PLC Systems Inc. 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 Italian distribution partner shortly. Finalization of a distribution agreement is expected to include an initial stocking order of product from the distributor to support the initial sales launch of RenalGuard at select hospital sites throughout Italy.
Approximately seven million patients worldwide undergo interventional cardiovascular therapeutic and diagnostic imaging procedures each year. Contrast-induced nephropathy, or CIN, is a major and growing problem due to the increasing number of older patients, diabetics and patients with pre- existing renal failure -- all of whose conditions make them at risk for CIN when they require interventional procedures that use radiographic contrast media. CIN is the third most common cause of in-hospital acute renal failure. It is associated with significant in-hospital mortality rates, and increases in long-term mortality rates, major in-hospital adverse cardiac events, and the risk of having to undergo renal dialysis therapy. Any of these can result in prolonged hospital stays and increased medical costs. Studies indicate that approximately 15-20% of all patients undergoing image-guided cardiology and radiology procedures are at risk of developing CIN. The estimated mortality rate for patients that acquire CIN may be as high as 35%.
RenalGuard is based on existing pre-clinical study data that suggests that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects. RenalGuard is a fully-automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media.