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.”
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.
This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. These forward-looking statements and their implications are based on the current expectations of the management of the Company only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our device studies; our products may not be approved by regulatory agencies: we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.
Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in BrainsWay Ltd.'s periodic filings with the Tel-Aviv Stock Exchange.
Chief Financial Officer