Announcement • Jun 13
Adagio Medical Holdings, Inc. Receives Nasdaq Notice Regarding Minimum Bid Price Requirement On June 12, 2026, Adagio Medical Holdings, Inc. (the Company) received a notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (Nasdaq) notifying the Company that the listing of its common stock was not in compliance with Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market, as the minimum bid price of the Company's common stock was less than $1.00 per share for the previous 30 consecutive business days (the Minimum Bid Price Requirement). The notification does not impact the listing of the Company's common stock on The Nasdaq Capital Market at this time. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from the date of notification, or until December 9, 2026, to regain compliance with the Minimum Bid Price Requirement. During this period, the Company's common stock will continue to trade on the Nasdaq Capital Market. If at any time before December 9, 2026, the bid price of the Company's common stock closes at or above $1.00 per share for a minimum of ten consecutive trading days, Nasdaq will provide written notification that the Company has achieved compliance with this minimum bid price requirement. The Company is considering all available options to regain compliance with the listing rule. However, there can be no assurance that the Company will be able to regain compliance with the rule or will otherwise be in compliance with other Nasdaq listing criteria. In the event the Company does not regain compliance by December 9, 2026, a second 180-day compliance period may be available if the Company provides written notice to Nasdaq that it intends to regain compliance with the bid price requirement during the second 180-day compliance period, by effecting a reverse stock split if necessary, and meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, except for the bid price requirement. If the Company does not qualify for the second compliance period or fails to regain compliance during the second 180-day period, then Nasdaq will notify the Company that its Common Stock is subject to delisting. Announcement • Apr 27
Adagio Medical Holdings, Inc. Announces Positive Pivotal Results for vCLAS Ventricular Ablation System Adagio Medical Holdings, Inc. reported six month results from its FULCRUM-VT Investigational Device Exemption clinical trial, which will be used to support the Company’s application for Food and Drug Administration Premarket Approval of the vCLAS Ventricular Ablation System. Key findings included: 98% non-inducibility of targeted ventricular tachycardias at end of procedure, promising safety profile with 2.4% protocol-defined Major Adverse Events, 84% freedom from implantable cardioverter defibrillator shock at 6 months, 59% freedom from any VT recurrence at 6 months (VT recurrence includes monitoring zone VT > 30 seconds, ICD shock, ATP, and anti-arrhythmic drug escalation), equivalent results for ischemic and non-ischemic cardiomyopathy patients, over 80% reduction in number of patients experiencing ICD shock over 6-months post ablation compared to equivalent time period pre-ablation, 72% of patients discontinued or reduced dose of amiodarone at 6 months, low 1.9% rate of 30-day VT-related hospital readmission. FULCRUM-VT is a prospective, multi-center, open-label, single-arm IDE study investigating the vCLAS Cryoablation System at 20 centers in the United States and Canada. The study enrolled 209 patients with structural heart disease, whether ischemic or non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory VT in accordance with current treatment guidelines. FULCRUM-VT is the first and only fully enrolled IDE clinical trial for VT to include patients with both ICM and NICM disease and includes one of the most challenging patient cohorts ever treated in a VT ablation trial. Ablation targets for VT associated with NICM disease tend to be in deeper myocardial substrate and therefore are more difficult to treat using an endocardial approach with currently approved technology. These two patient cohorts had equivalent outcomes, as measured by both freedom from VT recurrence and freedom from ICD shock, representing what the Company believes to be the first and only catheter ablation technology to show equivalent effectiveness in these distinct and historically challenging VT substrates. FULCRUM-VT included patients with both ICM and NICM disease (LVEF=35+/-10%, 34% NICM, 79% with congestive heart failure). Freedom from device intervention (ATP or shock) at 6 months was 61% for ICM and 63% for NICM; freedom from ICD shock at 6 months was 84% for ICM and 85% for NICM. Mean ablation time per patient was 54 minutes. Mean lesions per patient: 11.5 ± 6. Key safety findings included a 2.4% rate of major adverse events including four (1.9%) peri-procedural deaths, of which only two (1.0%) were adjudicated by an independent Clinical Events Committee as possibly related to the investigational device. All safety and VT recurrence data were adjudicated by independent Event Committees. The study also demonstrated clinically meaningful de-escalation of the use of amiodarone, an important clinical goal, with a substantial proportion of patients reducing or discontinuing amiodarone therapy post-procedure. The results also showed a significant reduction in hospital readmission rates compared to those historically reported in the VT ablation literature, underscoring the potential clinical and economic impact of the therapy. 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 dose beyond previously failed ablation. The results of the study, which have not yet been reviewed or approved by the FDA, will be used to apply for U.S. Food and Drug Administration premarket approval for Adagio’s vCLAS Cryoablation System, potentially leading to the broadest industry indication for purely endocardial ablation of scar-mediated VT. Adagio’s vCLAS Cryoablation 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. Announcement • Apr 21
Adagio Medical Holdings, Inc., Annual General Meeting, Jun 16, 2026 Adagio Medical Holdings, Inc., Annual General Meeting, Jun 16, 2026. 
