FRANKLIN, Mass., Aug. 31 PLC Systems Inc. (OTC Bulletin Board: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, today announced that it will demonstrate its RenalGuard System(TM) 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 are expected to attend this event.
In addition, Dr. Giancarlo Marenzi, Chief, Intensive Cardiac Care Unit, Centro Cardiologico Monzino-University of Milan (CCM) will present preliminary results of the MYTHOS investigator-sponsored clinical trial of RenalGuard.
In an update to the abstract published in late August, Dr. Marenzi is presenting initial results that indicate that patients with high risk for renal failure treated with RenalGuard((R) )while undergoing imaging procedures acquired contrast-induced nephropathy (CIN) at less than half the rate of 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.
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "We are extremely pleased with these very positive preliminary results of the MYTHOS clinical trial, since they greatly exceed the primary endpoint, which is defined as equivalency. These initial results confirm the initial direction seen in the earlier abstract, and provide strong evidence that RenalGuard is highly effective in reducing the incidence of CIN in millions of high-risk patients around the world every year. With these initial positive results in hand, we are firmly focused on accelerating the pace of signing up distributors in Europe and expanding our launch of RenalGuard to additional international markets."
The MYTHOS trial is a randomized clinical trial designed to provide an assessment of the potential benefits of induced diuresis with automated matched hydration therapy utilizing RenalGuard, compared to standard overnight hydration, a prevalent method of treatment in the EU, in reducing the incidence of CIN in patients undergoing cardiac catheterization procedures and percutaneous coronary interventions with baseline impairment in renal function. The study is designed as a non-inferiority trial, with the primary endpoint defined as equivalency or better to overnight hydration.
The investigators for the trial are Dr. Antonio L. Bartorelli, Director, Interventional Cardiology, CCM, and Professor of Cardiology, University of Milan, and Dr. Marenzi, two of the world's leading experts on CIN.
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.
"Contrast-Induced Nephropathy is a serious complication resulting from the use of contrast media for coronary and peripheral vascular diagnostic and interventional procedures in high-risk patients," stated Dr. Bartorelli. "These preliminary results indicate that furosemide-induced high urine output with maintenance of intravascular volume through matched hydration can be safely obtained with the RenalGuard System and reduces the risk of CIN in these at-risk patients undergoing imaging procedures."
PLC received the CE Mark Certificate for the RenalGuard System in December 2007, and concluded its pilot safety trial in the U.S. late in 2007. The company has received full approval from the FDA to commence a U.S. pivotal trial to study the effectiveness of RenalGuard in reducing the incidence of CIN. In March 2008, PLC signed its first international distribution agreement for RenalGuard with Artech s.r.l., Cavezzo, Italy for distribution of its RenalGuard System into Italy, and in May 2009, PLC announced its second European distributor, IZASA Distribuciones Tecnicas S.A., headquartered in Barcelona, Spain, for the distribution of RenalGuard in Spain.
Most recently, PLC was awarded its first patent for RenalGuard technology in Canada, and the Company announced that it had launched RenalGuard in Bangladesh. PLC also recently announced that a second investigator-sponsored clinical study of RenalGuard had begun, also in Italy, at the Clinica Mediterranea, under the leadership of Dr. Carlo Briguouri.
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.
Contact: Mary T. Conway Conway Communications 617-244-9682 [email protected]
SOURCE PLC Systems Inc.