ADGM May 21, 2026ADGMFDA Updates
Adagio Medical Submits Premarket Approval Application to FDA for vCLAS® Ventricular Ablation System for the Treatment of Ventricular Tachycardia
Adagio Medical has submitted a Premarket Approval Application to the FDA for its vCLAS® Ventricular Ablation System. This system is designed to treat ventricular tachycardia, a serious heart condition. The submission marks a significant step in advancing treatment options for patients with this arrhythmia.
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ADGM May 12, 2026ADGMGeneral
Adagio Medical Reports First Quarter 2026 Results and Meaningful Clinical Progress
Adagio Medical has reported its financial results for the first quarter of 2026, highlighting significant clinical advancements. However, specific details regarding the clinical progress and financial metrics were not disclosed in the article. The report suggests a stable outlook for the company in the near term.
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ADGM Apr 29, 2026ADGMConferences/Events
Adagio Medical to Participate in the BofA Securities 2026 Health Care Conference
Adagio Medical Holdings, Inc. will present at the BofA Securities 2026 Healthcare Conference on May 13, 2026. The company focuses on catheter ablation technologies for cardiac arrhythmias and is evaluating its vCLAS Ventricular Ablation System in the FULCRUM-VT U.S. Pivotal IDE Trial. This trial aims to support FDA premarket approval for the system.
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ADGM Apr 26, 2026ADGMGeneral
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Adagio Medical Announces Positive Pivotal Results for vCLAS® Ventricular Ablation System
Adagio Medical has announced positive pivotal results for its vCLAS® Ventricular Ablation System. The results indicate promising efficacy, which could lead to improved patient outcomes in the treatment of ventricular conditions. This development marks a significant step forward for the company's innovative technology in cardiac care.
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ADGM Apr 17, 2026ADGMConferences/Events
Adagio Medical’s ULTA Technology to Be Featured at the Heart Rhythm 2026 Conference
Adagio Medical Holdings, Inc. will showcase its Ultra-low Temperature Ablation (ULTA) technologies at the Heart Rhythm 2026 conference in Chicago. The presentations will highlight the use of ULTA for treating scar-related ventricular tachycardia. The company is also conducting the FULCRUM-VT trial, which is pivotal for seeking FDA approval for its vCLAS™ Cryoablation System.
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ADGM Apr 8, 2026ADGMFDA Updates
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Adagio Medical Receives IDE Approval from the FDA to Investigate Next-Generation vCLAS® Ventricular Ablation System
Adagio Medical has received Investigational Device Exemption (IDE) approval from the FDA for its next-generation vCLAS® Ventricular Ablation System. This approval allows the company to begin clinical investigations to evaluate the system's safety and effectiveness. The development marks a notable advancement in cardiac ablation technology.
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ADGM Apr 6, 2026ADGMConferences/Events
Adagio Medical to Participate in the 25th Annual Needham Virtual Conference
Adagio Medical is set to participate in the 25th Annual Needham Virtual Conference. The event will provide a platform for the company to showcase its innovations and connect with investors. Further details about the conference and Adagio's presentation are currently limited.
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ADGM Apr 1, 2026ADGMConferences/Events
Adagio Medical Ultralow Temperature Ablation U.S. Pivotal Study Results to be Presented in Late-Breaking Session at Heart Rhythm Society 2026
Adagio Medical Holdings, Inc. announced that pivotal results from the FULCRUM-VT study will be presented at the Heart Rhythm Society 2026 meeting. This study is the first IDE trial evaluating Ultra-Low Temperature Ablation for treating scar-related ventricular tachycardia. The presentation is scheduled for April 26, 2026, highlighting the significance of the findings for patient care.
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ADGM Mar 27, 2026ADGMGeneral
Adagio Medical Reports Fourth Quarter and Full Year 2025 Results
Adagio Medical Holdings, Inc. reported its financial results for Q4 and full year 2025, highlighting significant milestones including the completion of patient enrollment in the FULCRUM-VT trial. The company noted a substantial reduction in net losses compared to 2024, attributed to decreased expenses and improved financial management. Adagio is focused on advancing its ULTA technology and preparing for commercialization of its vCLAS system.
