Adagio Medical Holdings, Inc. (NASDAQ:ADGM, the "Company")), a leading innovator in catheter ablation technologies, provided updates today on the progress in its streamlined focus on leadership in ventricular tachycardia ("VT") solutions.
Recent Business Highlights:
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The Company will participate in the scientific program of the 2025 European Heart Rhythm Association (the "Association") Annual Meeting to be held from March 30 through April 1 in Vienna, Austria.
- At the Association's Ablation Innovation Summit, Dr. Tom De Potter, MD, PhD Associate Director, Cardiovascular Center at AZORG hospital in Aalst, Belgium will deliver a lecture on the use of the Company's proprietary ultra-low temperature cryoablation ("ULTC") technology for treatment of scar-related monomorphic ventricular tachycardia.
- In addition, Professor Mark Gallagher, MD from St. George's University Hospital in London, UK, will present a first-in-human case series using ULTC for ablation of premature ventricular complexes ("PVC"). The ablations of idiopathic PVCs constitute over half of current VT ablation cases. ULTC uniquely addresses some of the procedural challenges associated with these ablations.
- The Company announced that the FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia, NCT05675865) IDE Pivotal Study is over 40% enrolled. The trial, designed to support US premarket approval of the VT Cryoablation System with the vCLAS™ catheter is on track for completion of full patient enrollment in the second half of 2025. FULCRUM-VT is a prospective, multi-center, open-label, single-arm study, enrolling 206 patients with structural heart disease of both ischemic and non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory ventricular tachycardia in accordance with current treatment guidelines.
- In alignment with its key initiatives, prioritizing the FULCRUM VT US pivotal trial and product design optimization, the Company announced that John Dahldorf, the Company's CFO, has decided to leave the Company, effective March 21, 2025. Mr. Dahldorf will be replaced by a transitional CFO.
"I'm extremely pleased with the FULCRUM-VT enrollment progress and the expanded use of the vCLAS™ catheter by European thought leaders. This speaks to how effectively our Company's products address a universally recognized market need for purpose-built VT ablation technology," said Todd Usen, Chief Executive Officer ("CEO") of the Company. "I'd also like to thank John for his support as I took over the CEO position at the Company, and I sincerely wish him the best. We are confident we have the financial resources and the corporate structure to achieve our goals and drive the most meaningful impact for physicians, patients, and shareholders."
About Adagio Medical Holdings, Inc.
Adagio Medical Holdings, Inc. (NASDAQ:ADGM) is an early commercial stage medical device company located in Laguna Hills, California focused on developing proprietary Ultra-Low Temperature Cryoablation technology that creates contiguous, transmural lesions to treat cardiac arrhythmias, with an emphasis on ventricular tachycardia.
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