Adagio Medical closes $19 million financing for heart device development

Adagio Medical Holdings Inc. (NASDAQ: ADGM) completed a private placement financing that raised $19 million upfront from existing and new healthcare institutional investors, according to a company statement.

The medical device company plans to use the proceeds to support submission activities for its FULCRUM-VT pivotal clinical study seeking FDA premarket approval of its vCLAS ULTC System for treating ventricular tachycardia. The funds will also advance clinical experience for the company's next-generation ULTC catheter and expand manufacturing capabilities.

"We have treated over 350 patients, including those from our two regulatory studies, combined with commercial and compassionate use cases, which supports the potential of our Ultra Low ablation technology for VT to improve clinical outcomes and safety," said Todd Usen, CEO of Adagio Medical.

Adagio develops catheter-based Ultra-Low Temperature Cryoablation technology for treating cardiac arrhythmias. The company's vCLAS Cryoablation System is commercially available in Europe and select other regions but remains under investigational use in the United States.

The FULCRUM-VT study completed enrollment of 208 patients with structural heart disease on October 1, 2025. The prospective, multi-center study evaluates the treatment of drug refractory ventricular tachycardia in patients with both ischemic and non-ischemic cardiomyopathy.

The company expects the capital infusion to extend its cash runway into key development milestones. The securities were offered in a private placement and have not been registered under the Securities Act of 1933.

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