BURLINGTON, Mass. and JERUSALEM, Sept. 27, 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 the acceptance and upcoming presentation of two Deep TMS™ posters at the World Congress of Psychiatry (WCP) in Vienna, Austria, taking place September 28 – October 1, 2023.
The first poster presents a preliminary analysis of real-world results from 247 Deep TMS patients ranging in age from 60 through 91 who had been administered Deep TMS at 16 centers. This elderly patient population has long been considered to be more difficult to treat with TMS, principally because of the brain atrophy that occurs with age which displaces relevant brain structures further from the TMS coil which is placed on the scalp surface during therapy. Yet, results from this post-marketing analysis demonstrated that patients receiving at least 30 treatments of Deep TMS demonstrated 77% and 55% response and remission rates, respectively, using the PHQ-9 rating scale. These results are comparable to those seen in younger patients.
The second poster presents preliminary data from 111 MDD patients treated at 4 clinical sites. The patients underwent an “accelerated” Deep TMS treatment regimen whereby multiple treatments were administered each day using either high frequency or theta burst protocols, thus resulting in a shorter overall treatment period. Outcomes were comparable to those seen using longer, traditional protocols.
“We are excited to have our research accepted for presentation at such a prestigious conference,” said Hadar Levy, BrainsWay’s Chief Executive Officer. “This research expands the understanding of Deep TMS and its potential ability to meet the treatment needs of a varying population of patients. Those suffering from late life depression continue to be in need of innovative treatment options, and accelerated Deep TMS could potentially be used to reduce the burden imposed by traditional multiweek courses of treatment.”
BrainsWay Deep TMS is not currently FDA-cleared for either late life or accelerated depression treatments. Subject to further research and analysis, these preliminary results can potentially be used to assist in efforts to expand current labeling for Deep TMS. BrainsWay’s Deep TMS technology delivers magnetic pulses to targeted regions and circuits within the brain to regulate neuronal activity. Housed within a cooled, cushioned helmet, the Deep TMS H-Coil creates magnetic fields in the cortical structures of the brain associated with a variety of mental health and neurological conditions.
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 and/or preliminary 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 analysis, 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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