Concepta gets ethics committee approval for myLotus UK trials

The AIM-traded firm said it engaged UK-based firm, the Clinical Trial Company, to manage the trial, which will be conducted in Rhyl, Wales.

It said the trial was expected to begin 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 was expected to take approximately four months.

The results would be included alongside those of the stability trials and the technical file, to support the company's CE-mark.

Concepta also announced that the myLotus product format and the labelling for EU markets had been finalised, and it was currently waiting to undergo the strict audit process of the company's notified body, the BSI.

The audit was expected to be carried out upon completion of the trial in order to obtain final CE-marking.

“We are delighted to announce this important milestone,” said CEO Erik Henau.

“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."