{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-102862","form_type":"8-K","ticker":"OBIO","cik":"0001814114","company_name":"Orchestra BioMed Holdings, Inc.","filed_at":"2025-10-28T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.558181+00:00","generated_at":"2026-05-17T01:58:36.340143+00:00","sec_items":["1.01","1.02","3.02","7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Orchestra BioMed restructures Terumo deal: $30M total, retains Virtue SAB rights, starts pivotal trial","bullets":["Terumo pays $10M for ROFR on Virtue SAB coronary rights globally; $20M equity investment via Series A convertible preferred at $100/share.","Prior $30M non-refundable payment and $5M common stock investment unchanged; Terumo total commitment now $65M.","Orchestra BioMed retains full rights for below-the-knee peripheral artery disease and other non-coronary indications.","First patients enrolled in Virtue Trial (U.S. pivotal IDE for coronary ISR, 740 patients, enrollment mid-2027).","Virtue SAB has FDA Breakthrough Device Designation; pilot data showed 12-month TLF 2.8% and zero TLR from 12–36 months."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-102862","json":"https://secwatch.observer/filing/0001104659-25-102862.json","markdown":"https://secwatch.observer/filing/0001104659-25-102862.md","text":"https://secwatch.observer/filing/0001104659-25-102862.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1814114/000110465925102862/0001104659-25-102862-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1814114/000110465925102862/tm2529597d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T01:58:36.340143+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"}