Neuraxpharm and mjn-neuro are preparing to launch a digital health solution designed to detect the early risk of epileptic seizures in real time. The system, called EpiSeras, is based on a non-invasive wearable earpiece that monitors brain activity and uses artificial intelligence to identify patterns linked with an increased likelihood of a seizure. Patients and caregivers receive alerts minutes before an episode, offering time to move to safety or notify support networks.

The device was developed by mjn-neuro, a Spanish company working in AI-based neurotechnology, and will be commercialised through Neuraxpharm across Europe. The launch marks Neuraxpharm’s expansion beyond medicines into digital and device-based tools that complement its long-standing focus on central nervous system disorders.

The earpiece records electrical signals from the brain and transfers data to a connected mobile application, which interprets and displays risk-level information. It is intended for people with drug-resistant epilepsy, who often face unpredictable seizures and a persistent risk of injury. By giving advance warning, the system aims to offer an additional layer of safety alongside standard therapies. It has been validated as a Class IIa medical device in Europe with CE marking and holds equivalent UKCA certification.

A multicentre clinical study, Seras-Home_RWD, is ongoing in Spain, the UK and Germany. Interim data from this real-world evaluation are being prepared for publication. The study is assessing quality of life, seizure-related accidents and the performance of the system in day-to-day settings.

Jörg-Thomas Dierks, chief executive officer of Neuraxpharm, said: “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.”

Neuraxpharm expects the European roll-out to begin in the second half of 2026. The initiative strengthens its presence in epilepsy management, broadening existing medicines with a digital tool that supports personalised, real-time care and reflects wider momentum towards combining pharmacological and technological approaches in CNS treatment.