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Research at the University of Sheffield has resulted in FRAX, the first internationally-applicable fracture risk calculator that provides individualised 10-year probabilities of major osteoporotic fractures from readily available clinical risk factors. It has replaced bone mineral density (BMD) as the sole quantitative measure of fracture risk, thus increasing global access to risk assessment and improving targeting of treatment to patients at highest risk. FRAX is incorporated widely into national and international guidelines for osteoporosis management. Launched in 2008, it now provides country-specific calculations for 53 nations, in 28 languages. The online tool alone recently processed its 6.6 millionth calculation.
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.
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.
Seminal materials research at QMUL and its technological transfer via the QMUL spin-out ApaTech™, has led to the development of a range of cost-effective synthetic bone graft (SBG) products (ApaPore™, Actifuse™ and Inductigraft™), which safely and effectively stimulate rapid bone healing and are more reliable than previous autograft procedures. The successful use of the ApaTech™ range of products has delivered impact on health and welfare by reducing post-operative infection risks and improving recovery rates. To date, ApaTech™ products have been used to treat over 370,000 patients in over 30 countries. In 2010, ApaTech™ had 4% of the US SBG market, a $20 million annual turnover, employed 160 people in nine countries, and was sold to Baxter International for £220 million. By 2012, ApaTech™ products had attained a 10% share of the global SBG market (treating 125,000 patients per annum), estimated to be around $510 million. Other impacts include altering surgical clinical practice away from the use of autograft.
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.
Building on work which has contributed, via NICE guidance, to £1 billion in annual savings to the NHS in its healthcare provision for osteoporotic fractures in older adults, research at the £14.4 million MRC Lifecourse Epidemiology Unit (LEU), University of Southampton, has inspired the world's first randomised controlled trial of vitamin D supplementation versus placebo in pregnancy. This work was designed to provide a definitive answer to the question of whether supplementing pregnant women with vitamin D leads to increased bone mineral accrual in the offspring. This work has also shaped national and international guidance on vitamin D supplementation both during pregnancy and in older age; Southampton's programme of osteoporosis research has attracted £10 million in research funding from health organisations and the EU.
A routine test to screen for patients genetically disposed to serious side effects from treatment with thiopurine drugs has been widely adopted following research by the Academic Unit of Clinical Pharmacology at the University of Sheffield. The test has spared patients painful and potentially life-threatening sepsis, and saved the considerable associated treatment costs which have been estimated to be over £9,000 per patient for a 17 day hospital stay. It has also led directly to a change in clinical guidelines and recommendations in both the USA and UK.
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.
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.
Globally, around 400 people in every million head of population will present with a fracture of the tibia that requires surgical intervention. This case study describes the exploitation of research that commenced with a DTI/EPSRC grant. The results have a direct impact on the 400/million population, their family, employers, and associated healthcare providers.
During the period 2008-today:
over 200 surgeons in 10 countries have been retrained in the new methodology; between 2000-3000 patients have benefited from improved outcomes; 47 hospitals benefited from reduced operating times and reduced costs; and surgeons benefit from a marked reduction in per-operative x-ray exposure (reducing the risk of cancer).
The initial project was to identify the optimum movement of the fracture fragments to promote healing; this was to lead to devices with the potential for significant impact. A spin out company was formed which has attracted over £1.4 million investment.