MyLotus is a mobile application which allows women to monitor and track fertility.
Concepta has engaged the Clinical Trial Co, which conducts clinical studies for pharmaceutical, biotechnology and medical device companies to manage the trial, which is expected to start in the next month, with 120 women testing the device for ease of use and clarity of instructions.
The trial is expected to take four months to complete, with the results to be included alongside that of the stability trials and the technical file to support the company's CE mark.
Finally, the myLotus product format and labelling for EU markets has been finalised and is waiting to undergo the audit process of Concepta's notified body, while will go towards obtaining the final CE-marking.
"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
Shares in Concepta were up 1.9% at
