Concepta manufacturing site achieves certification
08 April 2018
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 achieved ISO13485 certification for its manufacturing site in Doncaster.
The ISO13485 certification represents a significant step-change in Concepta's operations as it allows the Company to utilise the automated production lines recently installed at the Doncaster facility to begin manufacturing its myLotus diagnostic tests.
Additionally, the Company announces that it expects to transfer the remaining manual assembly capability, currently located at the Colworth labs, to the Doncaster facility during April 2018. This will enable all manufacturing capacity to be operated from the specially designed facility.
Erik Henau, CEO of Concepta commented: "It is a great achievement for the team to reach this key milestone following the myLotus pre-launch in the UK. This development is important in enabling the Company to operate with greater capacity and improved efficiency at one site and is a crucial step towards offering myLotus direct to consumers here in the UK. We look forward to providing the market with further updates in the coming months."
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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 H2 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.
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