This is BrainsWay’s global website. The global website is not intended for persons in the United States and includes information on clinical indications that were not cleared by the FDA, which are subject to further US regulatory review for safety and efficacy. BrainsWay is cleared by the FDA only for patients with MDD who failed to respond to one or more anti-depressants in the current episode, and for patients with OCD as an adjunct treatment.
Approval allows BrainsWay’s Deep TMS System to be marketed throughout Japan.
JERUSALEM, January 29, 2019 – BrainsWay Ltd. (TASE: BRIN), a global leader in the advanced noninvasive
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 all import licenses 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.”
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.
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.