Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 127

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 127
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 NRT users relapse and return to smoking within six months.

First line treatment options
include antidepressants such as Zyban (bupropion) and Chantix (varenicline). Studies have found advantageous abstinence rates compared
to placebo. Yet, recent studies using objective measures found very low quit rates. A recent meta-analysis found that 20% of smokers treated
with medications remained abstinent for one year, compared to 12% with placebo. The medications may frequently be associated with undesirable
adverse events.

There are studies that indicate that combination of psychological support with pharmacotherapy may
increase the chances to quit smoking. Although there is not currently any reimbursement coverage for TMS therapy as a treatment for smoking
addiction, in October 2023, the Clinical TMS Society (CTMSS), an influential peer group, published the first coverage recommendations
for smoking addiction treatment using TMS. With this new coverage guidance for insurers, CTMSS now recommends TMS coverage for individuals
with a confirmed diagnosis of Tobacco Use Disorder (TUD) who failed two alternative treatment methods, cannot tolerate drugs, or have
other comorbid medical conditions (secondary to TUD) such as COPD, artery disease and lung cancer.

Deep
TMS for Smoking Addiction - Our Clinical Trials

Deep TMS presents a novel, FDA-authorized treatment
for smoking addiction. In August 2020, the FDA classified and provided marketing authorization for the use of Deep TMS as an aid in short-term
smoking cessation in adults. Deep TMS has the unique ability to simultaneously influence a network of specific regions in the brain associated
with reward and craving. The effects of the treatment begin within a relatively short time period and the duration of the entire treatment
plan is shorter compared to a medicinal treatment. Deep TMS therapy for smoking cessation has not demonstrated any systemic side effects,
and we believe that Deep TMS presents an attractive alternative to existing treatment options for smoking cessation because antidepressant
medications, due to their side effects, often lead to cessation of treatment by the patient and as a result, relapse to smoking.

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We concluded with positive results a pivotal multicenter
trial assessing the safety and efficacy of Deep TMS as an aid in smoking cessation in adults suffering from chronic smoking addiction.

The trial was a randomized, double-blind, multicenter
study designed to evaluate the safety and efficacy of Deep TMS treatment as an aid in reducing cigarette smoking in individuals suffering
from chronic