For Healthcare Professionals
EASEE® Animation Video
Benefits of EASEE®
Despite modern anti-seizure medications, approximately one third of people with focal epilepsy do not achieve adequate seizure control. Existing alternatives — from additional medications to vagus nerve stimulation and resection — are not suitable or sufficiently effective for all patients. The result: persistent seizures, reduced quality of life, and a daily life marked by uncertainty. EASEE® offers a new therapeutic option.
Minimally invasive. Close to the focus.
EASEE® is not placed in the brain but subcutaneously on the skull — individually positioned directly above the epileptic focus. From there, EASEE® precisely modulates the activity of the epileptic network. The epicranial approach is significantly less invasive than conventional neurosurgical procedures or other systems — a decisive advantage for patients for whom an intracranial intervention was previously not an option.
Clinically proven. Measurably effective.
The efficacy of EASEE® is supported by study data: after 24 months, the data show a median seizure reduction of 68%, with a responder rate of 65.4%. In the final month of the 24-month observation period, 23% of patients were seizure-free. EASEE® demonstrated a well-tolerated safety profile — no serious therapy-related adverse events were observed. Robust evidence for a therapeutic option that can be considered earlier than expected.
MRI clean. Without compromise.
The EASEE® system is MRI conditional at 1.5 and 3 Tesla, including in close proximity to the implant. Diagnostically relevant brain structures remain clearly assessable and artefacts are minimised. Full neurological diagnostics therefore remain possible after implantation — a decisive advantage in everyday clinical practice.
Reversible. Patient-specific.
The EASEE® therapy is individually adjustable and fully reversible. The system can be adapted, deactivated, or even completely removed as needed, without leaving permanent changes to the brain. The epicranial approach keeps the therapeutic decision open and flexible — an important consideration particularly in conditions with a variable course, such as focal epilepsy.
The EASEE® System
Placement of EASEE®
A thin, flexible electrode is implanted subgaleally. The connecting cable is guided subcutaneously to the chest area using a tunneller and connected there to the pulse generator placed beneath the skin. This requires a total of two small incisions.
Ultra-thin, implantable Pseudo LaPlace Electrode
The innovative electrode configuration of the EASEE® Lead enables focused stimulation of the brain — without touching it.
A so-called Laplace electrode generates fields and current flows perpendicular to the plane of the arrangement. In the EASEE® system, the outer ring electrode is replaced by four individual electrodes to adapt the orientation of the resulting electric field to spatially varying impedances. This allows significant current flows to be achieved at the brain surface and in deeper structures — comparable to those seen with more invasive procedures.
Implantable Pulse Generator (IPG)
The EASEE® Power IPG is designed for patient-specific therapy and precisely and safely controls two combinable stimulation patterns: HFS (high-frequency stimulation) for seizure interruption and DLS (DC-like cathodal stimulation) for neuromodulation. Customisable parameters and integrated safety mechanisms support flexible, evidence-based, and safe neurostimulation.
Therapy that adapts to the individual
The configuration of stimulation patterns has a decisive influence on therapeutic success. EASEE® allows stimulation parameters to be adjusted non-invasively from outside the body — individually tailored to each patient. In addition, patients experiencing an aura can trigger targeted stimulation themselves using a remote control, enabling them to take an active role in their own therapy.
How EASEE® works
DC-like Mode of Action (DLS)
The DC-like cathodal stimulation (DLS) of the EASEE® system enables long-term inhibition at the epileptic focus. It reduces cortical excitability of the epileptic network through hyperpolarisation. Its goal: a long-term reduction in seizure frequency in drug-resistant focal epilepsy.
HFS Mode of Action
High-frequency stimulation enables the acute interruption of incoming epileptic seizures by immediately suppressing pathological neuronal activity. With EASEE®, you combine long-term neuromodulation with acute seizure interruption.
