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. develops catheter-based ablation technologies for the treatment of cardiac arrhythmias. The company’s proprietary Ultra-Low Temperature Ablation technology and vCLAS® Ventricular Ablation System are focused on ventricular arrhythmias, including ventricular tachycardia, using an endocardial approach.
Recurring Adagio Medical news covers FULCRUM-VT clinical updates, FDA IDE activity, planned PMA support, CE Mark-related commercialization outside the United States, next-generation catheter development, pre-clinical publications, medical-conference presentations, financial results, and financing activity tied to its cardiac electrophysiology device programs.
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.
Adagio Medical Holdings (Nasdaq: ADGM) has announced its participation in the Stifel 2024 Healthcare Conference. CEO & President Olav Bergheim will deliver a presentation on Monday, November 18, at 9:45 a.m. Eastern Time at the Lotte New York Palace Hotel in New York. The company, which specializes in catheter ablation technologies for cardiac arrhythmia treatment, will provide a live audio webcast of the presentation, accessible through the 'Investors' section of their website. A replay will also be available for those unable to attend the live session.
Adagio Medical Holdings, Inc. (Nasdaq: ADGM) announced its sponsorship and participation in the 19th Annual International Symposium on Ventricular Arrhythmias, scheduled for October 11-12, 2024, in New York. The company's Ultra-Low Temperature Cryoablation (ULTC) technology will be featured in the symposium's scientific program.
Two presentations are highlighted:
- Dr. Atul Verma will present Cryocure-VT: One-year Results and Next Steps (FULCRUM-VT) on October 11 at 4:40 p.m. ET
- Professor Dr. Roland Tilz will present a recorded case on PVC Ablation using Ultra-low Cryoablation on October 12 at 12:35 p.m. ET
Olav Bergheim, President and CEO of Adagio, expressed pride in supporting the event and anticipation for discussing their technology and clinical program with experts in the field.
Adagio Medical Holdings, Inc. (Nasdaq: ADGM), a leader in catheter ablation technologies for cardiac arrhythmias, has provided a business update highlighting significant milestones. The company has obtained CE Mark approval and initiated the commercial launch of its vCLAS™ catheter and ultra-low temperature cryoablation (ULTC) system for ventricular tachycardia (VT) treatment in Europe. Additionally, Adagio has received FDA approval for the FULCRUM-VT Pivotal IDE study in the US, with patient enrollment expected to begin in September.
The company recently closed a business combination with ARYA Sciences Acquisition Corp IV, resulting in its listing on the Nasdaq Capital Market under the ticker symbol 'ADGM'. This transaction, along with concurrent financings, raised approximately $84.2 million, leaving the company with a proforma cash-on-hand of about $35 million after closing.