MYTHOS RenalGuard® Trial Demonstrates Greater Efficacy Than Current Standard of Care
Updated Results Presented at TCT 2010 Showed that Patients Treated with RenalGuard Developed CIN at a 69% Lower Rate than Those Treated With Overnight Hydration
FRANKLIN, Mass., Sept. 23 /PRNewswire-FirstCall/ -- PLC Systems Inc. (OTC Bulletin Board: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, today announced that updated results from the MYTHOS investigator-sponsored clinical trial of RenalGuard® in Italy showed that RenalGuard was more effective than the current standard of care at preventing Contrast Induced-Nephropathy (CIN). In scientifically significant results presented at Transcatheter Cardiovascular Therapeutics (TCT) 2010, the investigators found that patients treated with RenalGuard developed CIN, a serious and potentially fatal condition, at much lower rates than patients in the control group who were treated with overnight hydration, the current gold standard therapy.
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "We are extremely pleased that the latest updated results of the MYTHOS clinical trial corroborate earlier preliminary findings from this trial and provide scientific evidence that RenalGuard is more effective in combating CIN than overnight hydration. This is a pivotal point for PLC, one that we have awaited for several years, and we're delighted that these results are being shared at TCT with a wide range of clinicians and potential partners. We look forward to additional presentations on RenalGuard, in hopes that these strong scientific findings will help us attract additional interest from distributors, partners and customers for our proprietary device."
Dr. Antonio L. Bartorelli, Director, Interventional Cardiology, Centro Cardiologico Monzino-University of Milan (CCM), and Professor of Cardiology, University of Milan, one of the principal investigators for the MYTHOS trial, presented the results during a poster session at the conference.
The latest trial data presented is on 157 enrolled patients with chronic kidney disease (CKD) who underwent elective or urgent percutaneous coronary interventions (PCI) in Italy. The updated results indicate that patients who were at high risk for renal failure and who were treated with RenalGuard while undergoing certain imaging procedures developed CIN at a rate 69% lower than those who were treated beforehand with overnight hydration. Developing CIN has been found to lead to a range of serious and potentially deadly outcomes in patients who already have compromised kidney function. The trial also found that patients treated with RenalGuard had significantly fewer in-hospital adverse events than those treated with overnight hydration.
The principal investigators for this trial are Dr. Bartorelli and Dr. Giancarlo Marenzi, Chief, Intensive Cardiac Care Unit, CCM, two of the world's leading experts on CIN prevention.
Dr. Bartorelli will also present the trial results in the "Featured Clinical Research" session, on September 24, 2010 at 6:15 PM.
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, in reducing the incidence of CIN in patients with baseline impairment in renal function undergoing cardiac catheterization procedures and percutaneous coronary interventions.
TCT, sponsored by the Cardiovascular Research Foundation, is being held September 21 – 25, 2010, in Washington, DC. PLC is demonstrating RenalGuard during the exhibits portion of the conference in booth 1005. More than 12,000 clinicians and professionals from around the world are expected to attend this event.
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 near term to continue our ongoing operations and 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 be viewed as having produced 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, 2009, 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 firstname.lastname@example.org
SOURCE PLC Systems Inc.
Released September 23, 2010