MILFORD, Mass., Aug. 18, 2011 -- PLC Systems Inc., 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.abstract or by visiting PLC's website (www.plcmed.com).

Source: PLC Systems, Inc.