PCN Mode of Action
With Patient Controlled Neurostimulation (PCN), you enable your patients to trigger on-demand additional stimulation: they can initiate a burst themselves, for example during an aura. For you as the treating clinician, this means individualised therapy supplementation within a clearly defined neurostimulative framework.
Study Results
Proven Efficacy over 2 Years
As a treating clinician, you need robust long-term results: after 24 months, 65.4% of patients achieved a ≥50% reduction in seizure frequency. Almost one in three patients achieved a seizure reduction of ≥90% after 24 months. In the final month of the 24-month observation period, 23% of patients were seizure-free. This high responder rate confirms the sustained efficacy of EASEE® in drug-resistant focal epilepsy.
EASEE® also demonstrated a well-tolerated safety profile — no serious therapy-related adverse events were observed.1
Sustained Seizure Reduction over Time
The study data demonstrate not only early effects, but continuous improvement over time: after 2 years, a median seizure reduction of 68% was achieved — indicative of long-term neuromodulation rather than short-term effects.1, 2
High Therapy Retention Reflects Tolerability and Acceptance
Four out of five patients continued EASEE® therapy through at least the 2-year follow-up — despite the necessary pulse generator replacement in the second year. 1
*EASEE® now has a battery life of at least 3 years.
More than just Seizure Control
Beyond reductions in seizure frequency, the study data show positive effects on quality of life, mood, and neurocognition. Neurocognitive performance improved significantly (EpiTrack®), while emotional stability was maintained throughout the study period.1
Studies
EASEE II – Start First-in-Human Study
2019
Completed
EASEE II was a prospective, multicentre study in which adults with treatment-resistant focal epilepsy received the newly developed EASEE® system. The study investigated the safety, tolerability, and efficacy of the stimulation.
PIMIDES I – Second Study initiated
2020
Completed
PIMIDES I was the second prospective, multicentre study in which adults were treated with the EASEE® system. In addition to continuous stimulation, patients were able to trigger a bolus themselves on demand.
EASEE4YOU – Pivotal Study in Adolescents initiated
2023
Ongoing
The EASEE4YOU study investigates the safety and efficacy of EASEE® in adolescents aged 12–17 years as a new therapeutic option for medication-refractory focal epilepsy. With the completion of the recruitment phase in early 2026, an important milestone on the path to approval of EASEE® for patients aged 12 and above has been reached. First results are expected in 2027.
EASEE-LEE
2023
Ongoing
The international long-term registry study EASEE-LEE on efficacy and safety follows EASEE® patients for up to five years.
EASEE-PEARL – German Registry Study initiated
2024
Ongoing
The EASEE-PEARL registry study collects real-world data on the EASEE® system in Germany, following patients over three years.
EASEE4US – US Pivotal Study
2026
In Preparation
The US regulatory authority FDA has approved the conduct of a randomised, double-blind pivotal study with approximately 200 patients. The study is scheduled to commence in the second quarter of 2026.
What Clinicians say
Prof. Dr. Andreas Schulze-Bonhage
Head of the Epilepsy Centre at the Neurocenter, University Medical Center Freiburg
Since the electrode does not need to be placed in the brain but is positioned directly beneath the scalp, the skull does not need to be opened. This means the procedure does not carry the risks associated with brain surgery, such as vascular injury or infection.
PD Dr. Elisabeth Kaufmann
Consultant Neurologist at the LMU Munich
The high number of implantations shows that there continue to be many patients with drug-resistant epilepsy who are not candidates for resection or do not wish to undergo it, and who now have a new treatment option through EASEE. EASEE represents a valuable addition to the therapeutic spectrum.
MRI Guidelines
Sources
1 Schulze-Bonhage et al., Epilepsia 2025
2 Schulze-Bonhage et al., Epilepsy & Behavior 2025
Discover more from PRECISIS
PRECISIS GmbH, based in Heidelberg, develops bioelectronic therapies that target the very source of neurological diseases – the brain itself. Learn more about our technology, our team, and the vision behind EASEE®.
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