# EDGAR Filing Document

**Accession Number:** 0001505065
**File Stem:** 0001171843-26-001332
**Filing Date:** 2026-3
**Character Count:** 13476
**Document Hash:** 85a16fcce570f209f1e05230b5f42602
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001171843-26-001332.hdr.sgml**: 20260305

**ACCESSION NUMBER**: 0001171843-26-001332

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 2

**CONFORMED PERIOD OF REPORT**: 20260304

**FILED AS OF DATE**: 20260305

**DATE AS OF CHANGE**: 20260305

**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:** 26724026

**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

**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 March 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 ] &nbsp;&nbsp;&nbsp;&nbsp; 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 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).

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**EXHIBIT INDEX**

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| | |
|:---|:---|
| <u>**Exhibit**</u> | <u>**Title**</u> |
| [99.1](exh_991.htm) | [Landmark Data Validate BrainsWay's SWIFT™ Deep TMS, Beginning a New Era in Depression Treatment](exh_991.htm) |

---

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**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.

---

| | |
|:---|:---|
|  | <u>**&nbsp;&nbsp;&nbsp;&nbsp;BRAINSWAY LTD.&nbsp;&nbsp;&nbsp;&nbsp;**</u> |
|  | (Registrant) |
| Date: March 4, 2026 | <u>&nbsp;&nbsp;&nbsp;&nbsp;/s/ Hadar Levy &nbsp;&nbsp;&nbsp;&nbsp;</u> |
|  | Hadar Levy |
|  | Chief Executive Officer |

---

## Exhibit 99.1

**EXHIBIT 99.1**

**Landmark Data Validate BrainsWay's SWIFT™ Deep TMS, Beginning a New Era in Depression Treatment**

**World's only FDA-cleared Deep TMS™ accelerated treatment reduces the acute phase of treatment by 70%**

BURLINGTON, Mass. and JERUSALEM, March 04, 2026 (GLOBE NEWSWIRE) -- <u>BrainsWay</u> Ltd. (NASDAQ & TASE: BWAY) unveiled new clinical data showing a significantly faster, noninvasive way to treat depression without compromising the efficacy of one of psychiatry's most impactful treatments. The milestone advances BrainsWay's brain health vision and sets the stage for a neuromodulation platform that transforms lives.

Two new peer-reviewed manuscripts in *<u>Brain Stimulation</u>* found that BrainsWay's exclusive <u>FDA-cleared</u> SWIFT™ accelerated Deep Transcranial Magnetic Stimulation (<u>Deep TMS™</u>) protocol for the treatment of Major Depressive Disorder (MDD) achieved comparable remission and response rates when compared to the traditional standard protocol. The accelerated protocol reduces the traditional 20-visit acute treatment phase to just 6 half days, followed by weekly maintenance visits for 4 weeks.

Widespread adoption of the SWIFT approach, which reduces the number of clinic visits in the acute phase by ~70%, could alter how interventional psychiatry is delivered, improving patient retention and expanding clinical options at a time when demand for non-drug depression therapies is rising.

In a large, randomized, multisite non-inferiority trial, patients treated with BrainsWay's accelerated protocol achieved:

* 87.8% response rate

* 78.0% remission rates

* Median time to remission of 21 days, compared with 28 days under the standard daily protocol

"SWIFT demonstrates that we can substantially reduce treatment burden without compromising on outcomes, which fundamentally changes what access looks like for patients," said <u>Colleen A. Hanlon, Ph.D.</u>, Vice President of Medical Affairs at BrainsWay.

**Why SWIFT™ Matters: The Cost of Time** 

Over 20 million U.S. adults live with MDD, at an estimated <u>$333 billion</u> annual economic burden. Yet logistical barriers – time away from work, caregiving responsibilities, and travel – reduce the number of people who initiate access to this life-saving treatment. SWIFT™ lowers one of the most persistent barriers in interventional psychiatry: Time.

The second published manuscript, focusing on the patients' own ratings of perceived impact of the treatment on their lives, highlights the human impact of that efficiency. Key secondary outcomes in this study include:

* ~70% of the participants no longer suffered from severe quality of life impairment

* Approximately 60% returned to normal-range functioning after treatment

Patients also reported earlier symptom improvement across a range of measures, consistent with clinician-rated outcomes, suggesting not only statistical success, but lived recovery.

"Patients are reconnecting with work, relationships, and routines," said Hanlon. "That's the human outcome that matters most."

As clinical innovation improves access, payers are also reducing administrative barriers, including the previously announced move by Evernorth® Behavioral Health to <u>eliminate prior authorization requirements</u> for Deep TMS.

"We believe this marks the beginning of a new era for BrainsWay," said <u>Hadar Levy</u>, Chief Executive Officer of BrainsWay. "Innovation in mental health cannot stop at clinical efficacy – it must address accessibility and scalability. SWIFT demonstrates that we can advance neuroscience while expanding real-world reach. That is the future of interventional psychiatry."

**Study Design and Results** 

The trial incorporated input from both patients and providers in both urban and rural areas, reflecting a patient-centric approach uncommon in studies of this type. Each manuscript highlights different but complementary findings from the same clinical trial.

***Manuscript 1: Accelerated TMS with the H1-coil for Depression: A Multisite, Randomized Non-Inferiority Trial***

In the randomized non-inferiority comparison, the accelerated SWIFT protocol achieved an 87.8% response rate and a 78.0% remission rate on the clinician-rated Hamilton Depression Rating Scale (HDRS-21), establishing efficacy comparable to the standard once-daily protocol while requiring substantially fewer treatment days. (The standard protocol consists of an acute phase of 5 daily sessions over 4 weeks, followed by 2 daily sessions per week for 2 weeks.) Median time to remission was 21 days for SWIFT versus 28 days for the standard protocol. Outcomes were consistent across diverse patient subgroups, including individuals with moderate-to-severe depression and comorbid anxiety symptoms.

***Manuscript 2: Patient-Reported Outcomes Following Accelerated vs. Standard Deep TMS with the H1 coil for Major Depression: A Multisite Randomized Trial***

Clinician-rated measures remain the gold standard in depression trials; however, patient-reported outcomes provide critical insight into real-world experiences. Daily patient assessments confirmed substantial improvements in quality of life, functioning, and symptom burden among patients receiving accelerated treatment. By 6 weeks, quality-of-life scores improved by approximately 32 percentage points from those measured at baseline. The proportion of patients reporting severe functional impairment declined from 85–100% at baseline to 15–17% at the end of treatment, and approximately 60% reached normal-range functioning by the end of treatment. Patients receiving SWIFT also reported earlier perceived symptom improvement across a range of symptoms, consistent with clinician-rated findings.

For more information, visit <u>BrainsWay.com</u>.

**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 <u>www.brainsway.com</u>.

**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," "targets," "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 – especially preliminary data which remains subject to peer-review – 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'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

britchie@lifesciadvisors.com