MILFORD, Mass., May 30, 2012 /PRNewswire/ -- PLC Systems Inc. (OTC: PLCSF), a company focused on innovative medical device technologies, today announced that it had signed new distribution agreements for RenalGuard® with Girlow USA, LLC, Cenas, Co., Ltd, and Pyramed Ltd., following its successful participation in EuroPCR in France earlier this month. Under terms of these agreements, PLC will expand its ability to distribute its innovative RenalGuard System to Mexico and several countries in Central America and South America, as well as Turkey and the United Kingdom, and initial stocking orders of RenalGuard consoles and single use sets have been purchased.
RenalGuard is CE-marked and can be sold immediately in the United Kingdom. Cenas has applied for Ministry of Health approval to market the product in Turkey. Girlow USA is registering RenalGuard for sale in Mexico and on a country by country basis in Central America and South America.
"These new distributors will enable PLC to expand the use of RenalGuard more deeply in important markets in Europe, and to continue our penetration of the growing healthcare markets in Mexico, Central America and South America," said Mark R. Tauscher, President and Chief Executive Officer of PLC Systems. "Our new partners are successful distributors in their respective markets and we believe their addition to our worldwide distributor network will help in our efforts to increase worldwide adoption of RenalGuard."
These agreements expand RenalGuard's distribution footprint into three new markets, complementing its existing presence in Europe, Israel, and Brazil and in select other countries around the world. PLC's U.S. pivotal trial of RenalGuard, which is required to secure approval from the U.S. Food & Drug Administration to market and sell RenalGuard in the U.S., began in late 2011.
About PLC Systems
PLC Systems Inc., headquartered in Milford, Mass., is a medical device company focused on innovative technologies for the cardiac and vascular markets. PLC's newest product, RenalGuard, has been developed to help prevent the onset of Contrast-Induced Nephropathy (CIN) in at-risk patients undergoing certain cardiac and vascular imaging procedures. The Product is CE-marked and is being marketed in Europe and selected countries around the world. Two investigator-sponsored European studies have demonstrated RenalGuard's effectiveness at preventing CIN. RenalGuard is being studied in a pivotal trial in the U.S., as required for approval by FDA.
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, the U.S. clinical trial for RenalGuard may not be completed in a timely fashion, if at all, or, if this clinical trial is completed, it may not produce clinically significant or meaningful results, the RenalGuard product may not be commercially accepted, operational changes, the need for additional financing, 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, 2011, a copy of which is on file with the SEC.
PLC Systems, PLC Medical Systems, PLC, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.
Contact: Mary T. Conway
SOURCE PLC Systems Inc.