TransMedics Announces Positive Top-line Results from U.S. Pivotal OCS Liver PROTECT Trial - Seite 2

“Results from the OCS Liver PROTECT Trial set the stage for transformative changes in the field of liver transplantation by validating the benefits of reducing ischemic injury on the donor liver while continuously optimizing perfusion and assessing liver function on the OCS System,” said Dr. James Markmann, MD PhD, Chief Division of Transplant Surgery at Massachusetts General Hospital and the lead investigator of the OCS Liver PROTECT Trial. “We are looking forward to submitting these provocative clinical results for publication in a premier peer reviewed journal soon.”

“To our knowledge, these results from the OCS Liver PROTECT trial represent the first time a new technology or therapy has had a positive impact on both EAD and ischemic cholangiopathy in liver transplantation,” said Dr. Malcolm MacConmara, MD, Director of the Organ Research Lab at UT Southwestern Medical Center and a co-investigator of the OCS Liver PROTECT Trial.  “If approved, this would safely expand the utilization of donor livers and significantly increase the number of livers available for life-saving transplantation.”

“In addition to improved graft outcomes achieved with the OCS Liver System, we have seen in our clinical experience during the trial significant improvement in safety in the conduct of liver transplantation with adverse intraoperative reperfusion events being virtually eliminated after the use of the OCS Liver System,” said Dr. Marwan Abouljoud, MD, Director of the Henry Ford Transplant Institute and a co-investigator of the OCS Liver PROTECT Trial. “I believe this will open the gateway to using more livers for transplantation safely.”

“We are humbled and excited by these compelling top-line results from our OCS Liver PROTECT Trial,” said Waleed Hassanein, MD, President and Chief Executive Officer. “Data from the trial further support our belief that the OCS Liver System along with our OCS Lung and OCS Heart Systems has the potential to meaningfully improve patient outcomes and increase the number of organ transplants to help end-stage organ failure patients.  We are grateful for all the trial investigators, their teams and institutions for completing this seminal trial in liver transplantation.”