AI Earpiece to Predict Epileptic Seizures Minutes Before They Strike

DÜSSELDORF, Germany and BARCELONA, Spain – November 27, 2025 – A groundbreaking collaboration between pharmaceutical leader Neuraxpharm and neurotechnology start-up mjn-neuro is set to bring a new level of predictability to one of the world's most unpredictable neurological conditions. The companies have announced the upcoming launch of EPISERAS®, an AI-powered wearable device designed to provide real-time warnings of epileptic seizures minutes before they occur.

The device, a discreet earpiece, represents a significant leap forward in epilepsy management, particularly for the approximately 30% of patients whose seizures are not controlled by medication. By offering a crucial window of warning, EPISERAS® aims to transform daily life for patients, enhancing safety, reducing anxiety, and restoring a sense of autonomy that is often lost to the constant threat of a sudden seizure. The European launch is planned for the second half of 2026, signaling a new chapter in the integration of digital health and traditional CNS care.

From Detection to Prediction: A New Technological Paradigm

For years, the focus of wearable technology in epilepsy has been on seizure detection. Devices like wrist-worn smartwatches primarily use motion sensors (accelerometry) and electrodermal activity monitors to identify the convulsive movements typical of a tonic-clonic seizure, sending an alert to caregivers after an event has already begun. While valuable, this reactive approach does little to mitigate the immediate danger of a seizure's onset.

EPISERAS® operates on a fundamentally different principle: proactive prediction. Developed over more than a decade by mjn-neuro, the device is a non-invasive earpiece sensor that continuously monitors the brain's electrical activity. This bio-signal data is fed into a sophisticated artificial intelligence algorithm, which has been trained to recognize the subtle, often invisible, changes in brainwave patterns that precede a seizure.

When the algorithm identifies a high-risk state, it sends an alert to a dedicated mobile application on the user's or caregiver's smartphone. This warning, delivered minutes before the seizure, provides invaluable time for a person to move to a safe place, pull over if driving, or simply prepare themselves and notify others. It is this predictive capability, based on direct neurological data, that sets it apart in a growing market of epilepsy monitoring devices estimated to be worth nearly $600 million in 2024.

"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," said David Blánquez, Chief Executive Officer and Co-Founder of mjn-neuro. "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."

A Life-Changing Warning for Patients and Families

The true significance of this innovation lies in its potential impact on the lives of people with drug-resistant epilepsy. The unpredictability of seizures casts a long shadow, breeding constant anxiety and imposing severe limitations on daily activities like working, swimming, or even cooking. This chronic uncertainty affects not only the patient but their entire family and support network.

A reliable early warning system directly addresses this core challenge. By replacing uncertainty with a timely alert, EPISERAS® offers the potential to dramatically reduce seizure-related injuries. More profoundly, it can restore a measure of control and independence. The ability to know a seizure is imminent can empower individuals to participate more fully in life's activities, lessening the psychological burden of the condition.

Patient advocacy groups have long highlighted the need for better predictive tools. While usability, comfort, and accuracy will be critical for widespread adoption—with users intolerant of high false-positive rates or cumbersome designs—the promise of a discreet, brain-sensing predictor is a powerful one. The non-invasive earpiece form factor is a deliberate choice to create a solution that can be worn comfortably and continuously without drawing unwanted attention.

Pharma's Pivot: Neuraxpharm's "Beyond the Pill" Strategy

The launch of EPISERAS® is more than just a new product release; it represents a major strategic move by Neuraxpharm, a European specialty pharmaceutical company focused on central nervous system disorders. The company's partnership with mjn-neuro, first established in 2022, marks its formal entry into the digital health and medical device arena, embodying an industry-wide trend often referred to as "beyond the pill."

This strategy acknowledges that optimal patient outcomes, particularly in chronic conditions like epilepsy, often require more than just medication. By integrating digital tools, monitoring devices, and data analytics with their extensive portfolio of anti-epileptic treatments, Neuraxpharm aims to create a holistic, end-to-end care ecosystem. This positions the company not just as a drug manufacturer, but as a comprehensive partner in patient health management.

Dr. Jörg-Thomas Dierks, Chief Executive Officer of Neuraxpharm, framed the launch in these strategic terms. "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," he stated. "By combining our deep therapeutic expertise with cutting-edge technology, we are making our vision of holistic CNS care a reality."

This pivot allows established pharmaceutical players to tap into the innovation of agile start-ups and address unmet patient needs that medication alone cannot solve. It also diversifies their business model in an era of intense competition and evolving healthcare priorities.

The Road to Market: Validation and Commercialization

Bringing a novel medical device like EPISERAS® to patients is a complex process that requires rigorous scientific validation and regulatory approval. The device has already achieved significant milestones, securing both a CE mark under the EU's Medical Device Regulation (MDR) and a UKCA certification in the United Kingdom. These classify it as a Class IIa medical device, confirming it meets stringent safety and performance standards for the European and British markets.

To further bolster its clinical evidence, a multicentre, prospective study, SERAS-Home_RWD, is currently underway in Spain, the UK, and Germany. This study is designed to evaluate the device's impact on quality of life and seizure-related accidents in a real-world home environment. According to the companies, interim data from this crucial trial is now being prepared for publication, which will be a key moment for clinicians and patients evaluating the technology's efficacy.

With the regulatory framework in place and real-world data forthcoming, Neuraxpharm is planning a phased European launch beginning in the second half of 2026. This strategic rollout will allow the company to build market access and gather further post-market data, refining its approach to commercialization and reimbursement. The success of EPISERAS® will ultimately depend on its clinical robustness, user acceptance, and ability to integrate seamlessly into the existing epilepsy care pathway, but its impending arrival marks a hopeful new dawn for predictive, personalized neurology.