BioSyntech Files ITA Application for Canadian BST-CarGel Trial

BioSyntech is seeking approval from Health Canada to begin a pivotal clinical trial for its cartilage repair device, BST-CarGel. 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, Medical Device Branch, to support the application for investigational testing authorization (ITA).

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