PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted

Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market

Adagio Medical Holdings, Inc (NASDAQ:ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval ("PMA") application to the U.S. Food and Drug Administration ("FDA") for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia ("VT") in patients with ischemic or non-ischemic structural heart disease.

The PMA submission is supported by the FULCRUM-VT pivotal IDE trial, a single-arm study that enrolled 209 patients across 20 leading electrophysiology centers. The trial achieved 97.4% acute clinical success and demonstrated compelling 6-month outcomes, including 84.3% freedom from ICD shock, only 2.4% major adverse events and a 78% reduction or elimination of anti-arrhythmic drug ("AAD") use. Importantly, vCLAS demonstrated equivalent clinical effectiveness in both ischemic and non-ischemic cardiomyopathy, addressing the largest unmet need in VT ablation today.