ADGM

Advancing Toward Submission for PMA Approval Following Late-Breaking FULCRUM-VT Data LAGUNA HILLS, Calif., May 12, 2026--(BUSINESS WIRE)--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 first quarter ended March 31, 2026. Recent Business Highlights: Pivotal results from the FULCRUM-VT trial presented in late-breaking session at Heart Rhythm Society 2026 – the first large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic cardiomyopathies—which demonstrated 84% freedom from implantable cardioverter defibrillator ("ICD") shock at six months, a promising safety profile with 2.4% protocol-defined Major Adverse Events, and a 72% discontinuation or reduced dose of antiarrhythmic drugs, as well as equivalent results across both ischemic and non-ischemic cardiomyopathy patients with the Company's proprietary Ultra-Low Temperature Ablation ("ULTA") technology Received Food and Drug Administration ("FDA") Investigational Device Exemption ("IDE") approval to expand the FULCRUM-VT trial to evaluate the safety and effectiveness of the next-generation vCLAS Ultra System, which is designed to be faster, colder and deeper, with improved usability, compared to the first generation vCLAS catheter, underscoring the depth and durability of the Company's ULTA platform for the treatment of Sustained Monomorphic Ventricular Tachycardia Featured in over a dozen well-attended events, presentations, and posters at Heart Rhythm Society's 47th Annual Scientific Sessions—Heart Rhythm 2026—highlighting ULTA as a purpose-built endocardial solution for ventricular tachycardia ("VT") Announced the publication of pre-clinical results of the Company’s next generation ULTA technology in the Journal of Cardiovascular Electrophysiology, which describe titratable lesion depth exceeding 10 millimeters as well as significant functional improvements in catheter performance compared to first-generation ULTA, including improved handling characteristics, better compatibility with standard laboratory practices and the potential for 50-75% reduction in ablation time Successfully completed 13 cases under FDA Expanded Access using the vCLAS System in patients with recurrent VT and premature ventricular contra...

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 LAGUNA HILLS, Calif., April 26, 2026--(BUSINESS WIRE)--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 Approval of the vCLAS Ventricular Ablation System. The results were presented today in a late-breaking clinical trial session at the Heart Rhythm Society 2026 conference. Key findings included: 98% non-inducibility of targeted ventricular tachycardias ("VT") at end of procedure Promising safety profile with 2.4% protocol-defined Major Adverse Events 84% freedom from implantable cardioverter defibrillator ("ICD") 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 ("AAD") escalation1) Equivalent results for ischemic ("ICM") and non-ischemic cardiomyopathy ("NICM") 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 represents a seminal step forward in advancing ventricular tachycardia management by delivering positive, clinically meaningful results from the first large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic structural heart disease. Importantly, the study further highlights the potential of an endocardial-only approach using Adagio’s purpose-built ventricular ablation technology," said Dr. Atul Verma, Director, Division of Cardiology, McGill University Health Centre in Montreal. "The results of the trial, which were consistent with earlier ULTA studies, combined an excellent safety profile with impressive clinical effectiveness, inc...

LAGUNA HILLS, Calif., April 01, 2026--(BUSINESS WIRE)--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 selected for a late-breaking session at HRS is a testament to the significance of this work," said Matthew Hakimi, M.D., Cardiac Electrophysiologist, Cedars Sinai Medical Center and Medical Director at Adagio Medical. "On behalf of the entire Adagio team, I want to recognize the investigators, research coordinators, and patients whose dedication and perseverance made this study possible. Completing FULCRUM-VT marks a significant milestone — not just for Adagio, but for the millions of patients living with the burden of VT. We look forward to the results being shared by the investigators at HRS and the potential for these data to advance care for VT patients." The details of the late-breaking session are as follows: Adagio Medical will be hosting an event for analysts and institutional investors at 8:00 a.m. eastern time on Monday, April 27. During the webcast, Dr. Atul Verma, M.D. will present the results of the FULCRUM-VT study and then will be joined by Dr. William Stevenson, M.D., Professor of Medicine, Vanderbilt University Medical Center and Principal Investigator for FULCRUM-VT at Vanderbilt, and Dr. Matthew Hakimi, M.D. to discuss the results and answer questions from investors about the study. Investors and interested parties may join the live webcast through the registration link or by visiting the Investor Relations section of the Company's website at https://investors.adagiomedical.com. Pre-registration for the webcast is available beginning today. A replay of the webcast will be made available after the event. About Adagio Medical Holdings, Inc. Adagio is a medical device company focused on developing and co...

