Adagio Medical Holdings, Inc.

Adagio Medical Holdings, Inc. released an updated corporate presentation for investors and analysts, detailing the progress and potential of its vCLAS Ultra low-temperature cryoablation technology. The presentation highlights the significant market opportunity in VT ablation, positive clinical trial results, and a clear regulatory pathway. The company anticipates FDA approval for its first-generation vCLAS system by Q4 2026 or Q1 2027, with the next-gen vCLAS Ultra expected by Q1 2028.

Adagio Medical Holdings, Inc. announced its second quarter 2026 financial results and significant business updates. The company submitted its Premarket Approval (PMA) application to the FDA for the vCLAS Ventricular Ablation System, supported by positive pivotal results from the FULCRUM-VT trial which demonstrated strong safety and effectiveness. While the company achieved key clinical and regulatory milestones, it reported an increased net loss of $6.7 million for the quarter.

Adagio Medical Holdings, Inc. received a notice from Nasdaq on June 12, 2026, indicating non-compliance with the minimum bid price requirement of $1.00 per share for continued listing. The company has 180 calendar days, until December 9, 2026, to regain compliance by having its common stock close at or above $1.00 for at least ten consecutive trading days. Its stock will continue to trade on the Nasdaq Capital Market during this period, and the company is exploring options, including a potential reverse stock split.

Adagio Medical Holdings, Inc. announced the submission of its Premarket Approval (PMA) application to the U.S. FDA for its vCLAS® Ventricular Ablation System. This system is intended for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT) in patients with structural heart disease. The submission is backed by data from the FULCRUM-VT pivotal trial, which enrolled 209 patients and showed 97.4% acute clinical success and compelling 6-month outcomes, including 84.3% freedom from ICD shock and a significant reduction in anti-arrhythmic drug use.

Adagio Medical Holdings, Inc. reported a net loss of $7.0 million for the three months ended March 31, 2026, an improvement from a $7.7 million net loss in the prior year period. The company generated no revenue in either period. Adagio Medical also disclosed substantial doubt about its ability to continue as a going concern, with current cash expected to fund operations only into Q3 2026. The company is pursuing regulatory approvals and cost-cutting measures to mitigate this uncertainty.

Adagio Medical Holdings, Inc. reported its first quarter 2026 financial results, showing a net loss of $7.0 million, an improvement from $7.7 million in the prior year. The company also announced significant clinical progress, including pivotal results from the FULCRUM-VT trial demonstrating 84% freedom from ICD shock at six months and FDA IDE approval to expand the trial for its next-generation vCLAS Ultra System. These advancements underscore the potential of its Ultra-Low Temperature Ablation (ULTA) platform for treating cardiac arrhythmias.

Adagio Medical Holdings, Inc. announced its Annual Meeting of Stockholders will be held virtually on June 16, 2026. Stockholders will vote on the election of Class II director nominees, Orly Mishan and Sean Salmon, to serve until the 2029 Annual Meeting. Additionally, the appointment of WithumSmith+Brown, PC as the independent registered public accounting firm for the fiscal year ending December 31, 2026, will be ratified. The record date for voting is April 24, 2026.

Adagio Medical Holdings, Inc. announced positive six-month results from its FULCRUM-VT pivotal IDE clinical trial for the vCLAS® Ventricular Ablation System. The trial met safety and effectiveness endpoints, showing 84% freedom from ICD shock and 59% freedom from VT recurrence, with equivalent outcomes for both ischemic and non-ischemic cardiomyopathy patients. These results will support the Company's FDA Premarket Approval application, positioning vCLAS as a potential foundational technology for treating ventricular tachycardia.

Adagio Medical Holdings, Inc. has announced that its 2026 Annual Meeting of Stockholders will take place on June 16, 2026. The record date for determining stockholders eligible to vote at the meeting is set for April 24, 2026. Stockholders intending to submit proposals for inclusion in the proxy materials or to nominate directors must do so by April 30, 2026.

Adagio Medical Holdings, Inc. announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). This approval allows the company to expand its FULCRUM-VT trial to evaluate the safety and effectiveness of its next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventricular Ablation System. The system is designed to offer faster, more efficient ablation with improved usability for treating Sustained Monomorphic Ventricular Tachycardia (SMVT), addressing a challenging cardiac arrhythmia. This regulatory milestone is crucial for advancing Adagio's pipeline and potentially expanding its market presence in cardiac ablation technologies.