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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 (ADGM) treated the first patient in its FDA IDE study of the next-generation vCLAS™ Ultra Ultra-Low Temperature Ablation system for sustained monomorphic ventricular tachycardia at Banner – University Medical Center Phoenix.
The study is intended to support a Premarket Approval supplement to the company’s first-generation vCLAS system, which is under FDA review. vCLAS Ultra is designed to be more maneuverable and to deliver single-freeze ablations at approximately -170°C, with pre-clinical data suggesting a 50–75% reduction in ablation time and potential overall procedure time reductions of 30 minutes or more versus the first-generation system. The first patient, with non-ischemic cardiomyopathy and recurrent VT after prior ablation, was successfully treated in a challenging sub-valvular location and was reported to be doing well several weeks post-procedure.
Teleflex (TFX) appointed veteran medical technology executive Sean M. Salmon to its Board of Directors, effective September 8, 2026.
Salmon brings over 30 years of global leadership experience in medical devices and pharmaceuticals, including more than 20 years at Medtronic (MDT), where he most recently served as Executive Vice President and President of the Cardiovascular Portfolio, a business with fiscal 2025 revenue of approximately $12.5 billion. He has also led Medtronic’s Diabetes, Coronary and Structural Heart, and Coronary and Renal Denervation businesses and currently serves as an independent director of Adagio Medical Holdings (ADGM).
With his appointment, the Teleflex Board now has nine directors, eight of whom are independent, and one third of the Board has been refreshed in 2026. Salmon will also join the Board’s Growth and Operating Committee, which was created to support Teleflex’s strategic transformation and operational execution.
Adagio Medical (Nasdaq: ADGM) reported second quarter 2026 results, highlighting clinical and regulatory progress for its ULTA-based vCLAS ventricular ablation platform and widening losses amid a pause in commercial activity in Europe. Revenue was nil, with total operating expenses of $4.9 million and a net loss of $6.7 million, or $(0.30) per basic share, versus a $3.9 million loss a year earlier.
According to the company, the 209-patient FULCRUM-VT pivotal trial showed 2.4% protocol-defined Major Adverse Events, 84% six-month freedom from ICD shock and 78% discontinuation or dose reduction of antiarrhythmic drugs. Adagio submitted a PMA to the FDA for the vCLAS Ventricular Ablation System and treated the first patient with its next-generation vCLAS Ultra catheter under Expanded Access. Cash and cash equivalents were $7.7 million at June 30, 2026; total liabilities of $34.3 million exceeded total assets of $33.9 million, resulting in stockholders’ deficit of $0.4 million.
Adagio Medical (Nasdaq: ADGM) reported the first patient treatment with its next-generation vCLAS Ultra Ultra-Low Temperature Ablation (ULTA) system under FDA Expanded Access at the Hospital of University of Pennsylvania. The patient, with non-ischemic cardiomyopathy and prior failed ablations, remained free of ventricular tachycardia recurrence about two months post-procedure.
The vCLAS Ultra system is designed for single-freeze ablations at approximately -170°C, with pre-clinical data indicating a potential 50–75% reduction in ablation time and procedures up to 30 minutes shorter versus the first-generation device. The FDA has granted IDE approval to expand the FULCRUM-VT trial to evaluate vCLAS Ultra for sustained monomorphic VT, building on pivotal ULTA data showing 2.4% major adverse events and six-month results of 84% freedom from ICD shock and a 78% relative reduction in amiodarone use.
Adagio Medical (Nasdaq: ADGM) submitted a Premarket Approval application to the FDA for its vCLAS ventricular ablation system to treat drug‑refractory, recurrent, sustained monomorphic ventricular tachycardia in patients with structural heart disease.
The PMA is backed by the 209‑patient FULCRUM‑VT pivotal trial, which reported 97.4% acute clinical success, 84.3% freedom from ICD shock at 6 months, 2.4% major adverse events, and a 78% reduction or elimination of anti‑arrhythmic drug use. The device has Breakthrough Device designation and showed similar effectiveness in ischemic and non‑ischemic cardiomyopathy, targeting a $5.8B VT ablation market.
Adagio Medical (Nasdaq: ADGM) reported first quarter 2026 results and major progress for its Ultra-Low Temperature Ablation platform.
FULCRUM-VT pivotal data showed 84% freedom from ICD shock at six months, 2.4% major adverse events, and 72% reduction or discontinuation of antiarrhythmic drugs. Q1 2026 net loss was $7.0 million versus $7.7 million a year earlier, with lower R&D and SG&A expenses, no revenue, and cash of $12.9 million plus potential $31 million from warrant exercises.
Adagio Medical (Nasdaq: ADGM) said management will present at the BofA Securities 2026 Health Care Conference on May 13, 2026 at 4:35 PM PDT in Las Vegas.
Investors can watch a live webcast and replay via BofA’s webcast or the company’s investor website.
Adagio Medical (Nasdaq: ADGM) reported six-month FULCRUM-VT pivotal IDE results for the vCLAS ventricular ablation system, meeting safety and effectiveness endpoints.
Key metrics: 98% non-inducibility at procedure end, 84% freedom from ICD shock, 59% freedom from VT recurrence, 2.4% protocol-defined major adverse events, and equivalent outcomes for ischemic and non-ischemic cardiomyopathy.
Adagio Medical (Nasdaq: ADGM) announced that its Ultra-low Temperature Ablation (ULTA) technologies will be featured in multiple presentations at Heart Rhythm 2026 in Chicago, April 23–26, 2026. Presentations include case reports, preclinical studies, real-world series and a late-breaking pivotal trial.
Highlighted events include booth sessions, themed panels, and the late-breaking FULCRUM-VT pivotal trial presentation on April 26, 2026, discussing effectiveness and safety of ULTA for ventricular tachycardia in structural heart disease.
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.