BURLINGTON, Mass. and JERUSALEM, Feb. 23, 2022 (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


publication of results


in the Journal of Clinical Medicine further defining the efficacy of the Company’s proprietary


Deep TMS™


treatment in addressing anxiety symptoms comorbid to depression, also known as anxious depression.

In this analysis, the authors reviewed anxiety scores from multiple randomized controlled trials utilizing Deep TMS with the H1 Coil for major depressive disorder (MDD), including the Company’s

pivotal multicenter depression study

and the only

independent, head-to-head study

comparing Deep TMS to traditional transcranial magnetic stimulation (TMS).   Using commonly accepted anxiety thresholds, researchers were able to identify subjects with anxiety comorbid to their depression, stratify them into “high” and “low” anxiety subsets, and assess the efficacy of Deep TMS in reducing those anxiety symptoms. They found that Deep TMS had a statistically significant and meaningful effect in reducing anxiety symptoms among depression patients.

“With the publication of this data, BrainsWay continues to build on its leadership position in delivering superior science and evidence to the field of psychiatry and noninvasive brain stimulation research,” said Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “With an overwhelming majority of depression patients suffering concurrently from anxiety, we are excited to offer an alternative approach that provides hope in treating this complex condition. The findings of this publication support the concept that the uniquely broad and deep nature of stimulation induced by BrainsWay Deep TMS allows for simultaneous targeting of areas in the brain associated with both anxiety and depression.”

The Company previously reported on the results of the efficacy of Deep TMS in addressing both depression and comorbid anxiety symptoms within the same treatment, which led to its expanded

FDA depression clearance in August 2021

. The results of this publication further refine the understanding of the utility of Deep TMS in this regard. In direct contrast to evidence showing that subjects with high anxiety scores prior to treatment have historically been considered less likely to succeed with traditional TMS and anxiety medications, these new results show that Deep TMS is actually more effective with such patients.

“Patients with anxious depression typically have worse clinical outcomes, greater depression severity, lower remission rates, and an increased risk of suicide,” said Aron Tendler, MD, Chief Medical Officer of BrainsWay. “Patients with anxiety comorbid to their depression are prescribed higher doses of medication, increasing the likelihood of side effects while waiting up to three months for a clinical benefit. As a practicing physician and longstanding provider of TMS, these results are very exciting because they reflect a new positive predictor of high anxiety at baseline, which can help Deep TMS practitioners achieve better outcomes for their patients.”

The authors of this new publication also reviewed the existing body of evidence on comorbid anxiety symptom reduction with medications and traditional TMS. While differences between the various studies analyzed make it difficult to make direct comparisons, the authors noted a weighted, pooled effect size for Deep TMS which compared favorably to those seen with either drug-based data or traditional TMS.

About Anxious Depression


Comorbid anxiety symptoms are common in patients with major depressive disorder (MDD). Between 60-90% of patients with depression also exhibit moderate to severe anxiety. As the most common DSM-V specifier to MDD, anxious distress is reported in 75% of patients suffering from depression. In the United States, 21 million adults experience at least one major depressive episode per year. Considering the rate of comorbidity, 13 to 19 million adults experience moderate to severe anxiety in addition to their primary diagnosis of depression. Common anxiety symptoms include nervousness, worry, restlessness, being easily fatigued, difficulty concentrating, irritability, muscle tension, and sleep disturbance.. The economic burden in the United States for major depressive disorder totaled $326 billion prior to the pandemic.

About BrainsWay


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 (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, and include, but are not limited to, statements about the expected proceeds, use of proceeds and closing of the underwritten offering. 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. The publication referenced herein was based on research funded by the Company and utilized multiple comparison correction as a form of statistical penalty to account for the use of secondary endpoints. However, certain scientific data and results expressed herein may be subject to further analysis, modification and/or statistical penalties. 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; continuation and/or exacerbation of the global supply chain crisis and its impact on the Company’s ability to source components, meet customer demand, fill orders, maintain pricing levels, and support the Company’s service needs; 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


.

Contacts:


BrainsWay:

Scott Areglado

SVP and Chief Financial Officer

844-386-7001



[email protected]

Investors:

Bob Yedid

LifeSci Advisors

646-597-6989



[email protected]

Media Contact:

Will Johnson

Antenna

201-465-8019



[email protected]