Adagio Medical Surpasses 85% Enrollment in FULCRUM-VT Pivotal Study.

• Adagio Medical surpasses 85% enrollment in FULCRUM-VT pivotal study. • Study seeks to enroll 206 patients with drug-refractory VT. • Study on track for completion in H2 2025. • First-in-human results from PARALELL study. • PARALELL study evaluates safety and efficacy of vCLAS Cryoablation System. • Adagio Medical is a leading innovator in catheter ablation technologies.

Adagio Medical Holdings, Inc. (Nasdaq: ADGM), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, has reported significant progress in its FULCRUM-VT pivotal study. The study, which aims to enroll 206 patients with either ischemic or non-ischemic drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT), has surpassed 85% enrollment as of the second quarter ended June 30, 2025 [1].

The FULCRUM-VT study is being conducted at 20 U.S. and Canadian centers and is on track for completion of patient enrollment in the second half of 2025. The results of this study will be used to apply for FDA premarket approval (PMA) for Adagio’s vCLAS™ Cryoablation System, potentially leading to the broadest industry indication for purely endocardial ablation of scar-mediated VT [1].

Additionally, Adagio Medical has published first-in-human results from the PARALELL study, which evaluated the safety and effectiveness of its Pulsed Field Cryoablation (PFCA) system. The PARALELL study combined Pulsed Field Ablation (PFA) with Adagio’s proprietary Ultra-Low Temperature Cryoablation (ULTC) technology. The results were published in the Journal of Cardiovascular Electrophysiology [1].

Adagio Medical's financial results for the second quarter ended June 30, 2025, showed a reduction in cash burn quarter-over-quarter as a result of the company's corporate prioritization initiative. The initiative streamlined operations and focused resources on highest-value programs, leading to a net loss of $3.9 million for the period, compared to $5.7 million in the same period last year. The company reported cash and cash equivalents of $8.2 million as of June 30, 2025 [1].

References:

[1] https://www.theglobeandmail.com/investing/markets/markets-news/Business%20Wire/34126971/adagio-medical-reports-second-quarter-2025-results/