Adagio Medical Holdings, Inc.

Adagio Medical Holdings, Inc. is a medical device company that develops and commercializes products for treating cardiac arrhythmias using its proprietary catheter-based Ultra-Low Temperature Ablation (ULTA) technology. This technology was formerly known as Ultra-Low Temperature Cryoablation (ULTC) technology. The company's primary focus is on treating ventricular tachycardia (VT), a rapid, abnormal heart rhythm originating in the heart's lower chambers, or ventricles. VT can impair blood flow and, if sustained, can be fatal, with VT-associated sudden cardiac death accounting for approximately 300,000 deaths annually in the United States. Current radio frequency (RF) ablation catheters used for VT were primarily designed for atrial fibrillation (AF) and are not optimally suited for the specific anatomy and disease characteristics of the ventricle. This can lead to complex procedures and sub-optimal outcomes, potentially limiting market growth for VT ablations. Adagio Medical Holdings, Inc.'s clinically tested ULTA products are specifically designed for VT patients, addressing the unique ventricular anatomy and patient needs. The ULTA approach aims to create large and durable lesions extending through the depth of both diseased and healthy muscular tissue of the ventricular myocardium, which the company hypothesizes will improve the effectiveness of VT ablations and patient outcomes. Their differentiated catheters and consoles are designed to create titratable, large, durable, deep lesions within the ventricle using a stable, endocardial approach without requiring irrigation. In October 2025, the company completed enrollment in its FULCRUM-VT Pivotal FDA Investigational Device Exemption (IDE) study, evaluating the vCLAS™ Cryoablation System for ablating monomorphic ventricular tachycardia (MMVT) in patients with both ischemic and non-ischemic cardiomyopathy. The vCLAS System, which received Breakthrough Device Designation from the FDA in April 2025, utilizes the proprietary ULTA technology platform and typically employs a double freeze cycle (freeze-thaw-freeze) protocol.