Adagio Medical Announces Initiation and First Procedure in FULCRUM-VT Trial, Starting The Process For Bringing Ultra-Low Temperature Cryoablation for Ventricular Arrhythmias to US Market

FULCRUM-VT is set to enroll 20 patients across four investigational sites, including Banner - University Medical Center in Phoenix and three other world-renowned VT ablation programs: Vanderbilt University Hospital in Nashville, TN with Dr. William Stevenson, Mount Sinai Hospital, NY, with Dr. Vivek Reddy and University of California in San Francisco with Dr. Edward Gerstenfeld. The enrollment criteria of the trial include both ischemic and non-ischemic heart disease, implanted cardioverter defibrillator, and an indication for ventricular ablation due to recurrent symptomatic monomorphic VTs. Furthermore, the trial will accept the patients for both de-novo and a first repeat ablation, thus encompassing the clinical pathway for vast majority of patients undergoing ventricular ablations. The 64-patient CRYOCURE-VT trial conducted in Europe and Canada to evaluate safety and performance of vCLAS catheter has completed enrollment, and data will be used to support the CE-Mark approval of the…

FULCRUM-VT is set to enroll 20 patients across four investigational sites, including Banner - University Medical Center in Phoenix and three other world-renowned VT ablation programs: Vanderbilt University Hospital in Nashville, TN with Dr. William Stevenson, Mount Sinai Hospital, NY, with Dr. Vivek Reddy and University of California in San Francisco with Dr. Edward Gerstenfeld. The enrollment criteria of the trial include both ischemic and non-ischemic heart disease, implanted cardioverter defibrillator, and an indication for ventricular ablation due to recurrent symptomatic monomorphic VTs. Furthermore, the trial will accept the patients for both de-novo and a first repeat ablation, thus encompassing the clinical pathway for vast majority of patients undergoing ventricular ablations. The 64-patient CRYOCURE-VT trial conducted in Europe and Canada to evaluate safety and performance of vCLAS catheter has completed enrollment, and data will be used to support the CE-Mark approval of the device.

"The initiation of the FULCRUM-VT study is the first step towards bringing Adagio's ULTC platform technology to VT ablations market in the US," said Olav Bergheim, President and CEO of Adagio Medical. "The initial published data on procedural characteristics, acute effectiveness, and safety of ULTC ablations have been encouraging and, we believe, the combination of CRYOCURE-VT and FULCRUM-VT will result in the robust, multi-center, global dataset, essential for the assessment of this groundbreaking technology. The VT market is largely underserved by industry. Adagio's dedicated VT catheter is a testimony to our commitment to the advancement of clinical EP and our belief in the future growth of the market based on improved procedure effectiveness and long-term outcomes. The bi-directionally deflectable catheter is compatible with the same ULTC energy source which is currently under evaluation as a part of pivotal FDA IDE trial for the treatment of persistent AF (NCT # 04061603). We believe that if and once approved by regulatory authorities, vCLAS will be a must-have technology at every advanced EP ablation program."

About Banner – University Medical Center Phoenix

Banner – University Medical Center Phoenix is a large teaching hospital that has provided medical care to Arizona and the Southwest since 1911. It is part of Banner – University Medicine, a premier academic medical network. The institution, which has trained thousands of doctors over decades as a teaching hospital, is the academic medical center for The University of Arizona College of Medicine – Phoenix. The hospital, recognized by U.S. News and World Report as one of the nation's best hospitals, specializes in heart care, cancer care, high-risk obstetrics, neurosciences, organ transplants, medical toxicology and emergency care, including a Level I trauma center. Banner – University Medical Center Phoenix is part of Banner Health, a nonprofit health care system with 33 hospitals in six states. For more information, visit bannerhealth.com/universityphoenix.

About Adagio Medical
Adagio Medical, Inc. (www.adagiomedical.com) is a privately held company located in Laguna Hills, California developing innovative cryoablation technologies that create contiguous, transmural lesions to treat cardiac arrhythmias, including paroxysmal and persistent atrial fibrillation, atrial flutter, and ventricular tachycardia. Adagio Medical, Inc. is a Fjord Ventures portfolio company.

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