GAINESVILLE, Fla.--(BUSINESS WIRE)--Nephure™, an oxalate degrading enzyme manufactured by Captozyme, has received self-affirmed GRAS (Generally Recognized as Safe) notification by an independent panel of experts through scientific procedure following stringent US Food and Drug Administration (FDA) safety criteria. The independent panel evaluated a comprehensive dossier of characterization data and safety studies and concluded that Nephure is safe for use as a food ingredient.
“Our dedication to safe products and robust scientific data is confirmed in this conclusion by the independent expert panel,” said Helena Cowley, CEO of Captozyme Inc. “Nephure is a break-through product for those struggling on a low-oxalate diet and we are so excited to offer a change to the betterment of people’s lives,” she continues.
A growing number of people are recommended a low-oxalate diet for kidney health following kidney stone episodes. The Nephure Oxalate-Reducing Enzyme reduces exposure to oxalate in the diet and can make life easier when on a low-oxalate diet. Behind Nephure lies close to eight years of best practices research and development, partly funded through grants from the National Institute of Health. The enzyme has been shown to significantly reduce urinary oxalate in their preclinical trials and the company plans to move into clinical studies with the enzyme in the coming year.
Nephure is expected for market release in the 3rd QTR of this year.
About Captozyme, Inc.
Captozyme, Inc. is a biotechnology company developing enzymes and formulations to advance knowledge in the area of gut health and through our products advance the health and wellness of people. The company outsource manufacturing of Nephure to audited cGMP plants in Europe and the U.S., with plans to extend the product line around their IP-protected oxalate-degrading enzyme. Captozyme Inc., also house internally a fully equipped laboratory for research around gut health, with plans for a manufacturing facility with focus on probiotic development. The company is based in Gainesville, Florida. Learn more about Nephure by visiting www.nephure.com.