FDA Authorizes Pivotal US Trial of Minimally Invasive Neuromodulation System for Drug-Resistant Epilepsy
The Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for the EASEE4US clinical study, allowing PRECISIS (Heidelberg, Germany) to begin investigating its Epicranial Application of Stimulation Electrodes for Epilepsy (EASEE; PRECISIS, Heidelberg, Germany) system in approximately 200 individuals with drug-resistant focal epilepsy. The EASEE system was previously granted Breakthrough Device designation by the FDA, and according to a statement released by PRECISIS, the company secured a €20 million venture loan from the European Investment Bank to support its US trial and global expansion.
The pivotal, multicenter, randomized, double-blind, sham-controlled EASEE4US trial will enroll approximately 200 participants to evaluate the safety and efficacy of the EASEE system. Unlike traditional deep brain or vagus nerve stimulation devices, EASEE delivers epicranial neuromodulation through electrodes placed beneath the scalp and above the skull—avoiding a craniotomy and reducing procedural invasiveness. The therapy is designed to target the epileptic focus directly while maintaining the quality of life and cognitive function of its users. Results from the EASEE4US pivotal trial are expected to inform a future premarket submission to the FDA.
EASEE is already CE-marked and commercially available in parts of Europe, including Germany, the United Kingdom, and Switzerland, where early clinical use has shown promising outcomes. European data have helped shape the trial design of EASEE4US, which aims to confirm efficacy in reducing seizure frequency and improving quality of life among people with focal epilepsy unresponsive to medications.
Source: PRECISIS. FDA greenlights pivotal study for PRECISIS’ minimally invasive brain-stimulation therapy for drug-resistant epilepsy. PRECISIS. Published November 5, 2025. Accessed November 12, 2025. https://precisis.de/en/press/fda-greenlights-pivotal-study-of-precisis-minimally-invasive-brain-stimulation-therapy-for-drug-resistant-epilepsy/