YGEN.L Regulatory News (YGEN)

Premaitha Health Plc

("Premaitha" or the "Company")

AGM Statement

Manchester, UK - 27 October 2016 - At the Annual General Meeting of Premaitha to be held later today, Adam Reynolds, Non-executive Chairman, will make the following statement: 

"I am pleased to chair this annual general meeting which follows the IONA® test's first full year of commercialisation. During this period the Company made considerable progress in establishing an initial customer base of laboratories which are now processing tests for hospitals in the UK, Poland, Switzerland, France, Russia and the Middle East. This resulted in the sale of over 17,000 tests in our first commercial year, generating £2.5 million in sales for Premaitha.

The international landscape for non-invasive prenatal testing is evolving very considerably in Premaitha's favour - with numerous countries moving towards making this safer testing procedure more freely and readily available through public health services. We expect the UK to soon make NIPT freely available to high risk women on the NHS and for other countries to follow suit. The IONA® test is a fully CE approved system and is exceptionally well placed to win significant market share as awareness of the availability of NIPT increases.

The number of laboratories using the IONA® test continues to grow. I am pleased to note that trading in the first half of the current financial year was materially above the equivalent period last year, positioning Premaitha comfortably on track to outperform the IONA® test's first full commercial year.

With a total of eleven laboratories now operational, and two more due to go live before Christmas, along with substantial support from Thermo Fisher, Premaitha is in an excellent position to continue its growth path.

We are very encouraged by the growth we have seen in the Middle East and we are focusing substantial efforts within this region and in Asia Pacific and hope to announce shortly a number of sizeable commercial agreements. The demand within these territories for NIPT is very strong and in particular the quality of product offered by the IONA® test is a source of competitive advantage.

Litigation

Notwithstanding the commercial progress being made, the patent infringement proceedings launched by Illumina continue and we are not the only party receiving their attentions. We are mounting a vigorous defence, taking decisive steps to de-risk the business through geographic diversification, and we are encouraged by the intervention of the European Commission with an investigation into potentially anti-competitive behaviour by Illumina and Sequenom.

Despite short-term distractions caused by the infringement claims of Illumina, Premaitha is building a highly compelling business, which will be global within the next twelve months. Considering eighteen months ago we had zero sales, this is testament to the quality of offering that we have in the market place.

Widescale adoption of NIPT will not happen overnight; but we have absolutely no doubt that the developed world is moving towards it; and that Premaitha is well placed to gain a large share of the market."

The information contained within this announcement constitutes inside information stipulated under the Market Abuse Regulation (EU) No. 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 the mother's 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.