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PLC Systems Defers Pivotal Study of RenalGuard(TM) in the U.S.
Date:7/21/2008

o start the trial with our targeted study sites. We remain very confident that RenalGuard is a highly promising therapy addressing an unmet market need and are optimistic that the results from the CCM study will provide critical validation for our technology.

"In addition, beyond our focus on the CIN market in 2009, with a CE Mark in hand we plan to focus on several new applications for RenalGuard in the European Union (EU) capitalizing on the automated fluid balancing capabilities of our system. Specifically, there are several medical applications, such as cisplatin chemotherapy, where inducing high urine flow rates is beneficial for patients and is a standard of care. High urine flow rates are also frequently seen in post kidney transplant patients, where the careful monitoring and replacement of fluid losses helps avoid the risk of damage to the transplanted kidney. Accurate and timely matching of replacement fluids is important in these instances in order to best preserve and/or optimize kidney function. RenalGuard provides an automated method of measuring urine outputs and then matching these outputs with replacement fluid inputs, eliminating to a large degree what is otherwise an intensive and time-consuming manual balancing task for physicians and nurses in these situations. We plan to aggressively investigate these new market opportunities for RenalGuard throughout the EU in the coming year as part of our broader EU launch."

About RenalGuard

RenalGuard is designed to reduce the potentially toxic effects that contrast media can have on the kidneys when it is administered to patients undergoing image-guided procedures, such as those performed when placing drug-eluting stents. It is believed that allowing contrast media to dwell in the kidneys can lead to CIN. By inducing and maintaining a high urine flow rate before, during and after these image-guided procedures, it is believed the incidence rates of CIN in at-risk patients can be reduced
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SOURCE PLC Systems Inc.
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