PLC Systems Receives FDA Approval to Commence Pivotal Study Of RenalGuard(TM) I...(nese Ministry of Health Labor and Welfar...),Health

The company concluded a pilot clinical safety study of its RenalGuard Therapy and RenalGuard System in December 2007. In late 2007, the company received its CE Mark Certificate for RenalGuard System. RenalGuard Therapy is designed to reduce the toxic effects that contrast media can have on the kidneys. This therapy is based on the theory that creating and maintaining a high urine output is beneficial to patients undergoing imaging procedures where contrast agents are used. The real-time measurement and matched fluid replacement design of the RenalGuard System is intended to ensure that a high urine flow is maintained before, during and after these procedures. This should allow the body to rapidly eliminate contrast, reducing its toxic effects. The RenalGuard System, with its matched fluid replacement capability, is intended to minimize the risk of over- or under-hydration.

Additional company information can be found at http://www.plcmed.com.

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