REMEDIAL II Trial of PLC's RenalGuard® Demonstrates Greater Efficacy than Current Standard of Care
Results Presented at ACC 2011 Late Breaking Clinical Trials Showed that Patients Treated with PLC's RenalGuard had a 46% lower incident rate of CIN and an 85% lower rate of Dialysis among at-risk patients
FRANKLIN, Mass., April 4, 2011 /PRNewswire/ -- 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.
ACC.11, the annual meeting of the American College of Cardiology, is being held April 2-5, 2011 in New Orleans, Louisiana. PLC Systems is demonstrating RenalGuard in the exhibit hall of the conference in booth 3932. More than 12,000 clinicians and professionals from around the world are expected to attend this event.
About PLC Systems Inc.
PLC Systems Inc. is a medical technology company specializing in innovative technologies for the cardiac and vascular markets. Headquartered in Franklin, Massachusetts, PLC today focuses on its newest product, RenalGuard, which is approved for sale in the European Union as a general fluid balancing device. Additional company information can be found at www.plcmed.com.
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, results consistent with the results referenced in this press release, the results of future trials may be delayed and that the product may not receive regulatory approvals in the timeframes accepted, if at all, the RenalGuard product may not be commercially accepted, that pricing will not be supported at projected levels; the risk we will not be able to implement our business plans for RenalGuard successfully or as expected 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, and our other SEC reports.
RenalGuard is not approved for sale in the United States and PLC Systems will be required to conduct additional clinical trials before it may request approval to market RenalGuard in the United States.
PLC Systems, PLC Medical Systems, PLC, and RenalGuard are trademarks of PLC Systems Inc.
Contact: Mary T. Conway Conway Communications 617-244-9682 firstname.lastname@example.org
SOURCE PLC Systems Inc.
Released April 4, 2011