Healthcare Industry News: RenalGuard Therapy
News Release - May 18, 2011
PLC Medical Systems Adds Vice President of Clinical AffairsSusan Papalia, RN, BSN to Lead U.S. Pivotal Trial for RenalGuard®
FRANKLIN, Mass., May 18, 2011 -- (Healthcare Sales & Marketing Network) -- PLC Systems Inc. (OTCBB:PLCSF.ob ), a company focused on innovative medical device technologies, today announced that it has named Susan Papalia, RN, BSN, Vice President of Clinical Affairs. In her new role, she will be responsible for overseeing and leading the U.S. clinical study of the company's innovative product, RenalGuard®. RenalGuard has already obtained the CE Mark in the European Union, and PLC plans to commence the pivotal trial in the U.S. to seek approval for sales and marketing from the U.S. Food & Drug Administration.
Said Mark R. Tauscher, President and Chief Executive Officer, "Susan brings to PLC more than 20 years of experience in clinical research and regulatory approvals related to the launch of new medical devices in the U.S. and international markets. With her expertise and our innovative technology, we are looking forward to the first subject enrollments in the U.S. pivotal trial for RenalGuard. We are confident that the results will confirm the effectiveness of RenalGuard and the associated RenalGuard Therapy® in reducing the incidence of Contrast-Induced Nephropathy (CIN) in at-risk patients, as already demonstrated in the results from the investigator-sponsored REMEDIAL II and MYTHOS clinical trials in Italy."
Ms. Papalia joins PLC Medical Systems from Correx, Inc., where she was VP of Clinical Affairs and played a key role in the launch of the Correx Aortic Valve Bypass (AVB) kit in the EU and Canada. Prior to that, she held a series of senior clinical affairs positions at both Boston Scientific Corporation and Mitralign, Inc. and clinical research positions in cardiology at the New England Medical Center and St. Elizabeth's Hospital in Boston, MA. Ms. Papalia earned her degrees at SUNY Plattsburgh and her CCRA certification from the Association of Clinical Research Professionals. She is an active member of the Massachusetts Medical Reserve Corp and a certified medical volunteer for the Boston Athletic Association.
RenalGuard has been developed to help prevent the onset of Contrast-Induced Nephropathy (CIN) in at-risk patients undergoing certain imaging procedures. The RenalGuard System™ consists of a patented closed loop, software-controlled console and proprietary single-use sets that physicians and nurses use for automated matched fluid replacement to minimize over- or under-hydration of patients during medical procedures where creating and maintaining high urine outputs is beneficial.
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, Massachusetts, PLC today focuses on its newest product, RenalGuard, which is approved for sale in the EU as a general fluid balancing device. Additional company information can be found at 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 or that such approvals may be withdrawn, the current clinical trials in Italy and 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 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, 2010, a copy of which is filed with the SEC.
PLC Systems, PLC Medical Systems, PLC, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.
Source: PLC Systems
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