PLC Ramps Up for U.S. Clinical Trial of RenalGuardÃ‚®
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."