4 - Adagio Medical Holdings, Inc. (0002006986) (Issuer)

4 - Adagio Medical Holdings, Inc. (0002006986) (Issuer)

PMA Submission Supported by FULCRUM-VT Pivotal Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted Marks the First-Ever PMA Submission for a Purpose-Built VT Ablation System in a $5.8B Market Adagio Medical Holdings, Inc (NASDAQ:ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today 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 ("VT") in patients w

Adagio Medical Holdings, Inc. (NASDAQ:ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that management will be presenting at the BofA Securities 2026 Healthcare Conference on Wednesday, May 13, 2026 at 4:35pm PDT in Las Vegas. Presentation Information A live webcast and replay of the session will be accessible at https://bofa.veracast.com/webcasts/bofa/healthcare2026/051rbr.cfm or on the Company's website at https://investors.adagiomedical.com. About Adagio Medical Holdings, Inc. Adagio is a medical device company focused on developing and commercializing products for the treatment of c

84% Freedom From Shock and 59% Freedom From VT Recurrence in FULCRUM-VT Pivotal IDE Trial Meet Safety and Effectiveness Endpoints and Replicate CryoCure-VT Results First and Only Ablation Technology to Show Equivalent Effectiveness Across Ischemic and Non-Ischemic Cardiomyopathy All From Endocardial Approach Adagio Medical Holdings, Inc. (NASDAQ:ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today reported six month results from its FULCRUM-VT Investigational Device Exemption ("IDE") clinical trial, which will be used to support the Company's application for Food and Drug Administration ("FDA") Premarket

Designed to Deliver Faster, More Efficient Ablation with Improved Usability on Established, Titratable, Endocardial-Approach ULTA Platform Adagio Medical Holdings, Inc. (NASDAQ:ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that the U.S. Food and Drug Administration (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-Low Temperature Ablation (ULTA) Ventricular Ablation System for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT).

Adagio Medical Holdings, Inc. (NASDAQ:ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that management will be participating at the 25th Annual Needham Virtual Conference being held April 13-16, 2026. 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 Cardiac (ULTA) ablation technology. ULTA is designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue, all

Adagio Medical Holdings, Inc. (NASDAQ:ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that the pivotal results from the FULCRUM-VT study have been accepted for presentation in a late-breaking clinical science session at Heart Rhythm 2026 (HRS), the annual meeting of the Heart Rhythm Society. This is the first Investigational Device Exemption (IDE) study powered to evaluate the safety and effectiveness of Ultra-Low Temperature Ablation ("ULTA", formerly "ULTC") for the treatment of scar-related ventricular tachycardia (VT) in both ischemic and non-ischemic population. "Having FULCRUM-VT data

Adagio Medical Holdings, Inc. (NASDAQ:ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the fourth quarter ended December 31, 2025. Fourth Quarter and Recent Business Highlights: Announced the peer-reviewed publication in Circulation: Arrythmia and Electrophysiology, highlighting results from the U.S. Early Feasibility Study evaluating ultralow temperature cardiac ablation ("ULTA") for the treatment of scar-related ventricular tachycardia ("VT"), which demonstrated a favorable safety profile and no device- or procedure-related major adverse events in a real-world patie

Highlights Improvements in Next Generation ULTA Catheter, Including Potential 50-75% Reduction in Ablation Time Adagio Medical Holdings, Inc. (NASDAQ:ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the publication of pre-clinical results of the Company's next generation ultra-low temperature ablation ("ULTA") technology designed to treat ventricular arrhythmias. The publication, which is titled "Initial Pre‐Clinical Evaluation of the Augmented Ultra‐Low Temperature Cryoablation Catheter for Ventricular Ablation" was published in the Journal of Cardiovascular Electrophysiology and describes s

vCLASTM Used to Treat Patients with No Satisfactory Approved Treatment and/or Failed RF or PFA Adagio Medical Holdings, Inc. (NASDAQ:ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the successful completion of 13 ventricular ablation procedures at leading institutions using the Company's proprietary Ultra-Low Temperature Ablation (ULTA) technology under Expanded Access authorization from the U.S. Food and Drug Administration (FDA). The procedures addressed recurrent, symptomatic ventricular tachycardia (VT) or premature ventricular contractions (PVC) in patients who had previously failed abl

