Adagio Medical

Adagio Medical Holdings, Inc. is a medical device company, founded in 2011 by Olav Bergheim, focused on developing catheter-based cryoablation technologies to treat cardiac arrhythmias. Bergheim, a serial entrepreneur in the life sciences sector, established Adagio as a portfolio company of his accelerator, Fjord Ventures, leveraging his extensive background from Baxter Healthcare and Domain Associates to address unmet needs in cardiac rhythm management. The company operates in the cardiac ablation market, serving electrophysiologists and hospitals that treat patients suffering from conditions like atrial fibrillation, atrial flutter, and ventricular tachycardia. Its business model revolves around the development, clinical validation, and commercialization of its proprietary ablation systems. The company went public in August 2024 through a business combination with a special purpose acquisition company (SPAC), ARYA Sciences Acquisition Corp IV, and is now listed on Nasdaq under the ticker ADGM.

Adagio's core technology is its Ultra-Low Temperature Cryoablation (ULTC) system, which uses near-critical nitrogen at -196°C to create deep, continuous, and durable lesions in heart tissue to interrupt abnormal electrical signals. This differs from conventional cryoablation systems which use a warmer refrigerant. The company has developed several products based on this platform. The iCLAS™ system received CE Mark approval in Europe in June 2020 for treating paroxysmal and persistent atrial fibrillation. The vCLAS™ Cryoablation System, specifically designed for treating monomorphic ventricular tachycardia (VT), also secured CE Mark approval and began a limited commercial launch in Europe. A key milestone was achieved in April 2025 when the FDA granted the vCLAS™ system Breakthrough Device Designation for treating drug-refractory VT, a status intended to expedite its review and potential access for U.S. patients. The company is currently focused on its FULCRUM-VT pivotal IDE study in the U.S. and Canada to support FDA premarket approval for the vCLAS system.

The company's strategy involves securing regulatory approvals and demonstrating clinical efficacy to drive adoption. After going public, Adagio has undergone a strategic restructuring to prioritize the U.S. pivotal trial for its vCLAS catheter, pausing the European launch to focus resources. In late 2024, a leadership transition occurred, with Todd Usen, a veteran of the medical device industry, appointed as CEO to guide the company through its next phase of clinical and commercial development. Adagio has raised significant capital through various funding rounds, including a $42.5 million Series E in 2020 and approximately $84.2 million from its SPAC merger, with backing from investors like RA Capital Management, Perceptive Advisors, and ArrowMark Partners. Keywords: cardiac arrhythmia treatment, cryoablation technology, ventricular tachycardia, atrial fibrillation, catheter ablation, electrophysiology, medical device, ultra-low temperature cryoablation, ULTC, vCLAS system, iCLAS catheter, Fjord Ventures, Olav Bergheim, cardiac rhythm management, medical innovation, FDA Breakthrough Device, CE Mark, arrhythmia solutions, structural heart disease, endocardial ablation