secwatch.observer — SEC 8-K summary
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Issuer:     Adagio Medical Holdings, Inc. (ADGM)
CIK:        0002006986
Form:       8-K
Filed at:   2025-10-01T23:59:59+00:00
Accession:  0001104659-25-095343
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Adagio completes enrollment in FULCRUM-VT pivotal IDE study for vCLAS cryoablation system
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2006986/000110465925095343/0001104659-25-095343-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2006986/000110465925095343/tm2527681d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-095343

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer