Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 31

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 31
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 from using our devices off-label, when in the physician’s independent professional medical judgment
he or she deems it appropriate. There may be increased risk of injury to patients if physicians attempt to use our devices off-label,
which could harm our reputation in the marketplace among physicians and patients.

If the FDA or any foreign
regulatory body determines that our promotional materials or training constitute promotion of an off-label use, it could request that
we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance or imposition
of an untitled letter, which is used for violators that do not necessitate a warning letter, injunction, seizure, civil fine or criminal
penalties. It is also possible that other federal, state or foreign enforcement authorities might take action under other regulatory authority,
such as false claims laws, if they consider our business activities to constitute promotion of an off-label use, which could result in
significant penalties, including, but not limited to, criminal, civil and administrative penalties, damages, fines, disgorgement, exclusion
from participation in government healthcare programs and the curtailment of our operations.

In addition, physicians may
misuse our products or use improper techniques if they are not adequately trained, potentially leading to injury and an increased risk
of product liability. If our devices are misused or used with improper technique, we may become subject to costly litigation by our customers
or their patients. As described above, product liability claims could divert management’s attention from our core business, be expensive
to defend and result in sizeable damage awards against us that may not be covered by insurance.

If we do not obtain and maintain international
regulatory registrations, marketing authorizations or certifications for any product candidates we develop, we will be unable to market
and sell such product candidates outside of the United States.

Sales of our product candidates
outside of the United States will remain subject to foreign regulatory requirements that vary widely from country to country. In addition,
the FDA regulates exports of medical devices from the United States. While the regulations of some countries may not impose significant
barriers to marketing and selling our products or only require notification to regulators or third parties, others require that we obtain
affirmative marketing authorization or certification from a notified body. Complying with foreign regulatory requirements, including obtaining
registrations, certifications, clearances or approvals, can be expensive and time-consuming, and we may not receive necessary marketing
authorizations or certifications in each country in which we plan to market our