NORTHBROOK, Ill., Feb. 2, 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 first enrollment and orthotopic liver transplantation in its U.S. pivotal Bridge to HOPE Liver Clinical Trial (NCT05045794).
The Bridge to HOPE trial is evaluating 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 first transplant recipient was enrolled at Henry Ford Transplant Institute, Henry Ford Hospital in Detroit, MI. The trial is anticipated to enroll up to 244 patients undergoing transplantation at up to 15 hospitals over the next 2 years.
"I am so incredibly proud of our team here at Henry Ford for the hard work they put forth to make this clinical trial a reality," said Michael Rizzari, MD, Transplant Surgeon and site Principal Investigator. "We are very grateful for the partnership we have established with the Bridge to Life team. Their guidance has been invaluable in getting the study off the ground and we are looking forward to continued collaboration with them in the future. Most importantly, we are excited to experience first-hand the benefits that this technology can bring to our patients as well as the potential for increasing the organ donor pool."
The first study recipient received a donor liver perfused using the VitaSmart™ Liver Machine Perfusion System. "As a surgeon, I felt this pump had a great advantage of being easy to use while providing a great alternative to static cold storage," said Tayseer M. Shamaa, MD, General Surgery Research Resident and Sub-Investigator operating the VitaSmart™ Liver Machine Perfusion System. "The VitaSmart was a quick set up and required a relatively small team to operate. These features should allow its widespread use amongst transplant centers across the country."
"We celebrate this pivotal study milestone, thrilled with how well the inaugural Bridge to HOPE perfusion went. I salute my talented colleagues at Henry Ford and the dedicated professionals at Bridge to Life. We anticipate a rapid pace of enrolments at the various study sites – among the top tier of US transplant centers. We wish this recipient continued healthy recovery, and are grateful to the organ donor," said David J. Reich, MD, Professor of Surgery at Drexel University and lead investigator for the Bridge to HOPE Liver Clinical Trial.
"While the VitaSmart device and the HOPE protocol have been successful for organ transplantation in Europe and other parts of the world, the Henry Ford transplant today is an important first step to bring this device into the U.S. Hypothermic transplant using the vital component of highly concentrated oxygen is now being proven on our side of the Atlantic, case by case. Medical efficacy, combined with its ease of use, makes the HOPE procedure with VitaSmart widely accessible to hospitals because it fits easily into their logistical and cost models. This is how hospitals will want to perform transplants in the future," said Richard Birch, VP of Business Development.
About Bridge to Life
Bridge to Life was founded with the mission of improving organ transplants by licensing and developing new preservation solutions and technologies to provide the highest quality of service to organ procurement organizations and transplant centers. The U.S. based company, headquartered in Northbrook, Illinois, is a leading supplier of preservation solutions worldwide with a focus on innovation in organ preservation and machine perfusion. Through a strong focus on collaboration with surgeons and transplant professionals, it continues to explore emerging science and preservation technologies. Visit bridgetolife.com to learn more.
The Henry Ford Transplant Institute offers a distinguished history of excellence. The Henry Ford Transplant Institute is one of the busiest and most well-respected multi-organ transplant centers in the United States. As Michigan’s most comprehensive multi-organ transplant center the Henry Ford Transplant Institute performs transplantation of the Liver, Kidney, Pancreas, Small bowel and multivisceral organs, Lung and Heart.
As a major research institution, the Henry Ford Transplant Institute offers the latest treatments and most advanced surgical options and employs aggressive strategies to increase transplant opportunities for patients on the wait list while maintaining superior patient outcomes.
SOURCE Bridge to Life Ltd