Company: BWAY
Filing Date: 2025-09-30
Form Type: 6-K
Source: 0001171843-25-006185
Chunk: 16

Company: Brainsway Ltd.
Filing Date: 2025-09-30
Form: 6-K
Chunk 16
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 document and are expressly qualified in their
entirety as described herein and by the cautionary statements contained within the “Risk Factors” section of the 2024
Annual Report. We do not undertake to update or revise forward-looking statements to reflect events or circumstances that arise
after the date on which such statements are made or to reflect the occurrence of unanticipated events, except as required by law. In
evaluating forward-looking statements, you should consider these risks and uncertainties and not place undue reliance on our
forward-looking statements.

#### Company
Overview

General

BrainsWay is a global leader in advanced noninvasive neurostimulation
treatments for mental health disorders. We are boldly advancing neuroscience with our proprietary Deep Transcranial Magnetic Stimulation
(Deep TMS™) platform technology to improve health and transform lives. We are dedicated to leading through superior science and
building on what we believe to be an unparalleled body of clinical evidence. We are the first and only TMS company to be cleared by the
FDA for three separate mental health condition indications based on clinically proven efficacy as demonstrated in pivotal randomized placebo-controlled
studies. Current indications include major depressive disorder (MDD), including reduction of comorbid anxiety symptoms, commonly referred
to as anxious depression, obsessive-compulsive disorder (OCD), and smoking addiction. We have also received CE Mark for a variety of psychiatric
and neurological indications. We are focused on increasing global awareness of, and broad access to, Deep TMS. Deep TMS uses magnetic
pulses to stimulate neurons and consequently modulates the physiological activity of the brain. Our technology can either increase brain
activity in neuronal networks which are hypoactive, or alternatively decrease brain activity in neuronal networks which are hypoactive.
Our proprietary electromagnetic coils, which we refer to as H-Coils, are designed to safely stimulate deep and broad brain regions, which
we believe provides an advantage over other available TMS products, which we refer to collectively as Traditional TMS, that generally
use a “figure 8” design. In the United States, we sell our Deep TMS system for the treatment of MDD (including reduction of
comorbid anxiety symptoms, commonly referred to as anxious depression), OCD and smoking addictions. We believe that our Deep TMS technology
has the potential to be safe and effective for the treatment of a wide range of additional psychiatric, neurological, and addiction disorders.
Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway or