BioSyntech announces positive preliminary interim data for BST-CarGel® clinical trial
BioSyntech, Inc. (“BioSyntech” or “the Company”) (TSX: BSY), a biotechnology company developing novel products in regenerative medicine, today announced it has received positive preliminary results from a prospectively planned six-month interim analysis of its Canadian-European pivotal clinical trial for BST-CarGel®. Results drawn from a 20 subject subset of the trial indicate evidence of a positive effect of BST-CarGel®treatment on cartilage structure when compared to the surgical control. The interim analysis also showed the safety of BST-CarGel® to be comparable to the control. The sole purpose of this interim analysis was to obtain pilot data for submission to the U.S. Food and Drug Administration (FDA) as a pilot study in support of an Investigational Device Exemption (IDE) for a U.S. pivotal trial for this medical device.