MILFORD, Mass.--(BUSINESS WIRE)--Aug 22, 2018--RenalGuard Solutions ™, Inc., a medical device company focused on innovative fluid management technologies for the cardiac and vascular markets, today announced the treatment of 20,000 patients with RenalGuard ® for the prevention of Contrast-Induced Nephropathy (CIN). Contrast-Induced Nephropathy is a form of acute kidney injury (AKI) that affects 10 to 20 percent of patients undergoing imaging procedures that use toxic contrast dyes.

“We are very pleased by the positive response in the medical community in Europe towards the use of RenalGuard in high-risk patients undergoing cardiovascular procedures,” said Jim Dillon, Chief Executive Officer, RenalGuard Solutions. “This is a huge milestone for the product, the company, and our patients.”

Currently used in Europe and other countries that recognize the CE Mark, RenalGuard is designed to reduce the incidence of CIN found in the millions of at-risk patients undergoing cardiovascular imaging procedures by managing real-time fluid balance in conjunction with interventional procedures involving contrast media. A number of studies have demonstrated RenalGuard's ability to protect patients from AKI following catheterization procedures when compared to the standard of care.

“Our hospital has treated over 700 patients with RenalGuard Therapy, and has established a pathway to ensure patients with chronic kidney disease are identified and receive appropriate treatment. In many cases, patients display a broad range of diuretic efficiency and fluid balance within hours,” said Professor Bjoern Andrew Remppis, Herz- und Gefässzentrum, Bad Bevensen, Germany. “Our institution is happy to have an option for patients that circumvents contrast media, which are associated with worsening kidney function. We will continue to look to RenalGuard as an important therapy in the field of cardio-renal medicine and are intrigued at the potential of this valuable tool for automated negative volume management in heart failure patients.”

RenalGuard Solutions will demonstrate RenalGuard Therapy at two industry meetings: the European Society of Cardiology meeting, August 25-29, in Munich, Germany (Booth G400), and Transcatheter Cardiovascular Therapeutics (TCT), September 21-25, in San Diego, CA (Booth 823).

About RenalGuard Therapy

RenalGuard measures a patient's urine output and automatically infuses hydration fluid based on that urine output. The system is designed to induce high urine rates, which have been shown to protect the kidney from a range of insults. A number of studies have demonstrated RenalGuard's ability to protect patients from AKI following catheterization procedures when compared to the standard of care, including: MYTHOS, which found RenalGuard to be superior to overnight hydration; REMEDIAL II, which found RenalGuard to be superior to sodium bicarbonate hydration; Protect-TAVI, which reported a significant reduction in post-procedural acute kidney injury (AKI) following transcatheter aortic valve replacement (TAVR) when using RenalGuard during the procedure, compared to standard therapy; and AKIGUARD, which showed significant improvement in long-term outcomes when using RenalGuard vs. standard therapy. Two meta-analyses of these results (Putzu and Mattathil) found RenalGuard consistently reduced kidney injury, dialysis, adverse events and mortality compared to standard therapy.

About RenalGuard Solutions, Inc.

RenalGuard Solutions, Inc. is a medical device company focused on innovative technologies for the cardiac and vascular markets. The company's lead product, RenalGuard ®, is designed to protect patients from acute kidney injury (AKI), including contrast-induced AKI. Investigator-sponsored studies in Europe have demonstrated RenalGuard's effectiveness at preventing CI-AKI in at-risk patients. RenalGuard is CE-marked and is sold in Europe and certain countries around the world via a network of distributors. For further information, please visit the company's website at http://www.renalguard.com.

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CONTACT: for RenalGuard Solutions, Inc.

Jana Chow, 925-324-9846

jana@healthandcommerce.com

KEYWORD: UNITED STATES EUROPE NORTH AMERICA CALIFORNIA MASSACHUSETTS GERMANY

INDUSTRY KEYWORD: SURGERY HEALTH CARDIOLOGY MEDICAL DEVICES

SOURCE: RenalGuard Solutions, Inc.

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PUB: 08/22/2018 08:00 AM/DISC: 08/22/2018 08:01 AM

http://www.businesswire.com/news/home/20180822005084/en