{"filing":{"accession_number":"0001437749-26-031011","cik":"0000925741","ticker":"BCDA","company_name":"BioCardia, Inc.","form":"8-K","filing_date":"2026-09-23","report_date":"2026-09-23","primary_document":"bcda20260923_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/925741/000143774926031011/bcda20260923_8k.htm"},"events":[{"id":34519,"run_id":31763,"accession_number":"0001437749-26-031011","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"BioCardia disclosed timing and progress updates on two regulatory milestones: (1) a planned Shonin pre-market submission to Japan's PMDA in Q4 2026 for CardiAMP HF with potential market clearance by Q4 2027, and (2) an intended De Novo pre-submission for the Helix Transendocardial Delivery Catheter System to the FDA this quarter. These are material operational and regulatory developments affecting the company's product pipeline advancement, though they do not constitute a completed transaction, earnings release, or other specifically-named event type. The disclosure is material because regulatory progress on clinical-stage therapeutics directly affects investor assessment of the company's near-term value drivers and commercialization prospects.","company_name":"BioCardia, Inc.","ticker":"BCDA","filing_date":"2026-09-23","form":"8-K","submitted_at":null,"items":[{"id":38264,"accession_number":"0001437749-26-031011","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"BioCardia disclosed timing and progress updates on two regulatory milestones: (1) a planned Shonin pre-market submission to Japan's PMDA in Q4 2026 for CardiAMP HF with potential market clearance by Q4 2027, and (2) an intended De Novo pre-submission for the Helix Transendocardial Delivery Catheter System to the FDA this quarter. These are material operational and regulatory developments affecting the company's product pipeline advancement, though they do not constitute a completed transaction, earnings release, or other specifically-named event type. The disclosure is material because regulatory progress on clinical-stage therapeutics directly affects investor assessment of the company's near-term value drivers and commercialization prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-23T13:18:06.539640+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":38264,"accession_number":"0001437749-26-031011","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"BioCardia disclosed timing and progress updates on two regulatory milestones: (1) a planned Shonin pre-market submission to Japan's PMDA in Q4 2026 for CardiAMP HF with potential market clearance by Q4 2027, and (2) an intended De Novo pre-submission for the Helix Transendocardial Delivery Catheter System to the FDA this quarter. These are material operational and regulatory developments affecting the company's product pipeline advancement, though they do not constitute a completed transaction, earnings release, or other specifically-named event type. The disclosure is material because regulatory progress on clinical-stage therapeutics directly affects investor assessment of the company's near-term value drivers and commercialization prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-23T13:18:06.539640+00:00","company_name":"BioCardia, Inc.","ticker":"BCDA","filing_date":"2026-09-23"}]}