FRANKLIN, Mass., Nov. 29 /PRNewswire-FirstCall/ -- PLC Systems Inc. (Amex: PLC) today reported that it has discussed the results of its pilot safety study of the RenalGuard System(TM) and Therapy with the U.S. Food and Drug Administration. Based upon the positive safety data already collected in the pilot study and its discussions with FDA, PLC has stopped enrolling new patients in the pilot study and will submit a request to transition into a new pivotal trial protocol.
The pilot trial was originally designed as a safety study for up to 40 patients; PLC has successfully enrolled and treated 23 patients in the pilot study at five approved sites to date. The company concluded that finishing the total planned enrollment was now unnecessary based upon the initial review of safety data already obtained.
Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "We are very pleased with the successful early conclusion to our pilot safety trial. This enables us to move forward expeditiously with our planned pivotal trial for this innovative therapy. Our pivotal trial is expected to be a multi-center, randomized controlled study designed to demonstrate that RenalGuard is effective in reducing the incidence of Contrast-Induced Nephropathy (CIN) in at-risk patients undergoing cardiovascular imaging procedures. The results from this pivotal trial will be used to support the regulatory approval process needed to market RenalGuard as a CIN prevention device. We expect to enroll patients at up to 30 sites throughout the country in this trial."
He added, "With the number of cardiovascular imaging procedures expected to grow in the future and more patients being deemed at risk of CIN due to underlying health conditions, we believe the need for a product such as RenalGuard is more critical than ever in preventing this expensive and potentially life threatening condition."
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 has been conducting a pilot clinical safety study of its RenalGuard Therapy(TM) and 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 http://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, 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.
Contact: Mary T. Conway
|SOURCE PLC Systems Inc.|
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