Important improvements in the clinical management of hemicraniectomy

Important results from the project

The objectives of the project have been met. During the project, OssDsign finalized the implant design which, with the help of results from the project, received regulatory approval in the US. In addition, the studies have increased the understanding of mechanisms behind bone formation linked to these implants. This knowledge will be used in the continued development of products, for cranial as well as other bone defects. The retrospective clinical study has met the goal of demonstrating that OSSDSIGN Cranial PSI is comparable or better than other available cranioplasty alternatives

Expected long term effects

The project has resulted in several publications that have been presented or will be presented at conferences or in scientific journals. A better understanding of the mechanisms behind the material´s influence on bone regeneration has been achieved. The results have also been used to obtain regulatory approvals and to strengthen the marketing of the implants. The results are expected to facilitate stable growth for the company, which will be an advantage for patients with cranial and facial bone defects, who can thus get a better treatment method.

Approach and implementation

The project ran for 3.5 years and was a collaboration between OssDsign, Uppsala University and ETH in Zurich. It had several subprojects, aiming at improving current methods for the evaluation and development of implants for large cranial bone defects. A cost-neutral extension of 6 months was requested since many analyses were more time-consuming than foreseen. The project was carried out in a satisfactory manner and all sub-goals have been delivered. Cooperation between industry and academia and across national borders has worked well thanks to frequent meetings and good planning.