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. 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.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.
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