E!8237 Development of InsP6 bioactive medical devices for bone replacementimplantitis treatment

PHYTECH project aims at developing bioactive biomaterial surfaces through the coating of the titanium oxide layer of titanium implants or bone graft substitutes (BGS) with myo-inositol hexaphosphate (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. In this period the aim was to start (1) developing a manufacturing process capable of consistently producing InsP6 of the intended quality, (2) manufacturing and optimizing the coating of titanium implants with InsP6, (3)characterizing the physic-chemical properties and their biocompatibility in cell culture models.

Corticalis has developed and patented, as the only group in the world, loadable titanium dioxide bone graft substitute with compressive strength of 2.5 MPa. The following Norwegian invention was awarded a large EU project (E!5069 NewBone) worth 2.1 millio n Euro which is running from Feb 2010 until Jan 2013. This proposed project is a prolongation of that project and build on further innovative step of such bone graft substitute into third generation regeneration nano-structured biomaterials. In order to s uccess with the current project, interdisciplinary work between biochemistry, biotechnology and nano material science is crucial. The main objective is be develop a nano-structured surface which both enhances the mechanical strength of the bone graft to a bove 5 MPa and also provide anchorage bioactive molecules for enhanced bone response. Bone graft substitute with high strength would allow for use in high load bearing application, such as spine defects. Nano-modified materials would impose a paradigm shi ft in dentistry and orthopaedics, reducing the need for grafting procedures and cemented implants, maintain viability, and thus healing capacity, of the compromised bone, and prolong the lifespan of the implanted device. The size of the problem, both medi cal and financial, and the possible benefits of an actively integrating bone implant, predicts that research-based industrial development is one probable project outcome. There is an urge for new strategies that induce direct re-growth of lost or damaged bone. Proper regeneration of skeletal tissues is the only way to fully restore function in these structures. The techniques used in this study are novel and well documented approached developed by the applicant. BIOMAT has been successful in application d riven research and has in depth knowledge on which biomaterials are most suitable and which surfaces are most promising.