Healthcare Industry News: chronic kidney disease
News Release - September 11, 2009
PLC Medical Systems Reports Strong Success for RenalGuard(R) at ESC 2009FRANKLIN, Mass., Sept. 11 (Healthcare Sales & Marketing Network) -- PLC Systems Inc. (OTC Bulletin Board: PLCSF ), a company focused on innovative cardiac and vascular medical device-based technologies, today provided an update on its marketing activities at ESC Congress 2009, the annual meeting of the European Society of Cardiology, August 29 - September 2, 2009 in Barcelona, Spain. More than 30,000 clinicians and professionals attended this event, including representatives from potential partners and distributors for RenalGuard(R).
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "In participating in ESC, we were focused on leveraging opportunities to broaden RenalGuard's distribution in the European Union. As we evaluate our progress, we are very pleased with the attention RenalGuard garnered at this conference, from both clinicians and potential partners. We are also very happy with the strong scientific results on RenalGuard's efficacy that were presented, and the interest that drew from attendees. We very much look forward to continuing to build momentum for RenalGuard as we move ahead on discussions with prospective partners and distributors. To that end, we look forward to additional opportunities to continue to raise visibility for RenalGuard and engage the thought leaders in our market at the upcoming TCT conference in San Francisco later this month."
At ESC, Dr. Giancarlo Marenzi, Chief, Intensive Cardiac Care Unit, Centro Cardiologico Monzino-University of Milan (CCM) presented preliminary results of the MYTHOS investigator-sponsored clinical trial of RenalGuard, attracting strong interest from attendees. These results indicate that patients who were at high risk for renal failure, treated with RenalGuard(R) while undergoing certain imaging procedures, acquired contrast-induced nephropathy (CIN) at a significantly lower rate than those who were treated beforehand with overnight hydration. Acquiring CIN has been found to lead to a range of serious and potentially deadly outcomes in patients who already have compromised kidney function.
In the preliminary results presented at ESC, the trial had enrolled 90 chronic kidney disease (CKD) patients undergoing elective or urgent percutaneous coronary interventions (PCI). Approximately 14.9% of the patients in the control group were determined to have acquired CIN, whereas only 4.6% of those who were treated with RenalGuard acquired CIN. The MYTHOS trial anticipates enrolling a total of 120 patients, and is expected to be completed this year. More information about the trial is available at the company's website: http://www.plcmed.com/Products-Clinical-Investigations2.asp.
About PLC Systems Inc.
PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Massachusetts, PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina. PLC's newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device. Additional company information can be found at www.plcmed.com.
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, we may be unable to raise sufficient funds in the future to implement our business plan and/or commence our planned U.S. clinical trial for RenalGuard, 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 or future results from clinical trials may differ from results to date, 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, 2008, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC and CO2 Heart Laser, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.
Source: PLC Systems
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