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Investing.com -- TransMedics Group Inc (NASDAQ:TMDX) stock jumped 6.7% after the company announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval for its Investigational Device Exemption (IDE), allowing it to proceed with its Next-Generation OCS ENHANCE Heart trial.
The ENHANCE trial will be conducted in two parts, with Part A designed to support prolonged heart perfusion using the OCS Heart System, while Part B aims to demonstrate the superiority of OCS Heart perfusion in donation after brain death cases compared to static cold storage methods. The total sample size for both parts is expected to exceed 650 patients, which TransMedics believes would make it the largest heart preservation for transplant trial worldwide.
"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 address the major clinical needs of the cardiothoracic transplant community," said Waleed Hassanein, MD, President and Chief Executive Officer.
TransMedics plans to initiate both trials in the fourth quarter of 2025 while continuing to work with the FDA to address remaining questions related to pre-clinical testing. The company hopes these trials will drive clinical adoption for both heart and lung transplant technologies throughout 2026 and beyond.
The Nasdaq-listed medical technology company focuses on transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure through its Organ Care System (OCS) technology.
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