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Seizure Risk Asessment for Epilepsy

Periodic Reporting for period 1 - SERAS_v4.0 (Seizure Risk Asessment for Epilepsy)

Reporting period: 2019-04-01 to 2020-03-31

Epilepsy is a chronic condition of the brain that affects between 60 and 100 million people worldwide. The main risk of this disease is unplanned seizures that can cause serious accidents, particularly in the case of drug-resistant patients. The risk of suffering a fatal accident is 3 times higher than in a healthy person. And the probability of suffering a sudden death is 16 times higher. People affected cannot lead a normal life, as they must continually minimize the risk of an accident. Epilepsy is a stigmatized disease and those affected suffer from a lack of self-confidence and autonomy.

Current scientific knowledge about epilepsy is obtained by recording the signals from the brain with an EEG. However, this test requires hospitalization and the data recorded are temporary. No commercial technology exists that can provide an ongoing assessment of seizure risk by recording brain signals with clinical accuracy.

MJN Neuroserveis was founded in 2014 with the mission to improve the quality of life of people affected by epilepsy. Our MJN-SERAS solution is the first portable device that can warn patients before seizures occur by continuously recording signals from the brain. We launched our company because we detected the lack of seizure prediction systems, and wanted to create a very discreet and portable product with sufficient detection capability. From the beginning we had the vision to provide the market with a headset able to warn before a seizure by recording the EEG through the ear canal and applying the artificial intelligence to process the collected signal.

MJN-SERAS is a disruptive innovation that aims to fill this gap. It consists of a portable, wireless, non-invasive and discreet medical device that is able to generate an alarm signal a minimum of one minute before a seizure begins. During this time, the patient can reach a safe place until the seizure subsides.

Thanks to the help of the European Commission, we are making great progress in our project in different areas. In summary, we have improved our customised epilepsy seizure prediction algorithms. Developed a Social-SERAS mobile application that allows a better understanding of the disease. Created a big data engine and a cloud data storage system to collect and process the large volume of data obtained by MJN-SERAS and Social-SERAS. We have expanded our clinical studies. We are also communicating our project as a basis for the future commercialization of our solutions for people with epilepsy. And last but not least, we are building a team of highly qualified people, involved with MJN's objectives, who will allow the company to grow with a solid base and project it into the future to obtain a real and scalable positive impact on society.
"We can describe the work done during the 12 months of implementation of the SME Instrument Ph2 project and the main results as follows.

Improved epilepsy seizure prediction algorithms.
Every epilepsy attack is unique and personal. In other words, each affected person has his or her own seizures. For this reason, to obtain optimal results for our solution, it is needed the customization of the algorithms for each user. We have improved this customization in two ways. First, we get positive results on more types and classes of epilepsy. Second, we have reduced the algorithm customization time from 48 hours to 12 hours. In addition, the whole process has been automated so that it can be carried out autonomously. With this evolution we have managed to guarantee the scalability of our project since we can satisfy the expected demand by increasing the capacity and computing power of the servers where we have hosted the customization process of our algorithms.

Social-SERAS and big-data application.
Epilepsy is a great unknown to people and is strongly stigmatized. And although it is a disease of great social impact, the resources dedicated to research are much less than in other neurological diseases, such as Alzheimer's. To reverse this situation, MJN is developing the Social-SERAS. Thanks to this mobile application, a large amount of data from the ""daily life"" of people with epilepsy is collected and analyzed by a big data that has been developed, also, thanks to the SME Instrument Ph2 project. At this moment a functional version of the application is already available and is being tested by our beta-testers. With the first data collected we are also testing the performance of the big data.
Extension of clinical studies.
In order to increase the clinical validation of MJN-SERAS results, new clinical validation trials are planned in Spain and Germany. In the first completed clinical study, the results have been excellent, both for predicting and recording seizures. Sensitivity rates of over 90% and an average seizure prediction time of 8 minutes were obtained. Currently, we are waiting for the necessary certificates to extend the studies to new hospitals.

Dissemination of our project.
MJN-SERAS is a medical device that requires the necessary certifications to be commercialized. It is very important to have the support of the medical community as our solution is unique in predicting epilepsy seizures. Thanks to the support of the European Commission, we plan to attend several specific epilepsy scientific conferences in Europe and the United States, to organize workshops to present our solution and set up a Scientific Advisory Board, composed by top-level epilepsy specialists. These activities will allow us to access our market in a solid way and with the support of health professionals."
Our project has two different aspects. On one hand, the technological aspect. This is where artificial intelligence or big data comes in. And on the other hand, the social impact that our project implies. In this sense, during the first 12 months of the project's execution, the European Investment Bank has recognized us as one of the 15 projects with the greatest impact in Europe. And World Summit Awards has awarded us as GLOBAL CHAMPION in the category of health and welfare. This award is very important as we have competed against 160 selected projects from all over the world and it aligns us perfectly with the United Nations Sustainable Development Goals.

In summary, thanks to SME Instrument Ph2 program and all the tasks performed in the first 12 months of the project, MJN Neuroserveis is preparing to compete in a global environment. And it is making progress in achieving our main long-term goals: improving the quality of life of people with epilepsy today and helping people with other neurological diseases in the future. And all this from a social perspective and with a quantifiable and positive social impact.
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