Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 115

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 115
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 products can also include cognitive behavioral therapy (CBT) techniques designed to improve disease outcomes.

Deep
TMS for MDD - Our Clinical Trials

Phase III Trial Measuring Efficacy and Safety
of Deep TMS

We completed a Phase III trial at 20 different sites
in the United States, Canada, Israel, and Germany to test the efficacy and safety of using Deep TMS to treat MDD between 2009 and 2013.
The therapeutic effect was clinically meaningful in both patients who failed one to two medications and patients who failed three or more
medications, indicating that Deep TMS is effective in an even more treatment-resistant population.

Based on these results, we filed a 510(k) application
to the FDA for Deep TMS using BrainsWay’s H1 Coil. In 2013, the FDA cleared Deep TMS for the treatment of MDD in adult patients
who have failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode.

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  (a)      Trial Design  

This randomized, double-blind, placebo-controlled,
multicenter trial investigated the efficacy and safety of Deep TMS in 212 treatment-resistant adult MDD patients. Enrolled subjects were
randomized in a 1:1 ratio to undergo either monotherapy with active Deep TMS or with a sham. For active Deep TMS treatment, BrainsWay’s
H-Coils was used at 120% stimulation intensity and a frequency of 18 Hz.

The trial was designed with three phases. The first
phase was a wash-out phase in which patients slowly stopped any anti-depressants, mood stabilizers, or antipsychotics that they were previously
taking. This phase lasted one to two weeks. The second phase was a four-week acute treatment phase in which patients received daily treatment
with Deep TMS or a sham. The treatments were administered in a five-day sequence each week during the second phase. Measurements in respect
of this phase were taken in week five. The final phase was a 12-week maintenance-continuation phase in which patients received two treatments
per week of Deep TMS or a sham. Measurements in respect of the final phase were taken in week 16.

The primary efficacy endpoint was a change in the
21-question Hamilton Depression Rating Scale (HDRS) at week five (following the end of the acute treatment phase). The secondary efficacy
endpoints were response and remission rates at week five. Response was defined