Latest Results from End-Ischemic HOPE U.S. Randomized Clinical Trial for Liver Transplantation Show Safety, Reduced Early Allograft Dysfunction, and Shorter Hospital Stays with HOPE

CHICAGO, June 4, 2024 /PRNewswire/ -- Bridge to Life Ltd, a leading provider of organ preservation solutions, has announced the latest findings from the Bridge to HOPE clinical trial, utilizing the VitaSmart Machine Perfusion System. The trial evaluates the safety and efficacy of static cold storage (SCS), the current standard for ex-vivo organ preservation, compared to SCS followed by hypothermic oxygenated perfusion (HOPE) prior to the transplantation of extended criteria donation after brain death (DBD) and donation after circulatory death (DCD) livers. The near-complete one-year patient follow-up results, involving 219 participants, were presented today during the late-breaker clinical trial session at the 2024 American Transplant Congress (ATC) in Philadelphia, PA.

Key results include:

- A significant reduction in early allograft dysfunction (EAD) in the HOPE group (20%) compared to the SCS group (37%), the primary endpoint of the trial with a statistically superior finding (p=.003).

- A significantly shorter median hospital stay for the HOPE group (8 days) compared to the SCS group (11 days, p=.04).

- Favorable trends for HOPE, including fewer serious adverse events, lower rates of Clavien-Dindo grade >3 events (HOPE = 51%, SCS = 60%), reduced incidence of clinically significant DCD ischemic cholangiopathy (HOPE = 11%, SCS = 19%), and lower rates of DCD graft failure (HOPE = 7%, SCS = 19%) and re-transplantations.

- No device-related adverse events were reported.

David J. Reich, MD, Surgical Director of the Liver Transplant Program and Chief of Innovative Technology and Therapeutics at the Cleveland Clinic Transplant Center in Weston, FL presented results as Lead Investigator for the trial. "The newest results of the HOPE trial once again showed that dynamic organ preservation is an extremely promising area of study," said Dr. Reich. "We are encouraged by the improved clinical outcomes, and the continued advancement of care for transplant recipients."

Don Webber, President and CEO of Bridge to Life, expressed optimism about the results, stating, "Bridge to Life is highly encouraged by the latest outcomes of our VitaSmart development program, which continue to validate the benefits of actively oxygenated perfusion using VitaSmart prior to liver transplantation. We remain committed to advancing innovative technologies in liver transplantation for the organ transplantation community."

Dr. Reich has had a consulting relationship with Bridge to Life in the past. 

About Bridge to Life Ltd

Bridge to Life Ltd is a market leader in organ preservation solutions, offering premier products such as Belzer UW, EasiSlush, and the VitaSmart Machine Perfusion System. Focused on product quality, innovation, and accessibility, the company collaborates with leading Transplant Centers and Organ Procurement Offices (OPOs) worldwide.

Note: VitaSmart is CE Marked and available for sale in several markets outside the United States. It is not yet approved for sale in the U.S. The company completed enrollment of its pivotal, multicenter, randomized clinical study in the U.S. in 2023 and plans to submit to the FDA later this year upon completing all one-year patient follow-up.

SOURCE Bridge to Life, Ltd.