Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 37

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 37
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 which could affect our ability to operate our business.
Further, defending against any such actions can be costly, time-consuming and may require significant personnel resources. Therefore,
even if we are successful in defending against any such actions that may be brought against us, our business and our ability to sell our
products may be materially harmed.

If in the future our Alpha DaRT technology
is approved or certified for commercial sale, but we are unable to obtain adequate reimbursement or insurance coverage from third-party
payors, we may not be able to generate significant revenue.

Because the Alpha DaRT is
still in the development stage, it is not yet approved for third-party payor coverage or reimbursement. Coding and coverage determinations
as well as reimbursement levels and conditions are important to the commercial success of any product or offering. The future availability
of insurance coverage and reimbursement for newly approved medical devices is highly uncertain, and our future business will be greatly
impacted by the level of reimbursement provided by third-party payors.

In the United States, third-party
payors decide which cancer treatment products and services they will cover, how much they will pay and whether they will continue reimbursement.
Third-party payors may not cover or provide adequate reimbursement for the Alpha DaRT device, the Alpha DaRT sources or the procedures
using the system, assuming we are able to fully develop and obtain all marketing authorizations to market it in the United States or similar
certifications in other geographies. To date, we have not had any discussions with any third-party payors, including any regulatory agencies
administering any government funded healthcare programs, regarding the coding, coverage or reimbursement for treatment using the Alpha
DaRT, which may vary depending on the specific application or indication of our technology. Accordingly, unless government and other third-party
payors provide coverage and reimbursement for our products, patients and healthcare providers may choose not to use them, which would
adversely impact our future revenues.

No uniform policy of coverage
and reimbursement among payors in the United States exists and coverage and reimbursement for procedures can differ significantly from
payor to payor. Some third-party payors must approve coverage for new or innovative devices or procedures before they will reimburse healthcare
providers who use the products or therapies. Even though a new product may have been approved for commercial distribution by the FDA,
we may find limited demand for the product unless and until reimbursement approval has been obtained from governmental and private third-party
payors. We can provide no assurances that we would be successful