BioSyntech Reports Positive Results from Pivotal Trial for BST-CarGel(R) Cartilage Repair Device



    LAVAL, QC, June 17 /CNW/ - 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 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 the Interim Analysis. Secondary endpoints of safety
and knee-related pain, stiffness and function as measured using the Western
Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire
are also being compiled for the Interim Analysis. All of this end point data
and analysis continues to form part of the ongoing Interim Analysis and
results are expected in the next few months.

    About the Canadian-European BST-CarGel trial

    The ongoing, randomized BST-CarGel pivotal trial compares the treatment
of cartilage lesions using BST-CarGel applied following microfracture to
treatment with microfracture alone as a control. The trial enrolled 80
patients aged 18 to 55 years of age with focal cartilage lesions less than 10
cm(2) located on the femoral condyles of the knee. Patients were further
stratified by their lesion type, either characterized as acute (i.e.
traumatic) or chronic (i.e. degenerative). The primary endpoint for this 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 are safety and knee-related pain, stiffness and
function as measured using the Western Ontario and McMaster Universities
(WOMAC) osteoarthritis index questionnaire. Results from this study are
intended to support marketing applications in Canada and Europe. A previous
interim analysis demonstrated the safety of BST-CarGel to be comparable to the
Microfracture control on the first 23 patients at 6 months.

    About BioSyntech

    BioSyntech is a medical device company specialized in the development,
manufacturing and commercialization of advanced biotherapeutic thermogels for
regenerative medicine (tissue repair) and therapeutic delivery. BioSyntech's
platform technology is a family of hydrogels called BST-Gel(R), some of which
are liquid at low temperature and solid at human body temperature. These gels
can be injected or applied to a specific local site and offer beneficial
properties for the local repair of damaged tissue such as cartilage, bone and
chronic wounds and provide the benefit of avoiding invasive surgery. For
additional information, visit www.biosyntech.com.

    Forward-Looking Statements

    This press release contains forward-looking statements and information
which are subject to material risks and uncertainties. Such statements are not
historical facts and are based on the current expectations of management. You
are cautioned that such statements are subject to a multitude of risks and
uncertainties that could cause actual results, future circumstances, or events
to differ materially from those projected in the forward-looking information.
These risks include, but are not limited to, those associated with our
capacity to finance our activities, the adequacy, timing, and results of our
clinical trials, the regulatory approval process, competition, securing and
maintaining corporate alliances, market acceptance of the Company's products,
the availability of government and insurance reimbursements for the Company's
products, the strength of intellectual property, the success of research and
development programs, reliance on subcontractors and key personnel, and other
risks and uncertainties detailed from time-to-time in our filings with the
Canadian securities commissions.

    Readers should not place undue reliance on the forward-looking
information, given that (i) our actual results could differ materially from a
conclusion, forecast or projection in the forward-looking information, and
(ii) certain material factors or assumptions which were applied in drawing a
conclusion or making a forecast or projection as reflected in the
forward-looking information, could prove to be inaccurate. Additional
information about (i) the material factors that could cause actual results to
differ materially from the conclusion, forecast or projection in the
forward-looking information, and (ii) the material factors or assumptions that
were applied in drawing a conclusion or making a forecast or projection as
reflected in the forward-looking information, is contained in the Company's
annual report and other documents filed from time to time with the Canadian
securities commissions which are available at www.sedar.com. These statements
speak only as of the date they are made, and we assume no obligation to revise
such statements as a result of any event, circumstance or otherwise, except in
accordance with law.

    %SEDAR: 00020217EF




For further information:

For further information: James Smith, The Equicom Group, (416) 815-0700
x229, Jsmith@equicomgroup.com

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