Pressmeddelande från Emotra AB (publ)

11


Press release from Emotra AB (publ) Göteborg, March 11, 2016

The first stage of our clinical study has now been completed

Emotra AB is proud to announce that the first stage of our ongoing clinical multi-centre study has now been completed. More than 1,540 patients have been tested and analysed. In the second stage of our study, the patients will be monitored and checked during a 12-month period after testing. This stage of our study will be finalized on March 10, 2017.


The submission of new test data progressed at a high rate until the very end, with 1,540 patients being tested with EDOR™ since the trial was launched in the autumn of 2014.


Research centres and clinics in a large number of European countries have participated in the first stage of our study by regularly submitting test data to Emotra for analysis. All of this clinical patient data is now being compiled in Rome into a clinical database. At the same time, and without knowledge of the data in the clinical database, all of the test results are being compiled in an EDOR™ Test database in Linköping. These two databases will then be merged into a single, large BASELINE DATABASE. This work will enable us to study the relationship between hyporeactivity and previous suicide attempts, but also study the factors which are fundamental for theories of the reasons why some people commit suicide. The data analysis from the first stage of our study will result in a "Baseline publication".


Our study has now progressed to stage two. In this stage, the patients are monitored for signs of suicidal behaviour. This stage of our study will be finalized by March 10, 2017. After that we will move on to analysing the test results. We will be comparing the frequency of failed and successful suicide attempts among those patients we identified as hyporeactive and those who showed normal reactivity. After that, the material will be processed statistically. We have already secured the services of statistics experts and they have been continuously monitoring the progress of our study. They should therefore be able to begin their calculations with a minimum of delay. After this, we will gather all of the participating research groups to a consensus meeting to evaluate the results and compose a joint statement that everyone approves.


The Company plans to launch the product internationally once the study has been completed and we plan to base our marketing information to a large extent on the clinics' consensus statement. Our market launch will initially focus on the markets that were represented by clinics in our study and the Company's strategy is to start generating significant demand by reaching out to specialised psychiatric care clinics with information about EDOR™ and what our study has shown. Our idea is to let the involved clinics to a large extent act as ambassadors to the specialised care sector.


Our ambition is that our chosen strategy will lead to a quick market penetration. The Company's goal is to achieve stable and rapid growth under profitable conditions within two years of the product launch. The Company's organisation will grow in pace with our sales so that we can maintain maximum control of our costs in all stages of this process.


For further information about the Company, please contact:

Claes Holmberg, CEO, telephone: +46 708 25 45 47, E-mail: claes@emotra.se



Emotra AB (publ) is a medical technology company that carries out research, development, clinical studies and marketing in the area of suicide prevention. The Company's method, EDOR, is a proprietary, objective and quantitative diagnostic, psychophysiological test for detecting hyporeactivity in patients suffering from depression. During the test, the patient listens to a series of audio signals. The patient's response, in the form of very small changes in dermal electric conductivity, is measured and analysed. This extremely sensitive and specific test of suicidal risk has been developed as the result of research.


Emotra AB (publ), Göteborgsvägen 74, SE-433 63 Sävedalen, Sweden Tel: +46 708 25 45 47, www.emotra.se

Emotra AB issued this content on 11 March 2016 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 30 March 2016 16:46:02 UTC

Original Document: http://emotra.se/wp-content/uploads/2016/03/160311-Emotra-PM-First-stage-of-study-completed.pdf