NICE consults on draft guidelines for VisionĀ® Amniotic Leak Detector

                                                                                                                                                    25 March 2013
                                                              SUTHERLAND HEALTH GROUP PLC
                                                 (“Sutherland Health Group” or “the Company”)
                                                                         ISDX Symbol: SHGP

          NICE consults on Vision® Amniotic Leak Detector for assessing a pregnancy complication                                                                        which affects thousands of women

The Board of Sutherland Health Group, a national supplier of patient hygiene, sexual health and gynaecology products to customers including the National Health Service (“NHS”), announces today that The National Institute for Health and Clinical Excellence (“NICE”) issued a press release on 20 March 2013 regarding Sutherland Health Group’s Vision Amniotic Leak Detector (“Vision ALD”).


NICE was set up to reduce variation in the availability and quality of NHS treatments and care. Its evidence-based guidance and other products help resolve uncertainty about which medicines, treatments, procedures and devices represent the best quality care and which offer the best value for money for the NHS.
The NICE press release announces that it has opened a consultation on its draft medical technology guidance on the use of a device to assess the potentially serious complication of unexplained vaginal wetness in pregnancy. The wetness could simply be leaking urine which is not a cause for immediate concern, or it could be leaking amniotic fluid, which would indicate that the fetal membranes had ruptured, with the potential for
infection to occur. The draft NICE guidance supports the case for adopting the Vision ALD as a means to reliably exclude a leak of amniotic fluid as a cause of vaginal wetness in pregnancy.


The Vision ALD is a diagnostic panty liner that can be attached to underwear. The device is issued by a midwife or other healthcare professional and is then worn by the woman for up to 12 hours, before the liner is then placed in a drying unit. The indicator strip in the liner changes colour depending on the pH of the fluid causing the wetness, and whether ammonia (which is in urine) is present. If the indicator strip is yellow after
drying, then the leak is unlikely to be amniotic fluid and a speculum examination can be avoided. If the indicator strip is blue-green after drying, this indicates the wetness is likely to be amniotic fluid or infection, which can then be confirmed by a speculum examination and a vaginal swab.


The available evidence suggests that the device can exclude an amniotic fluid leak as causing vaginal wetness in pregnancy, avoiding the need for a speculum examination. There are estimated cost savings of up to £24 per woman compared with current management. The estimated saving depends on whether the pregnancy has reached 37 weeks gestation or if it is earlier, and whether the device is issued at a general practice or at the woman's home by a community midwife. The Vision ALD is intended for use by
women with normal pregnancies experiencing unexplained vaginal wetness and by those at high risk of premature rupture of membranes.


Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: "It's important to distinguish whether unexplained vaginal wetness in pregnancy is due to amniotic fluid leaking, or if it's due to urine which is far less of a worry. Leaking amniotic fluid is estimated to occur in 6% -19% of full term pregnancies, and around 2% of premature pregnancies, so between 64,000 and 170,000 pregnant women could be affected in the UK each year.


"The independent Medical Technologies Advisory Committee (MTAC) considered thatthere was evidence to support the use of the Vision ALD when it is provided to women at their general practice or by their community midwife. Using the device is estimated to save the NHS up to £24 per woman compared to standard management. The Committee concluded that the most likely benefit would be from using the Vision ALD in primary care settings as this would avoid unnecessary referrals to secondary care services, such as an antenatal day unit or maternity triage area, releasing resources and clinical time in these busy departments. The device is also more convenient for patients as it avoids potentially unnecessary speculum examinations, which are invasive and can carry a risk of infection.


"We are keen to receive comments on the draft guidance as part of this consultation, particularly from midwives, obstetricians, other antenatal health care professionals and groups representing pregnant women."


More information on the medical technology draft guidance consultation for Vision ALD is available on the NICE website. The consultation closes on 19 April 2013.


The Company announced on 18 March 2013 that it proposed to raise up to £150,000 in a placing of new ordinary shares at a price of 1.25p to Shareholders and Investment Professionals for additional working capital to advance its business strategy.

                                                                                  ---ENDS---


The Directors of the Issuer accept responsibility for this announcement

 

Enquiries:


Sutherland Health Group Plc
John French, Chairman
E: john@sutherlandhealth.com
T: 07836 722482


Peterhouse Corporate Finance Limited

Heena Karani
E: heena@pcorpfin.com
T: 0207 469 0930

 

Notes to Editors:


About Sutherland Health Group plc


1. Sutherland Health Group Plc is a national supplier of patient hygiene, sexual health
and diagnostic products to the UK National Health Service (NHS) and other UK
customers. Its aim is to supply innovative solutions to current health issues by studying
current trends and working alongside leading professionals who also work within the
health sector.


2. The company is committed to developing and marketing high quality brands and
products that will benefit health professionals and consumers alike in many areas of
health. The Group has established its own brands: Condomania® Condoms;
Sutherland® Patient Hygiene and Personal Care; Lubricating Jelly; and Vision®
pregnancy and gynaecology diagnostics. These products have already become
established within the NHS business.


3. The Group is ISO and MHRA registered, and at present principally manufactures and
operates within the United Kingdom.


For further information on the Company visit www.sutherlandhealth.com


 

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