TransMedics Group Inc. (NASDAQ: TMDX) stock gains by 5.10% in the current market trading session. TransMedics is the world’s leading provider of portable extracorporeal warm perfusion and donor organ evaluation for transplantation.
What is happening?
TransMedics Group confirmed today that the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee meeting that was held by the US Food and Drug Administration has granted a positive vote in support of authorization of the OCS Liver System after reviewing and discussing TransMedics’ clinical evidence from the OCS Liver PROTECT trial.
The panel voted 14 to 0 that there is a complete probability that the OCS Liver System is effective, and 14 to 0 that it is safe. The panel decided that the advantages of the OCS Liver System exceed the hazards by a vote of 12 to 1 with 1 abstention.
Dr. Waleed Hassanein, President, and Chief Executive Officer commented,
This decision is a significant step forward in the process of getting the OCS Liver technology approved by the FDA, which will assist patients with end-stage liver disease in the United States. They are looking forward to collaborating with the FDA to complete the evaluation of the OCS Liver PMA. He would I want to take a moment to thank the investigators, study organizers, patients who participated in the OCS Liver PROTECT Trial, and the TransMedics Liver team for their efforts.
With today’s FDA panel vote, all three OCS products for lung, heart, and liver transplantation might be FDA authorized and widely accessible in the United States.
Independent views and nonbinding suggestions from outside medical professionals are provided to the FDA via Advisory Committees. The FDA will decide whether to accept the premarket approval application for using the OCS Liver System for transplantation when it has completed its evaluation of the PMA while taking into account the opinions and suggestions made at the Advisory Committee.
The OCS Lung System is authorized in the United States, while the OCS Heart System is undergoing FDA evaluation after obtaining a favorable vote from the FDA’s Circulatory System Device Advisory Panel in April.