PLC Systems Receives CE Mark Approval for Rena... ( FRANKLIN Mass. Dec. 21 /- PLC Sys...)

PLC Systems Receives CE Mark Approval for RenalGuard(TM)

Date:12/21/2007

FRANKLIN, Mass., Dec. 21 /PRNewswire-FirstCall/ -- PLC Systems Inc. (Amex: PLC) announced today that it has received the CE Mark Certificate for its RenalGuard System(TM), clearing the way for the Company to begin its initial launch of the product in the European Union. The Company expects to initiate a limited launch of RenalGuard(TM) in the first quarter of 2008 in Italy, targeting early adoptors who recognize the 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 Contrast-Induced Nephropathy (CIN).

PLC's President and Chief Executive Officer, Mark R. Tauscher, said, "Receiving the CE Mark for RenalGuard is an important milestone for PLC in the development of our new product initiative. We are very enthusiastic about the potential opportunity for the RenalGuard System in Europe and look forward to working with leading practitioners there to introduce it to the market."

Mr. Tauscher added, "Our initial launch in Italy will be supported by the previously announced planned clinical trial at the Centro Cardiologico Monzino (CCM-University of Milan) in Milan, Italy, led by Drs. Antonio Bartorelli and Giancarlo Marenzi, two of the world's leading experts in the prevention of CIN. We anticipate that this study will receive final approval by the ethics committee at CCM and will greatly increase the visibility of our RenalGuard System and that the data gathered from the study will enable us to seek expanded claims in order to market RenalGuard as a CIN prevention device throughout the European Union."

Having secured CE Mark approval for RenalGuard, PLC expects to conclude negotiations with an Itali
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