{"filing":{"accession_number":"0001437749-26-018670","cik":"0000925741","ticker":"BCDA","company_name":"BioCardia, Inc.","form":"8-K","filing_date":"2026-05-28","report_date":null,"primary_document":"bcda20260528_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/925741/000143774926018670/bcda20260528_8k.htm"},"events":[{"id":8513,"run_id":7472,"accession_number":"0001437749-26-018670","anchor_item_number":"7.01","event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"summary":"BioCardia disclosed a positive Consultation Record from Japan's PMDA supporting regulatory submission for CardiAMP cell therapy for ischemic HFrEF, with clinical trial results showing positive outcomes (179-second improvement in exercise tolerance, 82% reduction in angina episodes) and no major adverse cardiac events. While this is a significant regulatory milestone affecting market opportunity (estimated 20,000 eligible patients in Japan), it does not fit neatly into the standard event taxonomy—it is neither an earnings release (no financial results), nor a material impairment, litigation, or M\u0026A event. The disclosure is material to investors as it represents meaningful regulatory progress toward commercialization in a major market.","company_name":"BioCardia, Inc.","ticker":"BCDA","filing_date":"2026-05-28","form":"8-K","submitted_at":null,"items":[{"id":2431,"accession_number":"0001437749-26-018670","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"reasoning":"BioCardia disclosed a positive Consultation Record from Japan's PMDA supporting regulatory submission for CardiAMP cell therapy for ischemic HFrEF, with clinical trial results showing positive outcomes (179-second improvement in exercise tolerance, 82% reduction in angina episodes) and no major adverse cardiac events. While this is a significant regulatory milestone affecting market opportunity (estimated 20,000 eligible patients in Japan), it does not fit neatly into the standard event taxonomy—it is neither an earnings release (no financial results), nor a material impairment, litigation, or M\u0026A event. The disclosure is material to investors as it represents meaningful regulatory progress toward commercialization in a major market.","classifier_version":"claude-haiku-4-5-20251001+prompt-9e0ffca5","taxonomy_version":"v1","classified_at":"2026-05-29T02:45:02.864181+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":2431,"accession_number":"0001437749-26-018670","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"reasoning":"BioCardia disclosed a positive Consultation Record from Japan's PMDA supporting regulatory submission for CardiAMP cell therapy for ischemic HFrEF, with clinical trial results showing positive outcomes (179-second improvement in exercise tolerance, 82% reduction in angina episodes) and no major adverse cardiac events. While this is a significant regulatory milestone affecting market opportunity (estimated 20,000 eligible patients in Japan), it does not fit neatly into the standard event taxonomy—it is neither an earnings release (no financial results), nor a material impairment, litigation, or M\u0026A event. The disclosure is material to investors as it represents meaningful regulatory progress toward commercialization in a major market.","classifier_version":"claude-haiku-4-5-20251001+prompt-9e0ffca5","taxonomy_version":"v1","classified_at":"2026-05-29T02:45:02.864181+00:00","company_name":"BioCardia, Inc.","ticker":"BCDA","filing_date":"2026-05-28"}]}
