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57M now covered for BrainsWay (NASDAQ: BWAY) accelerated Deep TMS

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

BrainsWay Ltd. reported a major expansion of insurance coverage for its SWIFT™ Accelerated Deep TMS™ protocol in the United States. Following several favorable policy changes, including a newly issued policy covering 2 million members in South Carolina, more payers now reimburse this accelerated treatment approach.

With these updates, eight major payers and the U.S. Department of Veterans Affairs now either cover or include policy language supporting accelerated TMS treatment approaches, representing over 57 million covered lives. Management highlights this as evidence of growing adoption of Deep TMS therapies and broader patient access.

The company positions itself as a leader in noninvasive neurostimulation, with its Deep TMS platform cleared by the FDA for major depressive disorder, obsessive-compulsive disorder, and smoking addiction. BrainsWay emphasizes ongoing clinical research and collaboration with providers and policymakers to further expand access to its treatments.

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Covered lives for accelerated TMS over 57 million covered lives Eight major payers plus U.S. Department of Veterans Affairs
New South Carolina policy members 2 million members Recently issued policy allowing coverage of SWIFT
FDA-cleared Deep TMS indications three indications Major depressive disorder, obsessive-compulsive disorder, smoking addiction
Year founded 2003 BrainsWay founding year mentioned in company background
SWIFT™ Accelerated Deep TMS™ protocol medical
"providing favorable coverage for its SWIFT™ Accelerated Deep TMS™ protocol"
Deep Transcranial Magnetic Stimulation (Deep TMS™) medical
"proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology"
major depressive disorder medical
"Deep TMS coverage for both major depressive disorder (MDD) and obsessive-compulsive disorder (OCD) patients"
A clinical condition characterized by persistent, severe low mood, loss of interest in daily activities, and reduced ability to function at work or home, lasting weeks or longer. It matters to investors because it drives demand for treatments and mental health services, affects workforce productivity and absenteeism, influences health-care and insurance costs, and shapes risks and opportunities for companies developing drugs, therapies or workplace programs—like a long-lasting storm that lowers economic output.
obsessive-compulsive disorder medical
"Deep TMS coverage for both major depressive disorder (MDD) and obsessive-compulsive disorder (OCD) patients"
Obsessive-compulsive disorder (OCD) is a mental health condition marked by unwanted, repetitive thoughts (obsessions) and time-consuming actions or rituals (compulsions) performed to ease anxiety. For investors, OCD matters because it influences demand for medical treatments, therapy services, and workplace accommodations, and can affect productivity, healthcare costs, and the commercial potential of drugs or devices aimed at managing the condition — much like how a chronic physical illness shapes markets and spending.
forward-looking statements regulatory
"This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
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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 EXCHANGE ACT OF 1934

For the month of June 2026

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 Statements on Form S-8 filed with the Securities and Exchange Commission on April 22, 2019 (Registration No. 333-230979) and on April 20, 2026 (Registration No. 333-295189) 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).


EXHIBIT INDEX  

Exhibit Title
   
99.1 BrainsWay Reports Favorable Coverage for Accelerated Deep TMS™ Rises to Over 57 Million Covered Lives
 


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: June 22, 2026     /s/ Hadar Levy     
  Hadar Levy
  Chief Executive Officer
  

 

EXHIBIT 99.1

BrainsWay Reports Favorable Coverage for Accelerated Deep TMS™ Rises to Over 57 Million Covered Lives

BURLINGTON, Mass. and JERUSALEM, June 22, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced further expansion in the number of medical policies across the U.S. providing favorable coverage for its SWIFT™ Accelerated Deep TMS™ protocol. The announcement comes after a series of favorable policy changes, the latest of which is a recently issued policy covering 2 million members in South Carolina allowing for coverage of SWIFT, in addition to various other increases in Deep TMS coverage for both major depressive disorder (MDD) and obsessive-compulsive disorder (OCD) patients.

With this update, eight major payers and the US Department of Veterans Affairs now either cover or include policy language supporting accelerated TMS treatment approaches, representing over 57 million covered lives.

“This milestone underscores the accelerating adoption of SWIFT and reflects the broader momentum toward improving patient access to Deep TMS therapies,” said Hadar Levy, Chief Executive Officer of BrainsWay. “The expansion is supported by our growing body of clinical evidence demonstrating the efficacy, durability, and real-world impact of Deep TMS across multiple indications, including our accelerated SWIFT protocol for depression. We remain focused on advancing additional coverage opportunities and strengthening access to evidence-based neurostimulation treatments, helping more patients benefit from innovative therapies with the potential to transform lives,” concluded Mr. Levy.

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 care and improve the lives of patients.

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 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.

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 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: risks relating to the Company’s ability to consummate, finance and close proposed or potential investments, 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, which could cause the actual 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 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.

Contacts: 
BrainsWay:
Ido Marom
Chief Financial Officer
Ido.Marom@BrainsWay.com

Investors:
Brian Ritchie
LifeSci Advisors LLC
britchie@lifesciadvisors.com

FAQ

What did BrainsWay (BWAY) announce in its June 2026 Form 6-K?

BrainsWay announced expanded U.S. insurance coverage for its SWIFT Accelerated Deep TMS protocol. Several medical policy updates now support accelerated TMS approaches, increasing reimbursement access for patients needing Deep TMS therapies for conditions like major depressive disorder and obsessive-compulsive disorder.

How many covered lives now have favorable access to BrainsWay’s accelerated Deep TMS?

BrainsWay reports that favorable coverage or supportive policy language for accelerated TMS approaches now represents over 57 million covered lives. This includes coverage from eight major payers plus the U.S. Department of Veterans Affairs across multiple U.S. markets.

Which new policy change did BrainsWay highlight in South Carolina?

BrainsWay highlighted a newly issued medical policy in South Carolina covering 2 million members. This policy allows coverage of the company’s SWIFT Accelerated Deep TMS protocol, adding to broader Deep TMS coverage for major depressive disorder and obsessive-compulsive disorder patients.

Which conditions are FDA-cleared for BrainsWay’s Deep TMS platform?

BrainsWay’s Deep TMS platform has three FDA-cleared indications. These are major depressive disorder, including anxious depression, obsessive-compulsive disorder, and smoking addiction, each backed by pivotal clinical studies demonstrating clinically proven efficacy according to the company.

How does BrainsWay describe the significance of the new coverage for SWIFT?

BrainsWay’s CEO says the milestone underscores accelerating adoption of SWIFT and broader momentum toward improving access to Deep TMS. The company links this expansion to its growing clinical evidence base and continuing efforts to secure additional coverage for evidence-based neurostimulation treatments.

Filing Exhibits & Attachments

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