Updated Data from MYTHOS Trial Continues to be Positive
FRANKLIN, Mass., Dec. 1 /PRNewswire-FirstCall/ -- 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(Ū) 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 difference (p=0.05) that was consistent with results revealed earlier this fall. More information about the trial is available at the company's 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.
About PLC Systems Inc.
PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Massachusetts, PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina. PLC's newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device. Additional company information can be found at www.plcmed.com.
This press release contains "forward-looking" statements. For this purpose, any statements contained in this press release that relate to prospective events or developments are deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will" and similar expressions are intended to identify forward-looking statements. Our statements of our objectives are also forward-looking statements. While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates change, and you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Actual results could differ materially from those indicated by such forward-looking statements as a result of a variety of important factors, including that we may not receive necessary regulatory approvals to market our RenalGuard product or that such approvals may be withdrawn, we may be unable to raise sufficient funds in the future to implement our business plan and/or commence our planned U.S. clinical trial for RenalGuard, the current clinical trials in Italy and the planned future U.S. clinical trial for RenalGuard may not be completed in a timely fashion, if at all, or, if these clinical trials are completed, they may not produce clinically significant or meaningful results, the RenalGuard product may not be commercially accepted, operational changes, competitive developments may affect the market for our products, regulatory approval requirements may affect the market for our products, and additional risk factors described in the "Forward Looking Statements" section of our Annual Report on Form 10-K for the year ended December 31, 2008, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC, CO2( )Heart Laser, and RenalGuard are trademarks of PLC Systems Inc.
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