PLC Announces Approval to Distribute RenalGuard@ in Brazil
PLC Systems Inc. (OTC: PLCSF), a company focused on innovative medical device technologies, today announced that it had received approval from the Brazilian government to market its innovative RenalGuard SystemT in that country. PLC's exclusive distributor in Brazil, DISCOMED Comercio de Produtos Hospitalares Ltda., Porto Alegre, Brazil, secured approval for both the RenalGuard@ system and its single use sets through ANVISA, the Brazilian registration authority. Discomed is now beginning launch efforts in Brazil, including placing an initial stocking order, scheduling training sessions and promoting RenalGuard to medical professionals in the market.
Brazil is the fifth largest country in the world, by population, and has a rapidly growing healthcare market. PLC appointed Discomed as its exclusive distributor for this region in late 2009.
"Approval to sell RenalGuard in Brazil is yet another significant development for PLC," said Mark R. Tauscher, President and Chief Executive Officer of PLC Systems. "Brazil is a pivotal country in South America, where new medical technologies are often first demonstrated, and we're delighted that Discomed is now ready to work with us to launch RenalGuard formally in this market. Following our launch in Israel earlier this month, today's announcement will certainly help drive increased adoption of RenalGuard worldwide." 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, 2010, a copy of which is on file with the SEC.
PLC Systems, PLC Medical Systems, PLC, RenalGuard and RenalGuard Therapy are trademarks of PLC Systems Inc.
Contact: Mary T. Conway 508-520-2545 firstname.lastname@example.org SOURCE PLC Systems Inc.
-0- 03/30/2012 (OTC-BB:PLCSF) / CO: PLC Systems Inc.; DISCOMED Comercio de Produtos Hospitalares Ltda.
ST: Brazil Massachusetts IN: HEA MTC SU: PDT LIC PRN -- NE79393 -- 0000 03/30/2012 12:00:00 EDT http://www.prnewswire.c