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26 September 2011 | PR 11/116

Loughborough University spin-out company achieves quality mark for life-saving innovation

A ground-breaking device which “sees” beneath the skin to spot circulation problems has passed an important milestone on its journey to commercialisation.

Padd® – a quick and painless diagnostic device which measures peripheral blood circulation – has achieved its CE mark and ISO certification 13485:2003, an internationally recognised quality management standard.

The CE Mark shows that the product conforms with the essential requirements of European Union directives and is approved for sale in Europe.

The International Organisation for Standardisation certification confirms that the makers of Padd® are authorised to design and manufacture medical devices.

The accreditations mark a significant milestone for Dialog Devices - the creators of Padd®. CEO Jody Brown said: “I am delighted that the company has successfully reached this key milestone with tremendous support from the Department of Health and the National Health Service in the UK where the early diagnosis of peripheral arterial disease will benefit patients and reduce the cost of managing cardiovascular disease and long-term conditions.”

Dialog Devices, based at Loughborough University’s Innovation Centre, was founded on research carried out at the University. It now employs an eight-strong team comprising business, marketing and technical expertise.

The Padd® technology can be used to diagnose peripheral arterial disease (PAD) - an early symptom of heart disease and stroke, affecting 90 million people worldwide.

Current screening for PAD is time-consuming and requires skilled operators. Padd® offers rapid, simple and robust assessment of blood circulation in the lower limbs and feet.

An infra-red probe, no more powerful than a TV remote control, is held to the foot for a couple of minutes to assess how well the blood supply adapts to forces of gravity caused by postural changes such as getting out of bed and standing up.  The test is easy and safe to perform and ideal for busy vascular clinics and GP surgeries. Earlier diagnosis of PAD has the potential to save lives.

Earlier this year, Dialog Devices was a winner in an NHS competition to find new ways to combat long-term conditions. The Smart Solutions for Healthcare competition was delivered by TRUSTECH, the North West NHS Innovation Hub, an NHS organisation that aims to improve healthcare through the development of innovative products and services.

Dr Bryan Griffiths of TRUSTECH said: “Padd® provides an easy way to diagnose peripheral arterial disease within the community, without the need to refer patients to hospital. By allowing earlier diagnosis, it can also help to improve outcomes for patients and ultimately save on long-term treatment costs. Innovations like Padd have a major role to play in helping the NHS meet the challenges ahead.”

The company’s quality management system was audited and assessed by TUV SUD Product Service GmbH, one of the world's leading certification bodies.

−ENDS−

For all media enquiries contact:

Sarah Hall
Marketing and Communications Officer
Enterprise Office
Loughborough University
T: 01509 228684
E: S.Hall@lboro.ac.uk

Notes for editors:

1. About Dialog Devices Ltd
Dialog Devices Ltd is one of the top spin out companies from Loughborough University. It has been trading since 2003 by supplying its core optoelectronic technology and expertise to other early stage biomedical device companies, and building its product base of non-invasive blood perfusion assessment devices.

The company has a strong awards portfolio, as follows: 2008/9 Department of Health: Health Technology Devices, 2008 Winner of Lord Stafford Award: Innovation in Development, 2008 Commendation at DaVinci Health Technology Innovation Network Awards, Innovator of 2007 in the Medilink East Midlands Awards,  IET Engineering Award, Medical Futures Finalist and 2011 Smart Solutions for Healthcare.

For more information, contact: Jody Brown, Chief Executive, Email: jody.brown@dialogdevices.co.uk

2. About Loughborough University
Loughborough is one of the country’s leading universities, with an international reputation for research that matters, excellence in teaching, strong links with industry, and unrivalled achievement in sport and its underpinning academic disciplines.

It was awarded the coveted Sunday Times University of the Year 2008-09 title, and is consistently ranked in the top twenty of UK universities in national newspaper league tables. In the 2010 National Student Survey, Loughborough was voted one of the top universities in the UK, and has topped the Times Higher Education league for the UK’s Best Student Experience every year since the poll's inception in 2006. In recognition of its contribution to the sector, the University has been awarded six Queen's Anniversary Prizes.

Loughborough is also the UK’s premier university for sport. It has perhaps the best integrated sports development environment in the world and is home to some of the country’s leading coaches, sports scientists and support staff. It also has the country’s largest concentration of world-class training facilities across a wide range of sports.

It is a member of the 1994 Group of 19 leading research-intensive universities. The Group was established in 1994 to promote excellence in university research and teaching. Each member undertakes diverse and high-quality research, while ensuring excellent levels of teaching and student experience.

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