Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 26

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 26
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ingly, our business and financial prospects, would be materially
adversely affected.

Even if we obtain marketing authorization
or certification, we will be subject to ongoing regulatory review and scrutiny. Failure to comply with post-marketing regulatory requirements
could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the
market.

If we obtain marketing authorization
or certification for a product candidate, we will remain subject to ongoing and pervasive regulatory requirements governing, among other
things, the manufacture, marketing, advertising, medical device reporting, sale, promotion, import, export, registration, and listing
of devices. For example, medical device manufacturers must submit periodic reports to the FDA as a condition of obtaining marketing authorization.
These reports include information about failures and certain adverse events associated with the device after its marketing authorization.
Failure to submit such reports, or failure to submit the reports in a timely manner, could result in enforcement action by the FDA. Following
its review of the periodic reports, the FDA might ask for additional information or initiate further investigation.

Regulatory changes could result
in restrictions on our ability to continue or expand our operations, higher than anticipated costs, or lower than anticipated sales. Even
after we have obtained marketing authorization or certification, we have ongoing responsibilities under FDA regulations and applicable
foreign laws and regulations. The FDA, state and foreign regulatory authorities have broad enforcement powers. Our failure to comply with
applicable regulatory requirements could result in enforcement action by the FDA, state or foreign regulatory authorities, which may include
any of the following sanctions:

  untitled letters or warning letters;  

  fines, injunctions, consent decrees and civil penalties;  

  recalls, termination of distribution, administrative detention, or seizure of our products;  

  customer notifications or repair, replacement or refunds;  

  operating restrictions or partial suspension or total shutdown of production;  

  delays in or refusal to grant our requests for future clearances, de novo classifications or approvals or comparable foreign marketing authorizations or certifications of new products, new inte...  
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  withdrawals or suspensions of any granted marketing authorizations or certifications, resulting in prohibitions on sales of our products;  

  FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries; and  

  criminal prosecution.  

Any of these sanctions could
result in higher than anticipated