QualityStocks News - PLC Systems Treats First Patient in RenalGuard® Pivotal Trial

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Enrollment of first patient advances PLC toward regulatory approval for RenalGuard® in U.S. market

This is a very important step on our path forward to seeking FDA approval to market RenalGuard in the U.S.

QualityStocks would like to highlight PLC Systems, Inc., a publicly traded company. Headquartered in Milford, Mass., PLC 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.

In the company’s news today,

PLC Systems, Inc., a medical device company focused on innovative technologies for the cardiac and vascular markets, today announced it has completed the enrollment of the first patient in the CIN-RG trial designed to study the efficacy of its RenalGuard Therapy® and RenalGuard System™ for the prevention of Contrast-Induced Nephropathy (CIN).

This achievement marks an important step toward obtaining U.S. Food and Drug Administration (FDA) approval to distribute RenalGuard® in the United States.

"RenalGuard offers us the potential for a method to reduce the incidence of CIN while allowing me as an interventional cardiologist to focus on the catheterization without having to worry that the contrast may be damaging the patient's kidney," Dr. Michael Kim, director of the Cornary Care Unit at Mount Sinai Hospital in New York, NY, stated in the press release.

Dr. Roxana Mehran serves as director of Interventional Cardiovascular Research at Mount Sinai and is one of the three Principal Investigators in the CIN-RG Trial. Dr. Mehran noted the risk of CIN in patients undergoing cardiac catheterizations and said RenalGuard trials offer an “opportunity to examine a tool that could significantly reduce the incidence of CIN in our at-risk patients."

PLC's U.S. pivotal study will be conducted at up to 30 sites in the U.S., involving participation of at least 326 patients and potentially up to 652 patients, and builds upon two clinical trials by independent clinical investigators in Europe. Both trials demonstrated significant reductions in incident rates of CIN in at-risk patients through the use of RenalGuard compared to the current standard of care.

"We're very pleased to be able to move forward with our U.S. pivotal trial, starting with many of the hospitals that had participated in our earlier trial. The team at Mt. Sinai, particularly Dr. Mehran, has led the way in our understanding of CIN, and we are honored that they would choose to participate in the CIN-RG study,” Mark R. Tauscher, president and CEO of PLC, stated. “Using lessons learned from the clinical trials of RenalGuard in Europe as well as other clinical developments since 2008, we made slight modifications to our original trial protocol that we believe will make it more robust. This is a very important step on our path forward to seeking FDA approval to market RenalGuard in the U.S."

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Forward-Looking Statement:
This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.

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