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Adagio Medical FULCRUM-VT U.S. Pivotal Study Acute Results to be Presented in Late-Breaking Session at VT Symposium

By: via Business Wire

Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that acute results from the Company’s FULCRUM-VT U.S. pivotal study have been accepted for presentation in a late-breaking clinical science session at The 20th Annual International Symposium on Ventricular Arrhythmias, being held from October 10- 11, 2025 at the Philadelphia Marriott Downtown. The Investigational Device Exemption (“IDE”) study is the first study powered to evaluate the safety and effectiveness of Ultralow Temperature Cryoablation (“ULTC”) for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT) in patients with both ischemic and nonischemic cardiomyopathy.

“We are delighted that the FULCRUM-VT acute data will be featured as part of a late-breaking session at VT Symposium,” said Todd Usen, Chief Executive Officer of Adagio Medical. “On behalf of the entire Adagio Medical team, I want to thank all of the investigators, research coordinators and patients who have supported this study and whose commitment to serving this underserved population of patients will bring us one step closer to a purpose-built solution for VT. We thank the VT Symposium for this opportunity, and we look forward to the results being shared in Philadelphia.”

Adagio Medical’s ULTC technology will be featured in the following presentations during the VT Symposium:

Friday October 10, 2025
SESSION VI: Late Breaking + New/Ongoing Trial Results/Information

Presentation Title:

Ultralow Temperature Cryoablation of Ventricular Tachycardia: Interim Analysis of Acute Outcomes of the FULCRUM-VT Trial

Time:

3:30- pm Eastern Time

Presenter:

Travis D. Richardson, MD, Assistant Professor of Medicine, Cardiac Electrophysiology, Vanderbilt University Medical Center

Saturday October 11, 2025
SESSION XIV VT Potpourri

Presentation Title:

Ultracool Cryoablation for VT: Initial Experience

Time:

3:05-3:15pm Eastern Time

Presenter:

Gregory E. Supple, MD, FACC, FHRS, Associate Professor of Clinical Medicine

Director, Cardiac Electrophysiology Fellowship Program, Associate Director, Electrophysiology Laboratory, Director, Inpatient EP Services at the Hospital of the University of Pennsylvania Perelman School of Medicine

 
SESSION XVI: Pulsed Field Ablation of VT

Presentation Title:

Pulse Field Ultra-Low Temperature Cryoablation: Lesion Creation and Effect on Coronary Arteries in a Swine Model

Time:

5:05-5:15pm Eastern Time

Presenter:

Edward P. Gerstenfeld, MD, MS, Cardiology Chief, Cardiac Electrophysiology and Arrhythmia, UCSF Health

About Adagio Medical Holdings, Inc.

Adagio is a medical device company focused on developing and commercializing products for the treatment of cardiac arrhythmias utilizing its novel, proprietary, catheter-based Ultra-Low Temperature Cryoablation (ULTC) technology. ULTC is designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue. The Company is currently focused on the treatment of ventricular tachycardia (VT) with its purpose-built vCLAS™ Cryoablation System, which is CE Marked and is currently under evaluation in the Company’s FULCRUM-VT U.S. IDE Pivotal Study.

About FULCRUM VT

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

Adagio’s vCLAS™ Cryoablation System is commercially available for the treatment of monomorphic ventricular tachycardia in Europe and select other geographies but is limited to investigational use in the United States.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” “plans,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: Adagio’s research, development and regulatory plans for its product candidates and Adagio’s ability to bring its proprietary ULTC solutions to patients. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio’s business are described in detail in Adagio’s Securities and Exchange Commission (“SEC”) filings, including in its Annual Report on Form 10-K for the full-year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, which are available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Adagio disclaims any obligation to update these statements except as may be required by law.

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