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ADGM Mar 24, 2026ADGMGeneral
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Adagio Medical Announces Publication of Pre-Clinical Results for Next Generation Ventricular Ablation Catheter
Adagio Medical has announced the publication of pre-clinical results for its next generation ventricular ablation catheter. The details of the results and their implications for future clinical applications were not disclosed in the announcement. This publication marks a significant step in the development of advanced cardiac treatment technologies.
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ADGM Feb 20, 2026ADGMConferences/Events
Adagio Medical to Participate in the TD Cowen 46th Annual Healthcare Conference
Adagio Medical Holdings, Inc. will present at the TD Cowen 46th Annual Healthcare Conference on March 3, 2026. The company specializes in catheter ablation technologies for cardiac arrhythmias and is currently evaluating its vCLAS™ Cryoablation System in the FULCRUM-VT trial. This trial aims to support FDA premarket approval for the device.
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ADGM Feb 5, 2026ADGMPhases
New Adagio Medical Publication Highlights Consistent Safety and Effectiveness with Ultralow Temperature Ablation in Broad Range of Patients with Ventricular Tachycardia
Adagio Medical announced positive results from its Early Feasibility Study on ultralow temperature cardiac ablation for ventricular tachycardia. The study showed no major adverse events and a high success rate in preventing VT recurrence. The findings support the efficacy of Adagio's technology and highlight its potential for broader application in treating cardiac arrhythmias. The results will be pivotal for future regulatory approvals.
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ADGM Feb 2, 2026ADGMConferences/Events
Adagio Medical to Participate at the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference
Adagio Medical Holdings, Inc. will participate in the BTIG 13th Annual MedTech Conference on February 10, 2026. The company focuses on catheter ablation technologies for cardiac arrhythmias, particularly with its vCLAS™ Cryoablation System. This system is currently under evaluation in the FULCRUM-VT U.S. Pivotal IDE Trial, which aims for FDA premarket approval.
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ADGM Dec 22, 2025ADGMGeneral
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Adagio Medical Appoints Two Seasoned Senior Executives to Accelerate Commercial Readiness
Adagio Medical has appointed Marie-Claude Jacques and Antwan Gipson as Senior Vice Presidents to bolster its commercialization strategy for the Ultra-Low Temperature Cardiac Ablation technology. Jacques brings over 15 years of experience in electrophysiology sales, while Gipson has a strong background in manufacturing operations. These appointments are aimed at achieving commercialization goals by 2026.
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ADGM Dec 11, 2025ADGMGeneral
Adagio Medical Appoints Industry Veteran Sean Salmon to Board of Directors
Adagio Medical has appointed Sean Salmon to its Board of Directors, enhancing its leadership with his extensive experience in the cardiovascular sector. Salmon, a former executive at Medtronic, will also serve on the Audit and Compensation Committees. His background in electrophysiology and catheter-based ablation is expected to support Adagio's innovative technologies for treating cardiac arrhythmias.
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ADGM Nov 12, 2025ADGMGeneral
Adagio Medical Reports Third Quarter 2025 Results Continued Momentum Toward PMA Submission of ULTC Technologies Recent Financing Positions Company to Execute Growth Strategy LAGUNA HILLS, CA, November 12 , 2025 - Adagio
Adagio Medical Holdings, Inc. has reported positive financial results for the third quarter of 2025, demonstrating significant progress towards a premarket approval (PMA) submission for its vCLAS System. The successful completion of recent financing not only positions the company to advance its PMA submission but also reflects strong investor confidence. However, despite promising developments, Adagio reported an increasing net loss and significant liabilities, raising concerns about its financial stability.
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ADGM Oct 20, 2025ADGMGeneral
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Adagio Medical Closes Financing of $19 Million Upfront; Positions Company to Advance Purpose-Built Technology for Treatment of Ventricular Tachycardia Proceeds Expected to Fund Ongoing Development and Submission Activiti
Adagio Medical has successfully closed a $19 million financing round to support its advancement of purpose-built cryoablation technology for ventricular tachycardia. The funds will be utilized for ongoing development, FDA submission activities, and to enhance the company's operational capabilities. The recent positive feedback from the FULCRUM-VT clinical study underscores the potential effectiveness of their technology in improving patient outcomes.
