SOURCE: RenalGuard Solutions, Inc.

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August 31, 2016 14:32 ET

Italian Study Reconfirming Safety and Effectiveness of RenalGuard® Presented at 8th World Nephrology Conference

MILFORD, MA--(Marketwired - August 31, 2016) - RenalGuard Solutions™, Inc., an innovative renal protection company, today announced that Carlo Briguori, M.D., Ph.D., an internationally-known expert on the prevention of Contrast-Induced Nephropathy, presented the results of his investigator-sponsored study on the use of RenalGuard® at the World Nephrology Conference, August 15-16, Sao Paulo, Brazil. This is the first presentation of his most recent work at an international nephrology conference. The study, "Renalguard system in high-risk patients for contrast-induced acute kidney injury," was published originally December 17, 2015 in the American Heart Journal. Dr. Briguori is the Chief of the 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.

"CI-AKI does not fit squarely in one field of medicine, which is one reason it is such a pernicious condition," said Andrew Halpert, President, RenalGuard Solutions. "The injury occurs in the context of the catheterization lab, but the impact of that injury might not become apparent for weeks or even months later to the physician responsible for the patient's kidney, their nephrologist. This leads to very different experiences of the condition; interventionalists rarely see the impact of contrast, while nephrologists are very familiar with the damage contrast can cause. We are extremely encouraged that the World Nephrology Conference invited Dr. Briguori to present his study results. This indicates a high level of interest within the nephrology community in RenalGuard's ability to prevent this dangerous and costly condition."

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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