SOURCE: RenalGuard Solutions, Inc.

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November 05, 2015 11:43 ET

RenalGuard® Data to Be Presented at Kidney Week, World's Premier Nephrology Conference

MILFORD, MA--(Marketwired - November 05, 2015) - RenalGuard Solutions™, Inc., an innovative renal protection company, today announced that Dr. Richard Solomon, Professor of Medicine and Director of Nephrology at the University of Vermont Medical Center, will be presenting a session titled "High Urine Flow System May Prevent CIN: Myth or Reality?" at Kidney Week, the American Society of Nephrology's annual conference in San Diego, CA. Dr. Solomon's talk 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 MYTHOS, REMEDIAL II, and AKIGUARD. He 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.

Dr. Solomon is one of the three Co-Primary Investigators on RenalGuard Solution's CIN-RG trial, an FDA-approved clinical trial designed to evaluate the effectiveness of RenalGuard Therapy® to reduce the incidence of contrast-induced acute kidney injury (CI-AKI) in at-risk patients. At last month's TCT conference in San Francisco, Dr. Roxana Mehran, also a Co-Primary investigator, announced that the interim analysis of the trial suggests that fewer than 430 patients will be required to complete the primary analysis, a significant reduction from the 652 patients the trial has been approved to enroll.

Kidney Week is the world's premier nephrology conference, drawing 13,000 attendees from around the world. It takes place November 3-8, 2015.

A previous presentation by Dr. Solomon to a group of CIN-RG investigators is available via the company's website at

http://www.renalguard.com/educational/renalguard-videos.

RenalGuard is currently available commercially in Europe. 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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