Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 136

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 136
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ant
medications in the current episode. Magnus Medical launched its SAINT Neuromodulation System in 2024 with this protocol being their main
offering. In addition, we may face competition from ketamine, which is used as an anesthetic to treat a variety of brain disorders. Currently
in clinical trials, there are a number of psychedelics including lysergic acid diethyamide (LSD), psilosybin, DMT, and methylendioxymethamphetatmine
(MDMA) showing early promise in the treatment of mental health conditions like depression and PTSD. Our commercial opportunity could be
reduced or eliminated if these competitors develop and commercialize antidepressant medications or other treatments that are safer, more
effective or more convenient than Deep TMS. At any time, these and other potential market entrants may develop treatment alternatives
that may render our products uncompetitive or less competitive. In addition, we could face competition by the recently approved AUVELITY
(dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of MDD in adults, which are the first and only oral N-methyl
D-aspartate (NMDA) receptor antagonist approved for the treatment of MDD.

We are also subject to competition
from invasive neuromodulation therapies such as ECT, VNS, and DBS. Major players in this space include Abbott, Boston Scientific Corporation,
LivaNova, and Medtronic. For example, the VNS system developed by Cyberonics (now LivaNova) is FDA-approved for MDD.

For smoking addiction, there are a wide range of
prescription and over-the-counter (OTC) short term aids in smoking cessation. Two prescription medications that are synonymous with the
market are Chantix® (varenicline) and Zyban (buproprion). OTC nicotine replacement therapies continue to play a major role in a multi-modal
approach to smoking cessation, with common forms ranging from chewing gums, to lozenges, to transdermal patches.

Digital therapeutics, including prescription digital
therapeutics (PDTs), are also gaining popularity in the space of mental health treatments given the availability and affordability of
smart phones. For all of the conditions we address in the United States, there are numerous popular phone applications to help reinforce
the multi-modal treatment algorithms.

In addition, we may face competition in the future
from