LAGUNA HILLS, Calif., March 27, 2026--(BUSINESS WIRE)--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 patient cohort of both ischemic and challenging non-ischemic patients Announced the successful completion of 13 cases with the vCLAS™ System under Expanded Access authorization from the U.S. Food and Drug Administration ("FDA"). The procedures, which included patients with premature ventricular contractions, were completed on patients who had previously failed ablations with conventional and/or experimental modalities Appointed industry veteran Sean Salmon to the Company’s Board of Directors, enhancing strategic and governance expertise; Sean recently retired from Medtronic, Inc after a distinguished 20+ year tenure, during which he held multiple senior global leadership roles across the company’s cardiovascular and diabetes businesses Strengthened executive leadership team with the appointments of Marie-Claude Jacques as Senior Vice President, Global Sales, and Antwan Gipson as Senior Vice President, Manufacturing & Operations, both seasoned senior executives who will help accelerate commercial readiness Attended multiple industry and investor conferences, which involved webcasts of the corporate presentation and multiple meetings with a large spectrum of investors Closed a private placement 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 development, with potential for up to $31 million in additional gross proceeds upon the exercise of outstanding warrants Completed enrollment of the 209-patient FULCRUM-VT Pivotal FDA Investigational Device...

Highlights Improvements in Next Generation ULTA Catheter, Including Potential 50-75% Reduction in Ablation Time LAGUNA HILLS, Calif., March 24, 2026--(BUSINESS WIRE)--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 significant functional improvements in ablation catheter performance compared to the Company’s first generation vCLAS™ ULTA catheter, including improved handling characteristics, better compatibility with standard laboratory practices and potential for 50-75% reduction in ablation time. The publication is authored by physicians from several leading ventricular ablation programs in Germany, Belgium and Canada "The investigators in this study all have extensive experience performing procedures with first-generation vCLASTM catheters, which has provided us each with deep appreciation of the unique advantages of ULTA in ventricular ablation, including titratable lesion depth exceeding 10 millimeters," said Katia Dyrda MD FRCPC MSc Eng, Electrophysiologist Cardiologist, Montreal Heart Institute, Associate Clinical Professor, University of Montreal and a lead author of the study. "Remarkably, this next- generation ULTA system achieves these same advantages with more powerful and faster ablations using a smaller, 8.5 French-size catheter with handling characteristics equivalent to those of our standard RF catheters. These technical advances translate into a number of clinical advantages, including potential reduction in procedure time by as much as 30 minutes compared to first-generation of ULTA." Adagio’s next generation proprietary ULTA technology achieves ablation temperatures of approximately -170°C enabling highly efficient, single-freeze applications that have been shown to produce 5-millimeter-deep lesions in as little as 15 seconds and 12.5-millimeter-deep lesions in approximately 120 seconds in pre-clinical models, as...

Adagio Medical Holdings Inc. (NASDAQ:ADGM) is one of the best up and coming penny stocks to buy. On February 4, Adagio Medical Holdings announced the publication of results from its US Early Feasibility Study/EFS evaluating ultralow temperature cardiac ablation/ULTC for treating scar-related ventricular tachycardia. The multicenter study involved 20 patients with ischemic and non-ischemic cardiomyopathy across four US centers. The research focused on the acute safety and performance of ULTC in individuals with drug-refractory conditions, marking the first published US clinical experience for this technology under the FDA’s EFS framework. The study showed a favorable safety profile with no major adverse events recorded at 7 or 30 days, alongside strong clinical performance. Pixabay/Public domain Among tested patients, 92.9% achieved non-inducibility of the targeted clinical arrhythmia after ablation. At a 24-week follow-up, 72% of patients successfully reduced or discontinued antiarrhythmic medications, and 83.3% remained free from implantable cardioverter-defibrillator shocks. Investigators noted that the technology’s ability to create deep, titratable lesions is particularly effective for treating deep intramural substrates found in challenging patient populations. Adagio Medical Holdings Inc. (NASDAQ:ADGM) is a developmental-stage medical device company that develops and commercializes ablation technologies for the treatment of cardiac arrhythmias. While we acknowledge the potential of ADGM as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you’re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. Follow Insider Monkey on Google News.

