Adagio Medical Announces Key Clinical and Business Developments
Adagio Medical Holdings, Inc. (Nasdaq: ADGM), a leader in catheter ablation technologies, has provided an update on its strategic focus and progress in advancing ventricular tachycardia (VT) solutions. The company continues to refine its approach to VT ablation, leveraging its innovative ultra-low temperature cryoablation (ULTC) technology to improve patient outcomes.
Recent Business and Clinical Milestones
Participation in the 2025 European Heart Rhythm Association (EHRA) Annual Meeting
Adagio Medical will participate in the European Heart Rhythm Association (EHRA) Annual Meeting from March 30 to April 1, 2025, in Vienna, Austria. This event serves as a critical platform for showcasing cutting-edge advancements in cardiac rhythm management, particularly in VT treatment.
As part of the meeting’s Ablation Innovation Summit, two leading cardiologists will present findings on the company’s proprietary ULTC technology:
- Dr. Tom De Potter, MD, PhD, Associate Director of the Cardiovascular Center at AZ ORG Hospital in Aalst, Belgium, will deliver a lecture on ULTC’s use for treating scar-related monomorphic ventricular tachycardia. His presentation will highlight the advantages of this advanced technology in treating VT patients who have structural heart disease.
- Professor Mark Gallagher, MD, from St. George’s University Hospital in London, UK, will present a first-in-human case series evaluating ULTC for the ablation of premature ventricular complexes (PVCs). Idiopathic PVCs account for over half of all VT ablation cases, and ULTC has the potential to overcome procedural challenges commonly associated with these cases.
These presentations underscore the growing adoption of ULTC technology in VT ablation and its potential to become a standard approach in addressing ventricular arrhythmias.
Progress in the FULCRUM-VT Pivotal Trial
Adagio Medical has also made significant progress in its FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) IDE Pivotal Study (NCT05675865). This trial aims to support U.S. premarket approval (PMA) for Adagio’s VT Cryoablation System, featuring the vCLAS™ catheter.
The FULCRUM-VT study has now surpassed 40% enrollment, with full patient enrollment expected to be completed by the second half of 2025. The study is a prospective, multi-center, open-label, single-arm trial enrolling 206 patients diagnosed with ischemic and non-ischemic cardiomyopathy who require catheter ablation for drug-refractory VT.
The trial design aligns with current treatment guidelines for VT ablation and seeks to demonstrate the safety and efficacy of ULTC technology in treating patients with structural heart disease. If successful, this pivotal study will pave the way for FDA approval of Adagio’s VT Cryoablation System, marking a major milestone for the company in bringing next-generation VT ablation technology to the U.S. market.
Leadership Transition: CFO Departure and Strategic Focus
As part of its continued commitment to optimizing its product pipeline and clinical research, Adagio Medical is making changes to its leadership team.
The company announced that John Dahldorf, Chief Financial Officer (CFO), will be leaving his position on March 21, 2025. A transitional CFO will take over as Adagio realigns its strategic priorities to focus on the FULCRUM-VT pivotal trial and product design optimization.
CEO Todd Usen expressed gratitude for Dahldorf’s contributions, stating:
“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. I’d also like to thank John for his support as I took over the CEO position, 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.”
This transition reflects Adagio Medical’s long-term commitment to streamlining its operations and maintaining a strong financial foundation as it advances its VT solutions toward commercialization.
The Growing Market Need for VT Ablation Solutions
VT remains one of the most challenging and life-threatening cardiac arrhythmias, particularly in patients with structural heart disease. Traditional radiofrequency (RF) and conventional cryoablation methods often face limitations in achieving long-term success due to incomplete lesion formation and difficulties in targeting arrhythmogenic substrates within scarred myocardium.
Adagio’s ULTC technology is specifically designed to overcome these challenges by offering:
- Deeper, more durable lesions compared to traditional cryoablation
- Shorter procedure times, improving efficiency for electrophysiologists
- Minimal collateral damage to surrounding cardiac tissue
- Increased precision in targeting arrhythmogenic foci
By focusing on ULCT for VT ablation, Adagio is addressing an unmet clinical need and positioning itself as a leader in next-generation electrophysiology technologies.
Future Outlook: Driving Innovation in VT Treatment
With the FULCRUM-VT pivotal study progressing ahead of schedule, increased clinical adoption of the vCLAS™ catheter in Europe, and continued engagement with key opinion leaders in the electrophysiology field, Adagio Medical is well-positioned for future growth.
The company’s strong focus on VT solutions, backed by ongoing clinical research and strategic corporate initiatives, highlights its commitment to advancing cardiac ablation technologies and improving patient outcomes worldwide.
As the FULCRUM-VT trial approaches full enrollment and regulatory approvals progress, Adagio Medical’s innovations in ULTC-based VT ablation are poised to transform the treatment landscape for ventricular arrhythmias.
