Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 123

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 123
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 alternative, and particularly indicate that it may serve as an incremental strategy
to employ when higher intensity strategies, such as facility-based approaches, are either unavailable, not financially feasible, or have
extended waits for admission.

Since 2021, several payors issued policies and coverage
determinations allowing for reimbursement coverage applicable to Deep TMS for OCD. While the criteria for this emerging Deep TMS coverage
varies with each payor, generally, coverage requires the failure of between two and four medication trials before qualifying for reimbursement.

The NIMH is supporting research into new treatment
approaches for people whose OCD does not respond well to the usual therapies. These new approaches include combination and add-on (augmentation)
treatments, as well as novel techniques such as deep brain stimulation (DBS).

Deep
TMS for OCD - Our Clinical Trials

Phase III Trial Measuring Efficacy and Safety

We completed a Phase III trial at 11 sites in the
United States, Israel, and Canada to test the efficacy and safety of Deep TMS as a treatment for OCD, which was conducted from 2014 through
2017. In this trial, Deep TMS met its safety and efficacy endpoints and based on these results, we filed a de novoapplication
to the FDA for the Deep TMS (using our H7 Coil) in this indication. In August 2018, the FDA classified and granted marketing authorization
for Deep TMS as an adjunct treatment for adult patients with OCD to be used together with other first-line therapies.

  (a)      Trial Design  

This double blind, placebo-controlled trial tested
the efficacy and safety of Deep TMS in the treatment of 94 treatment-resistant OCD patients. Enrolled subjects were randomized to either
treatment with active Deep TMS or a sham. Deep TMS for OCD was used for all treatment sessions, each of which lasted 18.3 minutes. Our
H7 Coil is specifically used in OCD treatment because it targets the anterior cingulate cortex, a region believed to be affected by OCD.

The trial consisted of three phases. The first phase,
lasting one to two weeks, was the screening phase, during which antidepressant medications other than SSRIs were tapered down and washed
out (i. e., to make sure that patients take during the trial only medications that were approved by the protocol (such as SSRIs), and that
they remained stable on these medications). Following the screening phase, patients entered into a six-week treatment phase.