SOURCE: RenalGuard Solutions, Inc.

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June 23, 2016 10:14 ET

Value of RenalGuard® Demonstrated in High-Risk Live Case Presentation at CTO Fundamentals Course in Europe

MILFORD, MA--(Marketwired - June 23, 2016) - RenalGuard Solutions, Inc., an innovative renal protection company, today announced its leading product, RenalGuard®, was prominently featured in a high-risk coronary chronic total occlusion (CTO) live case presentation at the recent CTO Fundamentals Course, June 3, 2016, VU University Medical Center, Amsterdam, The Netherlands. The case, performed by Drs. Paul Knaapen and Alex Nap, focused on a cardiac patient with stage 4 chronic kidney disease undergoing a CTO procedure while being treated with RenalGuard. Despite receiving a large volume of contrast as part of the procedure, the patient emerged with intact renal function.

"This case highlights the importance of protecting the kidney in high-risk CTO patients," said Andrew Halpert, President, RenalGuard Solutions. "The patient in the featured case presented with both severe cardiac disease and renal disease. The innovative techniques used during the case allowed the physicians to address a very complicated cardiac lesion, but required a large volume of contrast which can be toxic to the kidney. By using RenalGuard, they were able to treat the patient's cardiac disease while providing a high level of kidney protection."

"The purpose of the CTO Fundamentals Course is to help cardiologists build CTO programs that integrate the best practices in patient care," stated James C. Spratt, BSc, MD, FRCP, FESC, FACC, and Course Director. "To that end, we were pleased to include RenalGuard in this year's program."

Dr. Spratt practices at Spire Edinburgh Hospitals and Spire Murrayfield Edinburgh, Spire Shawfair Park Hospital, Edinburgh, United Kingdom, and is a Consultant Cardiologist for the Forth Valley Acute Hospitals NHS Trust.

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 clinical 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.

About RenalGuard Solutions, Inc.

RenalGuard Solutions, Inc. is a medical device company focused on innovative technologies for the cardiac and vascular markets. Our lead product, RenalGuard, is designed to protect patients from acute kidney injury (AKI), including contrast-induced AKI. Two investigator-sponsored studies in Europe have demonstrated RenalGuard's effectiveness at preventing CI-AKI in at-risk patients. RenalGuard is CE-marked and is being sold in Europe and certain countries around the world via a network of distributors. The CIN-RG RenalGuard pivotal study is underway in the U.S. to support a planned Premarket Approval filing with the U.S. Food and Drug Administration. For further information, please visit the website at www.RenalGuard.com.

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