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.
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.
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.
Professor Michael Malkoch
Michael Malkoch is professor in Functional Organic Nanomaterials. In 2003, he obtained his PhD in dendrimer chemistry from the department of Polymer Technology at KTH Royal Institute of Technology, Sweden. Shortly after, he joined Professor Craig J. Hawker, between 2003-2005, as a postdoctoral fellow at Stanford University, IBM Almaden Research Center and the Materials Research Laboratory in Santa Barbara (UCSB).
He has been awarded two distinguished fellowships from Swedish Research Council: Assistant Professor (VR-FOASS) in materials science and VR-senior research position (VR-Rådsforskare) in the field biomedical engineering. He is also selected as KAW Academy Fellow (2013 and 2018) in Engineering Science.
The Malkoch research group focuses on five main areas:
1) identifying novel and sustainable concepts to highly complex and functional macromolecules,
2) construction of precision dendritic drug delivery systems with emphasis on cancer.
3) fabrication of programmable networks with antibacterial properties to overcome current antibiotic resistance.
4) development of next generation biomaterials and methodologies for fixation and regeneration of damaged tissue and
5) polymer-based manipulations of generic surfaces towards sensitive biosensor applications.
His research portfolio is based on 25 years of collected experience from several universities and is reflected by over 100 internationally peer-reviewed publications excluding conference contributions. The interdisciplinary nature of the group research has allowed for publishing in high impact journals such as Advanced Materials, Advanced Functional Materials, Angewandte Chemie, JACS etc.
Dr. Peter Varga
Dr Peter Varga is the leader of the Biomechanics and Modelling focus area of the Biomedical Development Program at ARI and faculty Member of the Biomedical Engineering Master Program of the University of Bern.
Dr Varga obtained his PhD in bone biomechanics from the Technical University of Vienna. This work has been recognised with the "Award of Excellence 2010" of the Austrian Federal Minister for Science and Research. Prior to his position at ARI, Dr Varga had a postdoctoral fellowship at the Technical University of Vienna and a PI position at the Julius Wolff Institute at the Charité UM Berlin.
His research is focused on the biomechanical behaviour and failure of bone and bone-implant constructs and the computer simulation thereof. He currently serves as an academic editor for BioMed Research International.
Dr Varga has >62 peer-reviewed publications (H-index: 24), a book chapter and one patent. His current research interests are primarily focused on the biomechanical behaviour and failure of bone and bone-implant constructs and the computer simulation thereof.
This expertise will be employed to test the mechanical stability of the novel fracture fixation approach developed within the BoneFix project.
Website of the research group:
Professor Camilla Svensson
Professor Camilla Svensson is since 2008 a principal investigator and group leader at the Department of Physiology and Pharmacology and Center for Molecular Medicine at Karolinska Institutet in Sweden. She has extensive experience from research in the pain/rheumatology interface and her research focuses on molecular and cellular mechanisms underlying persistent pain in conditions with autoimmune and bone-related pathologies. Professor Svensson’s laboratory combines neuroscience, pharmacology, and immunology with an emphasis on translational research and the team is engaged in several collaborations with clinical researcher and engineering groups, with the goal to bring basic research findings from the lab bench to clinical and commercial applications. Professor Svensson’s research is funded by both the Swedish and European Research councils, the Knut and Allice Wallenberg Foundation, the family Lundblad Foundation and the Swedish Foundation for Strategic Research.
Professor Svensson served as a member and the president of the Young Academy of Sweden. Currently she serves on the executive board of the Department of Physiology and Pharmacology at the Karolinska Institutet, she is member of the board for the Scandinavian Association for the Study of Pain, an associate editor for the Scandinavian Journal of Pain and she serves on scientific advisory boards for several companies. She received her PhD in Molecular Pathology from University of California, San Diego in the US in 2005, where she also undertook three years postdoctoral training in rheumatology. Since she established her laboratory at the Karolinska Institutet in Stockholm she has received several prestigious awards and grants, including the Early Career Award from the International Association for the Study of Pain and the Future Research Leader grant from Swedish Foundation for Strategic Research. She is a Ragnar Söderberg Fellow in Medicine and a Wallenberg Academy Scholar.
Karolinska Institutet/Professor/Camilla Svensson/Molecular Pain group/https://www.cmm.ki.se/camilla-svensson-grupp
Lena Söderström is on the board of Biomedical Bonding. She has a Bachelor of Medical Science and an Executive MBA from Uppsala University. Lena has thirty years of experience in management positions from international pharmaceutical companies and the medical device industry. Her broad range of experience includes positions with people and project management, business development, international marketing and manufacturing. She has been CEO of Senzime, Isconova and Kibion and she is a member of the board of Uppsala University Invest AB, Dicot AB, Agricam AB and the Stockholm Chamber of Commerce. Lena is also the chairman of the board for SLU Holding and Inficure Bio AB.
Dr. Daniel Hutchinson
Dr Daniel Hutchinson is acting as project coordinator and manager for the BoneFix project. He is also a senior researcher in the Malkoch group in the Department of Fibre and Polymer Technology, KTH Royal Institute of Technology in Stockholm, Sweden.
