close
close

Adagio Medical offers business updates Page 1

Adagio Medical offers business updates Page 1

Adagio Medical Holdings, Inc. (Nasdaq: ADGM; the “Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today provided a corporate update.

Recent business highlights:

  • Obtained CE Mark and initiated commercial launch of the vCLAS catheter and ultra-low temperature cryoablation (ULTC) system for the treatment of ventricular tachycardia (VT) in selected European markets
  • CRYOCURE-VT trial data presented at the annual meetings of the European Heart Rhythm Association and Heart Rhythm Society, with results published in the journal EP Europace
  • Received U.S. Food and Drug Administration (“FDA”) approval for the FULCRUM-VT Pivotal IDE study
  • Closed Business Combination and PIPE Financing and Listing of the Company’s Common Stock on the Nasdaq Capital Market

“For years, there has been underinvestment and pent-up demand for innovation in ablation catheter technology for patients with VT,” said Olav Bergheim, Chief Executive Officer of Adagio Medical. “Adagio’s patented ULTC platform holds the promise of solving a number of unique technical and clinical challenges that make VT ablations complex and time-consuming, resulting in the underutilization of this potentially life-changing therapeutic procedure. We have received consistent, positive feedback from physicians on our published clinical data and are seeing a similar reception in the first commercial cases in Europe.”. Looking at the US and our FULCRUM-VT Pivotal Study, there is strong interest in participating in the study among top VT ablation centers. We expect patient enrollment to begin in September and look forward to providing updates on our progress.”

FULCRUM-VT Pivotal IDE Study is a prospective, multicenter, open-label, single-arm study that will evaluate the safety and effectiveness of the Adagio Medical VT Cryoablation System in patients with sustained monomorphic VT due to structural heart disease of both ischemic and non-ischemic origin. The study will enroll 206 patients at twenty U.S. and Canadian centers, with Roderick Tung (Banner University Medical Center Phoenix, Phoenix, AZ, USA) and Atul Verma (McGill University Health Centre, Montreal, Canada) as co-principal investigators. The FDA approved the Pivotal IDE protocol in May 2024. The first, Early Feasibility (EFS) phase of FULCRUM-VT has enrolled 20 patients at Banner University Medical Center Phoenix, Phoenix, AZ, Vanderbilt University Medical Center Nashville, TN, Mount Sinai Hospital New York, NY, and University of California at San Francisco, CA.