Adagio Medical Reports Second-Quarter 2026 Results as Ventricular Tachycardia Program Advances Toward FDA Review
Adagio Medical Holdings, Inc., a medical technology company focused on developing innovative catheter ablation solutions for cardiac arrhythmias, has reported its financial results for the second quarter ended June 30, 2026. The company highlighted several important clinical, regulatory and product-development milestones during the period, underscoring continued progress in its efforts to address challenging cases of ventricular tachycardia (VT).
The quarter represented an important period for Adagio as the company advanced its proprietary ultra-low-temperature ablation technology through pivotal clinical development, expanded experience with its next-generation catheter system and moved closer to potential regulatory clearance in the United States.
Among the most significant developments was the successful treatment of the first patient at the Hospital of the University of Pennsylvania using Adagio’s next-generation vCLAS™ Ultra Ultra-Low Temperature Ablation (ULTA) catheter. The procedure was conducted under an Expanded Access authorization from the U.S. Food and Drug Administration (FDA), providing an early clinical demonstration of the capabilities of the company’s next-generation technology.
Adagio also announced pivotal results from the 209-patient FULCRUM-VT trial. The findings were presented during a late-breaking session at the Heart Rhythm Society 2026 meeting and provided additional clinical evidence supporting the company’s fully endocardial ULTA platform for the treatment of ventricular tachycardia.
Advancing a New Approach to Ventricular Tachycardia
Ventricular tachycardia is a potentially life-threatening cardiac rhythm disorder that can occur in patients with structural heart disease. Treatment can be particularly challenging in individuals whose disease does not respond adequately to antiarrhythmic medications.
Catheter ablation is an established treatment option for selected patients, but complex ventricular arrhythmias can require sophisticated technology and highly specialized procedures. Adagio is developing its vCLAS Ventricular Ablation System with the goal of providing physicians with a purpose-built solution for drug-refractory, recurrent, sustained monomorphic VT in patients with either ischemic or non-ischemic structural heart disease.
The company’s technology uses ultra-low-temperature ablation, which is designed to create lesions through a controlled freezing process. Adagio believes this approach may offer advantages in treating difficult ventricular arrhythmia substrates while enabling a fully endocardial treatment strategy.
During the second quarter, the company submitted a Premarket Approval (PMA) application to the FDA for its vCLAS Ventricular Ablation System. The submission was supported by data from the FULCRUM-VT pivotal Investigational Device Exemption (IDE) trial.
The PMA submission represents an important regulatory milestone for Adagio. If approved, the system could potentially become an additional treatment option for patients with drug-refractory recurrent sustained monomorphic VT associated with ischemic or non-ischemic structural heart disease.
FULCRUM-VT Trial Delivers Positive Findings
The FULCRUM-VT pivotal trial enrolled 209 patients and evaluated Adagio’s proprietary ULTA technology in individuals with ventricular tachycardia. According to the company, the trial demonstrated a favorable safety profile, with protocol-defined Major Adverse Events occurring in only 2.4% of patients.
The six-month findings also showed that 84% of patients remained free from implantable cardioverter-defibrillator (ICD) shocks. In addition, 78% of patients were able to discontinue or reduce their dosage of antiarrhythmic drugs.
These findings are significant because recurrent ICD shocks can have a substantial impact on patients living with ventricular arrhythmias, while long-term dependence on antiarrhythmic medications may present additional challenges.
Adagio also reported that outcomes were comparable between patients with ischemic cardiomyopathy and those with non-ischemic cardiomyopathy. This broad performance across patient populations is particularly important because ventricular tachycardia can develop through different disease mechanisms and may present differently depending on the underlying cardiac condition.
The company believes the results support the potential versatility of its ULTA technology and reinforce its strategy of developing a system capable of addressing a broad spectrum of ventricular tachycardia cases.
First Patient Treated With vCLAS Ultra
Another major milestone during the quarter was the successful treatment of the first patient using Adagio’s next-generation vCLAS Ultra catheter at the Hospital of the University of Pennsylvania.
The vCLAS Ultra system is designed to build upon the capabilities of Adagio’s first-generation vCLAS Ventricular Ablation System catheter while offering improvements intended to make the device faster and more maneuverable.
The first treatment was conducted under an FDA Expanded Access authorization and involved a particularly complex case. Adagio views the procedure as an important early demonstration of the next-generation platform’s potential and an opportunity to gather additional clinical experience as development continues.
The company expects continued development of the vCLAS Ultra platform to complement its regulatory and commercial efforts surrounding the current vCLAS system.
Management Highlights Clinical Progress
Todd Usen, Chief Executive Officer of Adagio Medical, described the second quarter as an inflection point for the company. He emphasized the response from physicians to the FULCRUM-VT data presented at the Heart Rhythm Society meeting and pointed to the successful first treatment with vCLAS Ultra as another important validation of the technology.
