The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for our Endovascular EEG device (EP-01).
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.
Regarding our company name change
As of December 13, 2023, our company name has changed from E.P.Medical Inc. to Epsilon Medical Inc. We appreciate your continued support.
Certified as a venture company originating from the University of Tsukuba
Our company has been certified as a venture company spun out of the University of Tsukuba. University of Tsukuba
Series B funding from MedVenture Partners and DBJ Capital
We have raised Series B funding from MPI-2 Investment Limited Partnership, managed and operated by MedVenture Partners Co., Ltd., and DBJ Capital Co., Ltd.We will continue to develop intravascular EEG measurement devices. MedVenture Partners Inc. DBJ Capital Co., Ltd.
A specific clinical study at the University of Tsukuba has been published on jRCT
Following deliberation by the Clinical Research Review Committee of the University of Tsukuba, information on specific clinical research on our devices has been published on jRCT (Japan Registry of Clinical Trials, a clinical research submission and publication system).
Investment in E.P. Medical Inc.
MPI-2 Investment Limited Partnership, managed and operated by MedVenture Partners Co., Ltd., has underwritten a Series A1 investment in E.P. Medical Co., Ltd. (Representative Director: Yuji Matsumaru; Address: 3-11-5 Nihonbashi-Honcho, Chuo-ku, Tokyo), a company developing a transcutaneous transvascular electroencephalography device to identify focal location in intractable epilepsy. Details are attachedThis PDF (external link)Please check.
AMED grant recipient
Fiscal Year 2021「Medical and Engineering Collaboration Innovation Promotion Project (Development and Commercialization Project)」About the selected projects
E.P. Medical website launched
In November 2021, the E.P. Medical website was launched.