A PR? Why hasn't anyone read this??
PLC Announces Ministry of Health Approval to Distribute RenalGuard® in Israel Through A.M.I. Technologies, Ltd.
First Patient Cases Completed by Noted Expert on Contrast-Induced Nephropathy
MILFORD, Mass. , March 14, 2012 /PRNewswire/ -- PLC Systems Inc. (OTC: PLCSF), a company focused on innovative medical device technologies, today announced that it had received approval from the Israeli Ministry of Health to market its innovative RenalGuard System™ in that country. The company also announced it 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.
PLC also announced that Dr. Eugenia Nikolsky, Director, Cardiovascular Research Unit, Rambam Medical Center, Haifa, Israel, has successfully completed the first patient case in Israel using RenalGuard for the prevention of Contrast-Induced Nephropathy (CIN).
Dr. Nikolsky, a noted expert on CIN, commented, "RenalGuard offers us a potential method to reduce the incidence of CIN, a major issue when performing interventional procedures requiring contrast agents with high-risk patients. I am very pleased to have the opportunity to utilize RenalGuard Therapy®, especially after seeing the positive results presented in both the REMEDIAL II and MYTHOS trials, and look forward to continued use of the system."
"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.
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
mconway@plcmed.com
