MYTHOS Trial of PLC’s RenalGuard® Article Published in JACC — Cardiovascular Interventions
MILFORD, Mass., Jan. 13, 2012 /PRNewswire/ — 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.
The JACC – Cardiovascular Interventions article can be accessed at the following link: http://www.sciencedirect.com/science/article/pii/S1936879811007874, or by visiting PLC’s website (www.plcmed.com).
About PLC Systems
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 cardiac and vascular 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.
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 U.S. clinical trial for RenalGuard may not be completed in a timely fashion, if at all, or, if this clinical trial is completed, it may not produce clinically significant or meaningful results, the RenalGuard product may not be commercially accepted, operational changes, the need for additional financing, 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.