New Study Reports RenalGuard Therapy(R) Effective in Preventing Kidney Injury in High Risk Patients Undergoing Valve Replacement

MILFORD, MA--(Marketwired - April 14, 2016) - RenalGuard Solutions™, Inc., an innovative renal protection company, today announced that an investigator-sponsored prospective study reported on the results of the use of RenalGuard® to protect patients undergoing transcatheter aortic valve implantation (TAVI) who were at high risk of developing Contrast-Induced Acute Kidney Injury (CI-AKI). The study, "RenalGuard System for the prevention of acute kidney injury in patients undergoing transcatheter aortic valve implantation" was published April 10, 2016 in EuroIntervention by Gabriella Visconti, M.D., Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy.

The non-randomized study enrolled 48 consecutive patients scheduled for TAVI using local anesthesia. Patients were assigned to the Control group or the RenalGuard group, depending on risk factors. Criteria for treating the patients with RenalGuard System™ were: eGFR ≤30 mL/ min/1.73 m2, or a predicted risk for AKI ≥50%. The patients in the Control group received sodium bicarbonate in dextrose and water plus N-acetylcysteine (NAC) at a high dose. The patients in the RenalGuard group were hydrated with normal saline using RenalGuard System in order to achieve an optimal urine flow of ≥300 mL/hr.

Although the study design meant that patients in the RenalGuard Group had a higher risk of CI-AKI than those in the Control group, patients who received RenalGuard Therapy® had a much lower rate of kidney injury. AKI occurred in 38.5% of the control patients and 4.5% of the RenalGuard patients (p=0.005). In the control group, 8% of patients developed stage 2 AKI and another 8% developed Stage 3 AKI. No RenalGuard patients developed Stage 2 or stage 3 AKI. The results were similar when cystatin C was evaluated (Control 42% AKI vs. RenalGuard 9% AKI). Pulmonary edema only occurred in one of the control group patients and was not reported in any patients treated using RenalGuard.

The paper is accompanied in the publication by "Thinking kidneys: the prognostic importance of renal function in patients undergoing structural cardiac interventions" written by Prof. Eugenia Nikolsky, M.D., Ph.D., Rambam Health Care Campus and the Technion, Israel Institute of Technology, Haifa, Israel. The editorial highlights the importance of preventing kidney injury, and cites the growing body of evidence demonstrating that the use of the RenalGuard has a protective effect on kidneys in patients with various degrees of CKD undergoing coronary interventions or TAVI. Prof. Nikolsy is a leading expert on CK-AKI, and a member of the team that developed the Mehran Risk score.

Prof. Nikolsky's editorial also cites an article published in the Journal of Thoracic Disease in 2015 which reported that the development of AKI triples the risk of one-year. Stage 3 AKI, which RenalGuard eliminated in both this study and Protect-TAVI, increased the risk of one-year mortality more than 6 times.

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.