FRANKLIN, Mass., Feb. 15 /PRNewswire-FirstCall/ -- PLC Systems Inc. announced today that it has submitted an Investigational Device Exemption (IDE) supplement with the U.S. Food & Drug Administration (FDA) for its RenalGuard Therapy(TM) and RenalGuard System(TM). This supplement seeks approval to move to a pivotal trial to study the effectiveness of the Company’s RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy.
According to the current timetable, PLC expects to commence the pivotal trial after receipt of FDA approval. Contrast-Induced Nephropathy, or CIN, is a major and growing problem due to the increasing number of older patients, diabetics and patients with pre-existing renal impairment -- all of whose conditions make them at risk for CIN when they require interventional procedures that use radiographic contrast media. This study is designed as an adaptive, randomized control trial, with potentially up to 30 sites in the U.S. Enrollment in the trial is expected to last through 2009, and to include at least 250 patients. PLC is continuing discussions with FDA on metrics and endpoints to be used in the study, in addition to sample size and other aspects of the study design, which is currently expected to cost approximately $3 million.
This trial design builds upon the successful completion of the company’s pilot trial in December, a study that was designed to preliminarily evaluate safety associated with Renal Guard Therapy and RenalGuard System. A total of 23 patients were enrolled in the study.
Mark R. Tauscher, President and Chief Executive Officer of PLC, said, “We are very pleased with the continued progress on our RenalGuard studies. Submitting the IDE for the pivotal trial is an important milestone. We are working diligently to recruit sites for the pivotal trial, and anticipate continued positive interest from medical specialists who currently have no proven method to address the continued high incidence of CIN in their patients. At the same time, we are also pleased by our progress with RenalGuard in Europe. We anticipate that the planned Italian clinical trial of RenalGuard at the Centro Cardiologico Monzino (CCM-University of Milan) will begin in March, following receipt of final approval from the ethics committee at the institution. We expect that this effort, under the leadership of two renowned worldwide experts on CIN, Drs. Antonio Bartorelli and Giancarlo Marenzi, will provide additional confidence to early adopters who recognize the potential benefits of utilizing the unique fluid balancing capabilities of the RenalGuard System in a cath lab setting during cardiovascular imaging procedures for patients at higher risk of CIN. This study is expected to include 120 patients, and compare RenalGuard against overnight hydration, the prevalent standard of care currently in Europe.”
In addition to the CCM study, PLC continues to work towards a limited launch of RenalGuard in Italy, following receipt of CE Mark certification in late 2007. The initial launch will focus on early adopters in that country at approximately 10 sites in Italy. A more expanded all-European Union launch for RenalGuard is contemplated for 2009.
Contrast-Induced Nephropathy
Approximately seven million patients worldwide undergo interventional cardiovascular therapeutic and diagnostic imaging procedures each year. Contrast-Induced Nephropathy, or CIN, is a major and growing problem due to the increasing number of older patients, diabetics and patients with pre- existing renal impairment -- all of whose conditions make them at risk for CIN when they require interventional procedures that use radiographic contrast media. CIN is the third most common cause of in-hospital acute renal failure. It is associated with significant in-hospital mortality rates, and increases in long-term mortality rates, major in-hospital adverse cardiac events, and the risk of having to undergo renal dialysis therapy. Any of these can result in prolonged hospital stays and increased medical costs. Studies indicate that approximately 15-20% of all patients undergoing image-guided cardiology and radiology procedures are at risk of developing CIN. The estimated mortality rate for patients that acquire CIN may be as high as 35%.
RenalGuard is based on existing pre-clinical study data that suggests that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects. RenalGuard is a fully-automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media.
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, Mass., PLC pioneered the CO2 Heart Laser System, which cardiac surgeons use to perform CO2 transmyocardial revascularization (TMR) to alleviate symptoms of severe angina. CO2 TMR offers a treatment option for angina patients who suffer from severe coronary artery disease. The CO2 Heart Laser is the world’s first TMR angina relief device cleared for commercial distribution by both the U.S. Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare, and to obtain a CE Mark for European distribution.
The company recently concluded a pilot clinical safety study of its RenalGuard Therapy and RenalGuard System. In late 2007, the company received its CE Mark Certificate for RenalGuard System. RenalGuard Therapy is designed to reduce the toxic effects that contrast media can have on the kidneys. This therapy is based on the theory that creating and maintaining a high urine output is beneficial to patients undergoing imaging procedures where contrast agents are used. The real-time measurement and matched fluid replacement design of the RenalGuard System is intended to ensure that a high urine flow is maintained before, during and after these procedures. This should allow the body to rapidly eliminate contrast, reducing its toxic effects. The RenalGuard System, with its matched fluid replacement capability, is intended to minimize the risk of over- or under-hydration.
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, the clinical trials for that product may not be successful, 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 Report on Form 10-Q for the quarter ended September 30, 2007, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC and CO2 Heart Laser, RenalGuard, RenalGuard Therapy and RenalGuard System are trademarks of PLC Systems Inc.
mtconway@att.net
CONTACT: Mary T. Conway of Conway Communications, +1-617-244-9682,
mtconway@att.net, for PLC Systems Inc.
Web site: http://www.plcmed.com/
