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Research by Professor Joost de Bruijn and team at QMUL from 2004 was critical to demonstrating the efficacy and commercial viability of a novel Instructive Bone Graft (IBG) product, AttraXTM. The technology, commercialised via the spin-out business Progentix Orthobiology BV (founded in 2007) was sufficiently mature by 2008 to attract series A investment of €1 million series A financing by BioGeneration Ventures. The development of AttraXTM has led to a trade sale totalling up to US$ 80 million to the global top 5 spine company NuVasive Inc. in 2009. In 2011 an exclusive distribution deal with a global top 3 dental company was signed for use of the technology in the field of dentistry and craniomaxillofacial surgery. After regulatory approval of AttraXTM in Europe (CE mark), the product was commercialised in 2011 and has been used successfully in more than eleven thousand patients (as of 2013Q3) with global reach (including EU, US, Australia, New Zealand and Brazil). Within 1 year of commercialisation, a 1.1% share of the estimated US$2 billion global spinal bone graft market has been achieved. This research has seen an economical benefit in terms of newly formed jobs from 2 FTE in 2008 to 25 FTE in 2013 at Progentix Orthobiology BV.
Bone cement is widely used in joint replacement surgery, both for implant fixation and to enhance screw fixation in osteoporotic bone. Specific impacts include the development of two new orthopaedic cement systems by Summit Medical (Gloucester), also enabling that firm to obtain product approval and achieve significant new penetration of UK and international markets (UK bowl 70%; UK syringe 35%; US overall 15% — translating to total global sales 2009-2012 of £36M: 2012 = £9M).
Research outcomes have also impacted as a key element in the bid by Stryker Orthopaedics to obtain EU clinical approval and undertake US submission (ongoing) of injectable cements for augmenting bone screw fixation. Approval enabled the firm to establish Hydroset as a mainstream product with a cumulative total income of $180M since 2008 (income 2012 = $32M). The reach of these impacts also extends to improved clinical outcomes, resulting in improved quality of life and reduced healthcare costs.
NovaBone® (NovaBone Products LLC) is a synthetic bone graft. It is a Bioglass® (a specific composition of bioactive glass) powder that orthopaedic surgeons use to regenerate (heal) bone defects (holes in bone). Research by Larry Hench, Julia Polak and their student Ioannis Xynos, that was published in 2001, showed that the dissolution products of the glass particles stimulated bone cells to produce new bone. This gave NovaBone a competitive edge over all other synthetic bone grafts at the time. Due to the data, NovaBone coined the term Osteostimulation, which describes this property. The Federal Drug Agency in the USA (FDA) allowed the claim, which led to a 20% increase in sales for NovaBone.
GlaxoSmithKline (GSK) released a new toothpaste in 2011, Sensodyne Repair and Protect and in the first 16 weeks attracted a 2.7% (£10M) market share. The active ingredient is Bioglass (NovaMin®). The fundamental research was carried out in the Department beginning with the work of Larry Hench and Julian Jones in 1999. They reported the effect of glass particle size on active ion release. 57% of people suffer from hypersensitivity (tooth pain) caused by fluid flow into exposed tubules in dentin that lead to nerve endings. When teeth are brushed with toothpaste containing NovaMin®, the particles bind to the dentine, where they dissolve and produce mineral with similar composition to enamel, which occludes the tubules. GSK developed a new toothpaste based on this research — Sensodyne Repair and Protect. Sensodyne delivered remarkable growth of 14% driven largely by the successful rollout of Sensodyne Repair and Protect.
Research at the University of Sheffield has demonstrated that zoledronic acid is an effective and safe treatment for osteoporosis. It resulted in a new drug intervention (Aclasta/Reclast) which has been licensed in more than 100 countries and shows increased positive outcomes for patients.
As a result of the licensing of the drug, clinical guidelines have changed globally. For patients, the drug provides a preferred method of treatment, evidenced in surveys which show the majority of patients preferred an annual infusion of zoledronic acid to the alternative, which is the standard treatment of weekly oral alendronate.
