Biomedical Bonding - A paradigm shift in bone restoration surgeries
In order to fulfil the potential of the BoneFix technology we have assembled a renowned team of experts from across Europe with relevant background in chemistry, material science, bioengineering, cell biology, clinical evaluation, surgery and innovation.
The consortium is directed by Professor Michael Malkoch whose research team at the Department of Fibre and Polymer Technology, KTH Royal Institute of Technology will synthesize all the cutting edge chemicals that will power BoneFix.
The formulation and evaluation of the bone scaffold domain will be conducted by Professor Kamal Mustafa at the Tissue Engineering group, University of Bergen.
Professor David Eglin at MINES St Étienne will lead the biological evaluations of the BoneFix domains and the development of an origami membrane for use in the adhesive fixation patch. Dr Peter Varga at AO Research Institute Davos will perform the mechanical assessment of the developed BoneFix technology. Preclinical evaluations of BoneFix will be led by Dr. Christian Wong at the Department of Orthopaedics, Hvidovre University Hospital.
An evaluation on the pain response caused by BoneFix compared to metal fixators will be conducted by Professor Camilla Svensson at the Department of Physiology and Pharmacology, Karolinska Institute. Finally, the exploitation of BoneFix will be ensured by the involvement of Biomedical Bonding AB, a cutting edge SME focusing on bringing adhesive based fracture fixation technology to market.
The interplay between all of these partners will ensure that the objectives of the BoneFix project are met, resulting in the creation of a radically new biomedical technology which will overcome the numerous setbacks of the current metal based fixation technology and supplant it as the new SoC.
Background
BoneFix is a new adhesive based bone fixation and restoration technology which aims to supplant metal fixators and transplants as the gold standard in fracture fixation and reconstruction. BoneFix will provide surgeons will unparalleled freedom-to-operate, by allowing them to tailor-make biocompatible, biodegradable and antibacterial Bone Restoration Patches (BRPs) on the individual fracture. With BoneFix we aim to expand the scope of Open Reduction Internal Fixation (ORIF) procedures, while also minimizing the suffering and infection risk for patients.
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As the age of Europe’s population rapidly rises so do the socioeconomic costs of bone fractures. According to the WHO, the total number of osteoporosis-related fractures in EU patients will rise to 4.5 million in 2025, which translates to 8.5 incidents per minute. Bone fractures can occur throughout our daily lives and can be severely debilitating if treated incorrectly. A plaster cast may suffice for simple fractures, however complex fractures require surgical intervention and ORIF. The standard-of-care (SoC) involves fixation of the fracture with metal screws and plates, after which the bone regenerates and heals over a period of 3-6 months. Unfortunately, these rigid metal fixators are often unsuitable for use on small, thin, irregular or multi-fragmented bone and their need for open surgery under general anesthesia and drilling into the bone limits their use depending on the patients’ age and health and the incidence of osteoporosis. Their incompatibility with the surrounding tissue can create post-surgical problems, such as stress shielding, which weakens the healed bone, and soft-tissue adhesions, which may necessitate re-operations and removal of the implant.
The reoperation rate when SoC metal plates are used to treat phalangeal and metacarpal fractures, which account for 9.6% of all fractures, is as high as 40%. Infection of the fracture site is also a concern, as all surgeries carry a 2 to 5% chance of a surgical site infection (SSI). Additionally, reconstruction of the fracture site may be required prior to fixation if it exhibits large detects and voids; an issue that annually affects more than two million patients worldwide. Autologous bone transplants are considered the gold standard for reconstructing bone, however they require additional surgeries and therefore induce higher costs, longer rehabilitation periods, and an increased chance of infections.
BoneFix aims to overcome the substantial issues of SoC ORIF procedures by providing surgeons with an adhesive based fixation and restoration solution for fractures which will heal, fixate and protect complex fractures; making metal screws, plates and open surgery obsolete.