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ADGM Oct 15, 2025ADGMGeneral
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Adagio Medical Announces Pricing of up to Approximately $50 Million Private Placement of Securities Financing to provide approximately $19 million in upfront proceeds with up to approximately $31 million of additional pr
Adagio Medical Holdings, Inc. has announced a private placement of securities expected to raise up to approximately $50 million. The deal will provide around $19 million in upfront proceeds, with potential additional proceeds of approximately $31 million from warrant exercises. The funds will be utilized for working capital and the advancement of clinical and product development activities. The private placement is expected to close in mid-October 2025, pending customary closing conditions.
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ADGM Oct 10, 2025ADGMPhases
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Adagio Medical Unveils Preliminary Acute Results from FULCRUM-VT U.S. Pivotal Study in Late Breaking Session at VT Symposium 97% Acute Effectiveness and Favorable Safety Results from Proprietary ULTC for Ventricular Tach
Adagio Medical has released preliminary acute results from its FULCRUM-VT Study, which evaluates the efficacy of its proprietary Ultra-Low Temperature Cryoablation (ULTC) system for treating sustained ventricular tachycardia. The study showed an impressive 97.4% acute effectiveness rate and a favorable safety profile overall, despite reporting a small percentage of major adverse events, including peri-procedural deaths. The data, presented at the VT Symposium, highlight the technology's potential to transform treatment options for patients with cardiac arrhythmias. Ongoing evaluation will continue, with a focus on long-term outcomes and the system's effectiveness in different myocardial substrates.
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ADGM Oct 1, 2025ADGMPhases
Adagio Medical, Inc. Announces Completion of Enrollment for FULCRUM-VT Pivotal Clinical Trial Evaluating Ultra-Low Temperature Cryoablation for Ventricular Tachycardia Study Results are Intended to Support PMA Approval o
Adagio Medical, Inc. announced the completion of enrollment for its pivotal FULCRUM-VT clinical trial evaluating the vCLAS Cryoablation System for treating ventricular tachycardia. The study aims to demonstrate the safety and efficacy of this technology, for which results are intended to support a pre-market approval application. With an enrollment of 208 patients across 20 centers in the U.S. and Canada, Adagio anticipates completing the PMA process by the end of 2026. The vCLAS system has received Breakthrough Device Designation from the FDA and is already available in Europe.
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ADGM Sep 8, 2025ADGMGeneral
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Adagio Medical Expands Chief Business Officer Deborah Kaster's Role to Include Chief Financial Officer Responsibilities
Adagio Medical Holdings, Inc. has expanded the responsibilities of Chief Business Officer Deborah Kaster to include Chief Financial Officer duties. This change, effective September 5, 2025, follows her impact in driving strategic initiatives within just four months of joining the company. Kaster will oversee both business development and financial operations, fostering alignment between Adagio's strategic initiatives and financial goals. With a focus on the treatment of ventricular tachycardia, the company is currently engaged in a pivotal study for its vCLAS Cryoablation System, essential for its future regulatory approvals.
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ADGM Aug 13, 2025ADGMGeneral
Adagio Medical Reports Second Quarter 2025 Results
Adagio Medical Holdings, Inc. reported its financial results for the second quarter of 2025, highlighting significant progress in its FULCRUM-VT study aimed at treating ventricular tachycardia. The company reported a reduced net loss of $3.9 million compared to $5.7 million in the same quarter last year, alongside a decrease in operating expenses. Cash and cash equivalents stood at $8.2 million, showcasing the company's financial position. Moving forward, Adagio aims to advance its proprietary ULTC technology and prepare for FDA premarket approval of its vCLAS Cryoablation System.
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ADGM May 15, 2025ADGMGeneral
Adagio Medical Reports First Quarter 2025 Results
Adagio Medical Holdings, Inc. reported its financial results for the first quarter of 2025, highlighting significant advancements including FDA's Breakthrough Device Designation for its ULTC technology. The company expressed pride in its team's achievements, particularly in the continued momentum of the FULCRUM-VT trial aimed at patients with ventricular tachycardia. Financially, Adagio reported a net loss of $7.7 million, a slight improvement from the previous year's loss. While the company sees promise in its innovations, it faced a decline in revenue compared to the prior year.
