Updated results from MYTHOS clinical trial of RenalGuard presented at AHA meeting

Dec 2 2009

Updated Data from MYTHOS Trial Continues to be Positive

PLC Systems Inc. (OTC Bulletin Board: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, today announced that updated results from the MYTHOS investigator-sponsored clinical trial of RenalGuard(®) were presented at the American Heart Association (AHA) Scientific Sessions 2009, on Sunday, November 15 in Orlando, Florida.

Dr. Giancarlo Marenzi, Chief, Intensive Cardiac Care Unit, Centro Cardiologico Monzino-University of Milan (CCM), presented a poster reflecting the updated interim results covering 105 patients for the investigator-sponsored clinical trial. Earlier results presented this fall reflected completion of 90 patients.

In the results presented at AHA, the trial had enrolled 105 chronic kidney disease (CKD) patients undergoing elective or urgent percutaneous coronary interventions (PCI). Approximately 14% of the patients in the control group were determined to have acquired contrast-induced nephropathy (CIN), whereas only 4% of those who were treated with RenalGuard acquired CIN. Dr. Marenzi also reported that the incidence of in-hospital complications in the control group was 18%, compared to only 6% in the RenalGuard group, a statistically significant differences website: http://www.plcmed.com/Products-Clinical-Investigations2.asp.

Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "We continue to be very pleased by the consistent, positive interim results from the MYTHOS trial, since positive clinical data like this is imperative to accelerate RenalGuard adoption. We are also encouraged by the ever-expanding range of clinicians and potential partners to whom these results have now been disseminated, creating ever-broadening interest in our technological solution to the pervasive problem of CIN. These initial results provide strong evidence that RenalGuard could be highly effective in reducing the incidence of CIN in millions of high-risk patients around the world every year. We look forward to the completion of this study this year, and to the completion of additional studies, in hopes that RenalGuard can become the most effective tool in the continuing battle against CIN and its adverse consequences."

The MYTHOS data continues to indicate that patients who were at high risk for renal failure, treated with RenalGuard while undergoing certain imaging procedures, acquired CIN at a significantly lower rate than those who were treated beforehand with overnight hydration. Acquiring CIN has been found to lead to a range of serious and potentially deadly outcomes in patients who already have compromised kidney function.

The investigators for the trial are Dr. Antonio L. Bartorelli, Director, Interventional Cardiology, CCM, and Professor of Cardiology, University of Milan, and Dr. Marenzi, two of the world's leading experts on CIN.

The MYTHOS trial is a randomized clinical trial designed to provide an assessment of the potential benefits of induced diuresis with automated matched hydration therapy utilizing RenalGuard, compared to standard overnight hydration, in reducing the incidence of CIN in patients with baseline impairment in renal function undergoing cardiac catheterization procedures and percutaneous coronary interventions.