FDA Greenlights Pivotal Study of PRECISIS’ Minimally Invasive Brain-Stimulation Therapy for Drug-Resistant Epilepsy

Heidelberg, Germany – November 6, 2025. PRECISIS GmbH today announced that the U.S. Food & Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for its pivotal EASEE4US clinical study, marking a significant step toward U.S. market entry for its first-in-class epilepsy neuromodulation technology. Unlike traditional surgical neurostimulation implants, EASEE® electrodes are placed under the scalp and above the skull, offering a minimally invasive, targeted approach intended to fill the treatment gap between medication and brain surgery. “FDA clearance to begin this pivotal study marks a transformational moment for PRECISIS and underscores the significant value of our company as an investment opportunity,” said Karl Stoklosa, CEO of PRECISIS. “Securing IDE approval alongside our FDA Breakthrough Device designation places us among a select group of innovators advancing next-generation neuromodulation therapies through a structured and prioritized U.S. regulatory pathway. With this framework in place, we are now positioned to rigorously evaluate EASEE in a controlled clinical trial and take a decisive step toward making this minimally invasive approach accessible to patients and clinicians in the United States.” Michael Tittelbach, CTO of PRECISIS adds: “The FDA’s approval of our study design reflects the strength of our scientific and clinical strategy. EASEE is designed to offer a precise, personalized, and less-invasive neuromodulation option for people living with drug-resistant epilepsy. This pivotal study brings us closer to potentially expanding patient access to a new therapeutic approach.”

Epicranial Neuromodulation: A New Class of Epilepsy Therapy

The EASEE® System (Epicranial Application of Stimulation Electrodes for Epilepsy) is a CE-marked, minimally invasive neurostimulation therapy developed for patients with drug-resistant focal epilepsy. The system delivers electrical stimulation to the epileptic focus through electrodes placed beneath the scalp and above the skull, avoiding a craniotomy or direct contact to major nerves. EASEE® employs two distinct stimulation paradigms intended to modulate cortical excitability while preserving cognitive function and quality of life. The technology has been commercially available in Europe since 2023 and is currently in use in Germany, the UK, Austria, Switzerland, Portugal, and Italy. European clinical experience to date has been encouraging and has informed the design of the EASEE4US pivotal study, which aims to evaluate the therapy in a randomized, double-blind, sham-controlled setting in the United States, rather than in a head-to-head comparison against other therapies. “Approximately 30% of people with epilepsy do not respond to medication alone,” said Dr. Susanne Hager, Vice President of Medical Affairs at PRECISIS. “EASEE® offers a novel, less invasive approach positioned between pharmaceuticals and invasive epilepsy surgery. This pivotal study brings us closer to expanding patient access to a new therapeutic approach for drug-resistant epilepsy in the United States.”

Positioned for U.S. Expansion and Global Scale-Up

IDE approval represents a significant milestone for PRECISIS as the company advances toward U.S. market entry and scales its international clinical and manufacturing operations. The pivotal EASEE4US study is designed to generate data to support a future premarket submission to the FDA while expanding the global evidence base for epicranial neuromodulation. Dr. Felix Baader, Chairman of the Board, highlights, “This critical regulatory milestone marks the continuation of an exciting growth phase for PRECISIS—not only across Europe, but also as we advance toward the U.S. market. With this pivotal study approval, we are laying the foundation for further global expansion and broader patient access, creating an exceptional opportunity for new investors to join us at this transformative moment.” Building on the momentum of the recent €20 million venture loan from the European Investment Bank (EIB) under the European Commission’s InvestEU program, PRECISIS is actively engaging additional investment partners to complete a Series B and accelerate clinical development, scale manufacturing, and the successful execution of the U.S. trial strategy with the ultimate goal of receiving USA PMA approval and providing clinicians and their patients a new choice for the treatment of drug resistant focal epilepsy.