ADGM News & Events

Adagio Medical Holdings announced that the U.S. Food and Drug Administration, FDA, has granted Investigational Device Exemption, IDE, approval to expand the Company's FULCRUM-VT trial to evaluate the safety and effectiveness of the Company's next-generation vCLAS Ultra-Low Temperature Ablation Ventricular Ablation System for the treatment of Sustained Monomorphic Ventricular Tachycardia.

"2025 marked a pivotal year for Adagio as our first full year as a public company. We delivered a number of important milestones across the organization, which we believe significantly strengthen our position as we advance our ULTA technology towards commercialization," said Todd Usen, Chief Executive Officer of Adagio. "Importantly, we completed enrollment of the 209-patient FULCRUM-VT pivotal IDE trial in just eleven months, studying a real-world population of patients with both ischemic and non-ischemic cardiomyopathy, all of whom were treated with an endocardial approach. With enrollment now complete, we look forward to presenting pivotal results at the Heart Rhythm Society conference next month. As we advance toward the potential approval of vCLAS, our team is focused on preparing for commercialization while continuing to develop our next generation vCLAS technology. We remain committed to bringing our differentiated and proprietary solutions to the large and underserved population of patients living with ventricular tachycardia."

Adagio Medical Holdings announced the publication of pre-clinical results of the Company's next generation ultra-low temperature ablation, ULTA, technology designed to treat ventricular arrhythmias. The publication, which is titled "Initial Pre-Clinical Evaluation of the Augmented Ultra-Low Temperature Cryoablation Catheter for Ventricular Ablation" was published in the Journal of Cardiovascular Electrophysiology and describes significant functional improvements in ablation catheter performance compared to the Company's first generation vCLAS ULTA catheter, including improved handling characteristics, better compatibility with standard laboratory practices and potential for 50-75% reduction in ablation time. The publication is authored by physicians from several leading ventricular ablation programs in Germany, Belgium and Canada