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

LAVAL, Quebec -- BIOSYNTECH (TSX Venture:BSY) -

...and with the LIO (Imaging and Orthopaedics Research Laboratory) for BST-Inpod(TM) 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(TM) and BST-InPod(TM) 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(TM) and BST-InPod(TM) 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(TM) is a spreadable therapy designed for the treatment of chronic wounds.Developed from the BST-Gel(R) 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(TM) 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(TM):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(TM) 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(TM) 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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BioSyntech Inc. (TSX VENTURE:BSY)