Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 22

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 22
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  we may be unable to recruit a sufficient number of clinical trial sites;  
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  regulators, IRBs, or other bodies may fail to approve or subsequently find fault with our manufacturing processes or facilities of third-party manufacturers with which we enter into agreement f...  
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  marketing authorization or certification policies or regulations of FDA or applicable foreign regulatory authorities may change in a manner rendering our clinical data insufficient for marketin...  
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  our current or future products may have undesirable side effects or other unexpected characteristics.  
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Any of these occurrences may
significantly harm our business, financial condition and prospects. In addition, many of the factors that cause, or lead to, a delay in
the commencement or completion of clinical trials may also ultimately lead to the denial of marketing authorization or similar certification
of any product candidate.

Patient enrollment in clinical
trials and completion of patient follow-up depend on many factors, including the size of the patient population, the nature of the trial
protocol, the proximity of patients to clinical sites, the eligibility criteria for the clinical trial, patient compliance, competing
clinical trials and clinicians’ and patients’ perceptions as to the potential advantages of the product being studied in relation
to other available therapies, including any new treatments that may be approved for the indications we are investigating. For example,
patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment
procedures or follow-up to assess the safety and efficacy of a product candidate or does not allow them to receive other treatments during
the clinical trial, or they may be persuaded to participate in contemporaneous clinical trials of a competitor’s product candidate.
In addition, patients participating in our clinical trials may drop out before completion of the trial or experience adverse medical events
unrelated to our product candidate. Delays in patient enrollment or failure of patients to continue to participate in a clinical trial
may delay commencement or completion of the clinical trial, cause an increase in the costs of the clinical trial and delays, or result
in the failure of the clinical trial.

Clinical trials must be conducted