PLC Systems Receives Full FDA Approval for Pivotal Study of RenalGuard(TM) i...( Study Expanded to 406 Subjects ...),Health

Study Expanded to 406 Subjects

FRANKLIN, Mass., Nov. 26 /PRNewswire-FirstCall/ -- PLC Systems Inc. (OTC Bulletin Board: PLCSF) announced today that it has received full approval from the U.S. Food and Drug Administration (FDA) for its U.S. pivotal trial to study the effectiveness of the Company's RenalGuard System(TM) and associated therapy in the prevention of Contrast-Induced Nephropathy (CIN).

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. As a result of this and other changes, the study is no longer considered an adaptive study.

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. Full FDA approval of the IDE supplement is another major milestone on our path forward to commercializing RenalGuard(TM) in the U.S., and with its receipt, we are well-positioned to begin the trial with our targeted study sites, once we have the needed funding."

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."

Contrast-Induced Nephropathy, or CIN, is a major and gr
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