FRANKLIN, Mass., July 21 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 ofContrast-Induced Nephropathy (CIN). The company continues to support theinvestigator-sponsored clinical trial now ongoing in Milan, Italy as well asthe limited market launch of RenalGuard in Europe, which began in the firstquarter of this year, both of which are focused on the CIN prevention market.
Mark R. Tauscher, President and Chief Executive Officer of PLC, said, "Weare taking this action now because, while we have sufficient funds to commencethe U.S. pivotal trial at this time, we believe we will be in a betterposition to successfully raise the funding necessary to complete the trial andprepare for U.S. market launch in the future, once we have the expectedpositive clinical data from the study currently underway in Italy at theCentro Cardiologico Monzino-University of Milan (CCM). For these reasons,after consultation with our lead U.S. investigators, we have elected topostpone the start of the U.S. pivotal trial. We anticipate that thisdeferral will reduce the expected increase in our research and developmentcosts that we had previously estimated for the remainder of 2008, as we lowerour expenses associated with clinical trial oversight and management."
Mr. Tauscher added, "In the meantime, we are continuing our dualcommercialization strategy for RenalGuard. First and foremost, we arecontinuing to work with the U.S. Food and Drug Administration to secure a fullapproval of our RenalGuard study protocol so that we are well-positioned tostart the trial with our targeted study sites. We remain very confident thatRenalGuard is a highly promising therapy addressing an unmet market need andare optimistic that the results from the CCM study will provide criticalvalidation for our technology.
"In addition, beyond our focus on the CIN market in 2009, with a CE Markin hand we plan to focus on several new applications for RenalGuard in theEuropean Union (EU) capitalizing on the automated fluid balancing capabilitiesof our system. Specifically, there are several medical applications, such ascisplatin chemotherapy, where inducing high urine flow rates is beneficial forpatients and is a standard of care. High urine flow rates are also frequentlyseen in post kidney transplant patients, where the careful monitoring andreplacement of fluid losses helps avoid the risk of damage to the transplantedkidney. Accurate and timely matching of replacement fluids is important inthese instances in order to best preserve and/or optimize kidney function.RenalGuard provides an automated method of measuring urine outputs and thenmatching these outputs with replacement fluid inputs, eliminating to a largedegree what is otherwise an intensive and time-consuming manual balancing taskfor physicians and nurses in these situations. We plan to aggressivelyinvestigate these new market opportunities for RenalGuard throughout the EU inthe coming year as part of our broader EU launch."
RenalGuard is designed to reduce the potentially toxic effects thatcontrast media can have on the kidneys when it is administered to patientsundergoing image-guided procedures, such as those performed when placingdrug-eluting stents. It is believed that allowing contrast media to dwell inthe kidneys can lead to CIN. By inducing and maintaining a high urine flowrate before, during and after these image-guided procedures, it is believedthe incidence rates of CIN in at-risk patients can be reduced. RenalGuardfacilitates this increased urine clearance enabling the body to more rapidlyvoid the contrast media, thereby reducing its overall resident time and toxiceffects in the kidney.
CIN is a major and growing problem worldwide due to the increasin