Adagio Medical Holdings, Inc. develops catheter-based ablation technologies for the treatment of cardiac arrhythmias. The company’s proprietary Ultra-Low Temperature Ablation technology and vCLAS® Ventricular Ablation System are focused on ventricular arrhythmias, including ventricular tachycardia, using an endocardial approach.
Recurring Adagio Medical news covers FULCRUM-VT clinical updates, FDA IDE activity, planned PMA support, CE Mark-related commercialization outside the United States, next-generation catheter development, pre-clinical publications, medical-conference presentations, financial results, and financing activity tied to its cardiac electrophysiology device programs.
Adagio Medical (Nasdaq: ADGM) received FDA IDE approval (April 8, 2026) to expand its FULCRUM-VT trial to evaluate the next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventricular Ablation System for sustained monomorphic ventricular tachycardia (SMVT).
The staged sub-study will enroll 55 proposed patients to assess safety and effectiveness of the vCLAS Ultra catheter, which reaches approximately -170°C and showed >50% reduction in ablation time in pre-clinical models.
Adagio Medical (Nasdaq: ADGM) said its management team will participate in the 25th Annual Needham Virtual Conference held April 13–16, 2026. The presentation provides an investor-facing opportunity to discuss the company’s catheter ablation technologies and strategic progress.
Adagio Medical (Nasdaq: ADGM) announced that pivotal results from the FULCRUM-VT IDE trial evaluating Ultra-Low Temperature Ablation (ULTA) for scar-related ventricular tachycardia were accepted for a late-breaking clinical science session at Heart Rhythm 2026.
The presentation is scheduled for April 26, 2026 at 8:30 a.m. CT with Dr. Atul Verma presenting. Adagio will host an investor webcast on April 27, 2026 at 8:00 a.m. ET to review results and take questions.
Adagio Medical (Nasdaq: ADGM) reported fourth-quarter and full-year 2025 results and clinical progress. Key milestones include completion of 209-patient FULCRUM-VT pivotal IDE enrollment, preliminary 97% acute effectiveness, peer-reviewed ULTA publication, 13 Expanded Access vCLAS cases, board and executive hires, and a private placement up to $50M with ~$19M upfront.
Financials: 2025 net loss $25.1M, Q4 net loss $3.3M, and cash of $17.1M at December 31, 2025.
Adagio Medical (Nasdaq: ADGM) published pre-clinical results for its next-generation ULTA ventricular ablation catheter on March 24, 2026. The paper reports improved handling with an 8.5 French catheter, single-freeze ablations at ~-170°C, and lesion performance: 5 mm in 15s and 12.5 mm in ~120s.
Authors noted potential procedural gains including a 50–75% reduction in ablation time and up to 30 minutes shorter procedures versus first-generation ULTA in pre-clinical models.
Adagio Medical (Nasdaq: ADGM) reported completion of 13 ventricular ablation procedures using its vCLAS ULTA cryoablation system under FDA Expanded Access for patients with recurrent VT or symptomatic PVCs who failed prior therapies. The company says FULCRUM-VT fully enrolled in October 2025 and expects U.S. regulatory approval by year-end 2026.
Physicians reported favorable acute procedural outcomes and integration into EP lab workflow; PVC cases expand the platform's potential reach within the VT ablation market.
Adagio Medical (NASDAQ: ADGM) will participate in the 38th Annual Roth Conference on March 23-24, 2026 in Laguna Niguel, CA. Management will host one-on-one investor meetings during the event. Contact your ROTH representative or email ir@adagiomedical.com to schedule a meeting.
Adagio Medical (Nasdaq: ADGM) will present at the TD Cowen 46th Annual Healthcare Conference on March 3, 2026 at 2:30 PM ET in Boston. A live webcast and replay will be available via the event platform and on the company investor website.
Investors can watch the presentation live or access the replay at the company's investor relations site.
Adagio Medical (Nasdaq: ADGM) published U.S. Early Feasibility Study results showing favorable safety and performance for ultralow temperature cardiac ablation (ULTC) in scar-related ventricular tachycardia.
In 20 patients across four U.S. centers, no device- or procedure-related major adverse events were seen at 7 and 30 days; 92.9% non-inducibility among 14 tested; 72% reduced or stopped antiarrhythmic drugs; 83.3% free from ICD shock at mean 24-week follow-up.
Adagio Medical (Nasdaq: ADGM) said management will present at the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on February 10, 2026 in Snowbird, Utah.
The participation highlights investor outreach and provides a forum to discuss product development and corporate strategy.