Late-Breaking Data from PRESERVE Trial Evaluates XVIVO’s HOPE Preservation Approach in Heart Transplantation

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Preliminary results suggest potential to support extended preservation time and donor heart utilization TORONTO, April 22, 2026--(BUSINESS WIRE)--XVIVO, a global medtech company in the organ transplant industry, today announced late-breaking preliminary data from the PRESERVE Trial (NCT05881278) evaluating hypothermic oxygenated perfusion (HOPE) using the XVIVO Heart Assist Transport™. The trial met its pre-specified primary endpoints and was designed to assess the safety and efficacy for HOPE in the preservation and transport of extended-criteria donor (ECD) hearts with the potential to extend heart preservation time outside of the body. XVIVO intends to submit the results to the U.S. Food and Drug Administration (FDA) as part of the Pre-Market Approval (PMA) process later this year. HOPE is an investigational preservation method that circulates a cold, oxygenated solution through the organ to support preservation prior to transplant. It is being studied as an alternative to static cold storage. "For decades, organ preservation has been a limiting factor in heart transplantation, with approximately one in three DBD and one in five DCD hearts ultimately being transplanted," said Victor Pretorius, M.D., Cardiothoracic and Thoracic Surgery at Emory Healthcare, and Principal Investigator of the PRESERVE Trial. "The results of the PRESERVE Trial are encouraging. Through HOPE, XVIVO Heart Assist Transport is being studied for the potential to support the use of extended-criteria donor hearts that can be successfully utilized for transplant, with the possibility to expand access to lifesaving care for patients who may otherwise never receive an organ." Globally, only two out of 10 donated hearts are transplanted because many donor hearts are considered marginal or high-risk, or due to time constraints from existing preservation methods, which is currently a four-hour threshold. This narrow timeframe particularly impacts hearts that are donation after circulatory death (DCD), donation after brain death (DBD), and ECD, such as those from people over 60 years or with multiple risk factors. Today, transplant teams are hesitant to accept these high-risk hearts because of their condition that could lead to poorer outcomes. This poses further constraints on organs that could be transplanted, at a time when there are 3,456 people in the U.S. on the ...

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