According to Usen, the combination of clinical evidence across ischemic and non-ischemic patient populations and the development of the fully endocardial ULTA platform gives Adagio a differentiated position in the ventricular tachycardia treatment landscape.
The company is continuing to focus on its regulatory and clinical milestones as it works toward making its technology available to patients with difficult-to-treat ventricular arrhythmias.
Second-Quarter Financial Performance
Alongside its clinical and regulatory updates, Adagio reported its financial performance for the three months ended June 30, 2026.
The company reported no cost of revenue during the second quarter of 2026, compared with $0.3 million during the same period in 2025. The decrease was primarily related to a pause in commercial activity in Europe.
Adagio explained that depreciation associated with consoles loaned to customers is generally classified as cost of revenue. However, because the company did not generate revenue during the second quarter of 2026, the related depreciation expense was instead recorded under research and development expenses.
Research and development expenses increased to $2.5 million, compared with $2.0 million in the second quarter of 2025. The increase reflected higher product-development spending, including consulting and prototyping costs, as well as higher operational expenses. These increases were partially offset by lower clinical trial expenses.
The company’s selling, general and administrative expenses were $2.5 million, compared with $2.4 million in the corresponding quarter of 2025. The increase was primarily driven by higher stock-based compensation expenses, although this was partially offset by reduced professional-services costs.
Adagio reported a net loss of $6.7 million, or $0.30 per basic share, for the second quarter of 2026. This compares with a net loss of $3.9 million, or $0.26 per basic share, in the second quarter of 2025.
The weighted-average number of basic and diluted common shares outstanding was 22,210,459 as of June 30, 2026. The company’s fully diluted share count includes outstanding warrants, although warrants and certain other potentially dilutive securities are excluded from the calculation of loss per share when their inclusion would have an anti-dilutive effect.
As of June 30, 2026, Adagio reported $7.7 million in cash and cash equivalents.
Adagio enters the second half of 2026 with several important milestones in progress. The company’s FDA PMA submission for the vCLAS Ventricular Ablation System represents a critical step toward potential U.S. commercialization, while the FULCRUM-VT data provide clinical evidence supporting the company’s technology.
At the same time, the development of vCLAS Ultra is expanding Adagio’s next-generation technology platform and could provide physicians with a more maneuverable and efficient tool for complex ventricular ablation procedures.
With ventricular tachycardia continuing to represent a significant clinical challenge for patients with structural heart disease, Adagio is positioning its ultra-low-temperature ablation technology as a potential solution for patients who require alternatives to conventional treatment approaches.
The company’s focus now remains on advancing its regulatory review, developing its next-generation technology and leveraging its growing body of clinical evidence. If the vCLAS system receives FDA approval, Adagio could move closer to its goal of establishing a dedicated, fully endocardial technology platform for the treatment of a broad range of ventricular tachycardia cases.
About Adagio Medical Holdings, Inc.
Adagio is a medical device company focused on developing and commercializing products for the treatment of cardiac arrhythmias utilizing its novel, proprietary, catheter-based Ultra-Low temperature ablation (“ULTA,” formerly known as ULTC) technology. ULTA is designed to create large footprint, titratable lesions extending through the depth of both diseased and healthy cardiac tissue, all through an endocardial approach.
The Company is currently focused on the treatment of ventricular arrhythmias with its purpose-built vCLAS Ventricular Ablation System, which is CE Marked, and in May 2026 the Company submitted the results of the FULCRUM-VT pivotal study to support its PMA application to the FDA for the vCLAS Ventricular Ablation System. The Company is also developing a next-generation vCLAS Ultra catheter, designed to support faster ablation procedures with a smaller and more flexible form factor than its predecessor vCLAS device.
About FULCRUM VT
FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) is a prospective, multi-center, open-label, single-arm trial, which has fully enrolled 209 patients with structural heart disease of both ischemic and non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory VT in accordance with current treatment guidelines.
FULCRUM-VT 6-month primary chronic effectiveness was defined as freedom from sustained monomorphic VT lasting longer than 30 seconds or VT requiring appropriate ICD device therapy, in the absence of new or increase in antiarrhythmic drug therapy beyond previously failed dose.
The FDA has granted Investigational Device Exemption (IDE) approval to expand the Company’s FULCRUM-VT trial to evaluate the safety and effectiveness of the Company’s next-generation vCLAS Ultra catheter for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT).
Adagio’s vCLAS™ Ventricular Ablation System is commercially available for the treatment of monomorphic VT in Europe and select other geographies but is limited to investigational use in the United States.