Colworth Park

Concepta Diagnostic’s myLotus product gains CE-mark regulatory approval

Colworth based Concepta plc, 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

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.”

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