Adagio Medical Announces Restructuring to Accelerate US IDE Trial and Innovation
Adagio Medical Holdings, Inc. (Nasdaq: ADGM), a leader in catheter ablation technologies for treating cardiac arrhythmias, today announced a strategic restructuring aimed at prioritizing its FULCRUM-VT US pivotal investigational device exemption (Pivotal IDE) clinical trial and advancing its product design optimization program.
Todd Usen, CEO of Adagio, stated, “After a thorough strategic review, we are focusing our efforts on initiatives that will have the most significant impact for physicians, patients, and shareholders. Our resources are now dedicated to completing the FULCRUM-VT Pivotal IDE trial and securing premarket approval for the VT Cryoablation System with vCLAS™ catheter from the U.S. Food and Drug Administration (FDA). With over 35% of enrollment complete, we are encouraged by the system’s performance and early outcomes, alongside our physician partners.”
In addition to focusing on the trial, Adagio will invest resources into its product design optimization program. This initiative aims to enhance the company’s ability to efficiently design, iterate, and innovate, positioning Adagio as a leader in the underserved ventricular tachycardia market.
Adagio Medical Holdings, Inc. (Nasdaq: ADGM), a leading innovator in catheter ablation technologies for cardiac arrhythmias, has announced a strategic restructuring aimed at prioritizing critical initiatives, including its FULCRUM-VT US pivotal investigational device exemption (Pivotal IDE) clinical trial and its product design optimization program. The restructuring will involve a pause in the limited European launch of the vCLAS catheter while the company focuses its resources on advancing these key priorities.
The limited European launch of the vCLAS catheter provided valuable insights from European electrophysiology professionals. These insights deepened Adagio’s understanding of the broad applicability and unique clinical benefits of its proprietary ultra-low temperature cryoablation technology. This feedback will be instrumental in refining the product and preparing for future global market launches.
With a sharper focus on its core initiatives, Adagio’s restructuring plan also includes a reduction in force, effective February 28, 2025. This difficult decision aims to streamline the company’s operations and reallocate resources to accelerate progress on its critical priorities, such as the completion of the FULCRUM-VT trial and product design improvements.
CEO Todd Usen acknowledged the impact of this decision, stating, “The decision to part with valued colleagues is difficult, and we have deep gratitude for their contributions. We wish them the very best and will strive to build upon their efforts. I have tremendous confidence in Adagio’s future, and I 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.”
The FULCRUM-VT trial (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia, NCT05675865) is a pivotal study designed to evaluate the safety and effectiveness of the VT Cryoablation System with the vCLAS™ cryoablation catheter. The trial is a prospective, multi-center, open-label, single-arm study that is enrolling 206 patients with structural heart disease, including those with ischemic and non-ischemic cardiomyopathy. Participants are indicated for catheter ablation of drug-refractory ventricular tachycardia (VT) in accordance with current treatment guidelines.
The FULCRUM-VT trial results will be used to seek premarket approval from the U.S. Food and Drug Administration (FDA) for Adagio’s VT Cryoablation System. This system is the first in the industry to offer a broad indication for purely endocardial ablation of scar-mediated VT, a condition that significantly impacts patient quality of life and can be life-threatening if not properly managed.
Adagio Medical Holdings is committed to advancing its proprietary Ultra-Low Temperature Cryoablation technology, which is designed to create contiguous, transmural lesions to treat a range of cardiac arrhythmias, with a particular emphasis on ventricular tachycardia (VT). The company is focused on providing physicians with cutting-edge tools to improve patient outcomes, and its technology has the potential to revolutionize the treatment of VT, a historically underserved market.
Despite the challenges posed by the restructuring, Adagio is optimistic about its future prospects. The company is aligning its resources and efforts to position itself as a leader in the field of cardiac arrhythmia treatments. The progress made in the FULCRUM-VT trial and the advancements in product design are key to the company’s long-term success and its mission to improve the lives of patients suffering from ventricular tachycardia.
About Adagio Medical Holdings, Inc.
Adagio Medical Holdings, Inc. (Nasdaq: ADGM) is a medical device company based in Laguna Hills, California, focused on developing proprietary Ultra-Low Temperature Cryoablation technology for the treatment of cardiac arrhythmias, particularly ventricular tachycardia. The company is dedicated to improving patient outcomes by offering innovative, effective solutions for physicians and patients dealing with complex heart conditions.
