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

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 20
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 is a risk that our product certification could be delayed which might impact our ability
to market products in Great Britain.

The clinical trial process is lengthy and
expensive with uncertain outcomes. Results of earlier studies may not be predictive of future clinical trial results.

Clinical testing is difficult
to design and implement, can take many years, can be expensive and carries uncertain outcomes. The results of preclinical studies and
clinical trials of our products conducted to date and ongoing or future studies and trials of our current, planned or future products
may not be predictive of the results of later clinical trials, and interim results of a clinical trial do not necessarily predict final
results. The data and results from our clinical trials do not ensure that we will achieve similar results in future clinical trials. In
addition, preclinical and clinical data are often susceptible to various interpretations and analyses, and many companies that have believed
their products performed satisfactorily in preclinical studies and earlier clinical trials have nonetheless failed to replicate results
in later clinical trials, or have viewed such data in different ways than regulators do. Product candidates in later stages of clinical
trials may fail to show the desired safety and efficacy despite having progressed through nonclinical studies and earlier clinical trials.
Failure can occur at any stage of clinical testing. Our clinical studies or investigations may produce negative or inconclusive results,
and we may decide, or regulators may require us, to conduct additional clinical and nonclinical testing in addition to those we have planned.

The initiation and completion
of clinical studies may be prevented, delayed, or halted for numerous reasons. We may experience delays in our clinical trials for a number
of reasons, which could adversely affect the costs, timing or successful completion of our clinical trials, including related to the following:

  we may be required to submit an IDE application to the FDA, which must be approved prior to commencing certain human clinical trials of medical devices, and the FDA may reject our IDE applicati...  
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  regulators and other comparable foreign regulatory authorities may disagree as to the design or implementation of our clinical trials;  
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  regulators and/or IRBs, or other bodies may not authorize us or our investigators to commence a clinical trial, or to conduct or continue a clinical trial at a prospective or specific trial site;  
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