Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 178

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 178
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 reimbursement
from third-party payors for our product candidates, or adverse changes in government and private third-party payors’ coverage and
reimbursement policies, may adversely impact demand for our product candidates if cleared or approved.

A substantial portion of our
revenue will depend on the extent to which the costs of our products purchased by our customers (or services provided with our products)
will be reimbursed by third-party payors, including Medicare, Medicaid, other U. S. government sponsored programs and private payors. These
third-party payors exercise significant control over patient access and increasingly use their enhanced bargaining power to secure discounted
rates and impose other requirements that may reduce demand for our product candidates, if cleared or approved. Our potential customers’
ability to obtain adequate reimbursement for products and services from these third-party payors affects the selection of products they
purchase and the prices they are willing to pay. In addition, demand for new products may be limited unless we obtain favorable reimbursement
(including coverage, coding and payment) from governmental and private third-party payors at the time of the product’s introduction,
which will depend, in part, on our ability to demonstrate that our products have a positive impact on clinical outcomes. Third-party payors
continually review their coverage policies for existing and new products and procedures and can deny coverage for our products or revise
payment policies such that payments do not adequately cover the cost of our products. Even if third-party payors make coverage and reimbursement
available, that reimbursement may not be adequate, which may have an adverse effect on our business, results of operations, financial
condition and cash flows.

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 will be successful in obtaining coverage from Medicare or any other governmental or commercial
third-party payor. Moreover, we may be required to seek new billing codes for the components of the Alpha DaRT, and regulatory authorities
may not approve the creation of separate codes. Additionally, even if we are successful, these billing codes or the payment amounts associated