Adagio Medical Ultralow Temperature Ablation U.S. Pivotal Study Results to be Presented in Late-Breaking Session at Heart Rhythm Society 2026

Key Terms

investigational device exemption (ide) regulatory

An investigational device exemption (IDE) is a regulatory permission that allows a medical device to be used in clinical studies so companies can gather safety and effectiveness data before full market approval. For investors, an IDE is a key milestone because it lets a company test real-world performance and move toward commercial clearance or approval—much like a trial run that, if successful, can unlock larger revenue opportunities and reduce regulatory risk.

ultra-low temperature ablation medical

Ultra-low temperature ablation is a medical technique that destroys unwanted tissue—such as tumors or problematic nerve cells—by freezing them to very low temperatures. Think of it like using a precision freezer to create controlled damage that causes the targeted tissue to die and be removed by the body. Investors care because it represents a specific therapeutic approach with implications for device sales, regulatory approval, clinical adoption, and potential reimbursement, which all affect market opportunity and revenue.

ventricular tachycardia medical

A fast, abnormal heartbeat that starts in the heart’s lower chambers and can sharply reduce blood flow, potentially causing dizziness, fainting or, in severe cases, sudden collapse; picture an engine running so fast it loses power. For investors, ventricular tachycardia matters because demand for drugs, devices, diagnostic tests and emergency care tied to this condition affects clinical trial results, regulatory approvals, revenue prospects and legal or safety risks for healthcare companies.

cardiac arrhythmias medical

Cardiac arrhythmias are conditions in which the heart beats too fast, too slow, or with an irregular rhythm rather than its normal steady pulse. They matter to investors because arrhythmias drive demand for drugs, monitoring tools, implanted devices and hospital care, and because trial results, approvals or safety concerns related to arrhythmia treatments can quickly change a company’s revenue outlook—think of it as a steering issue in a car that affects repair and replacement markets.

structural heart disease medical

Structural heart disease describes physical problems with the heart’s valves, walls, chambers or the large vessels that change how blood flows — like a house with broken doors or plumbing that stops water moving correctly. It matters to investors because diagnosing and treating these conditions typically requires specialized devices, procedures and long regulatory reviews, so clinical results, approvals or new technologies can materially affect manufacturers, hospitals and healthcare spending.

LAGUNA HILLS, Calif.--(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 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:

Presentation Title:	Effectiveness and Safety of Ultra-low Temperature Ablation of Ventricular Tachycardia in Patients with Structural Heart Disease: Outcomes of the Pivotal FULCRUM-VT Trial
Time:	April 26, 2026 at 8:30 a.m. Central Time
Presenter:	Dr. Atul Verma, M.D. FRCPC FHRS, Director of Cardiology at McGill University Health Centre; Co-Principal Investigator of FULCRUM-VT

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.