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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.
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.
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.
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.
Aromatase inhibitors (AIs) significantly improve survival from breast cancer but are associated with increases in osteoporotic fractures and bone mineral density loss. Research at the University of Manchester (UoM) has provided key evidence that has contributed to preventing debilitating bone demineralisation safely in breast cancer patients undergoing adjuvant therapy with AIs. UoM findings have led to an international consensus on guidelines recommending Dual-energy X-ray Absorptiometry (DEXA) scanning to identify patients at risk of bone loss as well as the use of bisphosphonates where bone loss has been identified. Further guidelines advise against the use of HRT to treat bone loss as a result of its association with breast cancer recurrence.
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.
Cranfield's research on Osteomics (the science of bones) & Biominerals (O&B) has improved the manufacture and performance of biomedical prostheses. The techniques developed have also resulted in a spin-out company and analytical techniques with broader application in forensic casework. Specifically, our research has resulted in:
(i) Improved biomedical prostheses where new coating techniques and new product quality assurance protocols and standards underpin coating processes in industry; worth several £M/year. These have been developed with, and are currently used by Biomet, an international medical device manufacturer.
(ii) The creation of a spin-out company, HALO X-ray Technologies, to exploit the technologies based on our novel X-ray analytical techniques.
(iii) Several new analytical methods for the discrimination of bone in forensic case work (used by Cellmark Forensic Services (CFS)).