FRANKLIN, Mass., Oct. 19 /PRNewswire-FirstCall/ -- PLC Systems Inc. , a company focused on innovative cardiac and vascular medical device-based technologies, today announced that its RenalGuard System(TM) will be utilized as part of a live case transmission from the Clinica Mediterranea, Naples, Italy, to the 30th Congresso Nazionale della Societa’ Italiana di Cardiologia Invasiva (GISE) during the conference. The conference takes place October 20-23, 2009 in Bologna, Italy. Artech s.r.l., the exclusive distributor for RenalGuard in Italy, will also demonstrate RenalGuard as part of its exhibit at the conference.
Dr. Carlo Briguori, Chief of the Laboratory of Interventional Cardiology, Clinica Mediterranea, a noted expert on CIN, is currently conducting an investigator-sponsored multi-center randomized clinical trial on the efficacy of RenalGuard(R) at his hospital. He plans to make a presentation on the status of his study at GISE, and will include a video demonstrating the use of RenalGuard during his talk.
This live case transmission marks the second time RenalGuard has been utilized as part of a live case transmission during a cardiac procedure during a cardiology conference. In May 2009, RenalGuard was included as part of a live case transmission from Hospital Clinico San Carlos, Madrid, Spain, during the meeting of EuroPCR. The interventional cardiologists involved in that case demonstrated how RenalGuard is used to help prevent Contrast-Induced Nephropathy (CIN) in a patient with impaired renal function undergoing a Percutaneous Coronary Intervention (PCI).
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, “We are very pleased that Dr. Briguori will be demonstrating a live case at GISE illustrating how RenalGuard works and how it may benefit patients. CIN is a significant and growing concern worldwide, and we are very encouraged by the prospect that RenalGuard could prevent it, especially in light of the recently-announced preliminary results of the other investigator-sponsored clinical trial that is ongoing in Italy. We look forward to the completion of all of these studies, in hopes that continued positive results will help galvanize more adoption of RenalGuard in the continuing battle against CIN and its adverse consequences.”
Preliminary data from the first investigator-sponsored randomized clinical trial of RenalGuard, known as MYTHOS, has been presented at two international cardiology conferences, and indicates that patients at high risk for renal failure, when treated with RenalGuard while undergoing certain imaging procedures, acquired CIN at a significantly lower rate than those who were treated 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. More information about the trial is available at the company’s website: http://www.plcmed.com/Products-Clinical-Investigations2.asp.
The investigators for this trial are Dr. Antonio L. Bartorelli, Director, Interventional Cardiology, CCM, and Professor of Cardiology, University of Milan, and Dr. Giancarlo Marenzi, Chief, Intensive Cardiac Care Unit at CCM, two of the world’s leading experts on CIN.
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 Inc.
CONTACT: Mary T. Conway, Conway Communications, +1-617-244-9682,
mtconway@att.net
Web site: http://www.plcmed.com/
