NORTHBROOK, Ill., November 9, 2022 /PRNewswire/ — Bridge to Life, Ltd. (“Bridge to Life” or the “Company”), a leading global supplier of organ preservation solutions and organ perfusion technologies, announced early results from its multicenter, randomized, controlled Bridge to HOPE Liver Clinical Trial (NCT05045794).
The Bridge to HOPE trial is being conducted under U.S. Food and Drug Administration (FDA) approved investigational device exemption (IDE) to evaluate the clinical safety and efficacy of static cold storage (SCS), the current standard for ex-vivo organ preservation, compared to cold storage followed by hypothermic oxygenated perfusion (HOPE) with the VitaSmart™ Liver Machine Perfusion System.
Results from the first 61 enrolled patients undergoing liver transplantation demonstrate a lower rate of early allograft dysfunction (EAD) in the HOPE arm (22%) compared to the SCS arm (34%), a promising trend in the trial’s primary endpoint. Additionally, median length of hospital stay post-transplantation is trending shorter in the HOPE arm (9.5 days) than in the SCS group (11.4 days). To date, no device related serious adverse events or patient deaths have been reported.
Early trial results were presented on November 7 at the American Association for the Study of Liver Diseases 2022 Meeting by 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 and Lead Investigator for the Bridge to HOPE Trial. “I am thrilled with these efficacy and safety results and enthusiastic about being closer to providing widespread access to this game changing innovative technology to help patients and transplant centers” said Dr. Reich. The presentation was selected for inclusion in the prestigious “Best of the Liver Meeting” category.
“We’re very excited about these early trends in that they corroborate results from research in Europe where the VitaSmart System is already in commercial use” said Bridge to Life Chief Executive Officer Don Webber. “The hard work and dedication of participating transplant center teams and other trial partners has been critical to our enrollment success and brings us one step closer to offering this cost-effective technology to improve outcomes at U.S. transplant programs.”
The Bridge to HOPE Trial has enrolled 115 transplanted patients to date and is on track to complete target enrollment of up to 244 transplanted patients by late 2023.
About Bridge to Life
Bridge to Life is a recognized leader in organ preservation. The company distributes its products in over 60 countries and also has devices in development at its Edmonton, Alberta design center for lung and heart perfusion. Through a strong focus on collaboration with surgeons and transplant professionals, Bridge to Life continues to explore emerging science and preservation technologies.