myLotus gains CE-mark regulatory approval
29 October 2018
Concepta plc (AIM: CPT), the innovative UK healthcare company and developer of the proprietary self-test platform ("myLotus") and suite of emerging test products targeting the mobile health market is pleased to announce it has received CE-Mark certification for its myLotus branded products for women's fertility.
Given the stringent regulatory environment for diagnostics, CE certification is a major milestone enabling the Company to sell its breakthrough fertility test device 'myLotus' in the UK market and subsequently across CE-Mark territories.
myLotus allows women the ability to self-test to identify their optimal fertile days thereby improving their chances of naturally getting pregnant. myLotus enables women to monitor their fertile phase as part of their menstrual cycle and is the only home test to 'quantitatively' measure personalised hormone levels and the 'rate-of-change' of these levels preceding ovulation to help aid a natural conception. Users measure, record and track their hormone levels and follow their fertility journey in an accompanying free downloadable app.
The Company expects to launch its new fertility products under the brand name 'myLotus' with initial demand serviced via the Company's new eCommerce platform and website www.mylotus.com
The product will be available to women who are planning to start a family or for those who have previously struggled to naturally conceive, enabling couples an alternative prior to considering more costly IVF treatment.
Matthew Walls, Chairman said: "following several years of diligent work by our technology team, study doctors and trial users we are delighted to receive CE-Mark certification for our first myLotus products. Novel self-test diagnostics for home-use is a highly regulated field of healthcare and this is a fabulous and eagerly awaited endorsement for the Company. Importantly the certification signals our drive to help improve the chances of women naturally getting pregnant and our preparations for the launch of myLotus in the UK and other CE-Mark territories. We will advise on the timing of the UK launch very shortly."
Matthew Walls, Chairman
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Neil Baldwin / Mark Brady
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About Concepta Plc:
Concepta PLC is an AIM-quoted pioneering UK healthcare company that has developed a proprietary product, myLotus, targeted at the personalised mobile health market with a primary focus on increasing a woman's chances of getting pregnant naturally and for unexplained infertility in women.
myLotus is currently the only consumer product which allows both quantitative and qualitative home (self-test) test measurement of a woman's personal luteinizing hormone (LH) during ovulation and human chorionic gonadotropin (hCG) hormone level during pregnancy, facilitating higher conception rates and early diagnosis of fertility issues. The proposition of myLotus is to help women conceive naturally by identifying their window of fertility and optimal time for conception.
The Company has received CE-mark certification for myLotus and is preparing its B2C launch in the UK and Europe. The Company has identified a significant global market opportunity with revenue potential of the EU and Chinese unexplained infertility market estimated to be worth c.£600m per annum.
Concepta has also made progress in establishing relationships with a number of distributors in China where myLotus has been given cFDA approval. Concepta is initially targeting the traditional route to market in China through Chinese hospitals and plans to add the B2C route in the near future.
MyLotus is expected to be beneficial to users diagnosed with 'unexplained infertility' who have been unable to conceive after 6 months of trying. This highly motivated target group of consumers won't typically be offered medical intervention until 12 months of unsuccessfully trying, with IVF typically not offered until two years. Research indicates couples start to take positive action ahead of this time with little medical support to help them do so.