Industry has invested in research and development of the drug. Novartis has funded studies into the efficacy and safety profile (up to 2012); in 2011, sales of Aclasta/Reclast were US$0.6 billion.
The University of Aberdeen's discovery of a novel drug for the treatment of rheumatoid arthritis and related inflammatory/autoimmune disorders has brought substantial industrial investment in research and development. The new drug is expected to enter clinical trials shortly and has the potential to transform the way rheumatoid arthritis is currently treated, as few patients currently have access to the expensive biological agents which dominate existing therapy. Aberdeen has commercialised its research into a university spin-out company and subsequently licensed the programme to a UK drug-development company, Modern Biosciences plc. The research has created and protected UK expertise and jobs.
The specific impacts on commerce have been: substantial industrial investment in research and development, job creation and protection within UK industry, commercialisation of a new product via a licencing deal, and academic consultancy in industry.
Seven patients with avascular necrosis of the femoral head and bone cysts have been treated successfully with skeletal stem cell therapy, developed by Southampton researchers, resulting in an improved quality of life. This unique multi-disciplinary approach linking nano-bioengineering and stem cell research could revolutionise treatment for the 4,000 patients requiring surgery each year in the UK and reduce a huge financial burden on the NHS. The work has been granted three patents and the team are in discussions on development of the next generation of orthopaedic implants with industry.
Research into the biocompatibility of glass-ionomer bone cements conducted at the School of Clinical Dentistry led directly to the start-up of a UK company to manufacture a new medical device, creating jobs in the supply chain and wealth creation via international sales. The new bone cement is safe and clinically effective, and has maintained or restored hearing to improve the quality of life of over 10,000 patients worldwide since 1st January 2008. In the course of supporting this commercial partner, Sheffield's staff also contributed to other non-academic tasks.
Demand for cheap meat has increased the potential for fraudulent food labeling, which exploded in public debate in 2009 and 2013. Zooarchaeology by Mass Spectrometry (ZooMS) is a technology originally developed to identify bone fragments from archaeological sites by determining the sequence of the bone protein, collagen. By applying this research to the food industry we have provided evidence of fraud. In 2009 ZooMS identified pig and cow gelatin being pumped into chicken meat to increase weight. Action taken by the food producers when confronted with our research respected the beliefs of up to 3.8milliona people in the UK who choose to avoid pig and cow products.
York's analytical methods have been applied in food authentication, traceability and safety and have been shown to be superior to other methods. Mass spectrometric methods developed in York for the identification of archaeological bone samples rely on analysing surviving fragments of the bone protein, collagen. These techniques also identify collagen fragments present in gelatin-based plumping agents that retain water in meats for human consumption. York's authentication applications disclosed the animal species from which the collagen was derived, and revealed contamination of chicken with pork-derived plumping agents, a significant issue in communities with halal and kosher diets. These results have been disseminated by high-profile media reporting, including a one-hour BBC special, and the press. The Food and Environment Research Agency (FERA, a DEFRA agency) has validated the York analytical method and applied it to processed food and pharmaceutical products. An inter-laboratory trial transferred the method to other food enforcement laboratories across Europe and the USA (including the US FDA). The results were highlighted in the press in 2009 and the debate over food authentication exploded in 2013 highlighting the economic effects of mislabelling. This research therefore has impact on public and commercial services as well as public debate.
Our research has developed improved hip replacement fixation techniques, which have improved the biomechanical stability of implanted artificial joints. These techniques have been employed by orthopaedic surgeons, for example at Mid-Essex Hospitals Services Trust (MEHT), in primary and revision total hip replacement operations. As a result, the number of patients requiring revision hip surgery due to cup loosening has fallen by 50%. Additionally, these techniques have reduced the recovery time per operation by 3-5 days, which in addition to benefitting the patient have also resulted in an average saving per operation of £1,200.