Release Details

LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Apr. 1, 2026-- 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 the pivotal results from the FULCRUM-VT study have been accepted for presentation in a late-breaking clinical science session at Heart Rhythm 2026 (HRS), the annual meeting of the Heart Rhythm Society. This is the first Investigational Device Exemption (IDE) study powered to evaluate the safety and effectiveness of Ultra-Low Temperature Ablation (“ULTA”, formerly “ULTC”) for the treatment of scar-related ventricular tachycardia (VT) in both ischemic and non-ischemic population.

“Having FULCRUM-VT data selected for a late-breaking session at HRS is a testament to the significance of this work,” said Matthew Hakimi, M.D., Cardiac Electrophysiologist, Cedars Sinai Medical Center and Medical Director at Adagio Medical. “On behalf of the entire Adagio team, I want to recognize the investigators, research coordinators, and patients whose dedication and perseverance made this study possible. Completing FULCRUM-VT marks a significant milestone — not just for Adagio, but for the millions of patients living with the burden of VT. We look forward to the results being shared by the investigators at HRS and the potential for these data to advance care for VT patients.”

The details of the late-breaking session are as follows:

Adagio Medical will be hosting an event for analysts and institutional investors at 8:00 a.m. eastern time on Monday, April 27. During the webcast, Dr. Atul Verma, M.D. will present the results of the FULCRUM-VT study and then will be joined by Dr. William Stevenson, M.D., Professor of Medicine, Vanderbilt University Medical Center and Principal Investigator for FULCRUM-VT at Vanderbilt, and Dr. Matthew Hakimi, M.D. to discuss the results and answer questions from investors about the study.

Investors and interested parties may join the live webcast through the registration link or by visiting the Investor Relations section of the Company's website at https://investors.adagiomedical.com. Pre-registration for the webcast is available beginning today. A replay of the webcast will be made available after the event.

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 Ablation (ULTA, formerly known as ULTC) technology. ULTA is designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue, all through an endocardial approach. The Company is currently focused on the treatment of ventricular arrhythmias with its purpose-built vCLAS™ Cryoablation System, which is CE Marked and is currently under evaluation in the Company’s FULCRUM-VT U.S. Pivotal IDE Trial.

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 trial, which has fully enrolled 209 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 U.S. Food and Drug Administration (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 VT 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: the potential for data from the FULCRUM-VT study to advance care for VT patients; Adagio’s research, development and regulatory plans for its product candidates; and communications with the FDA. 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, 2025 , which is 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260401806541/en/

Debbie Kaster
Chief Financial Officer and Chief Business Officer
dkaster@adagiomedical.com

Source: Adagio Medical Holdings, Inc.