The FDA cleared technology is a noninvasive treatment for depression, OCD, and smoking addiction
CRESSKILL, N.J. and JERUSALEM, Israel, April 14, 2021 (GLOBE NEWSWIRE) – BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, announced today that 100,000 patients have been treated globally with Deep transcranial magnetic stimulation (Deep TMS).
The noninvasive therapy administers magnetic pulses through a proprietary H-coil to target structures of the brain associated with mental health conditions. The technology received FDA clearance for the treatment of major depressive disorder (MDD) in 2013 and for the treatment of obsessive-compulsive disorder (OCD) in 2018. Most recently, the technology was FDA cleared as an aid for short-term smoking cessation.
“As scientific founders of BrainsWay, it is rewarding to see the Company achieve this milestone and to witness the positive impact this groundbreaking technology has had on so many patients and families,” said Prof. Abraham Zangen, Co-Founder and Board Director of BrainsWay, and Yiftach Roth, Ph.D., Co-Founder and Chief Scientific Officer of BrainsWay. “This novel technology can help millions of patients in the coming years, and we are honored to be part of providing successful and noninvasive mental health solutions to those who need them most.”
BrainsWay’s Deep TMS has been investigated in more than 30 randomized clinical trials worldwide, with additional studies ongoing or planned. Conducted primarily in the outpatient setting, patients can return to normal activities immediately following the treatment session. By penetrating deeper and broader than traditional figure-8 TMS devices, Deep TMS has demonstrated versatility in addressing a range of disorders by safely targeting and stimulating deeper and broader brain regions.
“When I first had the opportunity to evaluate this technology, it was clear that this was a unique solution with the ability to transform lives,” said David Zacut, MD, Founder and Chairman of BrainsWay. “At that time, TMS technology had not yet been widely adopted clinically, but it showed substantial promise to advance the field of neuroscience. It has been a pleasure seeing how far the Company has grown and progressed the field over the past two decades.”
There are more than 600 BrainsWay Deep TMS Systems installed in private clinics, outpatient facilities, and hospitals globally. For more information around provider locations visit brainsway.com/find-a-provider.
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal studies demonstrating clinically proven efficacy. Current indications include major depressive disorder, obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Cresskill, NJ and Jerusalem, Israel, BrainsWay is committed to increasing global awareness and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. 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. Additionally, the claims contained herein are based on various internal data and assumptions which may be subject to differing interpretation, analysis, and further assessment. The following factors, among others, could cause actual results to differ materially from those described herein: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; inadequacy and/or inconsistency between different tracking processes; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, and the effect of the global COVID-19 health pandemic on our business and continued uncertainty and market impact relating thereto.
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 the Company’s filings with the U.S. Securities and Exchange Commission, including the Company’s Annual Report on Form 20-F. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov.
SVP and General Manager