{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-098701","form_type":"8-K","ticker":"ADGM","cik":"0002006986","company_name":"Adagio Medical Holdings, Inc.","filed_at":"2025-10-10T23:59:59+00:00","discovered_at":"2026-05-14T18:02:41.267541+00:00","generated_at":"2026-05-17T04:06:54.757296+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Adagio Medical reports 97.4% acute effectiveness in FULCRUM-VT pivotal study for VT ablation","bullets":["207 patients enrolled at 19 U.S./Canadian sites; 97.4% acute clinical success (non-inducibility of target VTs).","Major adverse event rate 2.5%; four peri-procedural deaths (1.9%), one device-related (0.5%).","Study included ICM and NICM patients (mean LVEF 35%, 75% with CHF); mean procedure time 206 min.","ULTC system uses -196°C cryoablation without irrigation; 6-month primary endpoint expected at HRS 2026.","Next-generation 8.5Fr catheter with shorter ablations in development."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-098701","json":"https://secwatch.observer/filing/0001104659-25-098701.json","markdown":"https://secwatch.observer/filing/0001104659-25-098701.md","text":"https://secwatch.observer/filing/0001104659-25-098701.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/2006986/000110465925098701/0001104659-25-098701-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/2006986/000110465925098701/tm2528457d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T04:06:54.757296+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"}