Opening up markets by developing new formulation for osteoinductive biomaterial

Important results from the project

The project have developed a prototype formulation of a bone replacement material for spinal fusion . The formulation was evaluated in an established pre-clinical model for spinal fusion. The results from the study have provided valuable input for further optimization of formulation, handling and manufacturing method.

Expected long term effects

The prototype formulations developed for the preclinical model in rabbit for spinal fusion showed clear bone formation, but not to the extent that fusion could be detected after 6 or 12 weeks. The choice of shorter times and not mixing the material with bone or bone marrow aspirate was to challenge the formulation developed to see if spinal fusion could be detected at an early stage and without biological additives. The study identified a number of important factors, which in the future will contribute to the development of an optimised spinal fusion formulation.

Approach and implementation

The project was divided into four parts. The first two parts included the development and verification of a formulation according to the requirements specification that has been established. The third part included design validation by evaluating the formulation in a FDA accepted and established pre-clinical model to detect spinal fusion of in rabbits. The fourth part, which aimed to investigate the regulatory and market requirements has only been partially implemented, as further development of the formulation is needed before the next step for commercialization can begin.