National Institute for Clinical Excellence (NICE) Publishes Positive Draft Guidance on DySIS Cervical Cancer Screening Product

Edinburgh – 3 April 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in female health, announces that the National Institute for Health and Clinical Excellence (‘NICE’) has today published draft guidance on its DySIS cervical cancer screening product for public consultation.

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. In clinical trials, it 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.

The provisional recommendation of NICE’s Diagnostic Advisory Committee was:

“DySIS is a cost-effective option for examining the uterine cervix in women referred for colposcopy and should be considered in procurement plans when replacing colposcopy equipment.”

Commenting on the announcement, Miss Theresa Freeman Wang, Consultant Gynaecologist MRCOG, Whittington Hospital, who has been using DySIS, said “The extra sensitivity that DySIS delivers could be very helpful in detecting the smaller pre-cancerous lesions that require treatment and may assist in safely reducing the need for Colposcopy follow up appointments.”

The report also noted: “The sensitivity of DySIS remained high (77.4%) in the subgroup of women referred to colposcopy with low-grade cytology, whereas the sensitivity of conventional colposcopy was low (19.4%).” A higher sensitivity in detecting cervical changes as early as possible implies a reduced cost burden to healthcare systems.

The NICE paper stated: “The Committee concluded that the modelling of DySIS colposcopy showed that it was robustly cost effective (possibly even cost saving) when compared with conventional colposcopy.” Specifically the draft guidance stated, “The base case indicates that standard colposcopy was more expensive and less effective [than DySIS].”

Alastair Atkinson, CEO of DySIS Medical said: “Today’s encouraging draft guidance from NICE coupled with an extremely positive response to our recent US launch are key milestones for the company. An important feature of the report is the acknowledgement that DySIS delivers a higher standard of care for women at a lower overall cost, and this is supported by our observations in other key international markets.”

The consultation document can be viewed in full at: http://guidance.nice.org.uk/DT/5 and a final decision will be made in May 2012 following a public consultation period.

For more information, please contact:

DySIS Medical Ltd

Tel: +44 (0)1506 592159

Alastair Atkinson, CEO

College Hill (PR for DySIS Medical)

Tel: +44 (0)20 7457 2020

Melanie Toyne Sewell / Gemma Howe

Email: DySIS@collegehill.com

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.

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