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LAGUNA HILLS, Calif. - Adagio Medical Holdings, Inc. (NASDAQ:ADGM), a micro-cap medical device company with a market capitalization of $14.2 million, known for its innovations in catheter ablation technologies, has been granted the Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its vCLASTM Cryoablation System. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet, though it’s currently experiencing rapid cash burn. This system is aimed at treating drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT) in patients with ischemic or non-ischemic structural heart disease.
The FDA’s Breakthrough Device Program is designed to expedite the development and review process for medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. To qualify, a device must either represent new technology, have no approved alternatives, offer significant advantages over existing alternatives, or its availability must be in the best interest of patients.
The vCLASTM Cryoablation System, which leverages Adagio’s proprietary Ultra-Low Temperature Cryoablation (ULTC) technology, is currently undergoing a study under an Investigational Device Exemption (IDE) known as FULCRUM-VT. This study enrolls patients with structural heart disease to evaluate the system’s safety and efficacy.
Todd Usen, CEO of Adagio, expressed the company’s excitement about the designation, highlighting that their system is the only technology granted the Breakthrough Device label for endocardial treatment of both ischemic and non-ischemic structural heart disease patients with sustained monomorphic VT. Despite this breakthrough, InvestingPro analysis indicates the company faces financial challenges, with a negative EBITDA of $33.57 million in the last twelve months. The stock has shown recent resilience with an 18% gain over the past week, though it remains significantly below its 52-week high.
Ventricular tachycardia is a serious condition characterized by a fast and abnormal heart rhythm that can lead to severe symptoms and, if sustained, can be fatal. The vCLASTM Cryoablation System is commercially available in Europe and other select geographies but is currently limited to investigational use in the United States.
The results from the FULCRUM-VT study are expected to support Adagio’s application for FDA premarket approval (PMA), potentially leading to a broad indication for endocardial ablation of scar-mediated VT. With a current Financial Health score of FAIR from InvestingPro, investors can access 8 additional ProTips and comprehensive financial metrics to better evaluate the company’s potential. The platform also offers exclusive insights into the company’s valuation and growth prospects, crucial for understanding medical technology investments.
The FDA’s priority review and interactive communication will be provided to Adagio during the vCLASTM Cryoablation System’s premarket review phase. This announcement is based on a press release statement by Adagio Medical Holdings, Inc.
In other recent news, Adagio Medical Holdings announced the termination of its Facilities and Services Agreement with Fjord Ventures, effective July 30, 2025. This decision, communicated on January 30, 2025, reflects the company’s reduced need for the services provided under the agreement, which included administrative support, IT services, and office space. The agreement, which began on June 1, 2011, and was amended over time, also involved a sub-lease for office and manufacturing space in Laguna Hills, California, which expired on March 31, 2024. Despite the termination, Adagio Medical Holdings remains open to negotiating a new contract with Fjord Ventures for future service or facility requirements. The company expressed that this move aligns with its evolving operations and business needs. Investors and stakeholders can find further details in the company’s Form S-4 filed on April 19, 2024. The company, previously known as Aja Holdco, Inc., changed its name on January 4, 2024. This information was based on a press release statement.
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