{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-095343","form_type":"8-K","ticker":"ADGM","cik":"0002006986","company_name":"Adagio Medical Holdings, Inc.","filed_at":"2025-10-01T23:59:59+00:00","discovered_at":"2026-05-14T18:02:41.267265+00:00","generated_at":"2026-05-17T05:09:11.768794+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Adagio completes enrollment in FULCRUM-VT pivotal IDE study for vCLAS cryoablation system","bullets":["Enrolled 208 patients across 20 U.S. and Canadian centers for vCLAS System to treat monomorphic ventricular tachycardia.","Study results support PMA application; FDA granted Breakthrough Device Designation for vCLAS.","Primary efficacy endpoint: six-month freedom from recurrent MMVT without new/increased antiarrhythmic drugs.","Company anticipates FDA PMA approval by year-end 2026, consistent with prior guidance.","vCLAS System commercially available in Europe for MMVT; limited to investigational use in the U.S."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-095343","json":"https://secwatch.observer/filing/0001104659-25-095343.json","markdown":"https://secwatch.observer/filing/0001104659-25-095343.md","text":"https://secwatch.observer/filing/0001104659-25-095343.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/2006986/000110465925095343/0001104659-25-095343-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/2006986/000110465925095343/tm2527681d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:09:11.768794+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"}