FRANKLIN, Mass., March 27 /PRNewswire-FirstCall/ -- PLC Systems Inc. , a company focused on innovative cardiac and vascular medical device-based technologies, today announced that the first data from its pilot safety trial for RenalGuard(R) will be presented in a poster session at the American College of Cardiology Annual Conference, on Sunday, March 29, 2009 at 3:30 PM in Orlando, Florida. The poster will be presented by Dr. Jean-Francois Dorval, of the Brigham and Women’s Hospital, Boston, Massachusetts.
The trial, the first in-man study involving RenalGuard in the United States, was designed to test the safety of the RenalGuard System(TM) when used to provide high volume matched diuresis in patients at high risk for Contrast-Induced Nephropathy (CIN) undergoing angiography. A total of 23 patients were enrolled in the study, which was completed in late 2007. The lead investigator for the trial was Dr. Frederic S. Resnic, Director of the Cardiac Catheterization Lab at Brigham and Women’s Hospital.
Dr. Resnic noted, “Our conclusion was that the system demonstrated effective high volume fluid balancing with acceptable safety. Further evaluation of system efficacy at preventing CIN is warranted.”
In November 2008, the company received full approval from the U.S. Food and Drug Administration (FDA) for its U.S. pivotal trial to study the effectiveness of RenalGuard and its associated therapy in the prevention of CIN. Under the trial design, 406 patients will be enrolled at up to 30 institutions.
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, “We are very pleased that Dr. Dorval will be presenting this important study, the first in-man study for the RenalGuard System, at ACC this year to further educate clinicians about RenalGuard Therapy(R) to address this critical problem. CIN is a significant and growing concern worldwide, and we are very encouraged by the potential ability of RenalGuard to remedy it. In addition, we are looking forward to receiving results from the investigator-sponsored clinical trial to evaluate the use of the RenalGuard system in the prevention of CIN in high risk patients currently underway in Europe.”
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 investigator-sponsored clinical trial underway in Europe and the planned future U.S. clinical trial for RenalGuard as a safe and effective CIN prevention device 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 our Quarterly 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, and RenalGuard are trademarks of PLC Systems Inc.
CONTACT: Mary T. Conway of Conway Communications, +1-617-244-9682,
mtconway@att.net
Web site: http://www.plcmed.com/
