Important Step in Process to Secure Regulatory Approval for RenalGuard in the United States
MILFORD, Mass., Jan. 23, 2012 /PRNewswire/ -- PLC Systems Inc. (OTC: PLCSF), a company focused on innovative medical device technologies, announced the successful enrollment of the first patient in the CIN-RG trial, the company's pivotal trial to study the efficacy of its RenalGuard Therapy® and RenalGuard System™ in the prevention of Contrast-Induced Nephropathy (CIN). This is an important step in the process to secure regulatory approval by the U.S. Food and Drug Administration (FDA) for the distribution of RenalGuard® in the United States.
The first patient was enrolled by Dr. Michael Kim, Director of the Coronary Care Unit at Mount Sinai Hospital in New York, New York.
"RenalGuard offers us the potential for a method to reduce the incidence of CIN while allowing me as an interventional cardiologist to focus on the catheterization without having to worry that the contrast may be damaging the patient's kidney," said Dr. Kim.
Dr. Roxana Mehran, Director of Interventional Cardiovascular Research at Mount Sinai and one of the three Principal Investigators in the CIN-RG Trial, said, "I am very excited to have this trial underway and overjoyed that Mount Sinai could enroll the first patient. CIN remains a real problem for patients undergoing cardiac catheterizations. RenalGuard trials give us the opportunity to examine a tool that could significantly reduce the incidence of CIN in our at-risk patients."
Mark R. Tauscher, President and Chief Executive Officer of PLC, said, "We're very pleased to be able to move forward with our U.S. pivotal trial, starting with many of the hospitals that had participated in our earlier trial. The team at Mt. Sinai, particularly Dr. Mehran, has led the way in our understanding of CIN, and we are honored that they would choose to participate in the CIN-RG study. Using lessons learned from the clinical trials of RenalGuard in Europe as well as other clinical developments since 2008, we made slight modifications to our original trial protocol that we believe will make it more robust. This is a very important step on our path forward to seeking FDA approval to market RenalGuard in the U.S."
PLC's U.S. pivotal study is under the supervision of Principal Investigators Charles Davidson, MD, Professor of Medicine, Northwestern University Medical School, Richard J. Solomon, MD, Professor of Medicine, University of Vermont College of Medicine and Dr. Mehran. It is designed as an adaptive, randomized controlled trial at up to 30 sites in the U.S. Enrollment in the trial will include at least 326 patients and potentially up to 652 patients, depending upon the outcome of a sample size re-estimation after 163 patients. The sample size re-estimation, often used in adaptive trials, enables investigators to ensure that the trial is sufficiently powered so that the final results are statistically meaningful.
PLC's U.S. study builds upon two clinical trials by independent clinical investigators in Europe, both of which showed significant reductions in incident rates of CIN in at-risk patients through the use of RenalGuard compared to the current standard of care.
About PLC Systems
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 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 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 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, 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.
Contact: Mary T. Conway
SOURCE PLC Systems Inc.