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BioSyntech Reports Positive Results from Pivotal Trial for BST-CarGel(R) Cartilage Repair Device
Date:6/17/2009

LAVAL, QC, June 17 /PRNewswire-FirstCall/ - BioSyntech, Inc. (TSX: BSY), a biotechnology company developing biotherapeutic thermogels for regenerative medicine, today announced statistically significant results from an analysis of patients who completed their 12 month follow-up in the BST-CarGel(R) randomized clinical trial. Specifically, statistically significant evidence of improved repair tissue quality due to BST-CarGel treatment was found during analyses of tissues biopsied from the knees of 22 patients. The ongoing multicenter pivotal trial is evaluating the ability of BST-CarGel to repair cartilage lesions in the knee when applied to a microfractured lesion compared to microfracture alone (control) in 80 patients. Final results on all 80 patients are expected in the first half of 2010.

"We are excited by these positive results, which will be highly supportive in our ongoing discussions with potential orthopedic partners. Although we have not yet completed all facets of this Interim Analysis, we felt obligated to disclose these first histology results as biopsy data is considered the gold standard for assessment of cartilage repair," said Mr. Michel Lagueux, Chairman of the Board.

Using histological methods (i.e. analyses by microscope) to process and analyze the biopsied tissues from 13 BST-CarGel patients and 9 microfracture patients, and using third parties to perform the statistical analysis, statistically significant improvements were identified for critical tissue characteristics following BST-CarGel treatment compared to microfracture alone. In particular, after applying the International Cartilage Repair Society's (ICRS) histological scoring systems I and II to the biopsies in a blinded manner, several parameters were found to be statistically significant between treatment groups at p(less than)0.05. First, the Overall ICRS II score was significantly better for the BST-CarGel group than for the microfracture group (p=0.045), with
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SOURCE BioSyntech, Inc.
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