Project: Development of InsP6 bioactive medical devices for bone replacement
Loss of skeletal tissue integrity and function is a major health problem for today’s ageing European population. It is estimated that around 90% of the European population at some time will experience hard tissue related conditions that require treatment. This figure is expected to increase in the future as the older age groups, which are most affected, is forming an increasing proportion of the population. Bones can become weak and fracture as a result of trauma or disease or both. Major bone fractures (hip, vertebrae, femur) are a major cause for hospitalization, high morbidity, including permanent disability, and significant mortality in today’s ageing population, and especially in Europe. Despite the fact that advances in surgical and therapeutic medicine and medical devices have greatly enhanced, limitations in the risk/benefit balance of current approaches leave much room for improvement. The costs related to hard tissue treatment are substantial, as they frequently involve hospitalization and surgical intervention, often with insertion of temporary implants or permanent replacements, with an annual European spending of e.g. €25 billion on treatment of orofacial hard tissues and €5 billion on revision of failing hip implants. _x000D__x000D_The purpose of the project is to provide the scientific and technological basis to develop new innovative biomaterials, especially bone graft substitutes (BGS) and dental implants, for repair and re-growth of viable skeletal tissues. In particular, we aim to develop bioactive biomaterial surfaces through the coating of the titanium oxide layer of titanium implants or BGS by InsP6 to enhance their osseointegration and to reduce the healing time, improving their performance in patients with reduced bone volume and quality as well as and in patients with impaired bone healing. An effective solution which provides extended, productive, quality lifespan, will allow the creation of economic value through access to large international markets and simultaneously will reduce costs for the public sector._x000D__x000D_The basis of this development will be the technology of covalent binding of myo-inositol hexaphosphate (InsP6) that has been developed by the NUMAT and SANIFIT Ps on different metal surfaces (with the patent application EP11382404.9, priority date 26.12.2011, “Biocompatible implant, covering all the CO innovation points, and which has now been extended with a PCT, PCT/EP2012/076906 and priority date 26.12.2012). CORTICALIS has developed cost effective synthetic bone grafts substitutes out of biocompatible and bone-friendly material that are ten times stronger than market competitors, and has one granted patent (metal oxide scaffolds, US 2010/0016989 A1) and filed three more patent application on invention related to this BGS. The project is highly interdisciplinary and can only be achieved by integrating expertise, experience and technical skills in the fields of materials science, cell biology, molecular biology, bio-nanotechnology, surgery and industrial development of medical devices. Through the co-operation between three biotechnology SMEs, and the subcontractors (UIB, HAR, ALM, ASP), the project will be of importance both for further development of medical devices and for the competitiveness of the European sector by providing a scientific basis for new therapeutics. _x000D__x000D_The PHYTECH project has the following verifiable objectives:_x000D_1. To compile a full profile for InsP6 as pharmaceutical active ingredient in terms of quality, safety and efficacy._x000D_2. To develop and characterize titanium implants and bone graft substitutes coated with InsP6, with the aim to generate new permanent implants and scaffolds which stimulate osseointegration._x000D_3. To develop in vitro and in vivo studies with the developed coated biomaterials with the aim to demonstrate that the prototype stimulates osseointegration._x000D_4. To bring at least one prototype to human randomized clinical trials._x000D_5. To gain commercial value and financial strength for the participating SMEs by means of IPR / prototype out-licensing to the large international companies to finish development and start market registration and commercialization._x000D_6. To protect the intellectual property of the project, by registering new patents on the acquired know-how and COtaining the already registered IP.
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Acronym
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PHYTECH
(Reference Number: 8237)
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Duration
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01/01/2014 - 31/05/2016
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Project Topic
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The PHYTECH project aims to develop a surface (optimized for implants and for synthetic bone graft substitutes) that actively improves osseointegration, which is suitable for use in patients with reduced bone volume and quality as well as and in patients with impaired bone healing.
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Network
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Eurostars
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Call
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Eurostars Cut-Off 10
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Project partner
