TransMedics Group’s (NASDAQ:TMDX) pivotal Organ Care System (OCS) liver trial, called PROTECT, achieved its primary and secondary effectiveness and safety endpoints.
TransMedics’ OCS technology addresses the major limitations of cold storage, which is the current standard of care for organ preservation, particularly the long ischemic time and inability to assess or optimize the organ ex vivo.
The use of OCS Liver resulted in a significantly lower incidence of early allograft dysfunction of 17.3%, compared with 30.5% in the control group, across donors after brain and circulatory death.
The trial also met its three secondary effectiveness endpoints of maintaining a near physiologic functioning state; non-inferior patient survival at 30 days post-transplant, compared with the control; and significantly lower incidence of ischemic cholangiopathy complications at six months post-transplantation.
“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 early allograft dysfunction and ischemic cholangiopathy in liver transplantation,” Dr. Malcolm MacConmara, the trial’s co-investigator, said in a statement.
“If approved, this would safely expand the utilization of donor livers and significantly increase the number of livers available for life-saving transplantation,” he added.