Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 13

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 13
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 or any similar foreign regulatory authority or notified bodies will accept data from trials conducted outside of the United
States or the applicable jurisdiction. If the FDA or any similar foreign regulatory authority or other bodies does not accept such data,
it would result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and
which may result in our Alpha DaRT not receiving approval, clearance or certification for commercialization in the applicable jurisdiction.

Risks Related to Government Regulation

Our Alpha DaRT technology and operations
are subject to extensive government regulation and oversight both in the United States and abroad, and our failure to comply with applicable
requirements could harm our business.

Any products or product candidates
which ultimately integrate our Alpha DaRT technology are expected to be regulated as medical devices in the United States. Medical devices
and their manufacturers and product developers are subject to extensive regulation in the United States and elsewhere, including by the
FDA and its foreign counterparts. The FDA and foreign regulatory agencies regulate, among other things, with respect to medical devices:
design, development and manufacturing; testing, labeling, content and language of instructions for use and storage; clinical trials; product
safety; establishment registration and device listing; marketing, sales and distribution; premarket clearance, classification and approval
or certification; recordkeeping procedures; advertising and promotion; recalls and field safety corrective actions; postmarket surveillance,
including reporting of deaths or serious injuries and malfunctions that, if they were to recur, could lead to death or serious injury;
post-market studies; and product import and export.

The regulations to which we
are subject are complex, and have tended to become more stringent over time. Regulatory changes could result in restrictions on our ability
to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales, if our product candidate receives
marketing authorization or certification. The FDA and foreign regulatory authorities enforce their regulatory requirements through, among
other means, periodic unannounced inspections. We do not know whether we or any contract manufacturers we may utilize will be found compliant
in connection with any future FDA or foreign inspections. Failure to comply with applicable regulations could jeopardize our ability to
sell our Alpha DaRT technology or any future products or product candidates, if they obtain marketing authorization or certification,
and result in enforcement actions such as: warning letters; fines; injunctions; civil penalties; termination of distribution; recalls
or seizures of products; delays in the introduction of products into the market; total or partial suspension of