Sign up UNITED KINGDOM
Proactive Investors - Run By Investors For Investors

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."

View full CPT profile View Profile

Concepta Timeline

Newswire
February 20 2018

Related Articles

laboratory
April 12 2018
Mission is to make stem cell treatments accessible and affordable to as many people as possible
scientist looking through microscope
April 11 2018
Kumaraguru Raja sees “multiple catalysts” in the year ahead which could put a rocket under the share price
numerous pills
March 23 2018
Genervon is on the lookout for pharma partners to help advance its GM6 drug, which takes aim at a range of deadly diseases hitting the central nervous system

No investment advice

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is suitable or advisable for any specific person. You further understand that none of the information providers or their affiliates will advise you personally concerning the nature, potential, advisability, value or suitability of any particular security, portfolio of securities, transaction, investment strategy, or other matter.

You understand that the Site may contain opinions from time to time with regard to securities mentioned in other products, including company related products, and that those opinions may be different from those obtained by using another product related to the Company. You understand and agree that contributors may write about securities in which they or their firms have a position, and that they may trade such securities for their own account. In cases where the position is held at the time of publication and such position is known to the Company, appropriate disclosure is made. However, you understand and agree that at the time of any transaction that you make, one or more contributors may have a position in the securities written about. You understand that price and other data is supplied by sources believed to be reliable, that the calculations herein are made using such data, and that neither such data nor such calculations are guaranteed by these sources, the Company, the information providers or any other person or entity, and may not be complete or accurate.

From time to time, reference may be made in our marketing materials to prior articles and opinions we have published. These references may be selective, may reference only a portion of an article or recommendation, and are likely not to be current. As markets change continuously, previously published information and data may not be current and should not be relied upon.

© Proactive Investors 2018

Proactive Investor UK Limited, trading as “Proactiveinvestors United Kingdom”, is Authorised and regulated by the Financial Conduct Authority.
Registered in England with Company Registration number 05639690. Group VAT registration number 872070825 FCA Registration number 559082. You can contact us here.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use