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PLC Systems Inc. (AMEX:PLC) announced that it will defer the commencement of the U.S. pivotal trial of its RenalGuard™ 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 to 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."

Source: http://www.plcmed.com/press206788378.asp