ZyCal Bioceuticals Healthcare announces self-affirmed GRAS status for Cyplexinol

Cyplexinol is nature’s BMP-Complex for bone & joint health

 ZyCal Bioceuticals Healthcare, announced that its Cyplexinol bio-active protein-complex for bone and joint health has obtained self-affirmed GRAS (generally recognized as safe) status for use as an ingredient in food and dietary supplement applications. Under provisions of the Federal Food, Drug and Cosmetic Act, administered by the U.S. Food and Drug Administration (FDA), ZyCal’s Cyplexinol was submitted for an extensive review by a panel of experts to thoroughly examine all aspects of process and production.

After a comprehensive evaluation of toxicology data and research studies, the panel concluded that Cyplexinol is safe for use as an ingredient in a variety of products including dietary supplements, confections and nutritional bars. According to the FDA, self-affirmed GRAS status is awarded to any substance that is generally recognized among qualified experts as having been adequately shown to be safe under the conditions of its intended use and is manufactured in accordance with current good manufacturing practices, (cGMPs).

ZyCal began producing Cyplexinol in 2007 using a patented process that preserves the bioactivity of extracted proteins to activate stem cells and grow new bone and cartilage tissue. While the proteins have been used surgically for over 25 years, and are supported by 40 years of clinical research, Cyplexinol is the first oral supplement clinically proven to stimulate the stem cells, which are differentiated, or transformed, into osteoblasts and chondrocytes, thus growing new bone and cartilage tissue.

Additionally, the proteins in Cyplexinol have been shown to work inflammatory pathways, providing clinical response in seven days. Participants in clinical research studies have reported significant declines in pain and stiffness, and significant increases in quality of life when using products made with the Cyplexinol bio-active protein complex.¹

Reference

¹Garian, R. & Scaffidi, J. J. (April/May 2013) Evaluating Clinical Response and Activity of Cyplexinol (Ostinol) Osteoinductive Proteins  in Osteoarthritis of the Hip and Knee: A Randomized, Double Blind, Placebo-Controlled Trial. Integrative Medicine: A Clinician’s Journal, volume 12 (2) 18-24

Source: ZyCal Bioceuticals Healthcare