BioSyntech to conclude enrolment for pivotal BST-CarGel(R) trial in February 2009

    LAVAL, QC, Jan. 13 /CNW/ - BioSyntech, Inc. (TSX: BSY), a biotechnology
company developing biotherapeutic thermogels for regenerative medicine, today
announced that it will conclude enrolment next month for the Canadian-European
pivotal trial of its cartilage repair device, BST-CarGel(R). To date, the
Company has enrolled more than 70 subjects and participating clinical sites
will be permitted to enrol additional subjects until February 10th, 2009.
    "With the certainty provided by this date, we are now sure that the final
results from this pivotal trial will be available in the first quarter of
2010, once the last treated subject has completed their twelve-month follow up
period. Furthermore, we are confident that the current number of enrolled
subjects already represents a sufficiently powered study and that with this
data we can meet the overall objectives of the study," said Michel Lagueux,
Chairman of the Board of Directors. "At the same time, we remain sensitive to
the fact that there are eligible individuals who still want a chance to
participate in the study and we will work closely with our investigators over
the next four weeks to ensure that as many as possible can be enrolled."
    "I am very proud to be involved in the clinical development of this
important new therapy in what is the largest randomized clinical trial for
cartilage repair ever conducted in North America. Enrolment was certainly the
greatest challenge, given our adherence to strict subject eligibility
criteria, but in the end this rigour will ensure trial data of the highest
quality and integrity," said Dr. William Stanish, Professor of Surgery at
Dalhousie University in Halifax, Nova Scotia, and Principal Investigator for
the trial.
    Mr. Lagueux continued, "BioSyntech would like to acknowledge the team of
over 25 orthopaedic surgeons and their support staff for their sincere
dedication and perseverance in achieving this enrolment milestone."
    This randomized trial compares the treatment of cartilage lesions using
BST-CarGel(R) applied following microfracture to treatment with microfracture
alone. The trial is enrolling subjects aged 18 to 55 years of age with focal
cartilage lesions less than 10 cm2 located on the femoral condyles of the
knee. Subjects are 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 twelve 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.

    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

    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 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

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