Welcome to our dedicated page for Adagio Medical news (Ticker: ADGM), a resource for investors and traders seeking the latest updates and insights on Adagio Medical stock.
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 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.
Adagio Medical Holdings (NASDAQ: ADGM) provided updates on its focus on ventricular tachycardia (VT) solutions. The company announced its participation in the 2025 European Heart Rhythm Association Annual Meeting, where two medical experts will present on the company's ultra-low temperature cryoablation (ULTC) technology.
The FULCRUM-VT IDE Pivotal Study has reached 40% enrollment, targeting 206 patients with structural heart disease for catheter ablation of drug refractory ventricular tachycardia. The study aims to support US premarket approval of the VT Cryoablation System with vCLAS™ catheter, with full enrollment expected in H2 2025.
The company also announced CFO John Dahldorf's departure, effective March 21, 2025, to be replaced by a transitional CFO. CEO Todd Usen expressed confidence in the company's financial resources and corporate structure to achieve their goals.
Adagio Medical Holdings (NASDAQ: ADGM) announced a strategic corporate restructuring to focus on two key priorities: accelerating the FULCRUM-VT US pivotal IDE clinical trial and enhancing their product design optimization program. The trial, which has achieved over 35% enrollment, aims to obtain FDA premarket approval for their VT Cryoablation System with vCLAS™ catheter.
As part of the restructuring, Adagio will pause its European launch of the vCLAS catheter and implement workforce reductions effective February 28, 2025. The company's European launch has provided valuable insights into their ultra-low temperature cryoablation technology's clinical benefits and applications in treating ventricular tachycardia, an historically underserved market.
Adagio Medical Holdings (Nasdaq: ADGM), a pioneer in catheter ablation technologies for cardiac arrhythmia treatment, has announced its participation in TD Cowen's 45th Annual Health Care Conference. The event is scheduled for March 4, 2025, and will take place at the Marriott Copley Place in Boston, MA. The company's management team will be present at this significant healthcare industry gathering.
Adagio Medical Holdings (NASDAQ: ADGM) announced leadership changes effective December 13, 2024. Founder Olav Bergheim stepped down as CEO and Board Chairperson after 13 years of leadership. Todd Usen was appointed as the new CEO and Director, while Orly Mishan became Chairperson of the Board.
Usen brings extensive medical device industry experience, having previously served as President & CEO of Minerva Surgical and CEO of Activ Surgical, where he secured over $92 million in funding. He also led Olympus 's $2B+ Medical Systems Group. Bergheim will remain as an advisor supporting the transition through December 13, 2025.
The company focuses on catheter ablation technologies for cardiac arrhythmias treatment, with ongoing commercial efforts in Europe and the FULCRUM-VT trial in the United States.
Adagio Medical (ADGM) reported Q3 2024 financial results with revenue of $185,000, up 351% from $41,000 in Q3 2023. The company secured CMS coverage for their vCLAS™ ultra-low temperature cryoablation catheter and initiated the FULCRUM-VT pivotal study. Operating expenses increased to $10.2 million from $8.9 million year-over-year, while net loss decreased to $4.6 million from $10.8 million. The company reported $28.3 million in cash and equivalents as of September 30, 2024. Commercial expansion continues in European centers, with positive one-year follow-up data from the Cryocure-VT study showing sustained VT burden reduction.
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