Benzinga | Apr 7, 2021 08:51AM EDT

TransMedics Stock Is Trading Higher After FDA Adcom Votes In Favor Of Its OCS Heart System

* The FDA Advisory Committee has voted in favor of TransMedics Group Inc (NASDAQ: TMDX) after reviewing clinical evidence from the OCS Heart EXPAND trial, the associated Continued Access Protocol (CAP) results, as well as the OCS Heart PROCEED II trial.

* The panel voted 12 to 5, with one abstaining, the benefits of the OCS Heart System outweigh its risks.

* The panel voted 10 to 6, with two abstaining, that the OCS Heart System is effective.

* The panel voted 9 to 7, with two abstaining, for the OCS Heart System's safety.

* The FDA will decide whether to approve the premarket approval application for the use of the OCS Heart System for donor hearts currently utilized and unutilized for transplantation after completing its review of the application.

* OCS Heart is a portable, warm perfusion and monitoring system designed to keep a donor heart at a human-like, metabolically active state.

* According to Jonah Lupton of Lupton Capital, TransMedics's stock should be up at least 20%-25% on Wednesday if the panel votes yes. He sees a $55-$60 target in the next month-and-a-half.

* Price Action: TMDX shares are up 12.3% at $38.74 in the premarket trading on the last check Wednesday.