Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 135

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 135
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 received FDA clearance for OCD, although these competitors did
not conduct randomized, controlled studies as a predicate to receiving such clearance. By contrast, our unique Deep TMS H-Coils are designed
to address a number of different brain disorders. Several competitors have obtained 510(k) clearance for their TMS device for an OCD indication,
using our de novoclassification as a predicate device in their submission, and others may follow suit. We remain the only company
to have proven clinical efficacy for this indication based on a randomized, double-blind, placebo-controlled, multicenter trial, while
other competitors that have since obtained FDA clearance for this indication, have done so in part relying on our clinical data. BrainsWay
remains the only company currently with marketing authorizations for MDD, OCD, and the treatment of smoking addiction.

Another competitive issue we face within the TMS
field arises from increasing interest in “accelerated” dosing schedules which involve multiple sessions each day to allow
for quicker overall treatment time. For example, one TMS competitor has developed a depression protocol involving 50 sessions of TMS over
a 5-day period with the assistance of functional MRI targeting. This protocol, involving a total treatment period that is significantly
shorter than traditional TMS protocols, has gained increasing commercial traction in the market. The appeal of the protocol has increased
with the FDA’s grant of clearance in September 2022 to the TMS competitor offering the protocol, and with payors issuing specialized
inpatient reimbursement codes applicable to the protocol. We accumulated our own data for several years demonstrating the potential efficacy
of various accelerated Deep TMS protocols, followed by an October 2023 peer-reviewed publication in the Psychiatry Research Journal and
our June 2024 launch of a prospective, randomized, controlled, multicenter clinical trial on accelerated Deep TMS for depression.

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We also face competition from
pharmaceutical and other companies that develop competitive products, such as antidepressant medications (including but not limited to
a nasal spray utilizing the drug esketamine approved by the FDA for use in conjunction with an oral antidepressant), with certain competitive
advantages such as widespread market acceptance, ease of patient use and well-established reimbursement. We also face competition from
the SAINT™ Neuromodulation protocol (Magnus Medical), a brain stimulation technique for treatment of neuropsychiatric disorders,
which received an FDA clearance for the treatment of MDD in adults who have failed to achieve satisfactory improvement from prior antidepress