Core Insights - Adagio Medical Holdings, Inc. is participating in the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on February 10, 2026, in Snowbird, UT [1] - The company specializes in catheter ablation technologies for treating cardiac arrhythmias, focusing on its proprietary Ultra-Low Temperature Cardiac (ULTA) ablation technology [1] - Adagio's vCLAS™ Cryoablation System is currently under evaluation in the FULCRUM-VT U.S. Pivotal IDE Trial, which has fully enrolled 209 patients [1] - The results from the FULCRUM-VT trial will be used to apply for FDA premarket approval for the vCLAS™ Cryoablation System [1] - The vCLAS™ Cryoablation System is commercially available in Europe and select other regions but is limited to investigational use in the U.S. [1] Recent Business Highlights - Adagio Medical closed a private placement on October 20, 2025, with gross proceeds of up to $50 million, led by healthcare-dedicated institutional investors [1]

Company Overview - Adagio Medical Holdings, Inc. is a medical device company based in Laguna Hills, California, specializing in catheter ablation technologies for treating cardiac arrhythmias [4] - The company focuses on developing and commercializing its proprietary Ultra-Low Temperature Cardiac (ULTA) ablation technology, which aims to create large, durable lesions in both diseased and healthy cardiac tissue [4] Recent Developments - The company will present live at the Small Cap Growth Virtual Investor Conference on February 5, 2026, allowing real-time interaction with investors [1] - Adagio has appointed Sean Salmon, a former Senior Executive from Medtronic, to its Board of Directors [8] - The company closed financing of up to $50 million, led by existing and new healthcare-dedicated institutional investors [8] Clinical Trials - Adagio's vCLAS™ Cryoablation System is currently under evaluation in the FULCRUM-VT U.S. Pivotal IDE Trial, which has fully enrolled 209 patients with structural heart disease [5] - The FULCRUM-VT trial aims to assess the feasibility of ultra-low temperature cryoablation for recurring monomorphic ventricular tachycardia and will be used to apply for FDA premarket approval [5] - Preliminary results from the FULCRUM-VT study indicate a 97% acute effectiveness rate and favorable safety profile [8] Product Availability - The vCLAS™ Cryoablation System is commercially available for treating monomorphic ventricular tachycardia in Europe and select other regions, but is limited to investigational use in the United States [5]

Core Insights - Adagio Medical Holdings, Inc. announced preliminary results from the FULCRUM-VT Study, demonstrating 97.4% acute clinical success in treating Sustained Monomorphic Ventricular Tachycardia (SMVT) using their proprietary Ultra-Low Temperature Cryoablation (ULTC) technology [1][2][5] Study Overview - The FULCRUM-VT Study involved 207 patients across 19 sites in the U.S. and Canada, focusing on both ischemic and non-ischemic cardiomyopathy [2][8] - The study reported a mean procedure duration of 206 minutes and a 2.5% rate of major adverse events, including four peri-procedural deaths [2][4] Efficacy and Safety Results - Acute clinical success was defined as the non-inducibility of target ventricular arrhythmias, achieved in 97.4% of cases, with 96.7% of patients having all clinically relevant ventricular tachycardias eliminated [2][4] - The safety profile of the ULTC system was deemed favorable, with a low rate of major adverse events [4][5] Future Outlook - The company plans to present six-month primary efficacy endpoint results at the Heart Rhythm 2026 conference, indicating ongoing commitment to research and development [4][5] - The FULCRUM-VT Study aims to support FDA premarket approval for the vCLAS™ Cryoablation System, potentially leading to broader indications for treating scar-mediated VT [8][9]