RNS Number : 0433H
08 March 2018
8 March 2018
("Concepta" or the "Company")
myLotus obtains Ethics Committee approval to commence trial in UK
Concepta plc (AIM: CPT) the UK healthcare company and developer of a proprietary product targeted at the mobile health market with a primary focus on women's fertility, is pleased to announce that it has received Ethics Committee* approval to commence the user trial for its myLotus product in the UK.
Concepta has engaged the renowned UK-based company, The Clinical Trial Company, which specialises in clinical studies for pharmaceutical, biotechnology and medical device companies to manage the trial, which will be conducted in Rhyl, UK.
The trial is expected to commence in the next month, with 120 women testing the device for ease of use and clarity of instructions. Patient recruitment for the trial, the process of testing, collecting samples, reporting, result analysis and the final report is expected to take approximately four months. The results will be included alongside those of the stability trials1 and the technical file2 to support the Company's CE-mark.
Concepta also announces that the myLotus product format and the labelling for EU markets has been finalised and it is currently waiting to undergo the strict audit process of the Company's Notified Body: BSI. The audit is expected to be carried out upon completion of the trial in order to obtain final CE-marking.
Erik Henau, CEO of Concepta commented: "We are delighted to announce this important milestone. Over the last few months, we have dedicated considerable effort to meet the necessary requirements and regulations in order to expedite our CE-marking process. We look forward to obtaining this key certification in the coming months, which will allow us to launch our myLotus product in our initial target European markets of the UK, and subsequently, other EU markets as the Company grows."
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Notes to Editors
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 unexplained infertility† in women.
myLotus is currently the only consumer product which allows both quantitative and qualitative measurements of a woman's personal LH and human chorionic gonadotropin (hCG) hormone levels in a home test, facilitating higher conception rates and early diagnosis of issues with fertility hormones. The proposition of myLotus is to help women conceive naturally.
Concepta has made significant progress recently, establishing agreements 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 direct-to-consumer route in the near future.
The Company is also well on its way to achieving CE-marking and commencing its direct-to-consumer launch in the UK and Europe in H1 2018. The Company has identified a significant global market opportunity, with revenue potential of the Chinese and EU unexplained infertility market estimated to be worth c.£600m per annum.
†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.
There are more than 80 NHS Research Ethics Committees across the UK. They exist to safeguard the rights, safety, dignity and well-being of research participants.
RECs consist of up to 15 members, a third of whom are 'lay' - their main professional interest is not in a research area, nor are they a registered healthcare professional.
RECs review research proposals and give an opinion about whether the research is ethical. They also look at issues such as the participant's involvement in the research. The committees are entirely independent of research sponsors (the organisations responsible for the management and conduct of the research), funders and the researchers themselves. This enables them to put participants at the centre of their review.
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1 Stability trials provide evidence on how the quality of the medical device varies with time under the influence of environmental factors, such as temperature, and are necessary for establishing a shelf life for the device and for recommended storage conditions.
2 A technical file is a set of documents that describes a product and can prove that the product was designed according to the requirements of a quality management system. Concepta operates under ISO13485 as its Quality Management System.
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