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DySIS Medical Ltd (DySIS or the Company): NICE Publishes Positive Diagnostics Guidance on DySIS Cervical Cancer Screening Product

Wed, 08/01/2012 - 4:34am
The Associated Press

EDINBURGH, Scotland--(BUSINESS WIRE)--Aug 1, 2012--DySIS Medical Ltd, the medical devices company in female health, announces that the National Institute for Health and Clinical Excellence (‘NICE’) has today published positive diagnostics guidance recommending its DySIS cervical cancer screening product to be considered in procurement plans.

DySIS colposcopy uses spectral imaging techniques during the course of a normal examination to highlight to clinicians any areas of concern by mapping the condition of a woman’s cervix. The DySISmap uses a range of colours to indicate normal and abnormal cells, and the degree of abnormality present.

In clinical trials, DySIS has been shown to significantly boost sensitivity in detecting cervical cancer in its earliest stages. Armed with this additional information, clinicians are able to take immediate steps to treat patients and prevent disease progression. This in turn creates a substantial economic impact by reducing the volume of higher cost surgical interventions.

The NICE guidance states: “DySIS is a clinically and cost-effective option, compared with standard colposcopy, for examining the uterine cervix in women referred for colposcopy, and should be considered in procurement plans for colposcopy equipment.” Every year in the UK, over 2,800 women will be diagnosed with cervical cancer and over 900 women will die from the disease despite the fact that it is entirely treatable if diagnosed early enough.

Mr Charles Redman, consultant gynaecological oncologist at North Staffs Hospital and an early user of DySIS commented "DySIS is a very exciting technology that delivers an excellent solution in a critical area of women's health. We have made excellent progress in reducing the incidence of cervical cancer in the UK through a good screening programme, but detecting the disease early is still a significant challenge. Today we have to use visual assessment, a lot of judgement, combined with several recall visits for some patients, to try to catch the disease. The DySIS instrument uses hi-tech imaging and provides objective measurements that we can use to substantially improve our sensitivity to detecting the disease before it's too late." Extensive clinical trials on DySIS have been undertaken across Europe involving hospitals in the UK, Netherlands and Greece. The most recently published results showed that DySIS helped clinicians to identify pre-cancer conditions caused by the virus responsible for the vast majority of cervical cancers in 97% of all cases.

New users can be trained to interpret the DySISmap, in 2-4 hours. The aim of the technology, is to provide reassurance that the highest level of analysis has been undertaken and abnormal cells or potential cancers have not been missed. DySIS has a CE mark and has been cleared for use by the USA’s Food and Drugs Administration. The company estimates that around 4,000 women to date have had a DySIS exam through the installed base of instruments across Europe.

Alastair Atkinson, CEO of DySIS Medical said: “Achieving NICE [approval] is a landmark event for our Company. This positive guidance recognizes the paradigm shift that DySIS can create – helping clinicians to deliver a higher standard of care at a lower overall cost.” The document can be viewed in full at: http://guidance.nice.org.uk/DG4 -Ends- Notes to Editors DySIS Medical Ltd DySIS Medical Ltd has its global headquarters in Edinburgh. The company is committed to saving lives through the early detection and diagnosis of disease using biophotonic innovations. It aims to be the global leader in automated optical molecular imaging technologies for medical diagnostic and screening applications. For more information, please visit: www.dysismedical.com The DySIS cervical cancer screening product employs advanced photonics and computer assistance to quantify and map the aceto-whitening process – providing clinicians with reliable information to assist in the identification of pre-cancerous lesions. The product is sold in Europe and the US.

Cervical Cancer and Screening Cervical cancer is the second most common cancer in women and accounts for more than one in ten (9%) of diagnosed female cancers. The World Health Organization estimates that there are over 500,000 new cases each year resulting in 250,000 deaths. In the developed world, where screening programmes are used, some 30 million women will receive an abnormal smear test result and be called for a colposcopy examination. If caught and treated at an early stage, there is a high degree of treatment success.

The introduction of cervical cancer screening in women over 25 has helped to reduce the incidence of the disease - about 4.4 million women are screened in the UK each year - even so, approximately, 900 women in England a year die of the disease and the cost to the healthcare services, including the NHS runs into multimillions.

CONTACT: DySIS Medical Ltd Alastair Atkinson, CEO Tel: +44 (0)1506 592159 or College Hill (PR for DySIS Medical) Melanie Toyne Sewell / Gemma Howe/ Jen Lewis Tel: +44 (0)20 7457 2020 Email:dysis@collegehill.com KEYWORD: UNITED KINGDOM EUROPE INDUSTRY KEYWORD: WOMEN HEALTH MEDICAL DEVICES ONCOLOGY CONSUMER SOURCE: DySIS Medical Copyright Business Wire 2012 PUB: 08/01/2012 04:34 AM/DISC: 08/01/2012 04:34 AM http://www.businesswire.com/news/home/20120801005549/

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