MILFORD, Mass., Aug. 18, 2011 /PRNewswire/ -- PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative medical device technologies, today announced that final results from the REMEDIAL II investigator-sponsored clinical trial of RenalGuard® in Italy have been published on-line in Circulation, a peer-reviewed journal of the American Heart Association with a distribution of 23,900 worldwide, and will appear in the September 2011 issue of the publication. The results from this trial showed that RenalGuard is superior to the current standard of care at preventing Contrast-Induced Nephropathy (CIN) and in-hospital dialysis in high-risk patients undergoing certain imaging procedures.
In this trial, the investigators discovered that patients treated with RenalGuard and N-acetylcysteine (NAC) developed CIN, a serious and potentially fatal condition, at a much lower rate than patients in the control group who were treated with an infusion of sodium bicarbonate and NAC. Sodium bicarbonate plus NAC remains the current standard of care for the prevention of CIN in many healthcare institutions worldwide. The results provided strong scientific data that RenalGuard Therapy® is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury (CI-AKI) in high-risk patients.
Mark R. Tauscher, President and Chief Executive Officer of PLC Systems, said, "The positive results of the REMEDIAL II clinical trial demonstrate with scientifically significant findings that RenalGuard is a superior approach to reducing the incidence of CIN in high-risk patients. This is another important proof point for RenalGuard and for PLC, and we're delighted that these results have been favorably evaluated by Circulation's advisory board and are now being shared with practitioners and potential partners from around the world. We believe that greater awareness of such positive scientific findings will help us attract more interest from distributors, partners and customers for RenalGuard in the markets were it is available. I would particularly like to thank Dr. Carlo Briguori, MD, PhD, Chief, Laboratory of Interventional Cardiology, Clinica Mediterranea, Naples, Italy, for his leadership in the field of CIN prevention and forutilizing PLC's RenalGuard in this trial."
Dr. Briguori reported on data from 294 patients with chronic kidney disease (CKD) who underwent elective catheterization procedures for diagnostic imaging. The primary end point for the study used a definition of CIN as a rise in serum creatinine (SCr) of 0.3mg/dl over the patient's baseline reading. The RenalGuard-treated group had a CIN incidence rate 46% lower than the control group using this definition of CIN. In secondary endpoints, he also reported a 60% reduction in CIN in the RenalGuard-treated group compared to the control group when defining CIN as a 0.5mg/dl absolute rise in SCr and an 80% reduction of CIN in the RenalGuard-treated group over the control group when defining CIN as a 25% rise over baseline SCr.
The development of CIN has been found to lead to a range of serious and potentially deadly outcomes in patients who already have compromised kidney function. Notably the trial also found that RenalGuard Therapy significantly reduced the need for in-hospital dialysis in high risk patients. In the control group, seven or 4.8% of these patients required some level of dialysis. Only 1 patient (0.7%), or 85% fewer, in the RenalGuard-treated group required dialysis.
The Circulation article can be accessed at the following link: http://circ.ahajournals.org/content/early/2011/08/13/CIRCULATIONAHA.111.030759.abstractor by visiting PLC's website (www.plcmed.com).
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 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, and has not been approved for patient use in the United States.
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 on file with the SEC.
PLC Systems, PLC Medical Systems, PLC, RenalGuard and RenalGuard Therapy are trademarks of PLC Systems Inc.
For information contact:
Mary T. Conway
SOURCE PLC Systems Inc.