Bridge to Life, Ltd. (“Bridge to Life” or the “Company“), a leading global supplier of organ preservation solutions and organ perfusion technologies, announced investigational device exemption (IDE) approval by the U.S. Food and Drug Administration (FDA) for its VitaSmart™ Liver Machine Perfusion System. Bridge to Life plans to enroll the first patient in its U.S. pivotal Bridge to HOPE Liver Clinical Trial (NCT05045794) by the end of 2021.
The Bridge to HOPE trial will evaluate the clinical safety and efficacy of static cold storage, 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. The primary endpoint for the trial is the rate of early allograft dysfunction between treatment groups; additional key endpoints include rates of ischemic cholangiopathy, and patient and graft survival up to 1-year post-transplantation. The trial is anticipated to enroll up to 244 patients undergoing transplantation over 2 years and will involve up to 15 hospitals.
“Early results of HOPE show that it rejuvenates donor livers, enabling safe transplantation of some that wouldn’t otherwise be used. HOPE-rejuvenated livers perform better after transplantation. With HOPE, we will do more transplants, saving lives of those on the ever-long waitlist, and improve results for transplant recipients. Through this well-thought-out and scientifically sound trial we will learn even more about HOPE. I am delighted to help lead this pivotal effort, along with a talented and inspiring team of collaborators,” said David J. Reich, MD, Professor of Surgery at Drexel University and lead investigator for the Bridge to HOPE Liver Clinical Trial.
The VitaSmart™ Liver Machine Perfusion System provides clinicians with the ability to implement hypothermic oxygenated perfusion (HOPE) of liver grafts in the transplant center operating room after ex-vivo cold storage prior to transplant surgery. The system is easy-to-use and simple-to-setup, requiring minimal personnel to monitor perfusion progress.
“Transplant surgeons in Europe and other countries who have switched to the VitaSmart™ Machine Perfusion System have commented on the system’s ease-of-use and ability to deliver the vital organ oxygenation component of machine perfusion,” said Richard Birch, Bridge to Life Vice President of Business Development. “This is the perfusion device hospitals have been asking for, providing efficacy for organ transplantation with a simple user experience at a cost-effective price.”
“Bridge to Life continues to research and develop technology to improve organ preservation and have now added organ perfusion devices to our portfolio of products,” said Bridge to Life Chairman and CEO Stevan Schweighardt. “The addition of perfusion technology provides for more and better-quality organs to the transplant community worldwide.”