{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-040763","form_type":"8-K","ticker":"OBIO","cik":"0001814114","company_name":"Orchestra BioMed Holdings, Inc.","filed_at":"2025-04-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.835523+00:00","generated_at":"2026-05-23T04:05:58.072017+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Orchestra BioMed gets FDA Breakthrough Device Designation for AVIM therapy and IDE approval for Virtue SAB trial","bullets":["FDA granted Breakthrough Device Designation for AVIM therapy; covers >7.7M U.S. hypertension patients.","AVIM therapy BDD may expedite FDA review and support higher reimbursement (NTAP/TPT).","FDA approved IDE amendment for Virtue SAB randomized trial vs AGENT paclitaxel DCB for coronary ISR.","Virtue Trial plans 740 patients across 75 U.S. centers; targeting H2 2025 start.","Virtue SAB pilot showed 12-month TLF 2.8% and 6-month late lumen loss 0.12mm."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-040763","json":"https://secwatch.observer/filing/0001104659-25-040763.json","markdown":"https://secwatch.observer/filing/0001104659-25-040763.md","text":"https://secwatch.observer/filing/0001104659-25-040763.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1814114/000110465925040763/0001104659-25-040763-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1814114/000110465925040763/tm2513456d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T04:05:58.072017+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"}