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PLC Systems Provides Update on Japanese Approval Process for RenalGuard®
Date:1/5/2012

procedures and patients undergoing these procedures with existing at-risk conditions for CIN.  We await approval of the larger patient study shortly, and following the successful completion of the trial, approval for the start of sales and marketing of RenalGuard in Japan, launching a major new phase in RenalGuard's adoption."

Dr. Michishita noted, "I am very pleased that the very first cases utilizing RenalGuard in Japan to prevent CIN were successful. I am very impressed with the ease of use of the system, and how it works to maintain the fluid balance of the body. Once it is approved by the MHLW, I believe that RenalGuard will be a great benefit for patients undergoing PCI requiring contrast media."

Contrast-Induced Nephropathy

CIN is a major and growing problem due to the increasing number of older patients, diabetics and patients with pre-existing renal impairment – all of whose conditions make them at risk for CIN when they require interventional procedures that use radiographic contrast media. More than 7 million such imaging procedures occur worldwide each year, and it is estimated that 15-20% of those patients are 'at risk' of acquiring CIN. 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 increased risk of renal dialysis therapy.  All of these lead to prolonged hospital stays and increased medical costs.  Estimated mortality rates for patients who acquire CIN may be as high as 35%. 

About RenalGuard

RenalGuard is based on data that shows 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 in
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SOURCE PLC Systems Inc.
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