Preliminary results suggest potential to support extended preservation time and donor heart utilization
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 heart waitlist.
"Today's late-breaking data is more than a single milestone. It represents an important step in advancing ongoing research in organ preservation," said Christoffer Rosenblad, CEO of XVIVO. "With the PRESERVE Trial, we are evaluating how new methods like HOPE may unlock new possibilities for how organs are preserved, transported, and ultimately utilized. We are encouraged by the preliminary findings and look forward to submitting the results to the FDA later this year."
The PRESERVE Trial enrolled 141 transplant recipients across 14 U.S. centers from October 2023 to November 2024. The study's primary efficacy endpoint evaluated the absence of severe primary graft dysfunction, death, re-transplant, or mechanical support at day 30. Its safety endpoint measured patient survival at day 365.
Results of the PRESERVE Trial showed:
- 73.8% of cases exceeded the traditional 4-hour preservation timeframe.
- A 92.1% success rate for the primary effectiveness endpoint at day 30, significantly higher than the pre-specified performance goal.
- A 91.4% survival rate at day 365, compared to the pre-specified performance goal.
"This study builds on our ongoing global pre-clinical and clinical research evaluating HOPE," said Jaya Tiwari, Senior Vice President of Global Medical Affairs at XVIVO. "The PRESERVE Trial is further evaluating how this technology may support organ preservation and expanded donor utilization in a challenging donor population, with the potential to support surgical teams across the U.S."
Based on these findings, XVIVO intends to submit the XVIVO Heart Assist Transport for review by the FDA.
For more information, visit: https://www.xvivogroup.com/products-services/xvivo-heart-assist-transport/
CAUTION-Investigational device. Limited by Federal (United States) law to investigational use. The safety and effectiveness of this device have not been established.
About XVIVO:
Founded in 1998, XVIVO is the only medical technology company dedicated to extending the life of all major organs so transplant teams around the world can save more lives. Our solutions allow leading clinicians and researchers to push the boundaries of transplantation medicine. XVIVO is headquartered in Gothenburg, Sweden, and has offices and research sites on two continents. The company is listed on Nasdaq Stockholm under the ticker symbol XVIVO. More information can be found on the website www.xvivogroup.com.
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XVIVO@rhstrategic.com
