Feasibility study of a novel calcium phosphate-based composition for orthopaedic device applications

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SIRAKOSS developed and manufacture a novel calcium phosphate-based bone graft substitute for use in spinal and trauma surgery and the first product was recently CE-marked. This material has shown excellent performance in pre-clinical models of these surgeries but the nature of this material has a disadvantage in that it cannot be processed using high temperatures (\>1000°C) that traditional calcium phosphate materials can be. This means it cannot be sintered to form a macroporous ceramic, so can't utilise 3D printing approaches to manufacture complex/custom implant designs, and it cannot be coated onto medical devices using industry standard approaches. We have identified a process to modify our existing technology to produce a new composition that initial studies have shown is thermally stable at the high temperatures required to manufacture such ceramics and coatings. This project aims to characterise fully this new composition, test its ability to be formed into a macroporous ceramic, and screen these samples in a pre-clinical study to evaluate the bone healing response. This proof of concept would allow SIRAKOSS to be able to develop new products in the future that utilise this new formulation, which could include customised implants utilised 3D printing and bioactive coatings in spinal cages and other orthopaedic medical devices.