<SEC-DOCUMENT>0001171843-26-000111.txt : 20260107
<SEC-HEADER>0001171843-26-000111.hdr.sgml : 20260107
<ACCEPTANCE-DATETIME>20260107073005
ACCESSION NUMBER:		0001171843-26-000111
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20260107
FILED AS OF DATE:		20260107
DATE AS OF CHANGE:		20260107

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Brainsway Ltd.
		CENTRAL INDEX KEY:			0001505065
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		ORGANIZATION NAME:           	08 Industrial Applications and Services
		EIN:				000000000
		STATE OF INCORPORATION:			L3

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-35165
		FILM NUMBER:		26513973

	BUSINESS ADDRESS:	
		STREET 1:		16 HARTUM STREET RAD TOWER, 14TH FLOOR
		STREET 2:		Har HaHotzvim
		CITY:			Jerusalem
		STATE:			L3
		ZIP:			9777516
		BUSINESS PHONE:		972 2 581-3140

	MAIL ADDRESS:	
		STREET 1:		16 HARTUM STREET RAD TOWER, 14TH FLOOR
		STREET 2:		Har HaHotzvim
		CITY:			Jerusalem
		STATE:			L3
		ZIP:			9777516
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>f6k_010726.htm
<DESCRIPTION>FORM 6-K
<TEXT>
<html><head><title></title></head><body style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><div align="center"><div style="margin-top: 3pt; margin-bottom: 12pt;"><div style="font-size: 1pt; border-top: Black 2.5pt solid; border-bottom: Black 1.1pt solid; width: 100%;">&#160;</div></div><p style="font-size: 14pt;" align="center"><strong>UNITED STATES</strong><br /><strong>SECURITIES AND EXCHANGE COMMISSION</strong><br /><strong>Washington, D.C. 20549</strong></p><p style="font-size: 14pt; text-transform: uppercase;" align="center"><strong>Form 6-K</strong></p><p style="text-align: center;"><strong></strong></p><p style="text-align: center;"><strong>REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934</strong></p><p style="text-align: center;"><strong></strong><strong>For the month of January 2026</strong></p><p style="text-align: center;">Commission File Number: <strong>001-35165</strong></p><p style="text-align: center;"><font style="font-size: 12pt;"><strong>BRAINSWAY LTD.</strong></font><br />(Translation of registrant's name into English)</p><p style="text-align: center;"><!--16 Hartum Street RAD Tower, 14th Floor <br>Har HaHotzvim--><strong>16 Hartum Street RAD Tower, 14th Floor </strong><br /><strong>Har HaHotzvim<br /> Jerusalem, 9777516, Israel<br />(+972-2) 582-4030<br /></strong>&#160;(Address and telephone number of Registrant&#8217;s principal executive office)</p></div><p>Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.<br />Form 20-F [&#160;X ] &#160;&#160;&#160;&#160;&#160;Form 40-F [&#160;&#160; ]</p><!--<p>Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): &#160;</p><p>Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): &#160;</p>--><p><font>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 Statements on Form F-3 filed with the Securities and Exchange Commission on July 22, 2024 (Registration No. 333-280934) and on April 22, 2025 (Registration No. 333-286672).</font></p><p><font> </font><font><hr style="page-break-after: always;" noshade="noshade" /><p style="text-align: center;"><font style="font-size: 10pt;"><strong>EXHIBIT INDEX</strong></font></p><p style="text-align: center;"><font style="font-size: 10pt;">&#160;</font></p><table style="font-size: 10pt;" border="0" cellspacing="0" cellpadding="0"><tr><td style="text-decoration: underline;" valign="bottom"><font style="font-size: 10pt;"><strong>Exhibit</strong></font></td><td width="20"><font style="font-size: 10pt;">&#160;</font></td><td style="text-decoration: underline;" valign="bottom"><font style="font-size: 10pt;"><strong>Title</strong></font></td></tr><tr><td><font style="font-size: 10pt;"></font></td><td width="20"><font style="font-size: 10pt;">&#160;</font></td><td><font style="font-size: 10pt;">&#160;</font></td></tr><tr><td><font style="font-size: 10pt;"><a href="exh_991.htm">99.1</a></font></td><td width="20"><font style="font-size: 10pt;">&#160;</font></td><td><font style="font-size: 10pt;"><a href="exh_991.htm">BrainsWay Announces First Coverage Policy for Accelerated Deep TMS&#153;</a> </font></td></tr></table>&#160;</font></p><p /><hr style="page-break-after: always;" noshade="noshade" /><p style="text-align: center;"><strong>SIGNATURES</strong></p><p>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.</p><table style="font-family: Times New Roman; font-size: 10pt;" border="0" width="100%" cellspacing="0" cellpadding="0"><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td style="text-decoration: underline;" align="center" width="47%"><strong>&#160;&#160;&#160;&#160;BRAINSWAY LTD.&#160;&#160;&#160;&#160;</strong></td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td align="center" width="47%">(Registrant)</td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td align="center" width="47%">&#160;</td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td align="center" width="47%"></td></tr><tr valign="top"><td width="47%">Date: January 7, 2026</td><td width="6%">&#160;</td><td style="text-decoration: underline;" align="center" width="47%">&#160;&#160;&#160;&#160;/s/ Hadar Levy &#160;&#160;&#160;&#160;</td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td align="center" width="47%">Hadar Levy </td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td align="center" width="47%">Chief Executive Officer</td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td align="center" width="47%"></td></tr></table><p><font>&#160;</font></p></body></html>