Continued Momentum Toward PMA Submission of ULTC Technologies Recent Financing Positions Company to Execute Growth Strategy LAGUNA HILLS, Calif., November 12, 2025--(BUSINESS WIRE)--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 development, with potential for up to $31 million in additional gross proceeds Completed enrollment of the 209-patient FULCRUM-VT Pivotal FDA Investigational Device Exemption ("IDE") trial intended to support the premarket approval ("PMA") application for the vCLAS™ System for ablation of ventricular tachycardia ("VT") Announced preliminary results from the FULCRUM-VT trial demonstrating 97% acute effectiveness and a favorable safety profile with the Company’s proprietary ultralow temperature technology Strengthened executive leadership team with the appointment of Deborah Kaster as Chief Financial Officer, adding to her role as Chief Business Officer "Adagio made exceptional progress this quarter, with strong clinical momentum, a clear regulatory path and a solid pipeline," said Todd Usen, Chief Executive Officer of Adagio. "The successful completion of our financing provides the resources to advance our PMA submission for the vCLAS System and prepare for commercialization. This financing also reflects the confidence leading healthcare investors have in our strategy and the potentially transformational impact of our proprietary ULTC technology to treat one of the broadest populations of patients with ventricular arrhythmias." Third Quarter 2025 Financial Results Cost of revenue was $31 thousand for the three months ended September 30, 2025, compared to $0.6 million for the three months ended September 30, 2024. Research and development expenses were $2.8 million for the three months ended September 30, 2025, compared to $2.5 million for the three months ended September 30, 2024. Selling, general and administrative expenses wer...

97% Acute Effectiveness and Favorable Safety Results from Proprietary ULTC for Ventricular Tachycardia LAGUNA HILLS, Calif., October 10, 2025--(BUSINESS WIRE)--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 preliminary acute (within 7 days) safety and efficacy results from the Adagio’s FULCRUM-VT Study evaluating Ultralow Temperature Cryoablation ("ULTC") for the treatment of Sustained Monomorphic Ventricular Tachycardia ("SMVT") in patients with both ischemic and nonischemic cardiomyopathy. The data are being presented by Travis Richardson, MD, Assistant Professor of Medicine, Clinical Cardiac Electrophysiology, Vanderbilt University Medical Center, in a Late Breaking Clinical Trials Session at the 20th Annual International Symposium on Ventricular Arrhythmias being held in Philadelphia on October 10, 2025. A total of 207 patients underwent ventricular tachycardia ("VT") ablation using Adagio’s ULTC system at 19 sites in the United States and Canada. The study included patients with both ischemic ("ICM") and non-ischemic ("NICM") cardiomyopathies (LVEF=35+/-10%, 33% NICM, 75% with congestive heart failure). Mean procedure duration was 206+/- 68 minutes and acute clinical success, defined as non-inducibility of target ventricular arrhythmias, was 97.4%, with all clinically-relevant ventricular tachycardias eliminated in 96.7% of patients tested by post-ablation programmed electrical stimulation. Key safety findings included a 2.5% rate of major adverse events including four (1.9%) peri-procedural deaths, of which one (0.5%) was adjudicated by an independent clinical events committee as definitely related to the investigational device. A presentation with additional details and accompanying figures are available on a Current Report on Form 8-K, which is being filed concurrently with this press release and available on the SEC’s website at www.sec.gov. "The patient profile in FULCRUM-VT is representative of what we see in real-world practice. The ability of Adagio’s ULTC system to produce deep, titratable endocardial lesions without irrigation and without concerns for catheter stability make it a promising tool for a broad patient population. These factors, along with the broad inclusion criteria for the study, fueled swift...

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 study, enrolling 206 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. The results of the study will be used to apply for FDA premarket approval (PMA) 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 ventricular tachycardia in Europe and select other geographies but is limited to investigational use in the United States. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: Adagio’s research, development and regulatory plans for its product candidates and Adagio’s ability to bring its proprietary ULTC solutions to patients. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio’s business are described in detail in Adagio’s Securities and Exchange Commission ("SEC") filings, including in its Annual Report on Form 10-K for the full-year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, which are available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Adagio disclaims any obligation to update these...

LAGUNA HILLS, Calif., August 13, 2025--(BUSINESS WIRE)--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 second quarter ended June 30, 2025. Recent Business Highlights: Surpassed 85% enrollment in the FULCRUM-VT pivotal study of the Company’s vCLAS™ Cryoablation System. The study, which seeks to enroll 206 patients with either ischemic or non-ischemic drug-refractory, recurrent, sustained monomorphic ventricular tachycardia ("VT") at 20 U.S. and Canadian centers, is on track for completion of patient enrollment in the second half of 2025 First-in-human results from the PARALELL study, which evaluated the safety and effectiveness of Adagio’s Pulsed Field Cryoablation ("PFCA"), a novel, dual-energy cardiac ablation modality combining Pulsed Field Ablation (PFA) with Adagio’s proprietary Ultra-Low Temperature Cryoablation ("ULTC"), were published in the Journal of Cardiovascular Electrophysiology Reduced cash burn quarter-over-quarter as a result of the Company’s corporate prioritization initiative, which streamlined operations and focused resources on highest-value programs "In the second quarter we saw continued strong momentum in the enrollment of our FULCRUM-VT study, which we believe validates the market need for our purpose-built technology and brings us one step closer to offering our proprietary ULTC solutions to patients in the United States who suffer from ventricular tachycardia," said Todd Usen, Chief Executive Officer of Adagio. "The team also made meaningful progress in advancing our pipeline through the continued development of our next-generation product, which is designed to improve usability for physicians while further enhancing the capabilities of our differentiated ULTC platform." Second Quarter 2025 Financial Results Cost of revenue was $0.3 million for the three months ended June 30, 2025, compared to $0.7 million for the three months ended June 30, 2024. Research and development expenses were $2.0 million for the three months ended June 30, 2025 compared to $2.9 million for the three months ended June 30, 2024 Selling, general and administrative expenses were $2.4 million for the three months ended June 30, 2025, compared to $3.4 million for the three months ended June 30, 2024...

