Established in 2017 with offices in the UK, USA and Taiwan, Biostone utilize a proprietary technology to create a new line of synthetic bone graft products to improve the clinical outcome and the life quality for the patient. Biostone received the US FDA 510K clearance for the first bone graft product, si-Mochi, in April 2021. In January 2023 Biostone also received the MDSAP certification with the standards and regulatory requirements of five different medical device markets including: Australia, Brazil, Canada, Japan, and the United States. Si-Mochi was created after years of academic and clinical research based on an ignored, but obvious nature of bone remodeling mechanisms. It’s unique porous structures not only accelerates osteoingrowth but also enables rapid integration with the host bone remodeling process providing an innovative and optimal solution for surgical bone graft procedures.
