PLC Systems Inc. (OTC: PLCSF), a company focused on innovative medical device technologies, has received approval from the Israeli Ministry of Health to market its innovative RenalGuard System™ in that country. The company has signed a distribution agreement with A.M.I. Technologies, Ltd. Under the terms of the agreement, A.M.I. will be the exclusive distributor of PLC’s RenalGuard® in Israel, expanding RenalGuard’s distribution to the Middle East. As part of the agreement, A.M.I. has agreed to purchase an initial stocking order of RenalGuard consoles and single use sets.
Headquartered in Milford, Mass., PLC Systems is a medical device company focused on innovative technologies for the cardiac and vascular markets. 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 the FDA.
“Today’s news enables PLC to expand the use of RenalGuard into the Middle East,” said Mark R. Tauscher, President and Chief Executive Officer of PLC Systems. “A.M.I. is an established, successful distributor and will help in our efforts to increase worldwide adoption of RenalGuard. Many Israeli cardiologists, such as Dr. Nikolsky, are considered thought leaders in interventional cardiology worldwide. Our success in receiving approval to market RenalGuard in Israel should help us continue to drive adoption of RenalGuard worldwide.”
PLC already has distribution agreements for RenalGuard in Germany, France, Italy, Spain, Portugal, The Netherlands, Austria, Belgium, Croatia, Luxembourg, Monaco and Switzerland in Europe, as well as 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.