Trial Confirmed Safety of RenalGuard System™ in At Risk Patients

MILFORD, Mass., Jan. 17, 2012 /PRNewswire/ -- PLC Systems Inc. (OTC: PLCSF), a company focused on innovative medical device technologies, today announced that an article summarizing the results from its U.S. pilot trial for RenalGuard® has been published online in the December 26, 2011 International Journal of Cardiology, a peer-reviewed journal affiliated with the International Society of Adult Congenital Heart Disease. The results from this trial, which was completed in 2007 and presented at the American College of Cardiology conference in March 2009, confirmed that RenalGuard System™ "is safe and dynamically balances volume hydration."   

The trial was conducted in four clinical sites in the U.S. in 2006 and 2007, with a total of 23 patients enrolled, and was designed to evaluate the safety of RenalGuard System and RenalGuard Therapy®, under an Investigational Device Exemption (IDE) approved by the U.S. Food and Drug Administration (FDA).  The results of this feasibility study illustrate that RenalGuard can safely help maintain high rates of urine output without significant hemodynamic or systemic adverse reactions.   

PLC's U.S. pivotal trial to study the efficacy of RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy (CIN) is currently underway under the supervision of Principal Investigators Charles Davidson, MD, Professor of Medicine, Northwestern University Medical School, Richard J. Solomon, MD, Professor of Medicine, University of Vermont College of Medicine and Roxana Mehran, MD, Professor of Medicine at Mount Sinai School of Medicine.

The International Journal of Cardiology article can be accessed at the following link:  http://www.ncbi.nlm.nih.gov/pubmed/22204847 or by visiting PLC's website (www.plcmed.com). 

About RenalGuard

RenalGuard is based on data that shows that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects.  RenalGuard is a fully-automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media. 

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.

SOURCE PLC Systems Inc.

Back to top

RELATED LINKS
http://www.plcmed.com