November 6, 2025

PRECISIS GmbH, a German neurotechnology company specializing in minimally invasive brain-stimulation therapies, has announced a major milestone in its efforts to enter the U.S. market. The U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for the pivotal EASEE4US clinical study. This authorization allows PRECISIS to begin evaluating its EASEE® system for treating drug-resistant focal epilepsy.

Addressing the Treatment Gap

EASEE® is described as a first-in-class epilepsy neuromodulation technology designed for patients living with drug-resistant focal epilepsy. Estimates suggest that approximately 30% of people with epilepsy do not respond to medication alone.

The EASEE® system aims to fill the treatment gap between medication and traditional brain surgery, offering a novel and less invasive approach. Unlike conventional surgical neurostimulation implants that require more extensive procedures, EASEE® utilizes epicranial neuromodulation. Its electrodes are placed beneath the scalp and above the skull, thereby avoiding a craniotomy (surgical opening of the skull) or direct contact with major nerves.

The device—its name derived from Epicranial Application of Stimulation Electrodes for Epilepsy—delivers electrical stimulation directly to the epileptic focus. It employs two distinct stimulation paradigms intended to modulate cortical excitability while preserving cognitive function and quality of life. Michael Tittelbach, CTO of PRECISIS, noted that EASEE® is designed to provide a precise, personalized, and less invasive neuromodulation option for patients.

The EASEE4US Pivotal Trial

The FDA’s decision to grant IDE approval follows the device’s earlier Breakthrough Device designation. Securing both IDE approval and Breakthrough Device status places PRECISIS among a select group of innovators advancing next-generation neuromodulation therapies through a prioritized U.S. regulatory pathway.

The pivotal EASEE4US clinical study will rigorously evaluate the safety and efficacy of the therapy. The trial is expected to enroll approximately 200 patients in a randomized, double-blind, sham-controlled study conducted in the United States. The results are intended to generate the data necessary for a future Premarket Approval (PMA) submission to the FDA.

Dr. Susanne Hager, Vice President of Medical Affairs at PRECISIS, stated that this pivotal study moves the company closer to expanding patient access to a new therapeutic approach for drug-resistant epilepsy in the United States.

Global Expansion and Financial Momentum

The EASEE® system is already commercially available in Europe, having received CE-marking. Early use in Europe has shown promising results. The technology has been available since 2023 and is currently in use in several countries, including Germany, the United Kingdom, Austria, Switzerland, Portugal, and Italy. European clinical experience has helped inform the design of the U.S. pivotal study.

This authorization marks a significant step for PRECISIS as it advances toward U.S. market entry and scales its global operations. To support expansion and the U.S. trial, the company recently secured a €20 million venture loan from the European Investment Bank (EIB). PRECISIS is also engaging with additional investment partners to complete its Series B funding round. The ultimate goal is to achieve U.S. PMA approval and provide clinicians and patients with a new option for treating drug-resistant focal epilepsy.

Karl Stoklosa, CEO of PRECISIS, referred to the FDA clearance to begin this pivotal study as a “transformational moment” for the company. Dr. Felix Baader, Chairman of the Board, added that this regulatory milestone lays the foundation for further global expansion and broader patient access.