MILFORD, MA--(Marketwired - June 06, 2013) - PLC Systems Inc. (PLCSF), a company focused on innovative medical device technologies, today announced it has been granted a new method patent by the U.S Patent and Trademark Office entitled, "Patient Hydration Method." The patent claims cover the use of RenalGuard Therapy® and the RenalGuard® device to protect patients' kidneys from therapeutic agents that are potentially toxic to the kidney, such as those used in the treatment of cancer or serious infections. This patent greatly expands PLC's intellectual property position. The company's existing core patents cover the use of the RenalGuard technology to reduce the risk of Acute Kidney Injury (AKI) from exposure to contrast agents which specifically lead to Contrast-Induced Acute Kidney Injury or CI-AKI.
RenalGuard therapy is designed to rapidly remove contrast dyes that are potentially toxic to patients with impaired kidney function, thereby preventing the occurrence of CI-AKI in millions of at-risk patients around the world. PLC's novel therapy creates and maintains a high urine output that allows the body to rapidly eliminate the contrast agent, reducing its toxic effects. In its most severe manifestation, CI-AKI can cause death or require the patient to undergo a kidney transplant. Treating CI-AKI can also be extremely costly, depending on the severity of the case.
Andrew Halpert, Director of Marketing and Engineering of PLC Medical Systems, Inc., stated, "Receiving this method patent in the U.S. for our proprietary RenalGuard Therapy is noteworthy in our efforts to protect our technology and the millions of patients from the adverse effects of contrast dyes, chemotherapy and other toxic agents. We intend to continue building our patent position to enhance the value of our RenalGuard technology as a crucial therapy to reduce the risk of damage to patients' kidneys from a variety of potentially toxic agents. Combined with the positive results produced in the investigator-sponsored clinical trials of RenalGuard in Europe, we believe this additional patent will be a useful tool in our efforts to accelerate and expand the use of RenalGuard around the world."
Including this patent, PLC has secured nine U.S. patents, one European Patent, 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 rapidly remove contrast dyes that are potentially toxic to 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 Contrast-Induced Acute Kidney Injury (CI-AKI). RenalGuard is being studied in a pivotal trial in the U.S., as part of the FDA approval process. For more information, visit www.plcmed.com, or connect with the Company on Facebook, Twitter, LinkedIn, YouTube and Google+.
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.