PLC Plc Systems,

First Public Showing for Innovative Approach to Renal Protection in the Cath Lab FRANKLIN, Mass., Nov. 13 /PRNewswire-FirstCall/ -- PLC Systems Inc. (AMEX:PLC), a company focused on innovative cardiac and vascular medical device-based technologies, announced today that it will demonstrate the RenalGuard System(TM) at Medica 2006, the 38th International Trade Fair with Congress and World Forum for Medicine, November 15-18, 2006 in Dusseldorf, Germany. RenalGuard(TM) will be shown as part of the Massachusetts trade pavilion sponsored by the Massachusetts Office of International Trade and Investment located in Hall 3, booth F16. RenalGuard Therapy(TM) 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. "We are extremely pleased to be part of the Massachusetts pavilion at Medica this year," stated Mark R. Tauscher, President and CEO of PLC Systems, Inc. "We look forward to the feedback we will receive on RenalGuard Therapy and the RenalGuard System from the international medical community." In October, the U.S. Food and Drug Administration (FDA) granted the company a conditionally approved investigational device exemption (IDE) to conduct a pilot clinical trial to evaluate the safety of the RenalGuard System and its ability to accurately measure and balance fluid inputs and outputs on patients undergoing a catheterization procedure where contrast media will be administered. Contrast-Induced Nephropathy A significant adverse effect of contrast agents is CIN, a form of Acute Renal Failure. For at-risk patients, CIN can lead to prolonged hospital stays, extended intensive care unit stays, dialysis, increased mortality and significantly higher healthcare costs. Studies indicate that approximately 15 percent of all patients undergoing image-guided cardiology and radiology procedures, or almost 1 million people annually are at risk of developing CIN. This number is expected to grow as the number of less invasive, image-guided procedures grows. Development Timeline Following the completion of the pilot trial, PLC plans to seek FDA approval to initiate a U.S. multi-center randomized clinical trial to demonstrate the system's ability to help protect high risk patients from developing CIN as a result of contrast media used during their diagnostic and interventional procedures. This trial is expected to begin in 2007 and continue through 2008. PLC is targeting its U.S. commercial launch in late 2008 or early 2009, subject to the receipt of necessary regulatory approvals. The company hopes to obtain CE Mark approval in the first half of 2007, which PLC expects would lead to commercial launch in Europe in the summer of 2007. 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 approved by both the U.S. Food and Drug Administration and the Japanese Ministry of Health, Labor and Welfare, and to obtain a CE Mark for European distribution. In a move to broaden its market, the company recently announced its intention to initiate clinical studies for its RenalGuard therapy 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," "estimates," "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 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-K for the year ended December 31, 2005, and our other SEC reports. PLC Systems, PLC Medical Systems, PLC, CO2 Heart Laser, RenalGuard, RenalGuard System and RenalGuard Therapy are trademarks of PLC Systems Inc. Contact: Mary T. Conway Conway Communications 617-244-9682 DATASOURCE: PLC Systems Inc. CONTACT: Mary T. Conway of Conway Communications, +1-617-244-9682, Web site: http://www.plcmed.com/

Copyright