MILFORD, MA--(Marketwired - January 26, 2017) -
- Over 15,000 Patients Treated Worldwide; Data Published from Over 1,500 patients Enrolled in International Clinical Studies
- Distribution and Sales Growing in Europe, Middle East and South Africa
- US Pivotal Trial Poised for Study Completion by End of 2017
Growing evidence from real-world use and published clinical studies detailing results on more than 1,500 patients supports the efficacy of RenalGuard Therapy® to protect at-risk patients undergoing cardiac and vascular imaging procedures from acute kidney injury, announced RenalGuard Solutions, Inc. The company said that as of the end of 2016, over 15,000 patients had been treated worldwide using RenalGuard, and study data from more than 1,500 clinical trial participants had been featured prominently at multiple international clinical meetings and in publications on coronary interventions.
RenalGuard Therapy is designed to reduce the toxic effects that contrast media can have on the kidneys for patients undergoing imaging procedures. This therapy is based on the theory that creating and steadily maintaining a high urine output allows the body to rapidly eliminate such agents, reducing their toxic effects.
"Recognition is growing rapidly in Europe, the Middle East and South Africa of the value that RenalGuard offers for improving renal protection from clinically important but potentially toxic coronary contrast agents," said Andrew Halpert, RenalGuard Solutions President. "During 2016, we grew our sales team in France and Germany, where our company handles sales directly, and secured our first orders from or signed agreements with new distributors in Scandinavia, the Netherlands, Saudi Arabia, Bahrain, South Africa, the United Arab Emirates and Poland. In the United States, enrollment in our pivotal trial is on track to complete by the end of 2017."
"While we remain focused on the use of RenalGuard in the cardiac catheterization laboratory," Mr. Halpert continued, "a number of investigator-sponsored studies are providing early evidence that supports its value as a platform technology to improve renal protection in other clinical indications."
Most recently, an article in the International Journal of Nephrology detailed the results of a study on the use of automated fluid management with RenalGuard to prevent acute kidney injury (AKI) versus manual fluid management in critically ill patients with rhabdomyolysis. The article, Automated Fluid Management for Treatment of Rhabdomyolysis, reports that the use of RenalGuard resulted in a higher urine output more quickly with these patients, with no adverse outcomes. Another investigator in France recently reported on the feasibility of RenalGuard in patients' post-kidney transplant.
About RenalGuard Therapy®
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. A number of studies 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.