TransMedics (NSDQ:TMDX) announced last night that an FDA advisory panel issued a favorable vote supporting approval for its OCS Liver System.
Yesterday, the Nasdaq market halted trading of TransMedics’ common stock as it awaited the outcome of a meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, set to review the premarket approval application for its Organ Care System (OCS) Liver System, a portable organ perfusion and monitoring medical device.
Shares of TMDX were up nearly 13% at $35.79 per share in pre-market trading as the news of the advisory committee’s ruling makes its way around.
Andover, Mass.–based TransMedics said in a news release that the panel voted 14-to-0 in favor of the fact that there is reasonable assurance that the OCS Liver System is effective, with a 14-to-0 vote favoring the fact that there is reasonable assurance of the OCS Liver System’s safety.
The panel voted 12-to-1 with one abstention concerning the benefits of OCS Liver System outweighing the 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,” TransMedics president & CEO Dr. Waleed Hassanein said in the release. “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 FDA will now consider the panel’s recommendations as it decides whether to issue the PMA for the OCS Liver System. The OCS Lung System is currently approved in the U.S., and the OCS Heart system is currently under FDA review after receiving a positive vote from an FDA panel in April.
“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,” Hassanein said.