MYTHOS clinical trial demonstrates superiority of RenalGuard in reducing CIN

Jan 13 2012

PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative medical device technologies, today announced that final results from the MYTHOS investigator-sponsored clinical trial of RenalGuard® in Italy have been published in the January 2012 issue of JACC – Cardiovascular Interventions, a peer-reviewed journal of the American College of Cardiology.  The results from this trial showed that RenalGuard is superior to the current standard of care at reducing rates of Contrast-Induced Nephropathy (CIN) and in-hospital dialysis in at-risk patients undergoing certain imaging procedures.

Initial results from this study were first presented at Transcatheter Cardiovascular Therapeutics (TCT) in September 2010.

Mark R. Tauscher, President and Chief Executive Officer of PLC Systems, said, "The positive results of the MYTHOS clinical trial demonstrate, in scientifically significant findings, that RenalGuard is a superior approach to reducing the incidence of CIN in at-risk patients. The results of this trial were the first important proof point for RenalGuard and for PLC, and we're delighted that these results are now being shared with practitioners and potential partners from around the world. We believe that greater awareness of these positive scientific findings and the positive findings from the REMEDIAL II trial will further drive the interest we are seeing from distributors, partners and customers for RenalGuard in the markets where it is available."

The trial data presented is on 170 enrolled patients with chronic kidney disease (CKD) who underwent elective or urgent percutaneous coronary interventions (PCI) in Italy. The results indicate that patients who were at higher risk for renal failure and who were treated with RenalGuard while undergoing imaging procedures developed CIN at a rate 74% lower than those who were treated with overnight hydration. Developing CIN has been found to lead to a range of serious and potentially deadly outcomes in patients who already have compromised kidney function. The trial also found that patients treated with RenalGuard had significantly fewer in-hospital adverse events than those treated with overnight hydration.