Data published in a major peer-reviewed publication, the Journal of Clinical Medicine
JERUSALEM and BURLINGTON, Mass., March 28, 2024 (GLOBE NEWSWIRE) — BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”) launches an advanced non-invasive neurological therapy for mental health disorders. The global leader in stimulation therapy has announced positive results from a recently announced post-market study of deep transcranial magnetic stimulation (Deep TMS™) for the treatment of late-life depression.
This data is highlighted in an article titled “It's never too late: The safety and efficacy of deep TMS for late-life depression.” clinical medicine journal, an international peer-reviewed open access journal. This post-marketing study demonstrated real-world results for older adults (60-91 years) suffering from major depressive disorder (MDD). The study analyzed data from 247 patients with depression from 16 clinical sites in this age group who were treated with BrainsWay's proprietary H1 coil. As a result, in patients who received at least 30 treatment sessions, he showed a response rate of 79.4% (more than 50% reduction in symptoms) and a remission rate of 60.3%, which is best for individual patients. Based on the rating scale used. These results were comparable to those reported in a post-marketing analysis of more than 1,350 patients published in 2023.
“As our population lives longer, late-life depression is rapidly becoming a significant medical problem, affecting a significant number of families and nursing homes around the world.Non-Invasive Neurostimulation with TMS Its use has shown good efficacy in depressed patients as young as 20 years old, but older adults as young as 65 years old may not receive adequate relief due to typical age-related changes in the brain. Specifically, as we age, the distance between the scalp and the brain tends to increase due to brain atrophy, said Dr. Colleen Hanlon, vice president of medical and clinical affairs at BrainsWay. “It can be difficult for certain non-invasive technologies to reach brain regions associated with depression. We believe that with the deeper and broader stimulation of BrainsWay’s Deep TMS, these age-related It plays an important role in overcoming challenges.”
BrainsWay's existing FDA depression labeling does not apply to patients age 68 and older, and the results of this study are subject to further review by the FDA.
About BrainsWay
BrainsWay is a global leader in advanced non-invasive neurostimulation treatments for mental health disorders. We are boldly advancing neuroscience with our unique Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to receive three FDA-approved indications, backed by significant clinical research demonstrating clinically proven efficacy. Current indications include major depressive disorder (including relief of anxiety symptoms commonly referred to as anxiety depression), obsessive-compulsive disorder, and smoking dependence. We are dedicated to leading through good science and building an unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric and neurological disorders and addictions are underway. Founded in 2003 and with offices in Burlington, Massachusetts and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of Deep TMS and increasing widespread 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,” and “expects.” “anticipate,” “predict,” “predict,” “estimate,” “target,” “believe,” “hope,” “may” or similar words. These forward-looking statements and their effects are based solely on the current expectations of the Company's management and are subject to a number of factors that could cause actual results to differ materially from those described in the forward-looking statements. may be affected by factors and uncertainties. Further, historical results or conclusions drawn from scientific and clinical research may be subject to change, or that future results may suggest similar conclusions, or that the historical results referenced herein may result in additional research or other It does not guarantee that it will be interpreted in the same way. The following factors, among other things, could cause actual results to differ materially from those described in the forward-looking statements. lack of financial resources to meet future capital requirements; changes in technology and market requirements; delays or failures in the initiation and/or successful completion of planned research and clinical trials; failure to obtain regulatory approvals within the Company's expected time frames or at all; our inability to retain or attract key employees with knowledge essential to the development of our Deep TMS products; unforeseen issues with Deep TMS products and processes and/or inability to develop required enhancements; unexpected costs associated with Deep TMS products; our inability to obtain and maintain adequate protection for our intellectual property, including intellectual property licensed to us; Possible Product Liability. changes in the law and applicable rules and regulations; unfavorable market perceptions and acceptance of Deep TMS technology; inadequate or delayed reimbursement from third party payers, including insurance companies and Medicare; Deep TMS may not be commercialized by us or through third-party distributors, including internationally. product development by competitors; If we are unable to develop and introduce new technologies, products and applications in a timely manner, our actual results or performance may differ materially from those contemplated by such forward-looking statements.
The forward-looking statements in this press release speak only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by applicable securities laws. Further information regarding the risks and uncertainties affecting us can be found under the heading “Risk Factors” in our filings with the Securities and Exchange Commission.
contact address:
Brainsway:
Ido Marom
CFO
844-386-7001 extension 5
Ido.Marom@BrainsWay.com
Investor:
brian richie
Life science advisor
646-889-1200
britchie@lifesciadvisors.com
Media contact:
Chris Boyer
844-386-7001
Chris.Boyer@BrainsWay.com
