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

Primary Effectiveness and Safety Endpoints Were Met. The OCS Liver Achieved Statistical Superiority of The Primary Effectiveness Endpoint by Demonstrating Significant Reduction of Early Allograft Dysfunction (EAD) Compared to Control.

ANDOVER, Mass., May 26, 2020 (GLOBE NEWSWIRE) -- TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart and liver failure, today reported positive top-line results from its U.S. Pivotal OCS Liver PROTECT Trial. The trial achieved its primary clinical objectives by meeting both the primary and secondary effectiveness and safety endpoints.  For the primary effectiveness endpoint, the use of OCS Liver resulted in a significantly lower incidence of early allograft dysfunction (EAD) compared to control (17.3% OCS vs. 30.5% Control p=0.009) across both the donors after brain death (DBD) and donors after circulatory death (DCD) cohorts in the trial. EAD is the most common severe complication that occurs early after liver transplantation. EAD serves as a potential indicator of preservation injury to the donor liver and is associated with significant increase in ICU and hospital stay.  The trial also met its three secondary effectiveness endpoints.  The OCS Liver was able to maintain a near physiologic functioning state and monitor the condition of the liver outside of the human body; patient survival at 30-days post-transplant was high and non-inferior to control (99.3% OCS vs. 99.3% Control p=0.0004). In addition, the use of OCS Liver resulted in a significantly lower incidence of ischemic cholangiopathy complications at 6 months post-transplantation (1.4% OCS vs. 8.5% Control p=0.005), a leading cause of late graft failure after liver transplantation.  The primary safety endpoint was also met, as the average liver graft-related serious adverse events (SAEs) per patient observed using the OCS Liver was non-inferior to Control (0.046 OCS vs. 0.075 Control p<0.0001). In the OCS Liver PROTECT Trial, 155 donor livers, including both DBD and DCD, were instrumented on the OCS Liver, of which 152 were successfully transplanted, yielding a 98.1% utilization rate.