PLC Systems Defers Pivotal Study of RenalGuard(TM) i...( Clinical study and limite...),Health

Clinical study and limited launch in Italy continue

FRANKLIN, Mass., July 21 /PRNewswire-FirstCall/ -- PLC Systems Inc. (Amex: PLC) announced today that it will defer the commencement of the U.S. pivotal trial of its RenalGuard(TM) System in the prevention of Contrast-Induced Nephropathy (CIN). The company continues to support the investigator-sponsored clinical trial now ongoing in Milan, Italy as well as the limited market launch of RenalGuard in Europe, which began in the first quarter of this year, both of which are focused on the CIN prevention market.

Mark R. Tauscher, President and Chief Executive Officer of PLC, said, "We are taking this action now because, while we have sufficient funds to commence the U.S. pivotal trial at this time, we believe we will be in a better position to successfully raise the funding necessary to complete the trial and prepare for U.S. market launch in the future, once we have the expected positive clinical data from the study currently underway in Italy at the Centro Cardiologico Monzino-University of Milan (CCM). For these reasons, after consultation with our lead U.S. investigators, we have elected to postpone the start of the U.S. pivotal trial. We anticipate that this deferral will reduce the expected increase in our research and development costs that we had previously estimated for the remainder of 2008, as we lower our expenses associated with clinical trial oversight and management."

Mr. Tauscher added, "In the meantime, we are continuing our dual commercialization strategy for RenalGuard. First and foremost, we are continuing to work with the U.S. Food and Drug Administration to secure a full approval of our RenalGuard study protocol so that we are well-positioned t
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