Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 35

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 35
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 or notified
bodies from conducting business as usual or conducting inspections, reviews or other regulatory activities, it could significantly impact
the ability of the FDA, foreign regulatory authorities and notified bodies to timely review and process our regulatory submissions, which
could have a material adverse effect on our business.

In the EU, notified bodies
must be officially designated to certify products and services in accordance with the EU Medical Devices Regulation. Their designation
process, which is significantly stricter under the new Regulation, has experienced considerable delays due to the COVID-19 pandemic. Despite
a recent increase in designations, the current number of notified bodies designated under the new Regulation remains significantly lower
than the number of notified bodies designated under the previous regime. The current designated notified bodies are therefore facing a
backlog of requests as a consequence of which review times have lengthened. This situation may impact the way we are conducting our business
in the EU and the EEA and the ability of our notified body to timely review and process our regulatory submissions and perform its audits.

Our business operations and current and
future relationships with investigators, healthcare professionals, consultants, third-party payors, and customers will be subject to applicable
healthcare regulatory laws, which could expose us to penalties.

Our business operations and
current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, and customers, may expose
us to broadly applicable fraud and abuse and other healthcare laws and regulations. These laws may constrain the business or financial
arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute our product
candidates, if approved or certified. Such laws include:

  the U. S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or providing any remuneration (inc...  
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  the U. S. federal civil and criminal false claims laws, including the civil False Claims Act, which, among other things, impose criminal and civil penalties, including through civil whistleblow...  
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  the federal civil monetary penalties laws, which impose civil fines for, among other things, the offering or transfer of remuneration to a Medicare