Adagio Medical Holdings, Inc. (Nasdaq: ADGM; the “Company”), a leading innovator in catheter ablation technologies for treatment of cardiac arrhythmias, today announced a corporate restructuring and realignment of resources to prioritize its FULCRUM-VT US pivotal investigational device exemption (“Pivotal IDE”) clinical trial activities and its new product design optimization program. “After a comprehensive strategic review, we are doubling down on the priorities that will drive the most meaningful impact for physicians, patients, and shareholders,” said Todd Usen, the Chief Executive Officer of Adagio. “Our resources are now focused on the completion of the FULCRUM-VT Pivotal IDE trial and subsequent premarket approval of the VT Cryoablation System with vCLAS™ catheter from the U.S. Food and Drug Administration (“FDA”). With over 35% enrollment complete, we, along with our physicians, are very encouraged by the system’s performance and early outcomes. In addition, we will dedicate the appropriate resources to our product design optimization program, which allows us to design, iterate and innovate more efficiently. We believe that this focused approach is crucial to position Adagio as a leader in ventricular tachycardia solutions, which has been a historically underserved market.”

The streamlining of the Company operations includes a pause in the limited European launch of the vCLAS catheter, while the product design optimization program is instituted. The limited launch provided valuable insights from European electrophysiology professionals, including gaining a more in-depth understanding of the broad applicability and unique clinical benefits of Adagio’s proprietary ultra-low temperature cryoablation technology.

With a narrower focus on key initiatives, the restructuring includes a reduction in force, effective February 28, 2025. This is expected to enable additional investment in the aforementioned critical priorities.

“The decision to part with valued colleagues is difficult, and we have deep gratitude for their contributions,” continued Mr. Usen. “We wish them the very best and will strive to build upon their efforts. I have tremendous confidence in Adagio’s future, and believe that our highly differentiated and validated technology will drive the best clinical results for our physicians and, ultimately, the best outcomes for ventricular tachycardia patients.”

About FULCRUM-VT

FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia, NCT05675865) 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 (“VT”) in accordance with current treatment guidelines. The results of the study will be used to obtain premarket approval from the FDA for Adagio’s VT Cryoablation System with the vCLAS™ cryoablation catheter with industry’s broadest indication for purely endocardial ablation of scar-mediated VT.

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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