Apr 5 2011
PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative medical device technologies, announced that final results from the REMEDIAL II investigator-sponsored clinical trial of RenalGuard® in Italy were presented today. The results showed that RenalGuard was much more effective than the current standard of care at preventing Contrast-Induced Nephropathy (CIN) and Dialysis in at-risk patients.
In scientifically significant results presented today at the American College of Cardiology Late Breaking Clinical Trial session of the annual conference (ACC.11), the investigators found 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 catheterization labs worldwide.
Mark R. Tauscher, President and Chief Executive Officer of PLC Systems, said, "We are extremely pleased that the results of the REMEDIAL II clinical trial are consistent with findings from the MYTHOS trial presented in September 2010 at TCT, and provide additional scientific evidence that RenalGuard is safe and effective in combating CIN. This is another important proof point for RenalGuard and for PLC, and we're delighted that these results are being shared with practitioners and potential partners from around the world at ACC.11. We believe continued positive scientific findings like these will help us attract more interest from distributors, partners and customers for RenalGuard Therapy. I would particularly like to thank Dr. Briguori for his leadership in the field of CIN prevention and for utilizing PLC's RenalGuard in this trial."
Dr. Carlo Briguori, MD, PhD, Chief, Laboratory of Interventional Cardiology, Clinica Mediterranea, Naples, Italy, and Co-Director of Clinical Research, Laboratory of Interventional Cardiology, San Raffaele Hospital, Milan, Italy, the principal investigator for the REMEDIAL II trial, presented the results at the conference today.
The REMEDIAL II trial is a randomized, multicenter clinical trial in Italy designed to provide an assessment of the potential benefits of induced diuresis with automated matched hydration therapy utilizing RenalGuard plus N-acetylcysteine, compared to N-acetylcysteine and a sodium bicarbonate solution in reducing the incidence of CIN in patients with baseline impairment in renal function.
Dr. Briguori reported on data from 294 patients with chronic kidney disease (CKD) who underwent elective catheterization procedures. 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 group had a CIN incidence rate of 46% lower than the control group using this definition of CIN. As secondary endpoints, he also reported a 60% reduction in CIN when defining CIN as a 0.5mg/dl absolute rise in SCr and an 80% reduction of CIN 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 dialysis in high risk patients. In the control group, 4.8% of these patients required some level of dialysis. In contrast, only 0.7%, or 85% fewer, in the RenalGuard group required dialysis.
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