BioSyntech Files Application for Investigational Testing Authorization 'ITA' for Canadian Multi-Center Clinical Trial for BST-CarGel'R'.LAVAL, Quebec -- BioSyntech, Inc (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension VENTURE:BSY.V) is seeking approval from Health Canada to begin a pivotal clinical trial for its cartilage repair device, BST-CarGel(R). Extensive documentation, encompassing product design and analysis of risk, 18 preclinical safety and efficacy studies, and clinical knowledge to date, was recently sent to Health Canada, Therapeutic Products Directorate Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. , Medical Device Branch, to support the application for Investigational Testing Authorization (ITA). Mr. Claude LeDuc, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , commented: "A major milestone has been reached today at BioSyntech.This submission represents the culmination of enormous efforts over the last 6 years by many people- efforts which have resulted in an off-the-shelf product optimized to meet both surgeon and market needs." The trial, a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. comparative multicenter study, aims to establish the ability of BST-CarGel(R) to repair damaged cartilage in the knee and subsequently improve associated pain and function. BioSyntech will add European sites under this clinical protocol with key opinion leaders. About BioSyntech - BioSyntech is a biotechnology company specializing in the discovery, development and manufacturing of innovative cost-effective and physician-friendly therapeutic thermogels for regenerative medicine and therapeutic delivery. BioSyntech's Quality Management System is registered to ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9001:2000 and ISO 13485:2001 standards. For additional information, visit www.biosyntech.com. NO REGULATORY AUTHORITY HAS APPROVED OR DISAPPROVED THE CONTENT OF THIS RELEASE. THE TSX VENTURE EXCHANGE TSX Venture Exchange Originally called the Canadian Venture Exchange (CDNX), this was a result of the merger of the Vancouver and Alberta stock exchanges. The goal of TSX Venture Exchange is to provide venture companies with effective access to capital while protecting investors. DOES NOT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE. BioSyntech Inc. (TSX VENTURE:BSY) |
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