SOURCE: PLC Systems, Inc.

May 01, 2013 08:00 ET

PLC Systems Receives First European Patent for RenalGuard®

MILFORD, MA--(Marketwired - May 01, 2013) - PLC Systems Inc. (OTCQB: PLCSF), a company focused on innovative medical device technologies, today announced it has been granted its first patent for RenalGuard® by the European Patent Office (EU Patent Number 2010268). This patent covers the core RenalGuard device and its redundant infusion rate monitoring which allows RenalGuard to safely infuse saline at very high and accurate rates. The patent has a term extending to April 2027.

"Receiving this first European patent for RenalGuard is a very important milestone for PLC," commented Andrew Halpert, Director of Marketing and Engineering of PLC Medical Systems, Inc. "This patent is an important step to help protect against infringement of our core technology in this important market. With this additional security, we have strengthened our presence in Europe, which is currently the largest market for commercial sale of the RenalGuard system." 

RenalGuard therapy is designed to rapidly remove contrast dyes that are potentially toxic to patients with impaired kidney function. Contrast dyes are used in many cardiovascular diagnostic and interventional imaging procedures to facilitate the capture and display of x-ray images. Approximately 10% to 20% of patients that undergo these procedures are at-risk of developing Contrast-Induced Nephropathy (CIN), a form of acute kidney injury resulting from toxic contrast dye. No other product on the market has been shown to consistently reduce the incidence of CIN. In two investigator-sponsored clinical trials, RenalGuard Therapy has reduced the incidence of acute renal failure. We believe that RenalGuard may help reduce morbidity and mortality, as well as hospital costs for the high-risk patients.

Mr. Halpert continued, "In-line with our strategic goals, we are continuing to pursue additional patent applications in Europe, the US and Japan. In addition to the positive results produced in the investigator-sponsored clinical trials of RenalGuard in Europe, we are bringing new energy to our efforts to accelerate expanded distribution of RenalGuard around the world."

To date, PLC has secured eight U.S. patents, one Canadian patent and one Japanese patent, all covering both core methodology and other aspects of RenalGuard Therapy.

About PLC Systems Inc.

PLC Systems Inc., headquartered in Milford, Mass., is a medical device company focused on innovative technologies for the cardiac and vascular markets. PLC's newest product, RenalGuard, has been developed to help prevent the onset of Contrast-Induced Nephropathy (CIN) in at-risk patients undergoing certain cardiac and vascular imaging procedures. The Product is CE-marked and is being marketed in Europe and selected countries around the world. Two investigator-sponsored European studies have demonstrated RenalGuard's effectiveness at preventing CIN. RenalGuard is being studied in a pivotal trial in the U.S., as required for approval by FDA.

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 U.S. clinical trial for RenalGuard may not be completed in a timely fashion, if at all, or, if this clinical trial is completed, it may not produce clinically significant or meaningful results, the RenalGuard product may not be commercially accepted, operational changes, the need for additional financing, 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, 2012, a copy of which is on file with the SEC.

PLC Systems, PLC Medical Systems, PLC, RenalGuard and RenalGuard Therapy are trademarks of PLC Systems Inc.

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