YGEN.L Regulatory News (YGEN)

Premaitha Health PLC

("Premaitha" or the "Company")

Middle East Business Update

Manchester, UK - 20 February 2017: Premaitha Health PLC (AIM: NIPT), developer of a leading CE-marked non-invasive prenatal screening system, is pleased to announce significant commercial progress in the Middle East through its distribution network.

Premaitha has appointed distributors across the Middle East and these partners have signed a number of new Middle Eastern customers which in aggregate are expected to generate over 10,000 samples per annum, once fully operational. The region offers greater intellectual property freedom, is attracted to the high quality in vitro diagnostic solution offered by Premaitha and is rapidly adopting non-invasive prenatal testing ("NIPT") as a general screening test.

United Arab Emirates ("UAE") and Saudi Arabia

Premaitha has appointed IgBioSystems ("IgBio") as a distributor for the IONA® test in the UAE and Saudi Arabia. IgBio has already secured its first customer in Dubai, which will initially send samples to Premaitha in Manchester before installation of its own laboratory later in 2017. Once installation is complete, the Dubai laboratory will act as a regional hub, processing samples from other hospitals in its local network and from West Africa where it has significant connections.

IgBio has also secured a customer in Saudi Arabia that will be looking to install a service laboratory later this year. Samples will initially be sent to St George's Hospital in London while the laboratory is undergoing set-up and installation.

Kuwait

Premaitha has also appointed a distributor in Kuwait which has secured its first customer. This customer will initially send samples to Manchester, and it is anticipated that demand for the services will result in a full laboratory installation in Kuwait later in 2017.

Intellectual Property landscape

The patents being asserted against Premaitha in the ongoing UK litigation are not present in the Middle East.

NIPT adoption

NIPT is being rapidly adopted across the Middle East for all pregnant women, in contrast to the high-risk focus of public programmes in Europe. This creates a sizeable target addressable market which is attracting high quality service providers who are keen to establish in-house laboratories using Premaitha's IONA® test technology. 

Premaitha's IONA® test estimates the risk of a fetus being affected with Down's syndrome or other genetic conditions. The test is performed on a maternal blood sample, containing traces of fetal DNA, which is then analysed using next generation DNA sequencing technology. The test is highly accurate and significantly reduces the number of women who are unnecessarily subjected to risky, invasive follow up procedures to diagnose Down's syndrome and other genetic conditions.

Dr Stephen Little, CEO of Premaitha Health, commented: "We are pleased to report increasing traction in the Middle East, where our existing installations are exceeding expectations and where we are seeing strong demand in local hospitals through our distributor network. This is a strategically important region which is unaffected by ongoing intellectual property disputes and therefore further de-risks the Company's position in this regard. 

"It is clear that there is increasing recognition of the benefits of NIPT as a general screening test in the region and this in turn is driving demand for the IONA® test as a complete in-house solution. The financial impact from these contracts will build during our next financial year creating a strong platform for recurring revenues in the years ahead. The Middle East is positioning itself as a leading global healthcare destination and we are rapidly establishing a significant market presence in the region."

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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About Premaitha

Premaitha is a molecular diagnostics company which uses the latest advances in DNA analysis technology to develop safer, faster and regulatory approved non-invasive screening tests for pregnant women.

Premaitha's lead test - the IONA® test - was launched in February 2015 and is the leading CE marked complete system which estimates the risk of a fetus being affected with Down's syndrome or other genetic conditions. The IONA® test is performed on a maternal blood sample - which contains traces of fetal DNA - and then analysed using next generation DNA sequencing technology from ThermoFisher Scientific.

Unlike existing prenatal screening methods, due to its high level of accuracy, the IONA® test can significantly reduce the number of women subjected to unnecessary stressful and invasive follow up diagnostic procedures which are costly, resource intensive and carry a risk of miscarriage.

Non-invasive prenatal screening is an emerging, multi-billion dollar global market and Premaitha's complete CE Marked system enables laboratories and health care practitioners to offer an approved, non-invasive prenatal screening system in-house.

Premaitha is based in Manchester Science Park, United Kingdom and its shares trade on the AIM market of the London Stock Exchange (AIM: NIPT). For further information please visit www.premaitha.com. Follow us on twitter @PremaithaHealth.