Concepta PLC Concepta achieves ISO13485 accreditation (5988T)
January 09 2017 - 2:00AM
UK Regulatory
TIDMCPT
RNS Number : 5988T
Concepta PLC
09 January 2017
9 January 2017
Concepta plc ("Concepta" or "the Company")
Concepta achieves ISO13485 accreditation for its myLotus
fertility product ahead of targeted commercial launch in the UK and
Europe in H2 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 GBP350 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."
ENDS
Enquiries:
The Company
Adam Reynolds, Chairman
Tel: +44 (0) 7785 908158
SPARK Advisory Partners Limited (Nomad)
Neil Baldwin/Mark Brady
Tel: +44 (0)20 368 3550
Beaufort Securities Limited (Broker)
Jon Belliss
Tel: +44 (0)20 7382 8300
Yellow Jersey PR Limited (Financial PR)
Felicity Winkles/ Joe Burgess/ Francesca Hillier
Tel: +44 (0) 7748 843 871
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.GBP600m 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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