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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.

NORTHBROOK, Ill., July 12, 2023 /PRNewswire/ -- Bridge to Life Ltd., a leading global supplier of organ preservation and perfusion technologies, announced results from interim analysis of its multicenter, randomized, controlled liver clinical trial presented at the 2023 American Transplant Congress (ATC). We are hopeful that the research will lead to continued advancement of care for transplant patients. 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 SCS followed by hypothermic oxygenated perfusion (HOPE) with the VitaSmart™ Liver Machine Perfusion System. Results from the planned interim analysis of the first 170 enrolled patients undergoing liver transplantation show a lower rate of early allograft dysfunction (EAD) in the HOPE arm (19%) compared to the SCS arm (39%), a statistically superior finding for the trial's primary endpoint. Trial results favor HOPE over SCS for other endpoints including: HOPE achieved 100% liver graft survival at 6 months, while SCS achieved 91% HOPE had a median hospital stay of 9.5 days, compared to 11.4 days for SCS Biopsy-proven liver rejection at 6 months was lower in HOPE (10%) compared to SCS (18%) Donation after circulatory death livers treated with HOPE had less ischemic cholangiopathy compared to SCS (5% vs. 14%), with 3 cases requiring re-transplant in the SCS arm compared to one in the HOPE arm These benefits were observed without device-related serious adverse events. Interim analysis trial results were recently presented at the ATC 2023 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. "The Bridge to HOPE interim study results are an encouraging contribution to the field of dynamic organ preservation that has increased transplant availability and improved recipient outcomes," said Dr. Reich. "We are hopeful that the research will lead to continued advancement of care for transplant patients." "We're excited about these safety and efficacy findings for HOPE and VitaSmart," said Bridge to Life Chief Executive Officer Don Webber. "The trial investigators and study team have done outstanding work to reach the interim analysis milestone well ahead of schedule. We're looking forward to results from continued follow-up of trial participants and to presenting this encouraging data to FDA." Patients in the Bridge to HOPE Trial will be followed for 12 months after transplant surgery. View original content to download multimedia: SOURCE Bridge to Life Ltd.

NORTHBROOK, Ill., Nov. 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). Continue Reading VitaSmart™ Liver Machine Perfusion System 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. Media Contact: Cynthia Willis [email protected] 704-998-9444 SOURCE Bridge to Life Ltd.