Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 142

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 142
---
 efforts to obtain reimbursement
coverage for Deep TMS in the relevant territory on our behalf.

In June 2022, for the first time, the Israeli Ministry
of Health approved coverage applicable it our Deep TMS system for the treatment of depression. The inclusion of the treatment within Israel’s
health basket of essential medical services means that Israel’s health funds must now make the treatment available to qualifying
patients free of charge. Qualifying patients include adults over the age of 21 with depression who have either not responded to two prior
antidepressants, or who are intolerant to other treatment alternatives. Coverage may be provided for up to 40 treatment sessions, which
are to be administered in hospitals. In addition, in September 2024, the Israel Ministry of Defense’s Rehabilitation Department
granted approval for the reimbursement of Deep TMS therapy for qualifying patients with PTSD at Israeli public hospitals. In Australia,
in November 2021, for the first time, coverage applicable to Deep TMS for MDD was granted for adults over the age of 18. Coverage in Australia
is available for 35 treatment sessions.

Government Regulation

United
States

Our products and our operations are subject to extensive
regulation by the FDA and other federal and state authorities in the United States, as well as comparable authorities in foreign jurisdictions.
Our products are subject to regulation as medical devices under the U. S. Federal Food, Drug and Cosmetic Act (FDCA), as implemented and
enforced by the FDA. The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling,
packaging, storage, installation, servicing, recordkeeping, premarket clearance or approval, import, export, adverse event reporting,
advertising, promotion, marketing and distribution, and import and export of medical devices to ensure that medical devices distributed
domestically are safe and effective for their intended uses and otherwise meet the requirements of the FDCA.

  82  

FDA Premarket Clearance and Approval Requirements

Unless an exemption applies, each medical device
commercially distributed in the United States requires either FDA clearance of a 510(k) premarket notification or premarket approval,
or PMA. Under the FDCA, medical devices are classified into one of three classes - Class I, Class II or Class III - depending
on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety
and efficacy. Class I includes devices with the lowest risk to the