TransMedics Group Inc (NASDAQ:TMDX) stock jumped 6.7% after the company announced that the U.S. Food and Drug Administration (FDA) granted conditional approval for its Investigational Device Exemption (IDE), allowing the Next-Generation OCS ENHANCE Heart trial to proceed.
The ENHANCE trial will be conducted in two phases: Part A will focus on supporting prolonged heart perfusion using the OCS Heart System, while Part B aims to demonstrate the superiority of OCS Heart perfusion over traditional static cold storage in donation after brain death cases. Together, the trial is expected to enroll over 650 patients, making it potentially the largest heart preservation transplant study worldwide.
Waleed Hassanein, M.D., President and CEO of TransMedics, commented, “The recent FDA approvals to initiate our Next-Gen OCS ENHANCE Heart and DENOVO Lung trials mark key milestones in our ongoing commitment to transforming the standard of care and addressing the major clinical needs of the cardiothoracic transplant community.”
TransMedics plans to launch both trials in the fourth quarter of 2025 while continuing to collaborate with the FDA on remaining pre-clinical testing questions. The company anticipates these trials will accelerate clinical adoption of its heart and lung transplant technologies throughout 2026 and beyond.
TransMedics, listed on Nasdaq, specializes in advancing organ transplant therapies for patients with end-stage heart, lung, and liver failure through its innovative Organ Care System (OCS) technology.
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