SOURCE: RenalGuard Solutions, Inc.

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December 14, 2015 09:03 ET

RenalGuard to Be Featured in Two Sessions During Upcoming Innovations in Cardiovascular Interventions Conference in Tel Aviv

MILFORD, MA--(Marketwired - December 14, 2015) - RenalGuard Solutions™, Inc., an innovative renal protection company, today announced that two sessions at the upcoming Innovations in Cardiovascular Interventions (ICI) conference in Tel Aviv, Israel will feature RenalGuard. Dr. Marie-Claude Morice, Head of the Insitut Cardiovasculaire Paris Sud, will be presenting a session titled, "Renal Protection with RenalGuard System" on Monday, December 14th. Prof. Eugenia Nikolsky, Director of the Intermediate Cardiac Care Unit at Rambam Medical Center in Haifa, will present a talk titled, "Non-pharmacological Therapies to Prevent Kidney Injury in Patients Undergoing Contrast Exposure." Both sessions will review the data supporting the use of RenalGuard® to protect patients from acute kidney injury (AKI) following non-invasive cardiac interventions using contrast, including study data and results from the MYTHOS, REMEDIAL II, and AKIGUARD trials. Dr. Morice will also discuss the recently published PROTECT-TAVI study, which reported a significant reduction in post-procedural acute kidney injury (AKI) following transcatheter aortic valve replacement (TAVR) from 25.0% to 5.4% when using RenalGuard during the procedure, compared to standard therapy.

RenalGuard will be demonstrated at the congress by AMI Technologies, the Israeli distributor of RenalGuard. ICI convenes global thought leaders in the field of interventional cardiology for a robust conversation around the latest innovations in the field.

Dr. Morice has led or participated in a number of important cardiology studies throughout her career. In the field of AKI, she was part of a team that published "Renal Function-Based Contrast Dosing Predicts Acute Kidney Injury Following Transcatheter Aortic Valve Implantation, a significant paper evaluating the impact of AKI after TAVI. Their results showed a 15% incidence of AKI after TAVI. The cumulative 1-year mortality for the AKI group vs non AKI group was (47.9% vs. 15.7%, p < 0.001), indicating a more than three-fold increase in mortality for patients who develop AKI post-TAVI.

Prof. Nikolsky has long been a leader in the field of contrast-induced nephropathy. Among the more than twenty papers she has published in the field, Prof. Nikolsky was part of the team that developed a scoring tool to evaluate the risk of a patient developing contrast-induced AKI (CI-AKI). Their "Mehran Score" is still used around the world to help cardiologists identify patients at high-risk of CI-AKI.

RenalGuard is currently available commercially in Europe, Israel, and a number of other countries around the world. In the US, RenalGuard is limited to investigational use only. CIN-RG, the U.S. Pivotal Trial which evaluates the efficacy of RenalGuard Therapy and RenalGuard System compared to the current standard of care, is currently enrolling patients. 

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. The contrast dyes used in many cardiovascular diagnostic and interventional imaging procedures to facilitate the capture and display of x-ray images are known to be toxic to kidney cells. Approximately 10% to 20% of patients that undergo procedures using contrast are at-risk of developing Contrast-Induced Acute Kidney Injury (CI-AKI), which has been shown to lead to a higher need for dialysis and increased mortality. 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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