Adagio Medical Holdings, Inc.

Adagio Medical Holdings, Inc. is a medical device company dedicated to the development and commercialization of innovative products for the treatment of cardiac arrhythmias. Headquartered in Laguna Hills, California, the company's mission is to advance cardiac arrhythmia treatment through cutting-edge medical device technology, providing physicians with tools that enhance precision and patient comfort.

The company specializes in proprietary catheter-based Ultra-Low Temperature Ablation (ULTA) or Ultra-Low Temperature Cryoablation (ULTC) technology, designed to create durable lesions for various cardiac arrhythmias. Its product portfolio includes the iCLAS atrial ULTC catheter, vCLAS ventricular ULTC catheter, and Cryopulse atrial pulsed-field cryoablation catheter systems. Adagio Medical is currently focused on the treatment of ventricular tachycardia (VT) with its purpose-built vCLAS™ Cryoablation System.

In December 2024, Todd Usen was appointed as the new CEO, with Orly Mishan becoming Chairperson of the Board, succeeding founder Olav Bergheim, who transitioned to an advisory role. Adagio Medical has recently announced positive pivotal results for its vCLAS® Ventricular Ablation System and received FDA IDE approval to investigate its next-generation system in April 2026. The vCLAS™ Cryoablation System holds FDA Breakthrough Device Designation and is commercially available in Europe and other select geographies, while undergoing the FULCRUM-VT U.S. IDE Pivotal Study for investigational use in the United States, with FDA approval anticipated by the end of 2026.