LAGUNA HILLS, Calif. - Adagio Medical (TASE:PMCN) Holdings, Inc. (NASDAQ:ADGM), a medical device company specializing in catheter ablation technologies for cardiac arrhythmias, announced leadership changes today. The company's founder, Olav Bergheim, has stepped down from his roles as CEO and Chairperson of the Board, effective last Sunday. Todd Usen has been appointed as the new CEO, and Orly Mishan has taken over as the Chairperson of the Board, both effective the same day. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 4.42, though it faces challenges with rapid cash burn and negative profit margins.
Bergheim, who has led the company for 13 years, will continue to serve as an advisor until December 13, 2025, to assist with the transition. During his tenure, the company achieved significant clinical and operational advancements and became listed on NASDAQ. The company's market capitalization currently stands at $29.36 million, with its stock price experiencing significant volatility - InvestingPro analysis reveals over 80% decline in share value over the past year.
Orly Mishan expressed gratitude for Bergheim's contributions and welcomed Usen, citing his extensive experience in leading complex medical device businesses and his focus on corporate development, product innovation, and go-to-market strategies. Usen's previous roles include President & CEO of Minerva Surgical and Activ Surgical, as well as leadership positions at Olympus Corporation, Smith and Nephew, and Boston Scientific Corporation (NYSE:BSX). He currently holds board positions at several medical companies.
Usen expressed enthusiasm for joining Adagio, particularly as the company advances its commercial efforts in Europe and continues the FULCRUM-VT trial enrollment in the United States. He highlighted the potential of Adagio's Ultra-Low Temperature Cryoablation technology and its vCLAS™ catheter for treating ventricular tachycardia, aiming to set a new standard of care.
Adagio is in the early commercial stage and is focused on developing technologies to create lesions for treating various cardiac arrhythmias. The FULCRUM-VT study is a significant step toward obtaining FDA premarket approval for Adagio's VT Cryoablation System. Financial metrics from InvestingPro show last twelve months revenue of $0.54 million, reflecting its early-stage status. Subscribers can access 13 additional ProTips and comprehensive financial analysis to better understand the company's growth trajectory.
The company cautions that statements regarding future events or performance may be considered forward-looking and are subject to risks and uncertainties. These statements are based on current estimates and assumptions, and actual results could differ materially.
This news article is based on a press release statement from Adagio Medical Holdings, Inc.
In other recent news, Adagio Medical Holdings has initiated a pivotal study for its VT Cryoablation System, aiming for FDA premarket approval. The FULCRUM-VT study, focused on treating ventricular tachycardia in patients with structural heart disease, is underway at Vanderbilt University Medical Center and Texas Cardiac Arrhythmias Institute. The study, which plans to enroll 206 patients, will evaluate the system's safety and efficacy. Adagio's technology is anticipated to address current limitations in radiofrequency ablation, especially in thicker cardiac tissue.
In addition to the FDA study, Adagio has launched its vCLAS™ catheter and ultra-low temperature cryoablation system in select European markets, following recent CE Mark approval. The company also successfully completed a business combination with ARYA Sciences Acquisition Corp IV, which raised approximately $84.2 million post-transaction costs. ARYA Sciences Acquisition Corp IV has extended its initial business combination to August 2024, with a plan to merge with Adagio Medical, resulting in the new entity to be known as New Adagio.
These developments are part of Adagio's continued focus on the development of cryoablation technologies for the treatment of various cardiac arrhythmias, with a recent emphasis on expanding patient enrollment and technology use in Europe.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.