Pharma company Neuraxpharm and medical device developer mjn-neuro have announced plans to launch EPISERA, an epileptic seizure alert wearable, across Europe in Q2 2026.
Mjn-neuro’s wearable earpiece sensor continuously records the brain activity of epilepsy patients. Using artificial intelligence (AI), Episera analyses electrical brain patterns to determine when a seizure is likely to occur. Pairing with a dedicated smartphone app, the sensor sends an alert minutes before a seizure is forecast to occur when it interprets that risk levels are high.
Episera, which is intended for homecare and ambulatory use, is the first digital health tool for real-time early seizure detection, according to the companies. The device is classified as a Class IIa medical device and gained a European CE mark in 2020. Episera’s European commercialisation will be handled by German pharma Neuraxpharma.
Neuraxpharma signed an exclusive licence agreement to market Episera in Europe in 2022. The agreement covers all EU member states as well as the UK, Norway, Iceland, Liechtenstein and Switzerland.
David Blánquez, mjn-neuro’s CEO, commented: “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.”
A multicentre, prospective clinical study called SERAS-Home_RWD (NCT05845255) is also currently underway.
“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., Blánquez added.
For Neuraxpharma, it marks an entry into the digital health arena. The company’s portfolio also includes Buccolam (midazolam), which is indicated for the emergency treatment of epilepsy with prolonged acute convulsive seizures (PACS). The company acquired global rights to the asset from Takeda in 2020 yet has not disclosed how much the drug has generated in revenue.
Epilepsy is a disorder of the CNS, with seizures a side effect of abnormal electrical activity in the brain. Research indicates that around 50 million people are living with epilepsy worldwide. The condition can significantly impact individuals’ physical, psychological, social, and practical aspects of their daily life.
Other companies developing tools for epilepsy include Australia’s Epiminder. In April 2025, the company received a de novo classification from the US Food and Drug Administration (FDA) for Minder, an implantable electroencephalogram (EEG) monitoring system (iCEM) that aims to help clinicians improve diagnoses for epilepsy and monitor how well treatments for the condition are working.
