FRANKLIN, Mass., June 2, 2011 /PRNewswire/ -- PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative medical device technologies, today announced that it is preparing to commence the pivotal trial in the U.S. for the company's innovative product, RenalGuard®, to seek approval for sales and marketing in the U.S. from the U.S. Food & Drug Administration. RenalGuard has already obtained the CE Mark in the European Union.
As part of this effort, the company has added Roxana Mehran, MD, Professor of Medicine at Mount Sinai School of Medicine, as a Principal Investigator for the trial, joining Charles Davidson, MD, Professor of Medicine, Northwestern University Medical School and Richard J. Solomon, MD, Professor of Medicine, University of Vermont College of Medicine. Dr. Mehran is well known worldwide for her work and leadership in the field of CIN prevention. She is internationally recognized for her work as a clinical trial specialist with complex data analyses and outcomes research within the field of interventional cardiology. She is recognized for her experience and expertise in working with regulatory agencies to conduct clinical trials.
Said Mark Tauscher, President and CEO, "We look forward to the commencement of our U.S. pivotal trial for RenalGuard. This trial will be conducted to test the effectiveness of RenalGuard and the associated RenalGuard Therapy® in reducing the incidence of Contrast-Induced Nephropathy (CIN) in at-risk patients. The Italian investigator-sponsored REMEDIAL II and MYTHOS clinical trial results have demonstrated meaningful reduction of CIN in at-risk patients using RenalGuard. Dr. Mehran is a noted expert in the field of CIN prevention, and her clinical trials expertise will prove to be extremely valuable moving forward. We are working diligently to lay the foundation for the first patient enrollments for the U.S. pivotal trial for RenalGuard."
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., headquartered in Franklin, 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.
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.
Contact: Mary T. ConwayConway [email protected]
SOURCE PLC Systems Inc.
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As part of this effort, the company has added Roxana Mehran, MD, Professor of Medicine at Mount Sinai School of Medicine, as a Principal Investigator for the trial, joining Charles Davidson, MD, Professor of Medicine, Northwestern University Medical School and Richard J. Solomon, MD, Professor of Medicine, University of Vermont College of Medicine. Dr. Mehran is well known worldwide for her work and leadership in the field of CIN prevention. She is internationally recognized for her work as a clinical trial specialist with complex data analyses and outcomes research within the field of interventional cardiology. She is recognized for her experience and expertise in working with regulatory agencies to conduct clinical trials.
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Said Mark Tauscher, President and CEO, "We look forward to the commencement of our U.S. pivotal trial for RenalGuard. This trial will be conducted to test the effectiveness of RenalGuard and the associated RenalGuard Therapy® in reducing the incidence of Contrast-Induced Nephropathy (CIN) in at-risk patients. The Italian investigator-sponsored REMEDIAL II and MYTHOS clinical trial results have demonstrated meaningful reduction of CIN in at-risk patients using RenalGuard. Dr. Mehran is a noted expert in the field of CIN prevention, and her clinical trials expertise will prove to be extremely valuable moving forward. We are working diligently to lay the foundation for the first patient enrollments for the U.S. pivotal trial for RenalGuard."
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., headquartered in Franklin, 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.
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.
Contact: Mary T. ConwayConway [email protected]
SOURCE PLC Systems Inc.
