Adagio Medical Reports First Quarter 2025 Results

About this update from Adagio Medical Holdings, Inc

[{"type":"text","content":"LAGUNA HILLS, Calif., May 15, 2025--(BUSINESS WIRE)--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 financial results for the first quarter ended March 31, 2025.","length":320,"tagName":"p"},{"type":"text","content":"Recent Business Highlights:","length":27,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Received Breakthrough Device Designation from the U.S. Food and Drug Administration (the "FDA") for the vCLAS™ Cryoablation System ("vCLAS"), for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia ("VT") in patients with ischemic or non-ischemic structural heart disease. The vCLASTM Cryoablation System is currently the subject of the FULCRUM-VT Investigational Device Exemption ("IDE") study designed to support FDA approval. The Breakthrough Device program allows for the FDA to potentially provide Adagio with priority review and interactive communication during the vCLASTM review phase.","length":672,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Surpassed 50% enrollment in the FULCRUM-VT pivotal study. The study, which seeks to enroll 206 patients with ischemic and non-ischemic disease at 20 U.S. and Canadian centers, is on track for completion of patient enrollment in the second half of 2025.","length":252,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Adagio’s Ultra-Low Temperature Cryoablation ("ULTC") and vCLAS technologies were showcased by leading electrophysiologists during multiple scientific sessions at the recent European Heart Rhythm Association (EHRA) and Heart Rhythm Society (HRS) industry meetings.","length":273,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Hired industry veteran Deborah Kaster, who has more than 25 years of leadership experience in the medical technology sector, as Chief Business Officer.","length":151,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Implemented a corporate prioritization initiative focusing all resources on the FULCRUM-VT clinical trial activities and the Company’s new product design optimization program, which has been designed to advance faste...

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