New Research on Deep TMS Depression Treatment to be Presented
BURLINGTON, Mass. and JERUSALEM, Israel, May 2, 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 its participation in the Annual Meeting of the Clinical TMS Society’s (CTMSS) from May 4-6 and the Annual Meeting of the American Psychiatric Association (APA) from May 20-24. The Company will present posters at both meetings focusing on BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS™) for treatment-resistant depression.
“It has been fantastic to see the growing level of interest clinical psychiatrists and clinical researchers have in Deep TMS technology. This is fueled, in part, by several influential publications, including real-world efficacy of Deep TMS as well as independent studies that have been done by academic research teams,” said Colleen Hanlon, Ph.D., BrainsWay Vice President of Medical Affairs. “We are delighted to continue advancing this field as we share new results at these upcoming conferences. We also look forward to speaking with and learning from the growing cohort of clinical researchers that are using Deep TMS in their clinical research programs.”
At the CTMSS meeting, Aron Tendler, M.D., BrainsWay Chief Medical Officer, will present a poster about quality-of-life improvement following Deep TMS for treatment-resistant depression. “Low quality of life is a potent and intransigent factor that contributes to the global disability associated with depression. While therapeutic trials for depression typically focus on primary mood symptoms, less is known about the impact of treatment on quality of life,” said Dr. Tendler.
The poster highlights the results of a secondary analysis on data from a multisite clinical trial for treatment-resistant depression, which showed that 20 sessions of Deep TMS significantly improved quality of life as well as primary depressive symptoms. The Company will also present a poster about individual trajectories of responses to Deep TMS in major depression, a step toward potentially improving capabilities to predict and personalize Deep TMS outcomes in patients.
In addition, several other clinical research groups will be presenting posters related to Deep TMS technology.
BrainsWay’s patented H-Coil technology was first FDA-cleared for treating major depressive disorder in 2013, and it is designed to penetrate deeper and broader structures of the brain than traditional TMS coils.
About Major Depressive Disorder and Anxious Depression
Major depressive disorder (MDD) is a common and debilitating form of depression characterized by physiological, emotional, and cognitive symptoms. According to the World Health Organization (WHO), depression affects approximately 264 million people worldwide, and the U.S. National Institute of Mental Health (NIMH) estimates that 21 million adults in the United States suffer from an MDD episode within a given year. Common symptoms of MDD include loss of interest, depressed mood, reduced energy, disturbed sleep, and changes in appetite. 60-90% of depression patients also exhibit comorbid moderate to severe anxiety, a condition commonly referred to as anxious depression. These anxiety symptoms include nervousness, feelings of panic, increased heart rate, rapid breathing, sweating, insomnia, trembling, and difficulty focusing or thinking clearly. The economic burden in the United States for major depressive disorder totaled $326 billion prior to the recent COVID pandemic.
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.
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. 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.
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.
SVP and Chief Financial Officer
Meghan Seale Laska