6-K
Brainsway Ltd. (BWAY)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington,D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGEACT OF 1934
For the month of October 2024
Commission File Number: 001-35165
BRAINSWAY LTD. (Translation of registrant's name into English)
16 Hartum Street RAD Tower, 14th Floor Har HaHotzvim Jerusalem, 9777516,Israel(+972-2) 582-4030 (Address and telephone number of Registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [ X ] Form 40-F [ ]
This Form 6-K is incorporated by reference into the Company's Registration Statement on Form S-8 filed with the Securities and Exchange Commission on April 22, 2019 (Registration No. 333-230979) and the Company's Registration Statement on Form F-3 filed with the Securities and Exchange Commission on July 22, 2024 (Registration No. 333-280934).
EXHIBIT INDEX
| Exhibit | Title |
|---|---|
| 99.1 | BrainsWay Further Penetrates East Asia with Placement<br> of 15 Additional Deep TMS™ Systems in Taiwan and South Korea |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| BRAINSWAY LTD. | |
|---|---|
| (Registrant) | |
| Date: October 9, 2024 | /s/ Hadar Levy |
| Hadar Levy | |
| Chief Executive Officer |
EdgarFiling
EXHIBIT 99.1
BrainsWay Further Penetrates East Asia with Placement of 15 AdditionalDeep TMS™ Systems in Taiwan and South Korea
BURLINGTON, Mass. and JERUSALEM, Israel, Oct. 09, 2024 (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 further expansion of its Deep Transcranial Magnetic Stimulation (Deep TMS™) platform in East Asia through the placement of 15 new systems in Taiwan and South Korea.
“The recent orders for 15 additional Deep TMS systems to be used by mental health centers in Taiwan and South Korea are indicative of the continued commercial success we are experiencing in penetrating this strategically important region. These countries each play an important role in our international growth strategy, and we are pleased to report the expanding demand from the East Asia region,” said Hadar Levy, BrainsWay’s Chief Executive Officer. “The BrainsWay team and our international distribution partners continue to focus on expanding access to our innovative Deep TMS platform among patients and healthcare providers globally.”
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 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 Statement
This press release contains “forward-looking statements” within the meaning of the Private SecuritiesLitigation 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 statementsinclude, among others, statements regarding the completion of the offering, the satisfaction of customary closing conditions related tothe offering, the anticipated use of proceeds therefrom, the ability of the Company to obtain shareholder approval, and the exercise ofthe Warrants prior to their expiration, and their implications are based on the current expectations of the management of the Companyonly and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those describedin the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do notguarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarlyin light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially fromthose described in the forward-looking statements: market and other conditions, inadequacy of financial resources to meet future capitalrequirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studiesand clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inabilityto retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties withDeep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failureto obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to theCompany; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perceptionand acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies andMedicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; productdevelopment by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause theactual 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 Companyundertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developmentsor otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertaintiesaffecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securitiesand Exchange Commission.
Contacts: BrainsWay: Ido Marom Chief Financial Officer Ido.Marom@BrainsWay.com
Investors: Brian Ritchie LifeSci Advisors LLC britchie@lifesciadvisors.com