Epsilon’s EP-01 Endovascular EEG Device Granted FDA Breakthrough Device Designation

May 20, 2025—Japan-based Epsilon Medical Inc. announced that the FDA has granted Breakthrough Device designation for the company’s EP-01 endovascular electroencephalogram (EEG) device.

According to the company, the EP-01 device is intended for temporary use in recording and monitoring brain electrical signals in patients with drug-resistant epilepsy. It is designed for percutaneous access via the jugular vein.

Epsilon’s CEO is Yuji Matsumaru, MD, Professor at the University of Tsukuba in Tsukuba, Japan.

“We believe that our endovascular EEG device will bring innovation to EEG diagnosis for patients with drug-resistant epilepsy,” commented Dr. Matsumaru in the company’s press release. “The Breakthrough Device designation underscores this belief, and we are committed to establishing minimally invasive EEG diagnostic technology.”

Additionally, the company stated that the first-in-human (FIH) clinical trial of the device was conducted in Japan. The trial, which was composed of five patients with drug-resistant epilepsy, confirmed that EEG was obtained in all patients and that the EP-01 could be safely implanted and removed, reported Epsilon Medical.

The findings from the first case of the FIH trial were published by Yousuke Masuda, MD, et al in the March 2025 issue of Epilepsy & Behavior Reports.

Further, the company noted that the EPSILON-IE pivotal clinical trial, composed of 37 patients with drug-resistant epilepsy, is being conducted in Japan.

Epsilon Medical advised that in parallel with clinical studies and regulatory applications in Japan, it is pursuing activities with a view to worldwide marketing.

“Conventional intracranial electrode placement is highly invasive because it requires craniotomy or brain puncture,” commented Kensuke Kawai, MD, in the company’s press release. “However, the EP-01 can measure EEG from within the blood vessels, allowing for high-quality EEG recordings with minimal invasiveness. This device has the potential to become an important diagnostic modality for patients with drug-resistant epilepsy, and we look forward to its future development.” Dr. Kawai is Professor at the Jichi Medical University in Shimotsuke, Japan.