An AI-powered wearable device that warns people with epilepsy about an impending seizure will launch in Europe next year.
The Episeras (formerly mjn-SERAS) device, developed by German specialty drugmaker Neuraxpharm and Spanish digital health startup mjn-neuro, is intended for use by people living with drug-resistant epilepsy who are at risk of sudden seizures that could lead to serious injury.
Drug-resistant epilepsy is when a person still has seizures after trying at least two types of anticonvulsant medicines at the prescribed dose, and is seen in around 30% of people with epilepsy overall and is even more common in disorders that start in childhood.
Episeras is a Bluetooth-enabled earpiece with a custom-designed, 3D-printed brain activity sensor which monitors for electrical signal patterns in the brain that may indicate a seizure is on the way in real-time, using an AI algorithm.
The sensor communicates with an app on a smart device, which can send a warning to the patient and trusted contacts, and can detect a seizure is on the way several minutes before it hits, according to the two companies. The app also displays seizure-risk data and notifications, supporting patients and their caregivers in daily monitoring.
They say Episeras is the first digital health solution for real-time early detection of seizures that will be available for both ambulatory and home care use. It has been validated and certified in Europe as a Class IIa medical device, holding both the EU CE mark and the UKCA mark.
Episeras is ready to start rolling out in Europe in the second half of next year, according to the two companies, which are running a prospective clinical trial of the technology (SERAS-Home_RWD) in Spain, the UK, and Germany. Interim results from that are currently being prepared for publication.
Central nervous system (CNS) disorder specialist Neuraxpharm has been pursuing a ‘beyond the pill’ strategy, aiming to combine drug therapies for disorders like epilepsy with digital health technologies and medical devices. The alliance with mjn-neuro – first signed in 2022 – represented its first concrete step in the strategy.
“With this launch, we are taking another important step in our journey to improve the daily lives of people with epilepsy,” said Dr Jörg-Thomas Dierks, Neuraxpharm’s chief executive. “This breakthrough embodies our commitment to digital personalised CNS care, helping patients feel safer, more in control, and better supported.”
The platform has been developed with support from the EU’s European Institute of Technology Health (EIT Health) and funding from the Horizon 2020 programme, along with industrial and academic partners.