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ADGM Mar 31, 2025ADGMGeneral
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Adagio Medical Reports Fourth Quarter and Full Year 2024 Results
Adagio Medical Holdings, Inc. reported its fourth quarter and full-year financial results for 2024, marking a significant year with the initiation of the FULCRUM pivotal trial targeting ventricular tachycardia (VT). The company experienced a 101% revenue increase for the full year, largely due to the introduction of its vCLAS catheter in Europe. However, gross margins remained negative, and operational expenses surged, resulting in a larger net loss compared to the previous year. Adagio aims to enhance patient outcomes for VT through its innovative cryoablation technology.
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ADGM Mar 17, 2025ADGMGeneral
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Adagio Medical Provides Clinical and Business Updates
Adagio Medical Holdings, Inc. (Nasdaq: ADGM) has provided positive updates regarding its clinical trials and business progress, particularly highlighting the FULCRUM-VT enrollment advancements. CEO Todd Usen emphasized the effective market needs address by their ablation technologies, particularly for ventricular tachycardia. The company has also seen increased use of its vCLAS catheter in Europe, showcasing momentum in their product acceptance and potential growth. Overall, the updates reflect confidence in their strategy and resources to impact the field of cardiac ablation.
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ADGM Feb 28, 2025ADGMGeneral
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Adagio Medical Announces Strategic Restructuring to Accelerate US Pivotal IDE Trial and Product Innovation
Adagio Medical has announced a strategic restructuring to enhance its focus on the FULCRUM-VT US pivotal IDE clinical trial and product innovation. CEO Todd Usen highlighted the positive early outcomes from the VT Cryoablation System, with over 35% enrollment in the trial. The company will pause its European product launch to better allocate resources for key initiatives. Despite a reduction in force, the restructuring is aimed at enabling further investment in critical projects to improve patient outcomes in ventricular tachycardia treatment.
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ADGM Dec 16, 2024ADGMGeneral
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Adagio Medical Announces Appointment of Accomplished Medical Device Leader Todd Usen as Chief Executive Officer and Director Founding Chief Executive Officer and Director Olav Bergheim to Depart
Adagio Medical Holdings, Inc. has announced the appointment of Todd Usen as the new Chief Executive Officer, succeeding founder Olav Bergheim, who will transition to an advisory role. Usen brings extensive leadership experience from prior roles in the medical device industry, which the company hopes will facilitate its growth and expansion. Adagio is focused on advancing its Ultra-Low Temperature Cryoablation technology, with plans to support commercial efforts in Europe and ongoing clinical trials in the U.S. This leadership change is intended to strengthen the company's strategic direction amidst ongoing innovations in cardiac arrhythmia treatment.
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ADGM Nov 14, 2024ADGMGeneral
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Adagio Medical Adagio Medical Reports Third Quarter 2024 Results
Adagio Medical Holdings, Inc. reported a significant increase in revenue for Q3 2024, driven by its new vCLAS technology, marking a 351% growth compared to the same quarter in 2023. The company's net loss decreased to $4.6 million, reflecting improved financial performance. Despite these positives, gross margin remains negative, and operating expenses have risen, which may affect profitability in the near term. Adagio continues to progress with its FULCRUM-VT study, which aims for FDA premarket approval for its cryoablation system.
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ADGM Aug 19, 2024ADGMGeneral
Adagio Medical Provides Business Updates
Adagio Medical (ADGM) provided a business update highlighting significant progress in its catheter ablation technologies for cardiac arrhythmias. The company received CE Mark approval for its vCLAS catheter and ultra-low temperature cryoablation system, which has been launched in select European markets. Additionally, Adagio reported strong interest in enrollment for its FULCRUM-VT Pivotal study. The business combination with ARYA Sciences has bolstered its financial standing, raising approximately $84.2 million.
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ADGM Jul 31, 2024ADGMGeneral
Adagio Medical Announces the Closing of the Business Combination with ARYA IV, Creating a Publicly Traded Company Focused on the Innovative Technologies for Treatment of Cardiac Arrhythmias Business combination transacti
Adagio Medical has completed its business combination with ARYA IV, resulting in the creation of Adagio Medical Holdings, Inc., which will begin trading on Nasdaq under the ticker ADGM. The new entity has raised approximately $84.2 million to support its initiatives in developing innovative cryoablation technologies for cardiac arrhythmias. Key focuses include commercializing their vCLAS ultra-low temperature cryoablation catheter and executing the FULCRUM-VT Pivotal IDE trial recently approved by the FDA. Despite the positive outcome of the business combination, the announcement included caution regarding potential risks and compliance related to future operations.
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