LAGUNA HILLS, Calif., May 15, 2025--(BUSINESS WIRE)--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 first quarter ended March 31, 2025. Recent Business Highlights: Received Breakthrough Device Designation from the U.S. Food and Drug Administration (the "FDA") for the vCLAS™ Cryoablation System ("vCLAS"), for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia ("VT") in patients with ischemic or non-ischemic structural heart disease. The vCLASTM Cryoablation System is currently the subject of the FULCRUM-VT Investigational Device Exemption ("IDE") study designed to support FDA approval. The Breakthrough Device program allows for the FDA to potentially provide Adagio with priority review and interactive communication during the vCLASTM review phase. Surpassed 50% enrollment in the FULCRUM-VT pivotal study. The study, which seeks to enroll 206 patients with ischemic and non-ischemic disease at 20 U.S. and Canadian centers, is on track for completion of patient enrollment in the second half of 2025. Adagio’s Ultra-Low Temperature Cryoablation ("ULTC") and vCLAS technologies were showcased by leading electrophysiologists during multiple scientific sessions at the recent European Heart Rhythm Association (EHRA) and Heart Rhythm Society (HRS) industry meetings. Hired industry veteran Deborah Kaster, who has more than 25 years of leadership experience in the medical technology sector, as Chief Business Officer. Implemented a corporate prioritization initiative focusing all resources on the FULCRUM-VT clinical trial activities and the Company’s new product design optimization program, which has been designed to advance faster innovation and iteration to meet market demands. "This has been a defining quarter for Adagio Medical and for our progress across the company. The FDA’s Breakthrough Device Designation, multiple impactful presentations at leading industry conferences, the introduction of our optimized smaller, faster next generation ULTC technology in development and the continued momentum in enrolling patients in our FULCRUM-VT trial all underscore the clinical promise and growing validation of our proprietary ULTC platform technology," said Todd Usen, Chief Ex...

LAGUNA HILLS, Calif., March 31, 2025--(BUSINESS WIRE)--Adagio Medical Holdings, Inc. (Nasdaq: ADGM), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today reported financial results for the fourth quarter and full year ended December 31, 2024. Recent Business Highlights: Reported total company revenue of $137 thousand in the fourth quarter of 2024, compared to $78 thousand in the fourth quarter of 2023. Full year revenue for 2024 was $0.6 million compared to $0.3 million in 2023. Surpassed 40% enrollment in the FULCRUM-VT pivotal study. The results of the study will be used to support FDA premarket approval (PMA) for Adagio’s VT Cryoablation System for endocardial ablation of scar-mediated ventricular tachycardia (VT). The study, which seeks to enroll 206 patients with ischemic and non-ischemic disease at 20 U.S. and Canadian centers, is on track for completion of patient enrollment in the second half of 2025. Announced focused realignment of resources to prioritize its FULCRUM-VT US pivotal investigational device exemption clinical trial activities and its new product design optimization program. Reported cash, cash equivalents, and short-term investments of $20.6 million as of December 31, 2024. "2024 was a pivotal year for Adagio, as we successfully commenced enrollment in our FULCRUM pivotal trial, securing the strategy to establish Adagio as a leading provider of treatments for ventricular tachycardia ("VT"). I am thrilled that the trial is enrolling ahead of expectations, bringing us even closer to providing a solution to this underserved patient population," said Todd Usen, Chief Executive Officer of Adagio. "With all of our resources today focused on two initiatives, the FULCRUM study and our product design optimization program, Adagio is well-poised to deliver on our critical mission of improving the quality of life and long-term outcomes for patients with VT." Fourth Quarter 2024 Financial Results Revenue was $137 thousand for the fourth quarter of 2024, up 76% compared to $78 thousand for the fourth quarter of 2023. The increase over the prior year quarter was driven primarily by the introduction of vCLAS in Europe. Gross margin was negative 1012% for the fourth quarter of 2024, compared to negative 328% for the fourth quarter of 2023. The year-over-year change was primarily due to increased sales vo...