{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-048833","form_type":"8-K","ticker":"ADGM","cik":"0002006986","company_name":"Adagio Medical Holdings, Inc.","filed_at":"2026-04-27T23:59:59+00:00","discovered_at":"2026-05-14T18:02:33.373623+00:00","generated_at":"2026-05-15T04:05:17.797479+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Adagio Medical reports positive pivotal vCLAS ventricular ablation trial results","bullets":["84% freedom from ICD shock and 59% freedom from VT recurrence at 6 months in FULCRUM-VT study.","2.4% protocol-defined major adverse events; 98% non-inducibility of targeted VT at end of procedure.","Equivalent outcomes for ischemic and non-ischemic cardiomyopathy patients from endocardial approach.","72% of patients discontinued or reduced amiodarone dose at 6 months; low 1.9% VT-related readmission rate.","Results from 209-patient IDE trial to support FDA Premarket Approval application for vCLAS system."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-048833","json":"https://secwatch.observer/filing/0001104659-26-048833.json","markdown":"https://secwatch.observer/filing/0001104659-26-048833.md","text":"https://secwatch.observer/filing/0001104659-26-048833.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/2006986/000110465926048833/0001104659-26-048833-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/2006986/000110465926048833/tm2612751d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T04:05:17.797479+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"}