The objective of the OSTEOforUNION project is to develop and commercialise OSTEOGROW-C, an innovative biological drug for the treatment of bone fracture non-unions (FNU), one of the most significant unmet needs in orthopaedics. The project encompasses the implementation of a pivotal Phase III clinical trial (TRL 8), the scaling up and optimisation of the production process for the active ingredient rhBMP6, and comprehensive preparation for regulatory submission and marketing authorisation in both the European Union and the United States. In parallel, the project focuses on establishing go-to-market strategies and strategic partnerships to ensure successful commercial deployment.