The FDA also approved PLC's request to expand their investigation from the 246 patients conditionally approved earlier this year to 406 patients and eliminate the requirement for an interim study analysis to be performed.
Mark R. Tauscher, President and Chief Executive Officer of PLC, said, We are very pleased with the FDA's full approval to the Investigational Device Exemption (IDE) supplement we filed in February to study RenalGuard in the U.S. While we have deferred the onset of the trial pending receipt of funding to complete it, the investigator-sponsored clinical trial at the Cardiologico Centrino Monzino (CCM) -University of Milan in Italy is continuing, as are our commercialization efforts in Europe, under the CE Mark we received in late 2007.
Mr. Tauscher added, We remain very confident that RenalGuard is a highly promising therapy addressing a large, unmet market need. We are optimistic that the results from the CCM study will provide critical validation for our technology, and support our efforts to raise funding for the U.S. pivotal study as well.