FRANKLIN, Mass., July 16 PLC Systems Inc. (OTC Bulletin Board: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, today announced that a follow-up study of the landmark Cardiac Angiography in Renally Impaired Patients (CARE) Study determined that Contrast-Induced Nephropathy (CIN) is associated with long-term adverse events, ranging from pulmonary edema to death, and that patients with CIN were twice as likely as those who did not develop CIN to experience adverse events.
The study was published in the June 25, 2009 issue of the Clinical Journal of the American Society of Nephrology (CJASN). This study, authored by Dr. Richard J. Solomon, Professor of Medicine, University of Vermont College of Medicine, et.al., followed more than 70 percent of the original subjects of the CARE study. Dr. Solomon is a member of the Scientific Advisory Board for PLC Medical Systems, and is one of the principal investigators for PLC's FDA-approved pivotal trial for RenalGuard in the U.S.
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "CIN is a significant and growing concern worldwide, and the publication of this study adds scientific weight to the need to find a way of preventing it. We continue to be very encouraged by the work of scientists who are studying our RenalGuard System((R)), which we believe could be an effective solution in reducing the incidence rate of CIN."
Currently, RenalGuard((R)) is the subject of an investigator-sponsored trial to study its efficacy in mitigating against CIN at the University of Milan-Centro Cardiologico Monzino (CCM). This trial is designed to assess RenalGuard compared to standard overnight hydration, a prevalent method of treatment in the EU, in preventing CIN in patients undergoing cardiac catheterization procedures and percutaneous coronary interventions with baseline impairment in renal function.
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 the prevention 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 in 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 trial in Italy and the planned future U.S. clinical trial for RenalGuard as a safe and effective prevention device for contrast induced nephropathy 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.
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