Concepta achieves ISO13485 accreditation for its myLotus fertility product ahead of targeted commercial launch in the UK and Europe in H2 2017
09 January 2017
Concepta plc (AIM:CPT), the UK healthcare company targeting the personalised mobile health market with a primary focus on women's fertility, is pleased to announce that it has achieved ISO13485 accreditation, a key step in attaining its CE marking for its 'myLotus' product for unexplained infertility*, ahead of a commercial launch in the UK and Europe in H2 2017.
The ISO13485 certification is an endorsement of the Quality Management System (QMS) that underpins the Company's position as a manufacturer of medical devices. The accreditation is recognised on an international scale and is a critical part of gaining regulatory approval for Concepta's myLotus to be sold in the European Union.
Commenting on the agreement, Erik Henau, CEO of Concepta said: "This is a proud moment for the Concepta team and importantly a crucial development towards the launch of our flagship myLotus fertility product into the UK and European markets, where the potential market opportunity is circa £350 million.
"It cannot be underestimated how much work goes into documenting the procedures of an entire organisation within a QMS system and ensuring that the procedures are followed to the point that they become a seamless part of everyday operations. It is a strong endorsement of the quality of an organisation at all levels.
"Further to this we are delighted to report that with regulatory approvals and manufacturing agreements already in place in China we remain on track to roll out the myLotus product into the Chinese market in H1 2017."
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About Concepta Plc:
Concepta plc is a pioneering UK healthcare company that has developed a proprietary platform and products targeted at the personalised mobile health market with a primary focus on women's fertility and specifically unexplained infertility*.
Founded in 2013, Concepta has developed a revolutionary flagship product 'myLotus' for home self-testing that helps women with unexplained infertility to conceive.
myLotus is the only consumer product which allows both quantitative and qualitative measurements of measurement of a woman's personal hCG and LH hormone levels in an easy to use home test to facilitate higher conception rates and early diagnosis of any fertility problems. Competitor products currently only allow qualitative measurement and are based on the 'average woman'.
Concepta has a defined route to market for its new 'myLotus' product with Regulatory approvals for launch in China in place for 2016 and CE-Marking for UK and Europe to follow in 2017 where the revenue potential of the Chinese and EU infertility market is worth c.£600m per annum for the company.
*Unexplained infertility refers to women that 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 not offered until two years. Research indicates couples start to take positive action ahead of this time and there is little medical support to help them do so.