Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 133

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 133
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2.9% heavy drinking
days (defined as a day on which four or more drinks were consumed for women, or five or more drinks for men) compared to 10.6% heavy drinking
days in the sham group. We are currently considering pursuing further alcohol treatment research including via our rotational field technology.

In December 2024, positive pilot data was released
from an independent, third-party study conducted at Stanford University evaluating an accelerated protocol using our Deep TMS technology
to treat AUD patients. The outcomes were reported in a publication in the Brain Stimulation journal titled, “ Accelerated deep TMS
in alcohol use disorder: A preliminary pilot trial targeting the dorsal anterior cingulate cortex increases neural target engagement and
abstinence.” The study compared outcomes achieved in a residential treatment program on a group of AUD patients treated with our
H7-Coil (n=5) using an “accelerated” protocol of multiple sessions of Deep TMS per day over several days, with those achieved
in a previously collected sample of data from patients in the same program (n=39) who had undergone other forms of treatment not involving
Deep TMS. In the follow-up period after treatment, subjects receiving accelerated Deep TMS showed notably better improvements when compared
to those treated by other means. The better outcomes were seen in several important areas, including lower percentages of heavy drinking
days (3% v. 22%) and regular drinking days (15% v. 28%), as well as lower relapse rates (60% v. 74%). The study also reported neuroimaging
MRI changes in brain activity and connectivity in areas of the brain implicated in addiction disorders and believed to be predictive of
AUD relapse. Shortly following publication of the pilot study, the U. S. National Institutes of Health (NIH) awarded approximately $1.5
million to the same research team to explore the efficacy of our Deep TMS system in treating substance use addictions, underscoring the
possibility of utilizing Deep TMS as a noninvasive treatment modality within the broader addiction space.

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We have conducted clinical
trials evaluating Deep TMS for a variety of neurological and psychiatric conditions and believe further investigation could pave the way
for marketing authorizations in new indications in the United States and expand the potential for treatment to a wider range of patients.
Recent areas of focus include post-stroke rehabilitation and OCD treatment using an accelerated protocol, which we are currently exploring
via 2