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

scores of 64.5 and 36.9 respectively. Considered to be the most important parameter within the ICRS II scoring system, the ICRS II Overall score assimilates all the parameters listed in the grading system to generate an overall assessment of tissue repair. Other statistically significant improvements were found in the assessments of Cell Morphology, Cell Viability and Superficial Zone morphology in the biopsies. Furthermore, Surface Architecture, collagen structure as observed by Polarized Light Microscopy, and repair tissue thickness measurements demonstrated improvement in favour of BST-CarGel. Macroscopic grading of the cartilage repair by the surgeon at the time of biopsy, which included the extent of lesion filling, tissue surface characteristics and integration with surrounding tissue, was also significant (p=0.016).

Dr. Kenneth Zaslav, an orthopaedic Key Opinion Leader from Richmond Virginia, was one of three independent experts who reviewed the data. He commented, "This randomized controlled study performed under good clinical practice guidelines is a well run study with robust data that will have an impact on scaffold directed cartilage repair in the coming years. I congratulate the Company on this early stage histological data and the rigor of the study design."

Dr. Matthew Shive, Chief Scientific Officer, added, "These compelling findings, particularly their statistical significance, provide a clear indication as to the positive effect of BST-CarGel in the treatment of cartilage lesions in the knee compared to the standard of care and affirm the value of BST-CarGel as a unique, single-stage product that has the potential to dramatically improve the outcome of cartilage repair procedures."

Analysis of other data for the primary endpoint of the trial, cartilage repair at 12 months, will be defined by the quantity and quality of the repaired tissue as measured by quantitative magnetic resonance imaging (MRI), and is still ongoing for
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SOURCE BioSyntech, Inc.
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