Adagio Medical Holdings, Inc. announced on October 1, 2025 that it has completed enrollment of its FULCRUM‑VT pivotal U.S. FDA Investigational Device Exemption (IDE) study for the vCLAS Cryoablation System. The study enrolled 208 patients across 20 centers in the United States and Canada in only 11 months, a record pace for a complex ventricular tachycardia trial.
The vCLAS System, built on the company’s proprietary ultra‑low temperature cryoablation (ULTC) platform, has already received FDA Breakthrough Device designation. Completion of enrollment positions the company to submit a pre‑market approval (PMA) application for the vCLAS System by the end of 2026, accelerating the regulatory pathway for a product that could address a large, underserved VT market.
CEO Todd Usen highlighted the milestone, noting that the enrollment success reflects the strong interest of leading VT programs and the clinical promise of ULTC technology. The company’s focus on the FULCRUM‑VT study underscores its strategy to bring a differentiated VT‑specific ablation system to market ahead of competitors.
For investors, the enrollment completion is a significant step toward FDA approval and potential commercialization, which could unlock future revenue streams. However, the company remains in a high‑cost developmental phase and will still require additional capital to sustain operations and complete the trial and regulatory submission.
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