Benzinga | Jul 15, 2021 06:34AM EDT

FDA Advisory Committee Gives Thumbs Up To TransMedics' OCS Liver System

* The Gastroenterology and Urology Devices Panel of the FDA's Medical Devices Advisory Committee has issued a favorable vote to support the approval of TransMedics Group Inc's (NASDAQ:TMDX) 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 one abstaining, that the benefits of the OCS Liver System outweigh its risks.

* 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's Circulatory System Device Advisory Panel in April.

* The Organ Care System (OCS) is a fully portable, multi-organ, normothermic preservation and assessment technology that mirrors human physiology, minimizes ischemia, and provides the ability to optimize the organ during transport.

* Price Action: TMDX shares closed at $31.69 on Wednesday.

* Related content: Benzinga's Full FDA Calendar.