FRANKLIN, Mass., May 12, 2011 /PRNewswire/ -- PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative medical
In addition, PLC will hold its second annual international distributor meeting, including a presentation on the recently-announced positive results of the investigator-sponsored REMEDIAL II clinical trial by Dr. Carlo Briguori, MD, PhD, Chief, Laboratory of Interventional Cardiology, Clinica Mediterranea, Naples, Italy, and Co-Director of Clinical Research, Laboratory of Interventional Cardiology, San Raffaele Hospital, Milan, Italy, the principal investigator of the trial. Those results indicated that RenalGuard was more effective than the standard of care in preventing the onset of Contrast-Induced Nephropathy (CIN) in at-risk patients, and that its use also greatly reduced the need for dialysis by those patients, with 4.8 percent of patients in the control group requiring some level of dialysis compared to only 0.7 percent in the RenalGuard-treated group.
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "CIN is a significant and growing concern worldwide, and we are very encouraged by the prospect that RenalGuard could prevent it. The very positive results from the REMEDIAL II trial in Italy showed that at-risk patients treated with PLC's RenalGuard had a 46% lower incidence of CIN and an 85% lower rate of requiring dialysis, both of which are clinically significant and meaningful in terms of patient care and costs. EuroPCR, one of the premier international cardiovascular events of the year, is a wonderful opportunity for us to showcase these results with our distributors and medical professionals in Europe."
About PLC Systems Inc.
PLC Systems Inc., headquartered in Franklin, Mass., is a medical device company focused on innovative technologies for the cardiac and vascular markets. PLC's newest product, RenalGuardŽ, has been developed to help prevent the onset of Contrast-Induced Nephropathy (CIN) in at-risk patients undergoing certain 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 current clinical trials in Italy and the planned future U.S. clinical trial for RenalGuard may not be completed in a timely fashion, if at all, or, if these clinical trials are completed, they may not produce clinically significant or meaningful results, the RenalGuard product may not be commercially accepted, operational changes, 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 filed with the SEC.
PLC Systems, PLC Medical Systems, PLC, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.
Contact: Mary T. ConwayConway [email protected]
SOURCE PLC Systems Inc.
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