Benzinga | Jun 8, 2021 04:06PM EDT

TransMedics Highlights Completed Results Of OCS Live PROTECT Trial Presented At American Transplant Congress

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, announced that the complete results of the OCS(tm) Liver PROTECT Trial ("PROTECT") were presented virtually at the American Transplant Congress on Tuesday June 8th, 2021. The presentation won the People's Choice Award for the most impactful presentation at the ATC 2021.





"The PROTECT trial results demonstrated superior short and mid-term clinical outcomes and improved utilization of donor livers for transplantation," - Dr. Markmann, Chief of the Division of Transplantation Surgery at Massachusetts General Hospital

Dr. James F. Markmann, Chief of the Division of Transplantation Surgery at Massachusetts General Hospital and the lead investigator of the PROTECT trial, presented the results, which included 12-month follow up data and were also highlighted in an abstract entitled Superior Post-transplant Clinical Outcomes Using Portable Normothermic Perfusion and Assessment with the Organ Care System (OCS) Liver System: 1-year Outcomes of the OCS Liver Protect Randomized Controlled Trial. The OCS Liver system premarket approval (PMA) application is currently under review by FDA and an Advisory Panel Meeting is expected to review the PROTECT results in the near future.

At ATC 2021, Dr. Markmann reported that PROTECT met its primary effectiveness endpoint and demonstrated a significant reduction in early allograft dysfunction (EAD) with OCS (OCS 18% vs. Control 31%, p=0.009). OCS preserved livers also demonstrated a significant reduction in histopathological evidence of IR injury after reperfusion and significant attenuation of reperfusion syndrome in the recipient. OCS use was also associated with significant reduction of ischemic biliary complications at one year, a leading cause of graft failure after liver transplant (OCS 2.6% vs. Control 9.9%, p=0.019). The OCS Liver System enabled ex-vivo liver allograft assessment and resulted in significantly higher utilization of livers from donors after cardiac death (DCD) (OCS 51% vs. Control 25%, p= 0.007). PROTECT's safety endpoint was met with low mean liver graft related serious adverse events (OCS 0.046 to Control 0.075, non-inferiority p<0.0001). Patient survival at one year was high at 94% for both OCS and Control arms.

"The PROTECT trial results demonstrated superior short and mid-term clinical outcomes and improved utilization of donor livers for transplantation," said Dr. Markmann. "The advent of a portable extracorporeal donor liver machine perfusion offers a convenient and effective approach to both assess and enhance donor liver function, thereby improving transplant safety, expanding the liver donor pool, and reducing waitlist mortality."

"We would like to congratulate Dr. Markmann and all of the PROTECT trial investigators on these superior and potentially transformative results in liver transplantation," said Waleed Hassanein, MD, President and Chief Executive Officer. "We are looking forward to our upcoming FDA Advisory Panel meeting to discuss the potential approval of the OCS Liver System based on these PROTECT trial results."