BIOSYNTECH is Seeking European Market Approval, CE Marking, for its Products for Cartilage Repair - BST-CarGel, Chronic Wounds - BST-DermOn, and Heel Pain - BST-InPod.

Health/Medical Writers

LAVAL, Quebec--(BUSINESS WIRE)--May 1, 2003

BIOSYNTECH (OTCBB: BSYI), restated today its commitment to obtaining CE Marking registration for their cartilage repair product, BST-CarGel(R), their chronic wound dressing, BST-DermOn(TM) and BST-InPod(TM), an injectable therapy for heel pain. Towards this end, an independent regulatory consultant(1) was commissioned to confirm Biosyntech's ability to manufacture injectable medical devices in conformity to international regulatory standards, including those for North America. A full-scale audit of the Biosyntech quality system and production facilities was carried out followed by a gap analysis relative to international regulatory bodies. The audit and gap analysis scrutiny was at the level of EN460001/ISO13485. (ISO9001 specific requirements for medical devices manufacturing), EN554 (steam sterilisation) and cGMP (CFR21/FDA).

Based on this evaluation, in addition to product Technical Files containing non-clinical and clinical data, Biosyntech has initiated the process of obtaining CE marking for BST-CarGel(R), BST-DermOn(TM) and BST-InPod(TM), as medical devices. CE Marking approval will entitle Biosyntech to commercialize the three products in Europe. One key step in this process is a site audit performed by a European notified body, who has the authority to deliver the CE Marking. This audit has been scheduled to occur May 21-23, 2003.

About BioSyntech

BioSyntech Inc. is an ISO 9001:2000 certified, advanced biomaterials company specializing in tissue repair and in the delivery of therapeutic products. The Company's patented platform technology BST-Gel(R), is a multifunctional injectable thermo-sensitive and self-forming hydrogel that can be used for tissue repair or for targeted delivery of therapeutic agents. These biomaterials are biocompatible, biodegradable, muco-adhesive and provide significant advantages in specialized medical fields including, Tissue Engineering Orthopedics, Reconstructive Surgery Oncology, Rheumatology, Vaccines and many other therapeutic areas.

(1) Validapro (Laval, Quebec)

THIS PRESS RELEASE CONTAINS CERTAIN "FORWARD-LOOKING" STATEMENTS, AS DEFINED IN THE UNITED STATES PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 THAT INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES. THERE CAN BE NO ASSURANCE THAT SUCH STATEMENTS WILL PROVE TO BE ACCURATE AND THE ACTUAL RESULTS AND FUTURE EVENTS COULD DIFFER MATERIALLY FROM MANAGEMENT'S CURRENT EXPECTATIONS. SUCH FACTORS ARE DETAILED FROM TIME TO TIME IN THE COMPANY'S FILINGS WITH THE REGULATORY AUTHORITIES HAVING JURISDICTION.

NO REGULATORY AUTHORITY HAS APPROVED OR DISAPPROVED THE CONTENT OF THIS RELEASE.