NORTHBROOK, Ill., May 25, 2023 /PRNewswire/ — Bridge to Life, Ltd. (“Bridge to Life” or the “Company”), a leading global supplier of organ preservation solutions and organ perfusion technologies, announced that it met positive criteria from interim analysis for early enrollment closure of 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 SCS followed by hypothermic oxygenated perfusion (HOPE) with the VitaSmart™ Liver Machine Perfusion System.
Results from the first 170 enrolled patients undergoing liver transplantation indicate that HOPE is statistically superior to SCS for the primary trial endpoint of early allograft dysfunction (EAD), which occurred in a significantly smaller proportion of patients in the HOPE arm compared to the SCS arm. The results were reviewed by the trial Data Safety and Monitoring Board and Bridge to Life, Ltd. subsequently closed enrollment on May 12, 2023.
Interim analysis results for efficacy and safety will be presented in early June at the American Transplant Congress 2023 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. “When several years ago we performed prototype device optimization and wrote the trial we were optimistic but didn’t anticipate such overwhelmingly positive results across the breadth of efficacy and safety outcomes,” said Dr. Reich. “This is a significant contribution to the field of machine perfusion dynamic preservation that is transforming organ transplantation. I’m exceedingly grateful to the donors and patients for making this possible, and to the investigators for their talented partnership and enthusiastic enrollment ahead of schedule.”
“We’re extremely pleased about the opportunity to stop trial enrollment early due to overwhelming efficacy results accompanied by favorable safety trends,” said Bridge to Life Chief Executive Officer Don Webber. “The fast-paced completion of enrollment is unprecedented for U.S. trials in liver machine perfusion and a testament to the tremendous effort by participating transplant center teams and simplicity of VitaSmart as a cost-effective technology to improve post-transplantation outcomes.”
The Bridge to HOPE Trial has enrolled 220 transplanted patients to date and is expected to complete patient follow-up by early summer, 2024.
About Bridge to Life
Bridge to Life is a recognized leader in organ preservation. The company distributes its products in over 50 countries and is currently enrolling patients in its multi-center, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart System. The company 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.