Adagio Medical Receives IDE Approval from the FDA to Investigate Next-Generation vCLAS® Ventricular Ablation System

Key Terms

investigational device exemption regulatory

An investigational device exemption (IDE) is a regulatory permission that allows a medical device maker to test an unapproved device in people so the device’s safety and effectiveness can be studied. For investors, an IDE matters because it marks a formal step toward regulatory approval—like getting a temporary test-drive permit—and influences clinical cost, timelines, and the likelihood a device will reach the market and generate revenue.

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.

endocardial medical

Endocardial describes anything related to the endocardium, the smooth inner lining of the heart chambers that sits next to the blood. It matters to investors because many medical devices, diagnostic procedures and treatments target this surface—think of it as the inner paint of a pump—so outcomes of related clinical trials, approvals or complications can directly affect the market value of companies working on heart therapies or tools.

catheter ablation medical

Catheter ablation is a minimally invasive medical procedure in which a thin, flexible tube is threaded into the heart to destroy tiny areas of tissue that cause abnormal heart rhythms, typically using heat or freezing. Investors watch it because growing use or improved success rates can shift demand for specialized medical devices, hospital procedures and follow-up care, alter treatment costs, and compete with drug or implantable alternatives — like repairing a faulty circuit to restore reliable performance.

cardiomyopathies medical

Cardiomyopathies are diseases that weaken or change the heart muscle so it can’t pump blood effectively or keeps the heart beating irregularly, like an engine losing power or a machine with faulty wiring. Investors pay attention because they drive demand for treatments, devices, diagnostics and long‑term care, influence clinical trial success and regulatory decisions, and can affect healthcare costs and insurance liabilities that shape company revenues and valuations.

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Designed to Deliver Faster, More Efficient Ablation with Improved Usability on Established, Titratable, Endocardial-Approach ULTA Platform

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 U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to expand the Company’s FULCRUM-VT trial to evaluate the safety and effectiveness of the Company’s next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventricular Ablation System for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT).

“Ventricular tachycardia remains one of the most difficult arrhythmias to treat, with current ablation approaches often limited by difficulty achieving sufficient lesion depth,” said Dr. William Stevenson, M.D., Professor of Medicine, Principal Site Investigator, Vanderbilt University Medical Center. “We have been impressed with the safety and clinical results of the initial ULTA system for treating VT in patients with ischemic and nonischemic cardiomyopathies. We are looking forward to evaluating the next generation of the system, which we anticipate will have improved catheter maneuverability and allow shorter freeze times, both factors that should reduce procedure times.”

The approval for IDE expansion enables Adagio to initiate a clinical sub-study designed to evaluate its next-generation vCLAS Ventricular Ablation System including the next generation vCLAS Ultra catheter, which has been built on the clinical foundation established by the Company’s all-endocardial ULTA technology. Adagio’s vCLAS Ultra catheter achieves ablation temperatures of approximately -170°C enabling highly efficient, single-freeze applications that have been shown to produce effective lesions with greater than 50% reduction in ablation time as demonstrated in pre-clinical models.

“The vCLAS Ultra, which was designed to improve energy delivery, navigation, lesion control, and overall procedural workflow efficiency, reflects our team's ability to expeditiously translate feedback from our physician partners into meaningful technological advancement. In parallel, the design incorporates improvements in manufacturability, supporting scalability and reducing overall system cost,” said Alex Babkin, Chief Technology Officer of Adagio Medical. “Importantly, this advancement positions us to potentially offer the market a single, versatile catheter capable of treating the full range of VT substrates, all through an endocardial approach, with our clinically established ULTA platform technology. This IDE approval is an important step toward clinically validating what we believe could be a paradigm-shifting technological solution for VT.”

The sub-study is a prospective, single-arm, multi-center, pre-market, clinical supplemental study designed to provide safety and efficacy data regarding the use of Adagio’s next generation vCLAS Ventricular Ablation System in the treatment of scar-mediated SMVT in ischemic and non-ischemic patients, which is the same population treated in the pivotal phase of the IDE study. The IDE expansion approval is for a total of 55 proposed patients in a staged sub-study design.

“We are building on a strong and growing body of clinical evidence supporting the effectiveness of our ULTA technology, which has already demonstrated the ability to create deep, effective lesions through a fully endocardial approach,” said Todd Usen, Chief Executive Officer of Adagio Medical. “IDE approval for this study expansion marks an important milestone as we continue to advance our vCLAS Ultra catheter, which we built to enable broader adoption across all electrophysiology practices. Our goal is to translate this proven technology into a highly scalable solution that can democratize the treatment of VT and become the go-to ablation catheter for treating the large, underserved population of patients who suffer from this disease. On behalf of the entire Adagio team, we would like to thank the FDA for their collaboration and partnership.”

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 in an endocardial only 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.

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 of Adagio’s ULTA technology, including the ability of Adagio’s next-generation vCLAS™ ULTRA system to provide clinical advantages; Adagio’s research, development and regulatory plans for its product candidates; the reproducibility and durability of any favorable results initially seen in pre-clinical trials; Adagio’s strategy and future operations; the expected timing and results of clinical trials; the plans and objectives of management; and the potential for FDA approval and commercialization of Adagio’s product candidates and whether, if approved, these product candidates will be successfully distributed and marketed and the potential market opportunity for Adagio’s product candidates. 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/20260408341039/en/

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

Source: Adagio Medical Holdings, Inc.