Panel votes unanimously in support of the OCS Liver System's safety and effectiveness

ANDOVER, Mass., July 14, 2021 /PRNewswire/ -- 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 today that after review and discussion of TransMedics' clinical evidence from the OCS Liver PROTECT trial, the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee convened by the U.S. Food and Drug Administration ("FDA") has issued a favorable vote in support of approval of the OCS Liver System.  

The panel voted 14 to 0, that there is reasonable assurance that the OCS Liver System is effective and 14 to 0, that there is reasonable assurance of the OCS Liver System's safety. The panel voted 12 to 1, with 1 abstaining, that the benefits of the OCS Liver System outweigh its risks.

"This vote marks a key milestone as we move towards potential FDA approval of the OCS Liver technology, which stands to benefit U.S. patients with end-stage liver failure. We are looking forward to working collaboratively with the FDA to finalize the review of the OCS Liver PMA," said Dr. Waleed Hassanein, President and Chief Executive Officer. "I want to take this opportunity to thank the OCS Liver PROTECT Trial investigators, trial coordinators, patients who enrolled in the OCS Liver PROTECT Trial, and the TransMedics Liver team."

"The OCS Liver PROTECT Trial demonstrated that the OCS Liver has the ability to provide superior clinical outcomes and improve utilization of donor livers for transplantation. This is truly a game-changer in the field of liver transplantation," said Dr. James F. Markmann, Chief of the Division of Transplantation Surgery at Massachusetts General Hospital and the lead investigator of the OCS Liver PROTECT Trial. "The OCS Liver System allows surgeons to both assess and enhance donor liver function before transplantation, which can improve transplant safety and enables the use of donor livers that would otherwise go unused. If approved by the FDA, I believe the OCS Liver will allow us to provide more life-saving transplants for patients with end-stage liver disease."

"Today's FDA panel vote brings us closer to potentially having all three OCS products FDA approved and commercially available in the U.S. for lung, heart and liver transplantation," Dr. Waleed Hassanein concluded.

FDA Advisory Committees provide the FDA with independent opinions and nonbinding recommendations from outside medical experts.  While the FDA will consider the opinions and recommendations expressed at the Advisory Committee, the FDA will make a decision regarding whether to approve the premarket approval application ("PMA") for the use of the OCS Liver System for transplantation after completion of its review of the PMA.

The OCS Lung System is approved in the U.S., and the OCS Heart System is currently under review by the FDA after receiving a positive vote by the FDA'sCirculatory System Device Advisory Panel in April.

PROTECT TrialThe OCS Liver PROTECT trial 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 in the incidence of ischemic biliary complications through 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, which resulted in a 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 a low average number of liver graft-related serious adverse events (OCS 0.046 to Control 0.075, non-inferiority p