Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 146

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 146
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 market
our MDD therapy for the reduction of comorbid anxiety symptoms among depressed patients, and we received an extension for the FDA clearance
of our H7 Coil for treatment of MDD (including anxious depression). In June 2024, the FDA granted us an expanded indication for our Deep
TMS system allowing for the treatment of patients with MDD ages 22 to 86, changing the previous upper age limit of 68. This represented
our 10thFDA clearance and made our Deep TMS the first and only form of TMS indicated for the treatment of patients over the
age of 68 suffering from MDD, including those with comorbid anxiety symptoms.

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Clinical Trials

A clinical trial is typically required to support
a PMA application or de novoclassification, and is sometimes required for a 510(k) premarket notification. Clinical trials for
significant risk devices generally require submission of an application for an Investigational Device Exemption, or IDE, to the FDA. The
IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test
the device in humans and that the investigational protocol is scientifically sound. The IDE application must be approved in advance by
the FDA for a specified number of patients, unless the product is deemed a non-significant risk device and eligible for more abbreviated
IDE requirements. Clinical trials for a significant risk device may begin once the IDE application is approved by the FDA as well as the
appropriate institutional review boards (IRBs), at the clinical trial sites, and the informed consent of the patients participating in
the clinical trial is obtained. After a trial begins, the FDA may place it on hold or terminate it if, among other reasons, it concludes
that the clinical subjects are exposed to an unacceptable health risk. Any trials we conduct must be conducted in accordance with FDA
regulations as well as other federal regulations and state laws concerning human subject protection and privacy. Moreover, the results
of a clinical trial may not be sufficient to obtain clearance or approval of the product.

Changes to Marketed Devices

After a device receives 510(k) marketing clearance,
or de novoclassification, any modification that could significantly affect its safety or efficacy, or that would constitute a
major change or modification in its intended use, will require a new 510(k) marketing clearance or, depending on the modification, a de
novoclassification or PMA. The FDA requires each