BRAINSWAY (BRSYF) Stock Price, News & Analysis

Brainsway Ltd. (BRSYF) is a foreign private issuer whose securities are registered with the U.S. Securities and Exchange Commission and report on Form 20-F. The company files current reports on Form 6-K and has used SEC registration statements on Form S-8 and Form F-3, indicating activity in the U.S. capital markets. Brainsway Ltd. is identified in SEC filings as having its principal executive office in Jerusalem, Israel.

According to multiple Form 6-K filings, Brainsway Ltd. is associated with neuromodulation technologies and treatments that involve Deep TMS™ (Deep Transcranial Magnetic Stimulation). The company reports on regulatory milestones, clinical initiatives, and coverage developments related to Deep TMS and other neuromodulation systems. These disclosures suggest a focus on medical applications in mental health and related conditions, as described in the titles of the exhibits attached to its 6-K reports.

Business focus and therapeutic areas

Exhibits to Brainsway Ltd.’s Form 6-K filings describe activities around neuromodulation systems and Deep TMS in connection with specific conditions. One filing reports that BrainsWay announced FDA approval of Neurolief’s Proliv™Rx neuromodulation system for Major Depressive Disorder (MDD). Other filings reference Deep TMS in the context of coverage policies and clinical use for depression, including adolescent depression, and a clinical trial for alcohol use disorder. These exhibit titles indicate that Brainsway Ltd. is involved in neuromodulation technologies that are used or studied in mental health indications such as major depressive disorder and alcohol use disorder.

Brainsway Ltd. has reported:

• An announcement regarding FDA approval of Neurolief’s Proliv™Rx neuromodulation system for Major Depressive Disorder (MDD), as reflected in an exhibit titled "BrainsWay Announces FDA Approval of Neurolief’s Proliv™Rx Neuromodulation System for Major Depressive Disorder (MDD)."
• An announcement of the first coverage policy for accelerated Deep TMS™, as reflected in an exhibit titled "BrainsWay Announces First Coverage Policy for Accelerated Deep TMS™."
• A report of expansion of adolescent depression coverage applicable to Deep TMS, as reflected in an exhibit titled "BrainsWay Reports Expansion of Adolescent Depression Coverage Applicable to Deep TMS."
• The launch of a first clinical trial of the Deep TMS 360™ system for alcohol use disorder, as reflected in an exhibit titled "BrainsWay Launches First Clinical Trial of Deep TMS 360™ System for Alcohol Use Disorder."
• FDA clearance of Deep TMS™ as adjunct therapy for Major Depressive Disorder (MDD) in adolescents aged 15 to 21, as reflected in an exhibit titled "BrainsWay Receives FDA Clearance of Deep TMS™ as Adjunct Therapy for Major Depressive Disorder (MDD) in Adolescents Aged 15 to 21."

Regulatory reporting and capital markets activity

Brainsway Ltd. indicates in its 6-K filings that it files an annual report on Form 20-F. The 6-K reports state that they are incorporated by reference into the company’s Registration Statement on Form S-8 filed with the SEC on April 22, 2019, and its Registration Statements on Form F-3 filed on July 22, 2024 and April 22, 2025. This pattern of filings shows that Brainsway Ltd. uses U.S. registration statements for securities offerings or related purposes and supplements those with current reports on Form 6-K that include press releases and other information as exhibits.

The company’s 6-K filings also identify it as "BRAINSWAY LTD." and specify that it is a foreign issuer choosing the Form 20-F regime rather than Form 40-F. This classification places Brainsway Ltd. among non-U.S. companies that access U.S. investors while following the disclosure framework applicable to foreign private issuers.

Location and regulatory framework

In each of the provided 6-K filings, Brainsway Ltd. lists its principal executive office in Jerusalem, Israel. As a foreign issuer, its SEC reporting focuses on Form 20-F for annual disclosure and Form 6-K for current reports. The exhibits to these 6-K filings provide insight into the company’s neuromodulation-related activities, including FDA-related developments, coverage policies, and clinical trials.

How Brainsway Ltd. information can be used by investors

Investors and researchers looking at Brainsway Ltd. can use its SEC filings to understand the areas highlighted by the company in its official communications. The exhibit titles in the 6-K filings emphasize neuromodulation systems, Deep TMS, coverage policies, and regulatory clearances related to major depressive disorder and alcohol use disorder. These topics, as disclosed in regulatory documents, can help readers identify the therapeutic areas and technologies that Brainsway Ltd. chooses to highlight in its reporting.