BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive treatment of brain disorders, today announced the distribution of its first 10 Deep Transcranial Magnetic Stimulation (Deep TMS) devices for smoking addiction to practices across the United States. The recently FDA-cleared aid for short-term smoking cessation offers a noninvasive treatment that administers electromagnetic pulses using BrainsWay’s patented H4-coil through a cushioned helmet, stimulating neurons in brain structures associated with addiction.

“Tobacco smoking is one of the leading causes of preventable disease and death throughout the world,” said Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “We have seen lives drastically changed after undergoing Deep TMS treatment and are eager to bring this same hope to those who desire to quit smoking. Research shows that there is often comorbidity between tobacco use and mental disorders, and the COVID-19 pandemic has exacerbated both. Many patients have given up trying to quit, but now, with a noninvasive option like Deep TMS, we are hopeful they are able to take that step.”

Deep TMS is the first FDA-cleared noninvasive treatment in the addiction space for any TMS device, and currently serves as the only TMS platform technology with clinical outcome data for multiple brain disorders. In 2019, a double-blind, sham-controlled, multicenter randomized controlled trial of 262 patients found Deep TMS to be an effective treatment, significantly improving the continuous quit rate, as well as reducing craving and the average number of cigarettes smoked per week. Participants in the study were highly addicted to smoking with a history of smoking an average of over 26 years and multiple failed attempts to quit.

Deep TMS treatment for smoking addiction is currently available at the following clinics:

  • Advanced Mental Health Care in Palm Beach, FL
  • Brooklyn Minds in New York, NY
  • Delray Center for Healing in Delray Beach, FL
  • Greenbrook TMS NeuroHealth in Richmond Heights, MO
  • Houston TMS Therapeutics in Bellaire, TX
  • Kadima Neuropsychiatry Institute in La Jolla, CA
  • Medical University of South Carolina (MUSC) in Charleston, SC
  • Novus TMS in Tuscaloosa, AL
  • PsyCare Inc. in Charleston, WV
  • TMS NW in Vancouver, WA

For more information on Deep TMS treatment for smoking addiction, visit www.brainsway.com.

About BrainsWayBrainsWay 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, 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 Cresskill, NJ and Jerusalem, Israel, BrainsWay is committed to increasing global awareness 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 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, 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.

Contact: BrainsWay:Hadar LevySVP and General ManagerHadarL@brainsway.com 

Media Contact:Will Johnson(201) 465-8019Brainsway@antennagroup.com