Adagio Medical Unveils Positive Results from FULCRUM-VT Pivotal Study.

Adagio Medical has announced preliminary acute results from the FULCRUM-VT study, evaluating the safety and efficacy of its ULTC technology for treating Sustained Monomorphic Ventricular Tachycardia. The results show 97% acute effectiveness and favorable safety outcomes. The data was presented at the VT Symposium.

Adagio Medical Holdings, Inc. (Nasdaq: ADGM) has announced preliminary acute results from the FULCRUM-VT study, evaluating the safety and efficacy of its proprietary Ultralow Temperature Cryoablation (ULTC) technology for treating Sustained Monomorphic Ventricular Tachycardia (SMVT). The results, presented at the 20th Annual International Symposium on Ventricular Arrhythmias in Philadelphia on October 10, 2025, show a 97% acute effectiveness rate and favorable safety outcomes.

The FULCRUM-VT study, a prospective, multi-center investigation, enrolled 207 patients with both ischemic and non-ischemic cardiomyopathy. The study's primary objective was to assess the acute safety and effectiveness of ULTC in patients with scar-related VT refractory to antiarrhythmic drug therapy and a left ventricular ejection fraction greater than 20%. The mean procedure duration was 206 minutes, with acute clinical success, defined as non-inducibility of target ventricular arrhythmias, achieved in 97.4% of patients.

Key safety findings included a 2.5% rate of major adverse events, with four peri-procedural deaths, one of which was adjudicated as related to the investigational device. The study's broad inclusion criteria, encompassing patients with both ischemic and non-ischemic cardiomyopathy, contributed to swift enrollment.

Dr. Travis Richardson, Assistant Professor of Medicine at Vanderbilt University Medical Center, presented the data, highlighting the potential of Adagio's ULTC system to treat a broad patient population. The system's ability to produce deep, titratable endocardial lesions without irrigation and without concerns for catheter stability makes it a promising tool for a wide range of patients.

Todd Usen, CEO of Adagio Medical, expressed satisfaction with the preliminary results and thanked the investigators, research coordinators, and patients who supported the study. He noted that the six-month primary efficacy endpoint results will be shared at the Heart Rhythm 2026 conference.

The FULCRUM-VT study is a critical step toward Adagio's goal of obtaining FDA premarket approval (PMA) for its vCLAS™ Cryoablation System, which could lead to the broadest industry indication for purely endocardial ablation of scar-mediated VT. The system is currently commercially available in Europe and select other geographies but is limited to investigational use in the United States.

Adagio's forward-looking statements highlight the potential of ULTC technology to transform treatment for patients with VT. However, these statements are subject to various risks and uncertainties, as detailed in the company's SEC filings.

Adagio Medical Unveils Preliminary Acute Results from FULCRUM-VT U.S. Pivotal Study in Late Breaking Session at VT Symposium^[1] https://finance.yahoo.com/news/adagio-medical-unveils-preliminary-acute-194000768.html