RenalGuard Solutions raised $14.5 million in a Series A round. The funds will support the pivotal trial of a device that protects the kidneys from harm caused by contrast dyes used in many cardiovascular procedures.
In some cases, the contrast agents used in diagnostic and interventional procedures, including CT scans and angiograms, may lead to contrast-induced nephropathy (CIN). While rare and reversible, the disorder can be serious—it is associated with a severe decline in kidney function over 48 to 72 hours, according to the National Kidney Foundation. The risk of developing CIN rises for people with diabetes, a history of heart and blood diseases and chronic kidney disease.
The RenalGuard System includes a console and components for infusion and urine collection. It is designed to protect the kidneys by increasing urine output and quickly flushing out contrast agents before they can do too much damage.
The device is CE-marked for the replacement of urine output by an infusion of sterile replacement solution for up to 14 days.
The company will use the new funds to expand its sales and marketing in Europe as well as to bankroll the U.S. pivotal trial of the device, said Ethan Benovitz, RenalGuard chairman, in a statement. The company hopes to receive FDA premarket approval next year.
Exigent Capital led the round, with participation from existing backer Genesis Capital Advisors and other private equity investors.
"Acute kidney injury (AKI) caused by cardiac interventional procedures is a serious and costly health care problem that is not currently remedied by any viable solution," said Alan Adler of Exigent Capital, who joined RenalGuard’s board, in the statement. "After spending much time extensively reviewing the published clinical data related to RenalGuard therapy and speaking with leading clinical practitioners who have become dedicated users of this technology, I am convinced that RenalGuard has the potential to become the standard-of-care for significantly reducing the incidence of AKI in the huge number of patients undergoing these procedures.”