09:21 AM EDT, 08/04/2025 (MT Newswires) -- TransMedics Group ( TMDX ) said Monday that the US Food and Drug Administration has granted conditional approval for its Investigational Device Exemption, allowing the company to move forward with its next-generation OCS heart trial.

The trial is divided into two parts: part A designed to support prolonged heart perfusion using the OCS heart system, and part B is aimed to show the superiority of OCS heart perfusion in donation after brain death cases, the company said.

TransMedics ( TMDX ) said the trial's total sample size for parts A and B will exceed 650 patients.

Shares of the company were up more than 4% in recent Monday premarket activity.