Adagio Medical Holdings, Inc. (NASDAQ:ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that management will be participating in the 38th Annual Roth Conference on March 23-24, 2026 in Laguna Niguel, CA and will be hosting one-on-one meetings with investors at the conference. For more information on the 38th Annual ROTH Conference, or to schedule a meeting with Adagio Medical management, please contact your ROTH representative or you may also email your request to ir@adagiomedical.com. About Adagio Medical Holdings, Inc. Adagio is a medical device company focused on developing and commerci

Marie-Claude Jacques appointed Senior Vice President, Global Sales; Antwan Gipson joins as Senior Vice President, Manufacturing & Operations Adagio Medical Holdings, Inc. (NASDAQ:ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced two key additions to its senior leadership team: Marie-Claude Jacques as Senior Vice President, Global Sales and Antwan Gipson as Senior Vice President, Manufacturing and Operations. "These appointments represent a significant milestone as Adagio prepares for commercialization of our proprietary Ultra-Low Temperature Cardiac Ablation technology ("ULTC") for electrophys

Adagio Medical Holdings, Inc (NASDAQ:ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that Sean Salmon has been appointed to its Board of Directors. Mr. Salmon will also serve on the Company's Audit Committee and Compensation Committee. Mr. Salmon, 60, recently retired from Medtronic after a distinguished, 20+ year tenure during which he held multiple senior global leadership roles across the company's cardiovascular and diabetes businesses. Most recently, he served as Executive Vice President and President of Medtronic's Cardiovascular Portfolio, which includes the Cardiac Rhythm, Cardiac Abl

Continued Momentum Toward PMA Submission of ULTC Technologies Recent Financing Positions Company to Execute Growth Strategy Adagio Medical Holdings, Inc (NASDAQ:ADGM) ("Adagio" or "the Company"), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the third quarter ended September 30, 2025. Recent Business Highlights: Closed a private placement on October 20, 2025, with gross proceeds of up to $50 million, led by a syndicate of healthcare-dedicated institutional investors; upfront proceeds of approximately $19 million expected to fund FDA submission activities and ongoing next generation catheter deve

Adagio Medical (NASDAQ:ADGM), a leading innovator in catheter ablation technologies for treatment of cardiac arrhythmias, is pleased to announce the appointment of Deborah Kaster as Chief Business Officer (CBO). Kaster brings more than 25 years of leadership experience in strategy, mergers and acquisitions, corporate finance, investor relations and strategic communications in the medical technology sector. Most recently, Kaster served as Vice President of Investor Relations at Shockwave Medical, where she played a pivotal role in the company's growth from IPO to its acquisition by Johnson & Johnson. During her time at Shockwave, the company's stock price appreciated nearly 2000%, a testame

Founding Chief Executive Officer and Director Olav Bergheim to Depart Adagio Medical Holdings, Inc. (NASDAQ:ADGM, the "Company" or "Adagio")), a leading innovator in catheter ablation technologies for treatment of cardiac arrhythmias, today announced that founder Olav Bergheim departed as Chief Executive Officer ("CEO") and Chairperson of the Board of Directors of the Company, effective December 13, 2024. Concurrently, the Company announced the appointment of Todd Usen, as Chief Executive Officer and Director of the Company and Orly Mishan, as Chairperson of the Board of Directors, effective December 13, 2024. Mr. Bergheim will serve as an advisor to the Company and will support Mr. Usen

SC 13G - Adagio Medical Holdings, Inc. (0002006986) (Subject)

SC 13G - Adagio Medical Holdings, Inc. (0002006986) (Subject)