FRANKLIN, Mass., Aug. 10 PLC Systems Inc. (OTC Bulletin Board: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, announced today that it has entered into a three year exclusive agreement with Medimen (Pvt.) Ltd., headquartered in Pakistan, for distribution of its RenalGuard System(TM) into Bangladesh and Pakistan. Medimen is an established distributor of medical technology and devices in this region, and has previously worked with PLC on distribution of the Heart Laser System. Medimen has already launched RenalGuard in Bangladesh, and will target early adopters in both countries who recognize the benefits of utilizing the unique fluid balancing capabilities of RenalGuard(R) in a cath lab setting during cardiovascular imaging procedures for patients at higher risk of Contrast-Induced Nephropathy (CIN).
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 region of the world, working with our partners at Medimen. We believe Medimen's efforts will help raise awareness of the benefits of RenalGuard to a wider community of physicians in both Bangladesh and Pakistan."
Bangladesh and Pakistan join Italy and Spain 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. Recently, PLC was awarded its first patent for RenalGuard technology, in Canada.
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 CO(2) Heart Laser System, which cardiac surgeons use to perform CO(2) 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 Italian clinical trials and the planned future U.S. clinical trial for RenalGuard as a safe and effective CIN prevention device 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, CO(2)( )Heart Laser, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.
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