://secwatch.observer/filing/0001437749-26-021041.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/925741/000143774926021041/0001437749-26-021041-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/925741/000143774926021041/bcda20260617_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-18T12:05:43.855837+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"}