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PLC Systems Files IDE Supplement to Begin Pivotal Study of RenalGuard(TM) and Provides Update on Planned Development Timeline
Date:2/15/2008

he pivotal trial is an important milestone. We are working diligently to recruit sites for the pivotal trial, and anticipate continued positive interest from medical specialists who currently have no proven method to address the continued high incidence of CIN in their patients. At the same time, we are also pleased by our progress with RenalGuard in Europe. We anticipate that the planned Italian clinical trial of RenalGuard at the Centro Cardiologico Monzino (CCM-University of Milan) will begin in March, following receipt of final approval from the ethics committee at the institution. We expect that this effort, under the leadership of two renowned worldwide experts on CIN, Drs. Antonio Bartorelli and Giancarlo Marenzi, will provide additional confidence to early adopters who recognize the potential benefits of utilizing the unique fluid balancing capabilities of the RenalGuard System in a cath lab setting during cardiovascular imaging procedures for patients at higher risk of CIN. This study is expected to include 120 patients, and compare RenalGuard against overnight hydration, the prevalent standard of care currently in Europe."

In addition to the CCM study, PLC continues to work towards a limited launch of RenalGuard in Italy, following receipt of CE Mark certification in late 2007. The initial launch will focus on early adopters in that country at approximately 10 sites in Italy. A more expanded all-European Union launch for RenalGuard is contemplated for 2009.

Contrast-Induced Nephropathy

Approximately seven million patients worldwide undergo interventional cardiovascular therapeutic and diagnostic imaging procedures each year. 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. CIN i
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SOURCE PLC Systems Inc.
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