<SEC-DOCUMENT>0001171843-24-002047.txt : 20240417
<SEC-HEADER>0001171843-24-002047.hdr.sgml : 20240417
<ACCEPTANCE-DATETIME>20240417080019
ACCESSION NUMBER:		0001171843-24-002047
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20240417
FILED AS OF DATE:		20240417
DATE AS OF CHANGE:		20240417

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
		IRS NUMBER:				000000000

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-35165
		FILM NUMBER:		24849385

	BUSINESS ADDRESS:	
		STREET 1:		19 HARTUM STREET, BYNET BUILDING, 3RD FL
		STREET 2:		Har HaHotzvim
		CITY:			Jerusalem
		STATE:			L3
		ZIP:			91451
		BUSINESS PHONE:		972 2 581-3140

	MAIL ADDRESS:	
		STREET 1:		19 HARTUM STREET, BYNET BUILDING, 3RD FL
		STREET 2:		Har HaHotzvim
		CITY:			Jerusalem
		STATE:			L3
		ZIP:			91451
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>f6k_041624.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 April 2024</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;"><strong><!--19 Hartum Street-->19 Hartum Street<br /> Bynet Building, 3rd Floor<br /> Har HaHotzvim<br /> Jerusalem, 9777518, Israel<br /> </strong>(Address of 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): </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): </p>--><p>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 September 17, 2021 (Registration No. 333-259610).</p><p> <!--<p style="text-align: center;"><font style="font-size: 10pt;"><strong>EXHIBIT INDEX</strong></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>&#160;</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 Expands Deep TMS&#8482; Access in Israel Following Significant Increase in Reimbursement Rates</a> </font></td></tr></table>--><hr style="page-break-after: always;" noshade="noshade" /><p style="text-align: center;"><font style="font-size: 10pt;"><strong>EXHIBIT INDEX</strong></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 Number</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>Description</strong></font></td></tr><tr><td>&#160;</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 Expands Deep TMS&#8482; Access in Israel Following Significant Increase in Reimbursement Rates</a> </font></td></tr></table>&#160;</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: April 17, 2024</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></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 Expands Deep TMS&#153; Access in Israel Following Significant Increase in Reimbursement Rates</strong></font></p><p style="text-align: center;"><strong>Company Announces 11th Recent System Installed in Israel, with More Expected this Year</strong></p><p>
 <p align="left">BURLINGTON, Mass. and JERUSALEM, April  17, 2024  (GLOBE NEWSWIRE) -- &#160;BrainsWay Ltd. (NASDAQ &amp; TASE: BWAY) (&#8220;BrainsWay&#8221; or the &#8220;Company&#8221;), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced the further expansion of access to its Deep TMS&#153; treatment in Israel. BrainsWay has steadily increased its presence in the country with 11 recent system installations, and this momentum has been driven in part by a 45% increase in reimbursement rates. The Company expects to have additional Deep TMS systems installed in Israel by the end of 2024.<br ></p>  <p>&#8220;BrainsWay continues to make significant strides in expanding its international footprint, and it is extremely meaningful for us to be able to offer our life altering Deep TMS therapy to mental health patients across Israel,&#8221; said Hadar Levy, Chief Executive Officer of BrainsWay. &#8220;Following recent events in the country, serious mental health conditions are on the rise, and it is profoundly important to us that Deep TMS be made available to as many patients as possible,&#8221; concluded Mr. Levy.</p>  <p>"This innovative technology represents a significant opportunity to treat numerous patients, including many who have not responded to medication,&#8221; said Reut Filipowicz, BrainsWay&#8217;s Head of Business Development for the Israeli market. &#8220;We are excited to bring Deep TMS to those suffering from mental health conditions who are truly in need of additional treatment solutions."</p>  <p align="justify"><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 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&#160;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;believes,&#8221; &#8220;hopes,&#8221; &#8220;potential&#8221; or similar words. 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: 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 >BrainsWay:&#160;<br >Ido Marom&#160;<br >Chief Financial Officer&#160;<br >Ido.Marom@BrainsWay.com&#160;</p>  <p>Investors:<br >Brian Ritchie<br >LifeSci Advisors<br >britchie@lifesciadvisors.com</p>  <p>Media Contact:<br >Chris Boyer<br >Vice President, Marketing<br >Chris.Boyer@BrainsWay.com</p>  <p>&#160;<br ></p> </p><p ></p></body></html>
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
