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 System™ 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.”
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.