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More comprehensive data are expected to be presented by one of the study's investigators, Dr. Giancarlo Marenzi, Chief, Intensive Cardiac Care Unit, Centro Cardiologico Monzino-University of Milan (CCM) in his session next week during the conference, at which PLC will also be demonstrating RenalGuard((R)).
The abstract details data on 43 patients at high risk for renal failure; the final study will include 120 such patients. The initial results indicate that none of the patients treated with RenalGuard( )while undergoing imaging procedures acquired contrast-induced nephropathy (CIN), but 17% of those who were treated beforehand with overnight hydration did acquire CIN. In fact, two of the patients in that group required temporary renal replacement therapy. Acquiring CIN has been found to lead to a range of serious and potentially deadly outcomes in patients who already have compromised kidney function.
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "We are extremely pleased with these very positive preliminary results of the CCM clinical trial. These initial results provide encouraging evidence that RenalGuard is highly effective in reducing the incidence of CIN, in millions of high-risk patients around the world every year. While we anticipate that later results may reflect higher rates of CIN with RenalGuard, we are very encouraged by the dramatic benefit already demonstrated by the initial results of the study."
The CCM trial, known as MYTHOS, 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, a prevalent method of treatment in the EU, in the reducing the incidence of CIN in patients undergoing cardiac catheterization procedures and percutaneous coronary interventions with baseline impairment in renal function. The study is designed as a non-inferiority trial, with the primary endpoint defined as equivalency or better to overnight hydration.
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.
PLC received the CE Mark Certificate for the RenalGuard System in December 2007, and concluded its pilot safety trial in the U.S. late in 2007. The company has received full approval from the FDA to commence a U.S. pivotal trial to study the effectiveness of RenalGuard in reducing the incidence of CIN. In March 2008, PLC signed its first international distribution agreement for RenalGuard with Artech s.r.l., Cavezzo, Italy for distribution of its RenalGuard System into Italy, and in May 2009, PLC announced its second European distributor, IZASA Distribuciones Tecnicas S.A., headquartered in Barcelona, Spain, for the distribution of RenalGuard in Spain.
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 and CO2( )Heart Laser, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.
Contact: Mary T. Conway
Conway Communications
617-244-9682
mtconway@att.net
SOURCE PLC Systems Inc.
http://www.plcmed.com
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