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PLC Systems Defers Pivotal Study of RenalGuard(TM) in the U.S.
Date:7/21/2008

. RenalGuard facilitates this increased urine clearance enabling the body to more rapidly void the contrast media, thereby reducing its overall resident time and toxic effects in the kidney.

Contrast-Induced Nephropathy

CIN is a major and growing problem worldwide 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 undergo interventional procedures that use radiographic contrast media. Approximately seven million patients worldwide undergo interventional cardiovascular therapeutic and diagnostic imaging procedures each year.

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%.

About PLC Systems Inc.

PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets.

PLC's newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device. The RenalGuard System consists of a unique, proprietary, closed loop, software-controlled console and accompanying single-use sets that can be used by physicians and nurses to balance patient fluid levels during a variety of medical procedures. The RenalGuard System, with its matched fluid replacement capability, is intended to minimize the risk of over- or under-hydration during medical procedures where creating and maintaining high urine outputs is deemed benefi
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