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Adagio Medical Holdings Inc (ADGM) is a leader in developing cryoablation systems for cardiac arrhythmia treatment, combining medical innovation with engineering precision. This page aggregates all official announcements, financial disclosures, and clinical progress updates directly from the company and verified sources.
Investors and healthcare professionals will find timely updates on regulatory milestones, product innovations, and strategic partnerships. Our curated feed includes earnings reports, FDA clearances, trial results, and executive commentary - providing essential context for understanding ADGM's market position in interventional cardiology.
Key coverage areas include quarterly financial performance, clinical study outcomes, technology patents, and partnerships with medical institutions. All content is verified for accuracy and updated as new developments emerge in cardiac ablation therapies.
Bookmark this page for streamlined access to ADGM's evolving story in medical device innovation. Combine real-time alerts with historical data analysis to track the company's progress in advancing cryoablation treatment standards worldwide.
Adagio Medical (Nasdaq: ADGM) reported preliminary acute (within 7 days) results from the FULCRUM-VT pivotal study presented October 10, 2025. The multi‑center trial enrolled 207 patients at 19 US and Canadian sites with ischemic and nonischemic cardiomyopathy (mean LVEF 35%±10%).
Key acute outcomes: mean procedure duration 206±68 minutes, 97.4% acute clinical success (non‑inducibility) and 96.7% elimination of clinically relevant VTs. Safety: 2.5% major adverse event rate, including four peri‑procedural deaths (1.9%) and one death (0.5%) adjudicated as definitely device‑related. Six‑month primary efficacy results are planned for Heart Rhythm 2026.
Adagio Medical (NASDAQ:ADGM) has completed enrollment for its pivotal FULCRUM-VT clinical trial, evaluating the vCLAS Cryoablation System for treating ventricular tachycardia. The trial, which enrolled 208 patients across 20 centers in the US and Canada, was completed in just 11 months.
The vCLAS System, granted FDA Breakthrough Device Designation, utilizes ultra-low temperature cryoablation technology and is the first VT-specific ablation technology to complete enrollment in a pivotal IDE study in the United States. The study's primary endpoint measures six-month freedom from recurring monomorphic ventricular tachycardia without increased antiarrhythmic drugs.
The company expects to complete the PMA process by year-end 2026. The system is already commercially available in Europe and select other regions, while remaining investigational in the US.
Adagio Medical (Nasdaq: ADGM) announced that acute results from its FULCRUM-VT U.S. pivotal study will be presented at The 20th Annual International Symposium on Ventricular Arrhythmias in October 2025. The IDE study is evaluating the safety and effectiveness of Ultralow Temperature Cryoablation (ULTC) for treating Sustained Monomorphic Ventricular Tachycardia in patients with ischemic and nonischemic cardiomyopathy.
The company's ULTC technology will be featured in three presentations at the symposium, including a late-breaking session on acute outcomes from the FULCRUM-VT trial, initial clinical experience with Ultracool Cryoablation for VT, and research on Pulse Field Ultra-Low Temperature Cryoablation in a swine model.
Adagio Medical (Nasdaq: ADGM), a cardiac arrhythmia treatment technology company, has expanded Chief Business Officer Deborah Kaster's role to include Chief Financial Officer responsibilities, effective September 5, 2025. Ms. Kaster replaces interim CFO Dan George, who served since April 2025.
In her expanded position, Kaster will maintain oversight of business development, corporate strategy, and investor relations while taking on responsibility for financial operations, including accounting, treasury, and financial planning. She will continue reporting to CEO Todd Usen, who praised her impact on strategic initiatives and partnership building during her four-month tenure at Adagio.
Adagio Medical (Nasdaq: ADGM), a cardiac arrhythmia treatment technology company, reported its Q2 2025 financial results. The company achieved 85% enrollment in its FULCRUM-VT pivotal study for the vCLAS™ Cryoablation System, targeting completion in H2 2025. The study involves 206 patients across 20 U.S. and Canadian centers.
