Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 102

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 102
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 deeper and broader penetration provides us
with the opportunity to address more indications with potentially greater clinical efficiency because Deep TMS stimulates a larger portion
of the brain and is less sensitive to coil orientation and position during treatment. In addition, Deep TMS is administered at stimulation
levels that we believe are as safe and tolerable as Traditional TMS.

  57  

  We have obtained FDA marketing authorizations of Deep                   

We are the only manufacturer of a TMS device to have
been cleared by the FDA for three separate mental health disorder indications based on clinically proven efficacy which was demonstrated
in pivotal randomized placebo-controlled studies conducted on the device: MDD, for which our H1 Coil device was cleared by the FDA in
2013, (and which clearance was expanded in August 2021 to include reduction of comorbid anxiety symptoms, or anxious depression, and then
again in May 2024 allowing for treatment of MDD patients ages 69-86) and for which our H7 Coil received 510(k) clearance from the FDA
in August 2022; OCD, for which our device was classified by FDA as a Class II device in a de novoclassification in August 2018;
and smoking addiction, for which our device was cleared for short term treatment in August 2020. For MDD (including anxious depression),
we are one of only two TMS companies that have performed clinical studies supporting an FDA clearance. For OCD, we are the only company
to have received such clearance based on clinical data from a pivotal study on the device. We remain the only company to have proven clinical
efficacy for OCD 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. For smoking addiction, and indeed addictions generally,
we are the first and only TMS company to have received FDA clearance.

  Our clinical data supports the efficacy and safety of Deep TMS  

We believe that our clinical
data supports the efficacy and safety of Deep TMS, which could accelerate its market acceptance by clinicians. Our pivotal trial for MDD
demonstrated statistically significant response and remission rates of 38.4% and 32.6%, respectively, in week five of Deep TMS treatment
of 20 minutes per session, compared to 21.4% and 14.6%, respectively, after sham treatment. Our pivotal trial for