Precisis, a German neurotechnology company developing minimally invasive brain stimulation therapies, has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for its pivotal EASEE4US clinical study.

This marks a crucial step toward U.S. market entry for the company’s first-in-class epilepsy neuromodulation technology. Unlike traditional surgical neurostimulation, EASEE electrodes are placed under the scalp and above the skull—providing a minimally invasive, targeted approach to fill the treatment gap between medication and brain surgery.

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. It delivers electrical stimulation to the epileptic focus through electrodes, avoiding a craniotomy or direct contact to major nerves.

“Approximately 30% of people with epilepsy do not respond to medication alone,” said Dr. Susanne Hager, VP 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.”

EASEE leverages two distinct stimulation paradigms meant to modulate cortical excitability while preserving cognitive function and quality of life. The technology has been sold in Europe since 2023 and is currently used in Germany, the UK, Austria, Switzerland, Portugal, and Italy.

“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.”

Precisis said European clinical experience has been encouraging and informed the design of the EASEE4US pivotal study, which aims to evaluate the therapy in a randomized, double-blind, sham-controlled setting in the U.S., instead of a head-to-head comparison against other therapies.

The pivotal study is intended to generate data to support future premarket submission to the FDA while growing the global evidence base for epicranial neuromodulation. Precusus is engaging additional investment partners to complete a Series B.

“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,” said Precisis chairman Dr. Felix Baader. “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.”