BioSyntech Inc.

BioSyntech Inc.

March 07, 2005 09:31 ET

BioSyntech Signs Agreement with MedQualis as BST-DermOn'TM' and BST-InPod'TM' Clinical Trial CRO...


NEWS RELEASE TRANSMITTED BY CCNMatthews

FOR: BIOSYNTECH INC.

TSX VENTURE SYMBOL: BSY

MARCH 7, 2005 - 09:31 ET

BioSyntech Signs Agreement with MedQualis as
BST-DermOn'TM' and BST-InPod'TM' Clinical Trial CRO...

LAVAL, QUEBEC--(CCNMatthews - March 7, 2005) - BIOSYNTECH (TSX
Venture:BSY) -

...and with the LIO (Imaging and Orthopaedics Research Laboratory) for
BST-Inpod™ Biomechanical Outcome Assessment

BIOSYNTECH (TSX Venture:BSY) is pleased to announce the appointment of
MedQualis, a contract research organization (CRO) to support BioSyntech
in their upcoming BST-DermOn™ and BST-InPod™ Canadian clinical
trials.

Following a comparative evaluation of CRO proposals, BioSyntech believes
that MedQualis' extensive experience in relevant therapeutic fields and
their focused network of clinical experts will become significant assets
in the regulatory filing process. It should also accelerate the
implementation of the protocols and support the timely completion of the
trials.

BioSyntech is glad to entrust the execution of these two key trials to
this capable partner. Clinical protocols have been drafted for both
studies. MedQualis will perform the study setup and protocol review,
monitoring, project management, data management, statistics and medical
writing for the BST-DermOn™ and BST-InPod™ clinical trials. They
will ensure that the protocols and the conduct of the studies adhere to
regulatory requirements and that the outcomes are acceptable by
regulatory agencies. Patient recruitment will start once the protocols
are finalized and regulatory approvals are obtained, which are expected
in May 2005.

BST-DermOn™ is a spreadable therapy designed for the treatment of
chronic wounds. Developed from the BST-Gel® platform technology, our
studies in animals have shown that it stimulates and supports the
intrinsic healing process of slow or non-healing wounds. BST-DermOn™
also acts as a barrier, sealing the wound and maintaining a moist
environment, while continuing to allow breathability. The trial will
evaluate the capability of the product to support the closure of chronic
wounds.

BST-InPod™: Heel pain is normally associated with atrophy of the
calcaneal fatty pads, the natural cushions in the heel that act as
shock-absorbers. BST-InPod™ is designed to replenish the natural
heel cushioning through an injection, and represents the first therapy
for heel pad thinning through restoration of their thickness and
cushioning properties. Each of the chemical components found within
BST-InPod™ is naturally occurring in the human body, and in addition
to being GRAS (Generally Regarded As Safe), they have a long clinical
history of safety as intravenous products available on the North
American and European markets. This trial will include heel pain
evaluation and objective outcome measurement. As such, we will evaluate
the biomechanical effect of the product on plantar pressure relief
through the use of sensitive pressure mapping insoles. This part of the
evaluation will be contracted to a leading academic center, the Imaging
and Orthopaedics Research Laboratory (LIO) at 'Ecole de technologie
superieure (ETS)' in Montreal. In addition, a US-based global
orthopaedic company has convened a scientific advisory board, and has
recently become involved in the preparation of this clinical trial.

About BioSyntech - BioSyntech is a biotechnology company specializing in
the discovery, development and manufacturing of innovative
cost-effective and physician-friendly biologic-implants for regenerative
medicine and therapeutic delivery. BioSyntech's Quality Management
System is registered to ISO 9001:2000 and ISO 13485:2001. For additional
information, visit www.biosyntech.com.

About MedQualis - MedQualis is a Clinical Research Consultant/CRO firm
located in Montreal Canada, providing a la carte clinical research
services to the pharmaceutical, biotech, medical device, Biologics, and
Natural Health Product industries. MedQualis is specialized in the
management and monitoring of small to medium sized clinical trials from
phase I to IV in North America. For additional information, visit
www.medqualis.com.

About the LIO - Located in the research centre of the Universite de
Montreal - affiliated hospital (CHUM), the Laboratoire de recherche en
imagerie et orthopedie (LIO), is a joint laboratory of Ecole de
technologie superieure (ETS) and Centre de recherche du Centre
hospitalier de l'Universite de Montreal (CRCHUM). The LIO is built
around a multidisciplinary team composed of about thirty professors,
health specialists, research associates and assistants. It has
positioned itself as a leader in the field of research in medical
imaging and biomedical engineering. For additional information, visit
www.etsmtl.ca/zone2/recherche/labo/lio/

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Contact Information

  • FOR FURTHER INFORMATION PLEASE CONTACT:
    BioSyntech, Inc.
    Claude LeDuc
    President & CEO
    (450) 686-2437