Neuraxpharm to commercialize mjn-neuro’s CE-marked seizure prediction earpiece

GERMANY—Pharma company Neuraxpharm and medical device developer mjn-neuro have announced plans to release EPISERA, a wearable designed to alert epileptic patients of seizures, across Europe in the second quarter of 2026.

This innovative device aims to provide early seizure detection, offering patients greater safety and peace of mind in everyday life.

The wearable sensor created by mjn-neuro is an earpiece that continuously monitors brain activity in epilepsy patients.

It uses artificial intelligence (AI) to analyze electrical signals from the brain and predict when a seizure is likely to occur.

When the device detects heightened risk, it sends an alert via a dedicated smartphone app several minutes before the predicted seizure.

This early warning system intends to give users sufficient time to seek safety or assistance.

Designed primarily for home and ambulatory use, EPISERA represents the first real-time digital health tool specifically focused on early seizure detection.

The device is classified as a Class IIa medical device and received its European CE marking in 2020.

Neuraxpharm, a German pharmaceutical company, will handle the commercialization of EPISERA throughout Europe.

In 2022, Neuraxpharm secured an exclusive license agreement to market EPISERA across all member states of the European Union, as well as in the UK, Norway, Iceland, Liechtenstein, and Switzerland.

David Blánquez, CEO of mjn-neuro, emphasized the company’s decade-long commitment to developing this technology.

He highlighted that clinical studies have provided solid evidence supporting EPISERA’s effectiveness.

Currently, a multicentre, prospective clinical trial, SERAS-Home_RWD (NCT05845255), is underway to validate the device’s benefits further.

Blánquez expressed the company’s focus on enabling patients to access this innovation, expecting it will improve their quality of life and reduce seizure-related accidents.

For Neuraxpharm, introducing EPISERA marks its entry into the digital health field.

Besides EPISERA, the company is also known for Buccolam (midazolam), a treatment approved for emergency intervention during prolonged acute convulsive seizures (PACS).

Neuraxpharm acquired global rights to Buccolam from Takeda in 2020, although financial details concerning its revenue have not been disclosed.

Epilepsy affects the central nervous system (CNS) and causes seizures due to abnormal electrical brain activity.

Globally, approximately 50 million people live with epilepsy, a condition that impacts their physical, psychological, social, and daily functional aspects.

In addition to EPISERA, companies such as Australia’s Epiminder are advancing tools for epilepsy care.

In April 2025, Epiminder received a de novo classification from the US Food and Drug Administration (FDA) for Minder, an implantable electroencephalogram (EEG) monitoring system.

Minder aims to assist clinicians in diagnosing epilepsy more accurately and assessing treatment effectiveness.

The innovation in real-time seizure monitoring devices like EPISERA and Minder reflects growing efforts to improve epilepsy management and enhance patient safety globally.