NORTHBROOK, Ill., July 11, 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).
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.
*Dr. Reich has had a consulting relationship with Bridge to Life in the past.