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A novel bone implant with enhanced bone healing capacity

Periodic Reporting for period 1 - CERAMENT-BC (A novel bone implant with enhanced bone healing capacity)

Reporting period: 2016-09-01 to 2017-02-28

Today, the key challenge is to reduce the number of bone fractures that suffer from delayed bone healing, especially in case of fragility fractures and bone voids/gaps caused by trauma, disease or other pathological reasons, thus, the market for bone graft substitutes is experiencing a stable and constant growth. A significant window of opportunity lies in the development and commercialization of a bone implant which combines secure local drug delivery, optimal drug release rate and decreased resorption rate of the bone and the bone substitute, maximizing curative effect and improved quality of life for the patient. The launch of such a product can introduce a cost-efficient, personalized medicine approach in the treatment of patients with large residual bone voids following surgery or high risk patients with metabolic diseases creating high risk for non-union or mal-union of the bone structures (e.g. diabetes, osteoporosis).
BONESUPPORT has developed and patented the CERAMENT™ material platform allowing for development of synthetic bone substitutes that are injectable, mimic natural bone, provide short-term support for fractures and bone voids with rapid pain relief and stabilization, as well as long-term osteoconductive support that allows for new bone formation. BONESUPPORT has the knowledge and experience in developing and commercializing combined products as, its portfolio comprises two products containing antibiotics.
The aim of this Feasibility Study was to develop a business plan for a new type of bone implant with enhanced bone healing capacity. The idea is to combine BONESUPPORT’s bone substitute CERAMENT™ with a Bone Active Drug.
The preliminary research was with positive outcome but also showed that, for the business plan development, more fundamental work is needed, e.g. in the areas of supplier establishment, as well as more in-depth studies of the bone healing process by performing an additional animal study. In parallel, a patent freedom-to-operate (FTO) search was performed, as well as a Market Survey. The Regulatory aspects have been evaluated as an integrated part of the project.
The research performed in Phase 1 has provided some very promising results, suggesting that a strong potential for the development of a pioneer product in this area exists. Nevertheless, additional work is necessary to cover all aspects and prospective questions, before being able to present the final ‘Business Plan’.