SOURCE: RenalGuard Solutions, Inc.

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January 21, 2016 08:00 ET

Italian Study Reconfirms Safety and Effectiveness of RenalGuard in Reducing Incidence of Contrast-Induced Acute Kidney Injury in High-Risk Patients

MILFORD, MA--(Marketwired - January 21, 2016) - RenalGuard Solutions™, Inc., an innovative renal protection company, today announced that an investigator-sponsored study reported on the results of the use of RenalGuard® in normal clinical use to protect patients who were at high risk of developing Contrast-Induced Acute Kidney Injury (CI-AKI) . The study, "RenalGuard system in high-risk patients for contrast-induced acute kidney injury," was published December 17, 2015 in the American Heart Journal by Carlo Briguori, M.D., Ph.D., Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy.

The study evaluated the use of RenalGuard in 400 patients treated in the course of normal clinical use of RenalGuard at the clinic. It reported that RenalGuard Therapy® is "safe and effective" at enabling patients to reach target urine rates. The study also found that patients who reached a urine flow rate ≥450 ml/hr during their catheterization saw the greatest protection from CI-AKI. Patients who did not reach the intra-procedural urine flow rate of 450 ml/hr had an increased hazard ratio for developing CI-AKI of 2.27 (95% CI 1.05-2.01; p = 0.012) compared to those who did. This further validates the value of RenalGuard Therapy's ability to safely induce high urine flow rates as a protective measure against CI-AKI.

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. This study follows a number of other studies that 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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