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
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
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
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.