$0.089
-0.026 (-28.97%)收盘时
ADGM 资讯
ADGM 事件
Adagio Medical Initiates Strategic Alternatives Review and Workforce Reduction
Adagio Medical announced that its Board of Directors has completed a comprehensive review of the Company's business, programs, resources and capabilities and has initiated a formal process to explore strategic alternatives focused on maximizing shareholder value. In connection with this decision, the Company is implementing a reduction in workforce to align its cost structure with its prioritized programs. Adagio will explore potential strategic alternatives that may include, but are not limited to, an acquisition, merger, business combination, or other transaction. There can be no assurance that its exploration will result in Adagio pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms, if at all. Adagio has not set a timetable for completion of this evaluation process and does not intend to disclose further developments unless and until it is determined that further disclosure is appropriate or necessary. As of June 30, 2026, the Company had a preliminary unaudited amount of approximately $7.7M in cash, cash equivalents and investments in marketable securities.
Adagio Medical Enrolls First Patient in vCLAS Ultra Study
Adagio Medical Holdings announced highlights from the first patient enrolled in the Company's study evaluating its next-generation vCLAS Ultra Ultra-Low Temperature Ablation, ULTA, Ventricular Ablation System. The study is designed to support a Premarket Approval, PMA, supplement to the Company's PMA for its first generation vCLAS system, which is presently under review by the to the U.S. Food and Drug Administration. The supplemental study is being conducted under the Company's FDA-approved Investigational Device Exemption designed to evaluate the safety and effectiveness of the vCLAS Ultra System for the treatment of Sustained Monomorphic Ventricular Tachycardia.
Adagio Medical CEO Highlights Significant Progress in Technology
"This quarter marked an inflection point for Adagio as our team continues to execute and deliver on our critical milestones. The enthusiastic physician reception of our FULCRUM-VT late-breaking data at HRS reinforced what we have long believed about the potential for this technology, and the successful treatment of the first patient with vCLAS Ultra - a particularly complex case - was a powerful proof point for our next-generation system," said Todd Usen, Chief Executive Officer of Adagio Medical. "We believe our progress - combined with the breadth of our clinical evidence for both ischemic and non-ischemic patients - positions our fully-endocardial ULTA platform as a uniquely differentiated solution capable of treating the entire spectrum of cases in an addressable market that has long needed a purpose-built solution. We remain focused on executing against the milestones ahead as we work to bring our proprietary technology to the many patients who suffer from VT."
Adagio Medical Treats First Patient with vCLAS Ultra System
Adagio Medical Holdings announced the treatment of the first patient with its next-generation vCLAS Ultra Ultra-Low Temperature Ablation system under Expanded Access authorization from the U.S. Food and Drug Administration. The patient, who presented with non-ischemic cardiomyopathy and a recent history of failed radiofrequency and coronary venous alcohol ablations to address the ventricular tachycardia, was treated at the Hospital of University of Pennsylvania by Dr. Gregory Supple, Director of Inpatient EP Services at HUP and an Investigator in the Company's FULCRUM-VT Pivotal Investigational Device Exemption trial.
Adagio Medical Submits PMA Application for vCLAS System to FDA
Adagio Medical announced the submission of its Premarket Approval, PMA, application to the U.S. Food and Drug Administration, FDA, for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia in patients with ischemic or non-ischemic structural heart disease. The PMA submission is supported by the Fulcrum-VT pivotal IDE trial, a single-arm study that enrolled 209 patients across 20 leading electrophysiology centers. The trial achieved 97.4% acute clinical success and demonstrated compelling 6-month outcomes, including 84.3% freedom from ICD shock, only 2.4% major adverse events and a 78% reduction or elimination of anti-arrhythmic drug use. Importantly, vCLAS demonstrated equivalent clinical effectiveness in both ischemic and non-ischemic cardiomyopathy, addressing the largest unmet need in VT ablation today.
本页仅供研究参考，不构成投资建议。模型可能出错。过往表现不代表未来结果。