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Mark R. Tauscher, President and Chief Executive Officer of PLC, said, "Weare very pleased with the FDA's conditional approval to the InvestigationalDevice Exemption (IDE) supplement we filed last month. This will enable us tocommence our pivotal study on schedule this spring. We are focused now onincorporating FDA's input into our final study protocol, and rapidly movingthrough the next phase of our clinical trial plan, which includes securingapprovals to begin our study from hospital Institutional Review Boards at thesites that have elected to participate. FDA approval of the IDE is anothermajor milestone on our path forward to commercializing the RenalGuard therapyand system, and we are very excited about beginning the pivotal trial."
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Contrast-Induced Nephropathy, or CIN, is a major and growing problem dueto the increasing number of older patients, diabetics and patients with pre-existing renal impairment - all of whose conditions make them at risk for CINwhen they require interventional procedures that use radiographic contrastmedia. The Company's U.S. pivotal study, under the supervision of principalinvestigators Charles Davidson, MD, Professor of Medicine, NorthwesternUniversity Medical School and Richard J. Solomon, MD, Professor of Medicine,University of Vermont College of Medicine, is designed as an adaptive,randomized controlled trial at up to 30 sites in the U.S. Enrollment in thetrial is expected to last through 2009, and will include a minimum of 246patients.
Contrast-Induced Nephropathy
Approximately seven million patients worldwide undergo interventionalcardiovascular therapeutic and diagnostic imaging procedures each year. CINis the third most common cause of in-hospital acute renal failure. It isassociated with significant in-hospital mortality rates, and increases inlong-term mortality rates, major in-hospital adverse cardiac events, and therisk of having to undergo renal dialysis therapy. Any of these can result inprolonged hospital stays and increased medical costs. Studies indicate thatapproximately 15-20% of all patients undergoing image-guided cardiology andradiology procedures are at risk of developing CIN. The estimated mortalityrate for patients that acquire CIN may be as high as 35%.
About RenalGuard
RenalGuard is based on existing pre-clinical study data that suggests thatinitiating and maintaining high urine output during imaging procedures allowsthe body to rapidly eliminate toxins in contrast media, reducing their harmfuleffects. RenalGuard is a fully-automated, real-time matched fluid replacementdevice intended for interventional cardiology and radiology patientsundergoing imaging procedures using contrast media.
About PLC Systems Inc.
PLC Systems Inc. is a medical technology company specializing ininnovative technologies for the cardiac and vascular markets. Headquartered inFranklin, Mass., PLC pioneered the CO2 Heart Laser System, which cardiacsurgeons use to perform CO2 transmyocardial revascularization (TMR) toalleviate symptoms of severe angina. CO2 TMR offers a treatment option forangina patients who suffer from severe coronary artery disease. The CO2 HeartLaser is the world's first TMR angina relief device cleared for commercialdistribution by both the U.S. Food and Drug Administration and JapaneseMinistry of Health, Labor and Welfare, and to obtain a CE Mark for Europeandistribution.
The company concluded a pilot clinical safety study of its RenalGuardTherapy and RenalGuard System in December 2007.
