A wearable medical device that can give an early warning of an epileptic seizure has been developed by medical device startup, mjn-neuro.\n\n\n\nCentral nervous system (CNS) specialist Neuraxpharm Group entered the digital health market by signing a commercialization agreement with the developer for mjn-SERAS with exclusivity in Europe.\n\n\n\nWith this agreement, Neuraxpharm increases its end-to-end offering for patients with epilepsy and enters the solutions beyond taking pills market. This is a significant step for the company on its path to entering the digital health and wearable medical devices markets.\n\n\n\nNeuraxpharm says there is a growing demand from patients looking for different solutions to unmet needs and healthcare systems. It wants to make solutions attainable for everyone and believes digital health is a critical component in CNS with significant potential.\n\n\n\nSolving planet's biggest problems \n\n\n\nThe agreement with mjn-neuro covers all EU member states as well as the UK, Norway, Iceland, Liechtenstein and Switzerland. Since 2020 mjn-SERAS has been receiving funding from the European Institute of Technology Health (EIT Health), a body of the European Union, during the development of the project thanks to the Bridgehead program and Start-up Amplifier.\n\n\n\nThe EIT Health’s Bridgehead program brings together European health entrepreneurs who want to grow their business beyond their home market. Start-up Amplifier's mission is to invest in and drive founders and engineers to solve our planet's biggest problems.\n\n\n\nIn 2018 the project was backed by the EU funding program Horizon 2020 initiated by the European Commission, and it also has the participation of a consortium of companies and healthcare professionals. \n\n\n\nHuge unmet need \n\n\n\nJörg-Thomas Dierks, CEO of Neuraxpharm, said: “The agreement to commercialize mjn-SERAS is an important step in our strategy to offer end-to-end solutions for patients with epilepsy. There is a huge unmet medical need for new and innovative solutions to help patients suffering from epilepsy.\n\n\n\n“By entering the digital health market, Neuraxpharm can provide further assistance and tap this unmet potential. We will continue expanding our offering to provide new digital health solutions to patients suffering from epilepsy and other CNS disorders across the world.”\n\n\n\nFirst wearable device \n\n\n\nmjn-SERAS is a digital health solution that provides advanced aid and helps to prevent accidents caused by epileptic seizures in drug-resistant patients. The medical device consists of a non-invasive sensor that records the electrical activity of the brain in real time and, thanks to artificial intelligence algorithms, triggers a warning when the risk of epileptic seizures is high.\n\n\n\nThe device received the CE marking for Europe in 2020 from BSI Group, the international notified body. Results of a clinical trial are expected in the second half of 2023. It will be the first wearable device to predict seizures, providing time to move to a safe place and helping to prevent accidents and injuries.\n\n\n\nBrain disorder \n\n\n\nDavid Blánquez, CEO and co-founder of mjn-neuro, added: “We are at a great point in the evolution of mjn-neuro. The agreement signed with Neuraxpharm is a major milestone for our strategy and scalability in the epilepsy market, a market that offers great potential.\n\n\n\n“We have a lot in common with Neuraxpharm - we’re both committed to innovation and digital health as a way to improve the quality of life of people with epilepsy. Therefore, we are confident that together we will be able to reach new exciting goals and objectives in the coming years.”\n\n\n\nEpilepsy is a brain disorder characterized by abnormal electrical activity that causes unpredictable seizures or unusual behavior and sensations and sometimes loss of consciousness. Such seizures can occur several times a day and may cause accidents and injuries. In addition to physical impacts, the unpredictability of the condition also negatively affects mental health.