Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 46

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 46
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 reputation, and adversely affect our business and results
of operations.

Risks Related to Our Reliance on Third Parties

We rely on a limited number of third-party
suppliers and, in some cases, sole suppliers, for the majority of our components, subassemblies and materials and may not be able to find
replacements or immediately transition to alternative suppliers.

We rely on several sole suppliers
for certain components of our Alpha DaRT technology. These sole suppliers, and any of our other suppliers, may be unwilling or unable
to supply components of these systems to us reliably and at the levels we anticipate or are required by us. For us to be successful, our
suppliers must be able to provide us with products and components in substantial quantities, in compliance with regulatory requirements,
in accordance with agreed upon specifications, at acceptable costs and on a timely basis. If we obtain marketing authorization or certification,
and we encounter delays or difficulties in securing these components, an interruption in our commercial operations could occur if we cannot
then obtain an acceptable substitute. If we seek or are required to transition to new third-party suppliers for certain components of
our Alpha DaRT technology or any future product or product candidates, we believe that there are a few other manufacturers that are currently
capable of supplying the necessary components. In addition, the use of components or materials furnished by these alternative suppliers
could require us to alter our operations. Any such interruption or change in supplier could harm our reputation, business, financial condition
and results of operations.

Furthermore, if we are required
to change the manufacturer of a critical component of our product candidates, we will be required to verify that the new manufacturer
maintains facilities, procedures and operations that comply with our quality and applicable regulatory requirements, which could further
impede our ability to manufacture our implant systems in a timely manner. We generally do not carry inventory for components for more
than three months at any given time. Transitioning to a new supplier could be time-consuming and expensive, may result in interruptions
in our operations and product delivery, could affect the performance specifications of our product candidates or could require that we
modify their design. If the change in manufacturer results in a significant change to any product after its authorization or certification
for marketing, a new marketing authorization from the FDA or similar international regulatory authorization or certification may be necessary
before we implement the change, which could cause substantial delays. The occurrence of any of these events could harm our ability to
meet the demand for our products in a timely