Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 95

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 95
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 35% response and remission rates, respectively,
using the self-administered Patient Health Questionnaire-9 (PHQ-9).

  53  

We were the first medical device company to offer
an FDA-authorized noninvasive treatment for OCD, the marketing authorization for which we received in August 2018 as an adjunct therapy
for adult patients suffering from OCD. Our pivotal trial for OCD demonstrated statistically significant response and partial response
rates of 38.1% and 54.8%, respectively, after six weeks of daily active Deep TMS treatment of 19 minutes per session, compared to 11.1%
and 26.7%, respectively, after sham treatment. We remain the only company to have proven clinical efficacy for this indication based on
a randomized, double-blind, placebo-controlled, multicenter trial, and our competitors that have since obtained FDA clearance for this
indication have done so in part relying on our clinical data.

We are the first and only TMS company to offer an
FDA-cleared treatment for smoking addiction, which also represents the first FDA clearance for any TMS device in the addiction space.
We received this clearance from the FDA in August 2020 for use of our Deep TMS system as an aid in short-term smoking cessation in adults.
Our pivotal trial for smoking addiction demonstrated statistically significant results, with a 28.4% Continuous Quit Rate (CQR) - 
defined as abstinence from smoking for any 4-week period during the study - achieved among patients who completed the full course
of therapy, compared with 11.7% of completers undergoing sham treatment.

We believe that Deep TMS represents a platform technology
with the potential to treat a variety of other psychiatric, neurological and addiction disorders. We are actively conducting and/or planning
clinical trials in new areas, including neurological and/or addiction disorders.

Our current customers are principally doctors, hospitals,
and medical centers in the field of psychiatry. Treatment with Deep TMS is typically performed as an office-based procedure using our
Deep TMS system, which consists of our proprietary H-Coil helmet, as well as several other components, including a stimulator, cooling
system, positioning arm and an operator interface. A course of treatment for MDD typically requires 20 treatment sessions five times a
week over a period of four weeks, and thereafter up to 24 additional maintenance-continuation sessions twice weekly over a period of up
to 12 weeks. The standard Deep TMS treatment protocol