Neuraxpharm and mjn-neuro announce plans to launch EPISERAS®, a digital health solution using an AI-powered wearable device for the early detection of epileptic seizures
A non-invasive, AI-based, wearable earpiece that continuously monitors brain activity to enable the early detection of seizure risk in real time, alerting patients and caregivers minutes before an episode occurs1
This breakthrough innovation represents a major milestone in Neuraxpharm's commitment to advancing both digital and personalised solutions that enhance safety and improve quality of life for people living with epilepsy
Interim data from the ongoing SERAS-Home_RWD clinical study currently being prepared for publication
BARCELONA, Spain and DÜSSELDORF, Germany, Nov. 27, 2025 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, and mjn-neuro, a start-up that designs, manufactures and markets medical devices, today announce the upcoming launch of EPISERAS®, a pioneering digital health solution designed to predict the risk of epileptic seizures in real time.1
The launch of this innovative digital solution, developed by mjn-neuro, a Spanish digital health company specialising in AI-driven neurotechnology, represents a significant milestone in Neuraxpharm's mission to go beyond providing medication only, by offering patients and healthcare professionals complementary digital tools that enhance safety, autonomy, and quality of life.
EPISERAS® is a non-invasive digital medical device that continuously records brain activity through a discreet, wearable earpiece sensor. Using advanced artificial intelligence algorithms, it analyses electrical patterns in the brain to identify when a seizure is likely to occur and sends an alert minutes before the seizure will happen when risk levels are high. The device connects to a dedicated mobile application that analyses and displays seizure-risk data and notifications, supporting patients and caregivers in daily monitoring. The solution is intended for use in patients with drug-resistant epilepsy, offering a proactive tool to help prevent accidents and improve safety in daily life. It is the first digital health solution for real-time early detection of seizures that will be available for both ambulatory and homecare use, providing patients with a warning that gives them valuable time to move to a safe place or notify caregivers. The medical digital solution has already been validated and certified in Europe as medical device Class IIa, holding the CE mark1 and UKCA.2
A multicentre, prospective clinical study SERAS-Home_RWD is currently underway.3 The study is being conducted across three countries —Spain, the United Kingdom, and Germany. Interim data is being prepared for publication.
Dr. Jörg-Thomas Dierks, Chief Executive Officer of Neuraxpharm, said: "At Neuraxpharm, we are dedicated to improving the lives of people with CNS disorders through continuous innovation and strong partnerships. With this launch, we are taking another important step in our journey to improve the daily lives of people with epilepsy. This breakthrough embodies our commitment to digital personalised CNS care, helping patients feel safer, more in control, and better supported. By combining our deep therapeutic expertise with cutting-edge technology, we are making our vision of holistic CNS care a reality. Our goal is to expand access to effective care that enhances safety, autonomy, and long-term wellbeing for patients."
David Blánquez, Chief Executive Officer and Co-Founder of mjn-neuro, added: "Our team has been developing this pioneering project for more than ten years, and thanks to the results obtained from several clinical studies, mjn-neuro has successfully demonstrated solid clinical evidence supporting its effectiveness. We are now focused on ensuring that patients can benefit from this innovation that will help improve their quality of life and reduce accidents caused by seizures. Working with Neuraxpharm on the European market launch is a key step in bringing this breakthrough solution to those who need it most."
The launch of this medical digital solution across Europe, scheduled to commence in the second half of 2026, will consolidate Neuraxpharm's strategic entry into the medical devices and digital health space. Neuraxpharm will strengthen its long-standing commitment to epilepsy management, building on a comprehensive portfolio of anti-epileptic treatments and formulations. This digital health solution expands these efforts, offering an innovative, non-pharmacological tool that complements standard therapies and brings personalised, data-driven care to patients.
Neuraxpharm first partnered with mjn-neuro in 2022, marking its entry into the wearable technology space. This initiative demonstrates Neuraxpharm's commitment to advancing breakthrough innovation across both pharmacological and technology-driven approaches to CNS care.
References
1 EU Medical Device Regulation (EU MDR) certificate 777314
2 UKCA Class IIa certificate 777308
3 MJN Neuroserveis, S.L. (2024). Evaluation of the epilepsy-related quality of life, seizure-related accidents and validation of the mjn-SERAS solution in the normalised patient environment with real-world data (SERAS_Home_RWD) [Clinical trial]. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT05845255
About EPISERAS®
EPISERAS® is a non-invasive medical digital solution that continuously records brain activity through a discreet, wearable earpiece sensor. Using advanced artificial intelligence algorithms, the solution analyses electrical patterns in the brain for the early identification of when a seizure is likely to occur and sends an alert when risk levels are high. This early warning enables patients to take preventive action, such as moving to a safe place or notifying caregivers, thereby reducing the risk of accidents and improving quality of life. 1
About the Neuraxpharm Group
Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders, with a unique understanding of the CNS market.
Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline, partnerships and acquisitions.
The company has c.1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East, in Australia and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira.
Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain.
For more information, please visit https://www.neuraxpharm.com/
About mjn-neuro
mjn-neuro is a Girona-based start-up founded in 2014 that designs, manufactures and markets medical devices with the aim of improving people's quality of life. The company's first product worldwide is the mjn-SERAS (EPISERAS®) medical device, which provides early warning of an epileptic seizure. The device has been developed from 2018 and tested in several clinical trials.
mjn-neuro continues working on new solutions for other neurological diseases based on new technology and artificial intelligence algorithms, in collaboration with clinical and technological centers. mjn-neuro is in close exchange with the medical side, which allows the company to understand the problems and needs of doctors and patients and help find the best solutions to address them, either through devices, technology or artificial intelligence solutions.
For more information please visit https://mjn.cat/en/
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