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
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CHICAGO, June 4, 2024 ~ Bridge to Life Ltd, a leading provider of organ preservation solutions, has recently released the latest findings from their clinical trial, Bridge to HOPE. The trial, which utilized the VitaSmart Machine Perfusion System, aimed to evaluate the safety and efficacy of static cold storage (SCS) compared to SCS followed by hypothermic oxygenated perfusion (HOPE) in the transplantation of extended criteria donation after brain death (DBD) and donation after circulatory death (DCD) livers.

The results of the near-complete one-year patient follow-up were presented today at the 2024 American Transplant Congress in Philadelphia, PA. The trial involved 219 participants and was presented during the late-breaker clinical trial session.

One of the key findings from the trial was a significant reduction in early allograft dysfunction (EAD) in the HOPE group (20%) compared to the SCS group (37%). This was also noted as the primary endpoint of the trial with a statistically superior finding. Additionally, patients in the HOPE group had a significantly shorter median hospital stay of 8 days compared to 11 days for those in the SCS group.

There were also favorable trends for HOPE, including fewer serious adverse events and lower rates of Clavien-Dindo grade >3 events. The incidence of clinically significant DCD ischemic cholangiopathy was also reduced in the HOPE group compared to the SCS group. Furthermore, there were lower rates of DCD graft failure and re-transplantations in patients who underwent HOPE.

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It is worth noting that no device-related adverse events were reported during the trial. Lead Investigator for the trial, Dr. David J. Reich, Surgical Director of the Liver Transplant Program and Chief of Innovative Technology and Therapeutics at Cleveland Clinic Transplant Center in Weston, FL presented these results at ATC.

Dr. Reich expressed his enthusiasm for the results, stating, "The newest results of the HOPE trial once again showed that dynamic organ preservation is an extremely promising area of study. 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, also shared his optimism about the results. He stated, "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."

It is worth noting that Dr. Reich has had a consulting relationship with Bridge to Life in the past. These latest findings from the Bridge to HOPE trial provide promising evidence for the use of hypothermic oxygenated perfusion in organ preservation and may lead to improved outcomes for transplant recipients in the future.
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