Adagio Medical Holdings, Inc.

Adagio Medical Holdings, Inc. (Nasdaq: ADGI) is a medical device company focused on developing and commercializing products for the treatment of cardiac arrhythmias using its proprietary Ultra-Low Temperature Ablation (ULTA) technology. The company's initial focus is on treating ventricular tachycardia (VT), a potentially fatal rapid heart rhythm disorder that accounts for approximately 300,000 deaths annually in the United States. VT-associated sudden cardiac death represents a significant clinical burden, particularly in patients with structural heart disease.

The company's lead product, the vCLAS Cryoablation System, represents a purpose-built solution designed specifically for ventricular ablation procedures. Unlike existing radiofrequency ablation catheters that were originally designed for treating atrial fibrillation, the vCLAS system creates large, durable, deep lesions extending through the ventricular myocardium using nitrogen gas cooled to negative 196 degrees Celsius. The technology operates without irrigation, eliminating risks of fluid overload complications common with current approaches. The vCLAS system received CE Mark approval in Europe and has completed enrollment in the FULCRUM-VT pivotal clinical trial in the United States, with preliminary results showing 97.4 percent acute clinical success and a 2.4 percent major adverse event rate.

Adagio is also developing next-generation ULTA technology, including the vCLAS ULTRA system designed for single-freeze protocols with improved usability, and Pulsed Field Cryoablation (PFCA) technology that combines ULTA with pulsed field ablation energy. The company's intellectual property portfolio includes 85 issued patents and 25 patent applications across multiple jurisdictions, covering foundational ULTA technology through specific catheter and accessory designs.

The global electrophysiology device market was valued at approximately 14 billion dollars in 2025, with the VT ablation market representing a significantly underpenetrated segment estimated at 5.8 billion dollars globally. Adagio targets the substantial opportunity within this market, where current procedural volumes represent only approximately six percent of the addressable patient population. The company's website is www.adagiomedical.com.