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Concepta to commence UK trials for myLotus fertility product after Ethics Committee approval

The AIM-listed firm said the trial is expected to start over the next few months and will take approximately four months, with 120 women testing the device for ease of use and clarity of instructions
MyLotus fertility product
Concepta also announced that the myLotus fertility product format and its labelling for EU markets has been finalised

Concepta PLC (LON:CPT) announced that it has received Ethics Committee approval to commence the user trial for its myLotus fertility product in the UK.

The AIM-listed firm said the trial is expected to commence in the next few months and will take approximately four months, with 120 women testing the device for ease of use and clarity of instructions.

READ: Concepta launches myLotus app in China

It added that the trial will be conducted in Rhyl, North Wales by The Clinical Trial Company, which specialises in clinical studies for pharmaceutical and medical device companies.

The results will be included alongside those of the stability trials and the technical file to support the company’s CE-mark, a certification that indicates that a product complies with EU safety and environmental requirements.

Concepta also announced that the myLotus fertility product format and its labelling for EU markets has been finalised and is currently waiting to undergo the strict audit process of the company’s Notified Body: BSI.

Erik Henau, CEO of Concepta, said: “"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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