PLC Receives Two Additional U.S. Patents and First Japanese Patent For Its RenalGuard® Technology
Further solidifies intellectual property position for proprietary device aimed at large unmet medical need
MILFORD, Mass., Sept. 22, 2011 /PRNewswire/ -- PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative medical device technologies, today announced it has been granted two additional U.S. patents by the U.S. Patent Office, as well as the company's first Japanese patent, all covering aspects of PLC's new product technology, RenalGuard®.
The innovative RenalGuard Therapy® is designed to reduce the toxic effects that contrast media can have on the kidneys for patients undergoing imaging procedures, and prevent the occurrence of contrast-induced nephropathy (CIN) in the millions of at-risk patients around the world. This novel therapy is based on the theory that creating and maintaining a high urine output allows the body to rapidly eliminate the contrast media, reducing its toxic effects, and especially reducing the incidence of CIN, which can be costly and deadly, and for which there is currently no other effective remedy available.
The patents issued in the U.S. cover both the core methodology as well as the actual RenalGuard device, with the method patent providing broad coverage for the use of matched fluid replacement to combat CIN. The Japanese patent covers the specific RenalGuard device and operation, and represents an important step forward.
Andrew Halpert, Director of Marketing and Engineering of PLC Systems Inc., stated, "Receiving these additional patents in the U.S. and Japan for our proprietary RenalGuard technology is truly noteworthy. These patents greatly strengthen our existing intellectual property position and provide us with important credibility in the medical community as we continue our efforts to expand adoption of RenalGuard in countries where it is able to be marketed. We intend to continue building our patent position to protect and enhance the value of our RenalGuard technology as a method of CIN prevention. Combined with the positive results produced in investigator-sponsored clinical trials of RenalGuard in Europe and recently published in peer-reviewed medical journals, we are bringing new energy to our efforts to accelerate expanded distribution of RenalGuard, especially in Europe."
The company intends to continue to work with the U.S. Patent Office as well as patent organizations in other countries, to obtain additional patents concerning RenalGuard, including several pending patent applications covering the RenalGuard product and fluid balancing techniques and systems. To date, PLC has secured seven U.S. patents, one Canadian patent and one Japanese patent, all covering both core methodology and other aspects of RenalGuard.
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 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, and has not been approved for patient use in the United States.
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 planned future U.S. clinical trial for RenalGuard 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 that may affect the market for our products, regulatory approval requirements that 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, 2010, 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.
For information contact:
Mary T. Conway
508-520-2545
[email protected]
SOURCE PLC Systems Inc.
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