QT Vascular said Friday its subsidiary, TriReme Medical, has completed the analysis of the 12-month post-procedure clinical data from the U.S. pivotal study of the Chocolate Touch Paclitaxel-Coated PTA Balloon Catheter.
For the trial, a total of 313 patients were randomised to either the Chocolate Touch product or the Lutonix DCB, a DCB device commercialized by Becton, Dickinson and Co., QT Vascular said in a filing to SGX.
The submission to the U.S. Food and Drug Administration (FDA) is expected later this month, the filing said.
The company had agreed last year to sell the Chocolate Touch® Paclitaxel-Coated PTA Balloon Catheter to G Vascular.
So far, G Vascular has paid US$5.9 million, including a closing payment of US$4.9 million and the assumption of US$1 million of liabilities, to QT Vascular, and has made the investments to hold the trial and will continue to do so until obtaining the FDA’s pre-market approval (PMA), the filing said.
“The completion of the analysis of the 12-month post-procedure clinical data of the Chocolate Touch Pivotal Trial, which is expected to be the last major item required for FDA submission of a PMA, is a significant step towards unlocking the post-closing payment of at least US$16.1million from G Vascular,” QT Vascular said.