Our lead product, RenalGuardŽ, is designed to rapidly remove contrast dyes that are known to be toxic to the kidneys. Contrast dyes are used in many cardiovascular diagnostic and interventional imaging procedures to facilitate the capture and display of x-ray images. Approximately 10% to 20% of patients that undergo these procedures are at-risk of developing Contrast-Induced Nephropathy (CIN), a form of acute kidney injury resulting from toxic contrast dye. RenalGuard is CE-marked and is being sold in Europe and certain countries around the world. Two investigator-sponsored European studies have demonstrated RenalGuard's effectiveness at preventing CIN. The CIN-RG pivotal study is underway in the U.S. to support a planned Premarket Approval (PMA) filing with the U.S. Food and Drug Administration.
RenalGuardŽ is a closed loop system designed to minimize the risk of over- or under-hydration while maintaining the high urine flows recommended for the prevention of CIN.