UA-118257413-1 UA-124410294-1 hih | news | 1.19

Jan

2019

BrainsWay Receives PMDA Approval in Japan of Deep Transcranial Magnetic Stimulation System for Treatment of Major Depressive Disorder

6Approval allows BrainsWay’s Deep TMS System to be
marketed throughout Japan

JERUSALEM, Jan. 29, 2019 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (TASE: BRIN), a
global leader in the advanced non-invasive treatment of brain disorders, today announced
that its Deep TMS System has been approved in Japan by the Pharmaceuticals and Medical
Devices Agency (PMDA) for the treatment of patients suffering from Major Depressive
Disorder (MDD) who did not benefit from previous antidepressants. The PMDA approval was
obtained in collaboration with BrainsWay’s exclusive distributor in Japan, Century Medical,
Inc. (CMI), an ITOCHU Group company. According to the World Health Organization, an
estimated 5 million people suffer from depressive disorders in Japan. 

 
“This PMDA approval represents a significant milestone in our efforts to expand our existing
commercial footprint globally for BrainsWay Deep TMS,” said Yaacov Michlin, president and
chief executive officer of BrainsWay. “Japan represents a significant market opportunity for
BrainsWay and we look forward to providing our unique therapeutic solution to the many
patients suffering from MDD throughout the country.”


The PMDA is the agency responsible for regulation of pharmaceuticals and medical
equipment into Japan, and this approval was required to begin marketing BrainsWay Deep
TMS in Japan. Additionally, PMDA approval is a precondition to receiving reimbursement
coverage under the Japanese National Health Insurance Plan. CMI is working with relevant
bodies in Japan in an effort to ensure that appropriate coverage of Deep TMS in Japan is
ultimately achieved.


Takahiko Motani, president and CEO of CMI, stated, “We’re pleased to have secured this
important approval. We expect that with this leading technology we will be able to significantly
help Japanese patients who suffer from depressive disorders.”


About BrainsWay
BrainsWay is engaged in the research, development and sales and marketing of a medical
system for non-invasive treatment of common brain disorders. The medical system developed
and manufactured by the company is based on a unique breakthrough technology called

Deep TMS, which can reach significant depth and breadth of the brain and produce broad
stimulation and functional modulation of targeted brain areas. In the U.S., the Company’s
device has been FDA cleared for the treatment of major depressive disorder (MDD) since
2013, and is now FDA cleared (De-Novo) for the treatment of Obsessive Compulsive Disorder
(OCD). The Company's systems have also received CE clearance and are sold worldwide for
the treatment of various brain disorders.


About Century Medical, Inc.
Century Medical, Inc. (CMI) is a wholly owned subsidiary of ITOCHU Corporation
(PINKSHEETS: ITOCY), one of the largest Japanese general trading companies. CMI has
been a pioneering force successfully introducing many new technologies to the Japanese
healthcare community with more than 40 years of experience marketing medical devices in
Japan.


Harel-Hertz Investment House (HIH) initiated and engineered the project
between CMI and Brainsway