</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exh_991.htm
<DESCRIPTION>PRESS RELEASE
<TEXT>
<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"><html lang="en-US"><head><title>EdgarFiling</title><meta content="text/html; charset=windows-1252" ><meta name="GENERATOR" content="MSHTML 8.00.7601.18094" ></head><body bgcolor="#ffffff"><p style="text-align: right;"><strong>EXHIBIT 99.1</strong></p><p style="text-align: center;"><font style="font-size: 14pt;"><strong>BrainsWay Announces First Coverage Policy for Accelerated Deep TMS&#153;</strong></font></p><p style="text-align: center;"><strong>New Premera Blue Cross Blue Shield&#174; policy extends to both adolescent and adult depression patients</strong></p><p>
 <p>BURLINGTON, Mass. and JERUSALEM, Jan.  07, 2026  (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ &amp; TASE: BWAY) (&#8220;BrainsWay&#8221; or the &#8220;Company&#8221;), a global leader in advanced noninvasive brain stimulation technologies, today announced that Premera Blue Cross Blue Shield<sup>&#174;</sup>, a company with over 2.8 million covered lives serving Alaska and Washington state, has adopted a new final medical policy which, among other developments, expands coverage to include patients ages 15 and older with moderate to severe major depressive disorder (MDD) treated with BrainsWay&#8217;s accelerated SWIFT&#153; (Short-course with Intrinsic Field Targeting) Deep TMS&#153; protocol.</p>  <p>&#8220;We are elated at Premera&#8217;s decision to formally adopt a policy covering our SWIFT depression protocol, which marks a first among payers. SWIFT entails significantly fewer days spent in the clinic, allowing patients to achieve meaningful improvement more quickly than our standard Deep TMS protocol,&#8221; stated Hadar Levy, Chief Executive Officer of BrainsWay.</p>  <p>BrainsWay&#8217;s SWIFT depression protocol consists of an acute phase of five treatment sessions (ten minutes each) per day for six days, followed by two sessions per day once a week for four weeks, for a total of 38 sessions. There is no need for any functional MRI or other expensive neuronavigational equipment.</p>  <p>&#8220;BrainsWay&#8217;s clinical trial and real-world evidence demonstrates comparable response and remission outcomes for its SWIFT accelerated depression protocol when compared to the standard Deep TMS protocol. We are committed to continuing our efforts to educate stakeholders within our space on the compelling data supporting additional favorable coverage of this novel protocol,&#8221; stated Colleen Hanlon, PhD, Vice President of Medical Affairs for BrainsWay.</p>  <p>BrainsWay continues to lead the field with its proprietary H-coil technology, robust clinical research, and ongoing collaboration with providers and policymakers to expand access to advanced neurostimulation therapies.</p>  <p><strong>About BrainsWay</strong><br >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&#153;) 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 operations in the United States and 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.</p>  <p><strong>Forward-Looking Statements</strong><br >This press release contains &#8220;forward-looking statements&#8221; within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words &#8220;intends,&#8221; &#8220;may,&#8221; &#8220;will,&#8221; &#8220;plans,&#8221; &#8220;expects,&#8221; &#8220;anticipates,&#8221; &#8220;projects,&#8221; &#8220;predicts,&#8221; &#8220;estimates,&#8221; &#8220;aims,&#8221; &#8220;targets,&#8221; &#8220;believes,&#8221; &#8220;hopes,&#8221; &#8220;potential&#8221; or similar words, and also includes any financial guidance and projections contained herein. 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 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 research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the failure to realize anticipated synergies and other benefits of the proposed transaction; the failure of our investments in management services organizations and/or other clinic-related entities to produce profitable returns; 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&#8217;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&#8217;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.</p>  <p>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 &#8220;Risk Factors&#8221; in the Company&#8217;s filings with the U.S. Securities and Exchange Commission.</p>  <p><strong>Contacts:</strong><br ><u>BrainsWay:</u><br >Ido Marom<br >Chief Financial Officer<br >Ido.Marom@BrainsWay.com</p>  <p><strong>Investors:</strong><br >Brian Ritchie<br >LifeSci Advisors<br >britchie@lifesciadvisors.com</p> </p><p ></p></body></html>
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
