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, announced the launch of EPISERAS^®, a pioneering digital health solution designed to predict the risk of epileptic seizures in real time.

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 mark and UKCA.

A multicentre, prospective clinical study SERAS-Home_RWD is currently underway. 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.