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PLC Systems Receives FDA Approval to Commence Pivotal Study Of RenalGuard(TM) In the U.S.
Date:3/20/2008

FRANKLIN, Mass., March 20 /PRNewswire-FirstCall/ -- PLC Systems Inc. (Amex: PLC) announced today that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin enrollment in a U.S. pivotal trial to study the effectiveness of the Company's RenalGuard Therapy(TM) and RenalGuard System(TM) in the prevention of Contrast-Induced Nephropathy (CIN).

Mark R. Tauscher, President and Chief Executive Officer of PLC, said, "We are very pleased with the FDA's conditional approval to the Investigational Device Exemption (IDE) supplement we filed last month. This will enable us to commence our pivotal study on schedule this spring. We are focused now on incorporating FDA's input into our final study protocol, and rapidly moving through the next phase of our clinical trial plan, which includes securing approvals to begin our study from hospital Institutional Review Boards at the sites that have elected to participate. FDA approval of the IDE is another major milestone on our path forward to commercializing the RenalGuard therapy and system, and we are very excited about beginning the pivotal trial."

Contrast-Induced Nephropathy, or CIN, is a major and growing problem due to the increasing number of older patients, diabetics and patients with pre- existing renal impairment - all of whose conditions make them at risk for CIN when they require interventional procedures that use radiographic contrast media. The Company's U.S. pivotal study, under the supervision of principal investigators Charles Davidson, MD, Professor of Medicine, Northwestern University Medical School and Richard J. Solomon, MD, Professor of Medicine, University of Vermont College of Medicine, is designed as an adaptive, randomized control
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