Healthcare Industry News: CO2 Heart Laser
News Release - November 10, 2009
PLC Systems Announces Distribution Agreement for RenalGuard(R) in BrazilAgreement Signed as a Result of Positive Clinical Trial Results Announced at ESC 2009 and TCT 2009
FRANKLIN, Mass., Nov. 10 (Healthcare Sales & Marketing Network) -- PLC Systems Inc. (OTC Bulletin Board: PLCSF ), a company focused on innovative cardiac and vascular medical device-based technologies, today announced that it has entered into a five year exclusive agreement with DISCOMED Comercio de Produtos Hospitalares Ltda., Porto Alegre, Brazil, for distribution of its RenalGuard System(TM) in Brazil. DISCOMED is an established distributor of medical technology and devices in Brazil. The company will target early adopters who recognize the benefits of utilizing the unique fluid balancing capabilities of RenalGuardŽ in a cath lab setting during cardiovascular imaging procedures for patients at higher risk of Contrast-Induced Nephropathy (CIN).
DISCOMED is applying for the needed registration through ANVISA, the Brazilian registration authority, and expects approval in approximately 9 months.
PLC's President and Chief Executive Officer, Mark R. Tauscher, said, "We are very pleased to extend the launch of our RenalGuard technology to another important region, South America, working with our newest partner, DISCOMED. We see significant market potential for RenalGuard in Brazil due to its large population, and the high number of cardiovascular procedures undertaken each year. We look forward to working with DISCOMED to heighten awareness among clinicians in Brazil of how RenalGuard can help prevent CIN and its repercussions."
Brazil joins Italy, Spain, Bangladesh and Pakistan as countries where PLC has now launched RenalGuard. PLC received the CE Mark Certificate for the RenalGuard System in late December 2007, and concluded its pilot safety trial in the U.S. late in 2007. Two investigator-sponsored randomized clinical trials to evaluate the use of RenalGuard in the prevention of CIN are currently underway in Italy. Positive preliminary results from one of these, the MYTHOS trial, were recently announced at the European Society of Cardiology annual conference and the Transcatheter Cardiovascular Therapeutics conference.
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 or future results from clinical trials may differ from results to date, 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.
Source: PLC Systems
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