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Adagio Medical Provides Business Update: 22 Patients Treated with Next-Generation vCLAS™ Ultra System as FULCRUM-VT IDE Sub-Study Advances

ADGM
  • Adagio Medical Holdings reports continued progress in its strategic alternatives review & execution of the FULCRUM-VT IDE study.
  • The company has treated 22 patients total with the vCLAS Ultra system across 7 centers in the U.S. & Canada, including 19 sub-study patients & 3 compassionate use cases.
  • McGill University Health Centre performed 8 procedures, the highest globally, noting workflow advancements & over 60% reduction in ablation times compared to the first-generation system.
  • Patient enrollment, data collection, & product development for the FULCRUM-VT sub-study continued despite operational restructuring & the strategic review.
  • Adagio is working with the FDA on its Premarket Approval application for the first-generation vCLAS system, submitted in May 2026.
  • The Board of Directors is actively evaluating strategic options to maximize shareholder value but has set no definitive timetable for completion.
  • No further disclosure regarding the strategic review is intended until a specific course of action is approved or required by law.
  • CEO Todd Usen emphasized prioritizing the sub-study & validating the ULTA platform's ability to reduce ablation times & improve catheter flexibility.
  • The FULCRUM-VT trial is a multi-center, open-label study that enrolled 209 patients with drug-refractory ventricular tachycardia.
  • The FDA granted Investigational Device Exemption approval to expand the trial to evaluate the next-generation vCLAS Ultra catheter.
  • The vCLAS system is commercially available in Europe & select geographies but remains limited to investigational use in the United States.