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 the publication of pre-clinical results of the Company’s next generation ultra-low temperature ablation (“ULTA”) technology designed to treat ventricular arrhythmias. The publication, which is titled “Initial Pre‐Clinical Evaluation of the Augmented Ultra‐Low Temperature Cryoablation Catheter for Ventricular Ablation” was published in the Journal of Cardiovascular Electrophysiology and describes significant functional improvements in ablation catheter performance compared to the Company’s first generation vCLAS™ ULTA catheter, including improved handling characteristics, better compatibility with standard laboratory practices and potential for 50-75% reduction in ablation time. The publication is authored by physicians from several leading ventricular ablation programs in Germany, Belgium and Canada
“The investigators in this study all have extensive experience performing procedures with first-generation vCLASTM catheters, which has provided us each with deep appreciation of the unique advantages of ULTA in ventricular ablation, including titratable lesion depth exceeding 10 millimeters,” said Katia Dyrda MD FRCPC MSc Eng, Electrophysiologist Cardiologist, Montreal Heart Institute, Associate Clinical Professor, University of Montreal and a lead author of the study. “Remarkably, this next- generation ULTA system achieves these same advantages with more powerful and faster ablations using a smaller, 8.5 French-size catheter with handling characteristics equivalent to those of our standard RF catheters. These technical advances translate into a number of clinical advantages, including potential reduction in procedure time by as much as 30 minutes compared to first-generation of ULTA.”
Adagio’s next generation proprietary ULTA technology achieves ablation temperatures of approximately -170°C enabling highly efficient, single-freeze applications that have been shown to produce 5-millimeter-deep lesions in as little as 15 seconds and 12.5-millimeter-deep lesions in approximately 120 seconds in pre-clinical models, as detailed in the published paper.
“This publication highlights the continued successful evolution of our ULTA platform, the meaningful innovation behind our next-generation technology, and our team’s ability to quickly and efficiently work with our physician partners to adapt our purpose-built VT technologies to their needs,” said Todd Usen, Chief Executive Officer of Adagio Medical. “By enabling faster, single-freeze ablation with a smaller, more maneuverable catheter, we believe this advancement has the potential to significantly improve procedural efficiency while maintaining all of the advantages that are core to our ULTA technology as we seek to provide a solution for the underserved population of patients who suffer from VT.”
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. 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 ULTA system to provide clinical advantages; the reproducibility and durability of any favorable results initially seen in pre-clinical trails; Adagio’s strategy, future operations, the expected timing and results of clinical trials, prospects, 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, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260324055565/en/
Debbie Kaster
Chief Financial Officer and Chief Business Officer
dkaster@adagiomedical.com
