Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 29

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 29
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 but may still impact the success of our clinical trials. The inclusion
of critically ill patients in our clinical trials may result in deaths or other adverse medical events due to other therapies or medications
that such patients may be using or due to the gravity of such patients’ illnesses. Even if the side effects do not preclude the
product candidate from obtaining or maintaining marketing authorization or certification, undesirable side effects may inhibit market
acceptance due to its tolerability versus other therapies. Any of these developments could materially harm our business, financial condition
and prospects.

Additionally, if our Alpha
DaRT technology or any future product candidate receives marketing authorization from the FDA, the side effects observed in clinical studies
could result in a more restrictive label and we will be subject to the FDA’s medical device reporting regulations and similar foreign
regulations, which require us to report to the FDA or to foreign regulatory authorities when we receive or become aware of information
that reasonably suggests that one or more of our products may have caused or contributed to a death or serious injury or malfunctioned
in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious injury. The timing of our obligation
to report is triggered by the date we become aware of the event as well as the nature of the event. We may fail to report events of which
we become aware within the prescribed timeframe. We may also fail to recognize that we have become aware of a reportable event, especially
if it is not reported to us as an adverse event or if it is an adverse event that is unexpected or removed in time from the use of the
product. If we fail to comply with our reporting obligations, the FDA or foreign regulatory authorities could take action, including warning
letters, untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our marketing
authorizations or certification, seizure of our products or delay in obtaining marketing authorizations or certification for our product
candidates.

The FDA and foreign regulatory
bodies have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design
or manufacture of a product or in the event that a product poses an unacceptable risk to health. The FDA’s authority to require
a recall must be based on a finding that there is reasonable probability that the device could cause serious injury or death. We may also
choose to voluntarily recall a product if any material deficiency is found. A government-mandated or voluntary recall by us