PLC Systems Inc. (PLC), a medical technology company for the cardiac and vascular markets, has entered into a five year exclusive agreement with DISCOMED Comercio de Produtos Hospitalares Ltda., Porto Alegre, Brazil, for distribution of its RenalGuard System in Brazil. DISCOMED is a 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 RenalGuard 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 US 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.