An injectable ready-to-use polysaccharide-based scaffold combined with hydroxyapatite tailored for oral bone defect reconstruction to be developed for 2 different indications
Bone defects in the orofacial region are mainly due to inflammatory diseases and induce significant damage to the structures in the facial area, leading to visible deformity and dysfunction, usually associated with compromised quality of life of the patients. As an alternative to the currently used calcium phosphate-based materials, which have their disadvantages with regard to resorption and bone regeneration, TBMED partners INSERM and SILAB/Siltiss developed Glycobone®, a material based on natural polysaccharides, which has shown osteoinduction properties (i.e. bone formation) on top of good osteoconduction properties.
In parallel, Glycobone® is under evaluation for a second application, i.e. alveolar reconstruction with a membrane-assisted surgical technique.
Development in TBMED using potential OITB services
Clinical investigations will be the main focus with regard to Glycobone® in TBMED. This includes the preparation of the Investigational Medical Device Dossier (IMDD) with all regulatory documents to demonstrate clinical suitability. In addition, bench marking analysis will be conducted to complete the feasibility studies prior to CE marking.
Glycobone® for alveolar reconstruction foresees the application of the QbD approach to the manufacturing of the Glycobone-based membrane under GMP guidelines and in accordance with standard ISO 13485. Clinical Proof of Concept (CPoC) will be carried out to validate the MD prototypes in the project.