Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 21

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 21
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or inconclusive results from clinical trials; unforeseen safety issues; an inability to monitor patients adequately during or after treatment;
placement of a clinical trial on hold by the FDA, institutional review boards/ethics committees or other regulatory authorities; changes
in governmental regulations or administrative actions, including governmental changes in permissible endpoints or other measures utilized
in clinical trials; problems with investigator or patient compliance with the trial protocols; the FDA or other regulators disagreeing
as to the design, protocol or implementation of our clinical trials; exceeding budgeted costs due to difficulty in accurately predicting
costs associated with clinical trials; the quality of the products falling below acceptable standards; and the inability to manufacture
sufficient quantities of our products to commence or complete clinical trials.

  13  

Additionally, the FDA or other regulatory entities
may disagree with our interpretation of the data from our pre-clinical studies and clinical trials, or may find the clinical trial design,
conduct or results inadequate to demonstrate safety or efficacy, and may require us to pursue additional pre-clinical studies or clinical
trials, which could further delay authorization of additional indications, expansion of labeling for existing indications or new treatment
protocols for Deep TMS. A number of companies in the medical device and biotechnology industries, including those with greater resources
and experience than us, have suffered significant setbacks in advanced clinical trials, even after seeing promising results in earlier
clinical trials. We do not know whether any clinical trials we or our clinical partners may conduct will demonstrate adequate efficacy
and safety to result in regulatory authorization to market new indications for Deep TMS. In addition, the results of our past clinical
trials of Deep TMS may not be predictive of future trial results. If later-stage clinical trials involving Deep TMS for new indications,
expansion of labeling for existing indications or new treatment protocols do not produce favorable results, our ability to obtain regulatory
authorization for such indications, expansion or treatment protocols may be adversely impacted, which will have a material adverse effect
on our business, financial condition, and results of operations.

We rely on
third parties, including suppliers for some components used in manufacturing our Deep TMS products, distributors to market and promote
our products internationally and third parties to conduct our clinical trials, which exposes us to uncertainty and instability.

We rely on suppliers for most of the components
used in manufacturing Deep TMS, including the computer controlling the stimulator, the helmet, and the arm of the helmet, and we may
not have sufficient contractual assurances for the