Oct. 23 at 2:58 PM
$TMDX
TransMedics (NASDAQ: TMDX)
Buy (1)
ESG Score: 61/100
Price Target:
$170.00
XVivo Pauses its US Trial of Liver Assist, Marking a Relative Win for OCS Liver
THE TD COWEN INSIGHT
XVivo indicated today that it has paused Liver Assist's US IDE trial "to evaluate potential alternative regulatory pathways." While XVivo has not yet given details on what other options it has, we do not think anything but a PMA filing with US data on 200+ patients will support an FDA approval since this is the standard both TMDX and OrganOx followed in order to get their systems to the US market.