Soft bone cement for brittle bones
|Funding from Vinnova||SEK 1 010 000|
|Project duration||January 2018 - December 2018|
Purpose and goal
The project aimed to produce a new soft bone cement to improve fracture treatment for osteoporotic patients. We have achieved the goal and produced a product that is ready for patient studies. We have implemented a quality system that is currently being validated by our first customer, a European cement manufacturer, and the patient study is planned to start in 2019.
Expected results and effects
We will conduct a clinical study as a result of this project and the study is required for CE marking of this type of product. The project has already led to our first customer, a European cement manufacturer, who will co-finance the CE application and the commercialization of our product. We have signed a license agreement with them and they have placed a pre-order of 700 units. Future goals are to be on the market within 2 years and within 10 years see that the degree of treatment of vertebral fractures in Sweden has increased significantly and that the product is sold internationally.
Planned approach and implementation
The project was divided into 4 work packages: 1. Production and sterilization of product: carried out in automatic production line for easy upscaling 2. Implementation of quality system: implemented and being validated by the first customer 3. Stability study of sterile product: ongoing and currently the validated shelf-life of the product is 18 months 4. Planning of patient study: The important product requirements have been verified by surgeons both in Sweden and in Italy. A patient study is planned and is expected to start in 2019.