Dr Hutchinson has worked as a postdoc in the Malkoch group since 2018, focusing on the development of light-curable adhesives for use in bone fracture fixation. He has been involved in all aspects of the adhesive development, from monomer synthesis, to testing the adhesive’s mechanical properties, to the ex vivo and in vivo evaluation of the fixation properties of the adhesive on bone fractures. In the BoneFix project he will be supervising the synthesis of monomers and polymers for use in the bone substitution and adhesive fixation patch domains of the bone restoration patch.
Before joining the Malkoch group, Dr Hutchinson primarily worked on synthesising responsive, metal-coordinating molecular strands and studying the conformation of their metal complexes. In 2013, he graduated with a PhD from the University of Otago, New Zealand, where he created polymer gels whose swelling was controlled by the metal-induced conformational changes of the molecular strands built into the gel network. Before moving to Sweden, he worked as a postdoctoral fellow of the Alexander von Humboldt foundation at the University of Leipzig, Germany, where he focused on the synthesis of versatile heterobimetallic complexes for catalysis
Professor David Eglin
David Eglin is Professor of Biomaterials Science and Engeneering at the Center for Biomedical and Healthcare Engineering, at Mines Saint Etienne, France since 2020. He holds the chair of Translational Biomaterials Research in Orthopedics at the University of Twente, The Netherlands, since June 2019.
He has extensive expertise in the synthesis and processing of responsive materials based on biopolymers such as hyaluronic acid and collagen. He designs, syntheses, and characterizes biopolymers derivatives and composites with endowed stimuli responsive behavior. He develops processes for the delivery of biologics and drugs, and for the creation of microenvironments to control cell behavior. His group is notably developing additive manufacturing and biofabrication processes for both basic understanding of biomaterials and cells interaction, and for translational research in the orthopedic field.
In 2011, Prof Eglin was given the Jean Leray award by the European Society for Biomaterials for outstanding research contributions to the field of biomaterials. He has published over 150 peer-reviewed articles and book chapters, as well as eight patents. He has just completed his term as president of the Swiss Society of Biomaterials and Regenerative Medicine and is the current treasurer of the European Chapter of the Tissue Engineering and Regenerative Medicine International Society.
Center for Biomedical and Healthcare Engineering (CIS)
Dr. Christian Wong
Biosketch - Christian Wong Christian Wong is a full-time consultant at the children's section, Hvidovre Hospital, Copenhagen. He became a medical doctor in 1995, received a PhD study degree in 2001, and became an orthopedic surgery specialist in 2006.
After working with general fracture and prosthesis surgery, he joined the pediatric orthopedic section at Hvidovre hospital in 2010. Here, he worked in a highly specialized function with children with cerebral palsy (CP). He became a consultant in 2013 with special interest in surgical treatment of children with CP. In the course of the last 3-4 years, he discovered an overlooked important and insufficiently treated problem for these children, namely pain, which is central for quality of life for these children.
This has not been addressed adequately either nationally or internationally. He has set up a small research group with special interest in aspects of pain and improved, novel surgery for these children. He is chairman and member in the Danish and European pediatric orthopedic research society, respectively. He is member of the specialist council innational patient organisation 'CP Danmark', and national and regional board for the national database for children with CP, CPOP.
He has supervised two PhD students, multiple for clinical interns, medical and engineering students in research projects. At conferences, he has had > 50 oral and poster presentations, and has held eight formally invited international and national lectures.
He is now supervising 3 PhD students and also has 1 full time researcher.
Total number of peer-reviewed publications 33. Number of first authorships 14. Number of corresponding authorships 14. Number of citations 698. H-index 10. Book chapters 3.
He has received larger grants (>~500.000 dkk) from the Lundbeck foundation, the Jascha foundation, the ELSASS foundation, and the EC grants of Eurostars, Horizon 2020 - Marie Curie and Horizon 2020 -EIC-FETPROACT-2019.
Professor Kamal Mustafa
Professor Kamal Mustafa is the Head of the Tissue Engineering Group and the Leader of the Research Laboratory at the Department of Clinical Dentistry, Faculty of Medicine, University of Bergen in Norway since 2010. He has extensive management experience from life science and participation and coordination of European projects. Prof. Mustafa’s main research activities were incorporated in the large EU projects financed by the FP7 and H2020 and several projects financed by national funding agencies. He is currently leading and sponsoring a multicenter clinical trial to reconstruct alveolar bone using stem cells and biomaterials, which is among few trials in Europe using advanced cell therapy.
His laboratory combines chemistry, biology, engineering with medicine to bring basic research findings from the lab bench to the clinic and commercial applications. He is one of the founders of Bergen Stem Cell Consortium and a committee member of the Research Council Board at the The Department of Clinical Dentistry. He received his PhD from Karolinska Institutet, Stockholm, Sweden in 2001. Prof. Mustafa was a post-doc at Karolinska Institute (Sweden) and associate professor at University of Bergen as well as visiting scientist in NIOM, Scandinavian Institute of Dental Materials, Oslo and University of North Carolina, Chapel Hill, USA and visiting professor in University of Malmo, Sweden. During the last 5 years, his research increasingly focused on the development of toolbox for bone regeneration according to the concept of tissue engineering. He is a frequently invited speaker at international events and has published >200 scientific papers.