Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 28

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 28
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 recalls of our products; total or partial
suspension of production or distribution; administrative or judicially imposed sanctions; the FDA’s refusal to grant pending or
future clearances or approvals for our products or similar decisions by foreign regulatory authorities or notified bodies; clinical holds;
refusal to permit the import or export of our products; and criminal prosecution of us, our suppliers, or our employees. Similar requirements
may apply in foreign jurisdictions.

Any of these actions could
significantly and negatively affect supply of our product candidates, if authorized for sale or certified by the FDA, foreign regulatory
authorities or notified bodies. If any of these events occurs, our reputation could be harmed, we could be exposed to product liability
claims and we could lose customers and experience reduced sales and increased costs.

Any product candidate we develop may cause
or contribute to adverse medical events, which could interrupt, delay, or prevent their continued development. If certain events occur
after marketing authorization or certification, we may be required to report them to the FDA or foreign regulatory authorities, and if
we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations.
In addition, the discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction
of the FDA, another governmental authority or foreign regulatory authorities, could have a negative impact on us.

As is the case with cancer
therapies generally, it is likely that there may be side effects and adverse events associated with our Alpha DaRT technology or any future
product or product candidate’s use. Results of our clinical trials could reveal a high and unacceptable severity and prevalence
of side effects or unexpected characteristics. Undesirable side effects caused by our product candidates could cause us or regulatory
authorities or other bodies to interrupt, delay or halt clinical trials or may cause us to abandon their development or limit development
to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or
more acceptable from a risk-benefit perspective. Undesirable side effects could also affect patient recruitment or the ability of enrolled
patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm our business, financial
condition and prospects significantly.

Patients treated with our
product candidates may also be undergoing surgical, chemotherapy, immunotherapy or alternative radiation treatments, which can cause side
effects or adverse events that are unrelated to our product candidate,