New Articles Enhance Understanding of Deep TMS Safety Profile and Survey Addiction Research
BURLINGTON, Mass. and JERUSALEM, August 3, 2023 (GLOBE NEWSWIRE) – BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced three recent publications highlighting its Deep Transcranial Magnetic Stimulation (Deep TMS™) in leading peer-reviewed medical journals.
Two of the publications enhance understanding of the safety profile of TMS. The first, published in Brain Stimulation, provides a concise overview of the adverse event profile of the H1, H4, and H7 Coils as studied in five (5) large, multicenter, randomized controlled trials (RCTs). It is the most transparent review on the safety record of a TMS device, and the only one of its kind published by a TMS manufacturer. The second, published in the Journal of Clinical Psychiatry and on Psychiatrist.com, provides practical recommendations on performing TMS on patients having metallic implants, a common contraindication for all forms of TMS.
The third, published in Brain Sciences, is a comprehensive review on the use of TMS to address smoking addiction, an existing indication supported by clinically proven efficacy, and potential indications including alcohol use disorder (AUD) and other substance use disorders (SUDs). BrainsWay Deep TMS™ for smoking addiction represents the only FDA-cleared TMS solution for any addiction. The publication highlights preliminary research of Deep TMS in various other addictions, and underscores the need for further randomized controlled clinical trials in these difficult-to-treat conditions.
“One of BrainsWay’s three pillars is ‘superior evidence,’ and we are committed to advancing the field of neuroscience through a greater understanding of this life-changing technology for mental health patients, their caregivers, and providers,” said Colleen Hanlon, Ph.D., BrainsWay’s Vice President of Medical Affairs and Director of Innovation. “The body of evidence supporting Deep TMS is unparalleled in depth and breadth, and we are excited to continue conducting research and analyzing existing datasets to provide our customer partners with informed science to best treat their patients.”
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 clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), 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 Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.
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. 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: 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; 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, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.
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