BioSyntech, Inc. (BSY.TO,BSYI.PK), a provider of bio therapeutic thermogels for tissue repair, Thursday announced plans to conduct an interim analysis on forty patients, who completed the 12-month, follow-up trial for its cartilage repair device, BST-CarGel-R for the treatment of cartilage lesions. The trial includes 80 patients aged between 18 years to 15 years., Results from the study are expected to support marketing applications in Canada and Europe. Final clinical results from the trial are expected in the first half of 2010.
BioSyntech said it would analyze the safety and effectiveness of the device on 40 patients and expects a good indication as to the performance of BST-CarGel-R in the treatment of cartilage lesions in the knee.
The ongoing, randomized BST-CarGel(R) pivotal trial compares the treatment of cartilage lesions using BST-CarGel(R) applied following microfracture to treatment with microfracture alone as a control.
In the clinical trail, patients would be categorized as acute or chronic according to the lesion they have. The primary endpoint of the trial is cartilage repair at 12 months, defined by the quantity and quality of the repaired tissue as measured with quantitative magnetic resonance imaging -MRI.
Secondary endpoints of the trial include safety and knee-related pain, stiffness and function as measured using the Western Ontario and McMaster Universities-WOMAC osteoarthritis index questionnaire.
BSY.TO closed Wednesday trading at $0.09 on a volume of 30k shares on the Toronto Stock Exchange.
BSYI.PK is currently trading at $0.02 or 22.22%.
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