We are pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for our Endovascular EEG device (EP-01).The First-in-Human clinical trial was conducted in Japan and involved five patients with drug-resistant epilepsy. It was confirmed that EEG was obtained in all patients, and that the EP-01 could be safely implanted and removed. Dr. Yousuke Masuda et al. published the first case of the trial in Epilepsy & Behavior Reports 29 (2025).In addition, the pivotal clinical trial, EPSILON-IE, is being conducted for 37 patients with drug-resistant epilepsy in Japan.We are vigorously pursuing activities with a view to worldwide marketing in parallel with clinical studies and regulatory applications in Japan.