XVIVO Reveals Positive Outcomes for its Organ Preservation Technology

XVIVO is sharing encouraging preliminary data from the PRESERVE Trial, which evaluated hypothermic oxygenated perfusion (HOPE) using the XVIVO Heart Assist Transport device.

Meeting its pre-specified primary endpoints, the trial assessed the safety and efficacy of HOPE in preserving and transporting extended-criteria donor (ECD) hearts with the potential to extend heart preservation time outside of the body. XVIVO will submit the trial’s 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., a cardiothoracic and thoracic surgeon at Emory Healthcare, and PRESERVE Trial principal investigator. “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, two of 10 donated hearts are transplanted because many donor hearts are considered marginal or high-risk, or because of time constraints from existing preservation methods (currently a four-hour threshold). This narrow timeframe particularly impacts hearts donated after circulatory death (DCD), donation after brain death (DBD), and ECD, such as those from people older than 60 years or with multiple risk factors. Transplant teams currently are hesitant to accept these high-risk hearts because of their condition, which could lead to poor outcomes. This poses further constraints on organs that could be transplanted, at a time when there are 3,456 U.S. residents on the heart waitlist.

“This data is more than a single milestone. It represents an important step in advancing ongoing research in organ preservation,” XVIVO CEO Christoffer Rosenblad stated. “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 four-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,” XVIVO Senior Vice President of Global Medical Affairs Jaya Tiwari said. “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. The XVIVO Heart Assist Transport device is currently limited by U.S. law to investigational use.

Founded in 1998, XVIVO is the only medical technology company dedicated to extending the life of all major organs so transplant teams can save more lives. Its solutions allow 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.