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FDA APPROVES PLC SYSTEMS PIVOTAL TRIAL OF RENALGUARD IN U.S.

Publication: Biotech Business
Publication Date: 01-JAN-09 		Format: Online
Delivery: Immediate Online Access

Article Excerpt
PLC Systems Inc. (OTC Bulletin Board: PLCSF), Franklin, Mass., 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 CEO of PLC, said, "We are very pleased with the FDA's full approval...

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