Seizure Risk Asessment for Epilepsy

Project Information

SERAS_v4.0

Grant agreement ID: 849781

DOI

10.3030/849781

Project closed

EC signature date 13 March 2019

Start date 1 April 2019

End date 31 March 2022

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 2 568 300,00

EU contribution

€ 1 797 810,00

Coordinated by

MJN NEUROSERVEIS SL
Spain

Periodic Reporting for period 2 - SERAS_v4.0 (Seizure Risk Asessment for Epilepsy)

Reporting period: 2020-04-01 to 2022-03-31

Summary of the context and overall objectives of the project

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 has been the first medical device in Europe approved for seizure prediction in epilepsy. 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 European Commission grant we have brought the device to the market, from technical development, artificial intelligence algorithms, clinical studies and the commercialization task for reaching real patients in outside hospital environment. We have performed not only the needed app for the device but also a Social-SERAS app to help affected people, caregivers and families, so the product is able to contribute to better quality of life for those people.

MJN has also been improved in professionality and team members, where people have a task but also a commitment with the project and the social task of the company. We have the Social Impact seal and we have been awarded in so many social events.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

We have split the work done in several aspects :

Technology, AI algorithms for seizure prediction.
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 2 hours process. 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.

Clinical studies, evidences.
We have improved our clinical studies and results by working directly with hospitals and clinical centers, neurologists and related professionals are very interested in the results of the project and next steps, performance in real life conditions.
Our results in hospital have been increased, in patients and performance, more than 80 patients with a final result of 95% sensitivity, 0’55 false alarm rate per day and average time before the seizure of 9 minutes. Correlation between hospital machine for EEG recording and our device goes to 83% to 96%.

Commercialization of the product.
We have reached the CE mark in 2020, a permission for sales devices in all Europe, this is the main goal of the company, so now we are able to start Spanish market but also other countries. And this is the main step that we need to negotiate commercial relationships, as done with a pharma company specialized in central nervous system, neurology, for a distribution in all European countries plus some others.

Dissemination of the project.
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 has been talking and promoting the project and also the disease to make a normalization for the disease in all environments.
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.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Our project has two different aspects. On one hand, the technological aspect, where we are working with Artificial Intelligence and we have received some recognitions, as scientific entrepreneur in Barcelona, best wearable in Berlin, Fenin price in medical technology in Madrid or a 2nd place in Medica competition Innovation World Cup Series in Dusseldorf . And on the other hand, the social impact that our project implies. We have been awarded in some contests, like 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.

All these recognitions, among a total of 26, means that we are performing a next step in both technical and social aspects, we have developed a smart tool able to help people with epilepsy and in future other diseases.

We have a positive impact in the patient’s quality of life, reducing accidents and injuries, but also improving anxiety and stress, and health system is reducing activities due to the seizures and accidents, so reducing the cost of epilepsy. Our cost reduction for health systems will be 400M€ in 2026.

Main innovation is developing a portable and discrete EEG for long recording, daily monitoring, with integrated AI algorithms to help the users, focused on epilepsy but with the potential to develop other algorithms that can benefit from the EEG recording, as Alzheimer, Parkinson, schizophrenia, and others, like a useful tool for patients or like a holter EEG for doctors.

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