Financial highlights include a reduced net loss of $3.9 million ($0.26 per share) compared to $5.7 million in Q2 2024. The company reported cash holdings of $8.2 million as of June 30, 2025, with decreased operational expenses across all categories due to corporate prioritization initiatives.
Notable achievements include the publication of first-in-human results from the PARALELL study, evaluating their novel Pulsed Field Cryoablation (PFCA) technology in the Journal of Cardiovascular Electrophysiology.
Adagio Medical (NASDAQ: ADGM) reported Q1 2025 financial results and significant operational progress. The company received FDA Breakthrough Device Designation for its vCLAS™ Cryoablation System for treating ventricular tachycardia. The FULCRUM-VT pivotal study has surpassed 50% enrollment of its targeted 206 patients across U.S. and Canadian centers.
Financial highlights include a net loss of $7.7 million ($0.50 per share), compared to $8.0 million loss in Q1 2024. The company reported cash reserves of $13.0 million. Operating expenses included $3.7 million in R&D and $3.5 million in SG&A costs.
Notable developments include hiring Deborah Kaster as Chief Business Officer and implementing a corporate prioritization initiative focused on FULCRUM-VT trial activities and product design optimization.
Adagio Medical Holdings (NASDAQ: ADGM), a company specializing in catheter ablation technologies for cardiac arrhythmias treatment, has announced its participation in the upcoming BofA Securities Health Care Conference. The presentation is scheduled for Tuesday, May 13, 2025, at 9:20 a.m. PT and will take place at the Encore Hotel in Las Vegas, NV. Interested parties can access both live and recorded versions of the presentation through the provided webcast link.
Adagio Medical Holdings (Nasdaq: ADGM) has received FDA Breakthrough Device designation for its vCLAS™ Cryoablation System, designed to treat drug-refractory, recurrent, sustained monomorphic ventricular tachycardia in patients with ischemic or non-ischemic structural heart disease.
The system utilizes proprietary Ultra-Low Temperature Cryoablation (ULTC) technology and is currently under evaluation in the FULCRUM-VT IDE study, enrolling 206 patients. The study's results will support FDA premarket approval application, potentially leading to the broadest industry indication for purely endocardial ablation of scar-mediated VT.
The Breakthrough Device designation provides priority review and enhanced communication with the FDA during the premarket review phase. The vCLAS™ system is already commercially available in Europe and select geographies but remains to investigational use in the United States.
Adagio Medical (ADGM) has appointed Deborah Kaster as Chief Business Officer, bringing over 25 years of leadership experience in medical technology. Kaster previously served as VP of Investor Relations at Shockwave Medical, where she contributed to the company's 2000% stock price appreciation from IPO to Johnson & Johnson acquisition.
At Adagio, Kaster will oversee business development, strategic partnerships, investor relations, and corporate communications. Her notable achievements include leading Kyphon's $725 million acquisition of St. Francis Medical Technologies, which led to Kyphon's subsequent $4 billion acquisition by Medtronic.
Adagio Medical specializes in Ultra-Low Temperature Cryoablation (ULTC) technology for cardiac arrhythmias treatment. The company's vCLAS catheter, designed for ventricular tachycardia treatment, is CE Marked and currently under evaluation in the FULCRUM-VT U.S. IDE Pivotal Study.
Adagio Medical Holdings (NASDAQ: ADGM) reported its Q4 and full-year 2024 financial results. The company achieved Q4 revenue of $137,000, up 76% from Q4 2023, and full-year revenue of $0.6 million, a 101% increase from 2023.
Key highlights include surpassing 40% enrollment in the FULCRUM-VT pivotal study for their VT Cryoablation System, which aims to enroll 206 patients across U.S. and Canadian centers by H2 2025. The company reported cash and equivalents of $20.6 million as of December 31, 2024.
Financial results showed significant challenges with negative gross margins of -1012% in Q4 2024 and -451% for the full year. Operating expenses increased to $56.7 million in Q4 and $81.4 million for the full year, primarily due to a $49.2 million impairment. Net losses widened to $57.4 million in Q4 and $75.0 million for the full year 2024.
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