Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 16

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 16
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 approvals for modifications to any previously approved products for which we have concluded that new approvals are unnecessary,
we may be required to cease marketing or to recall the modified product until we obtain approval for the modification, and we may be subject
to significant regulatory fines or penalties. Furthermore, approved products could be subject to recall if the FDA determines, for any
reason, that such products are not safe or effective or that appropriate regulatory submissions were not made. We may not be able to obtain
marketing authorizations for redesigned products in a timely manner, or at all. Delays in receipt or failure to receive approvals for
device modifications could reduce our sales, profitability and future growth prospects.

The FDA, applicable foreign
regulatory entity or notified body can delay, limit or deny marketing authorization or certification of a device for many reasons, including:

  our inability to demonstrate to the satisfaction of the FDA or the applicable regulatory entity or notified body that our products are substantially equivalent to a predicate device or are safe...  
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  the disagreement of the FDA, foreign regulatory authorities or notified body with the design or implementation of our clinical trials or the interpretation of data from preclinical studies or c...  

  serious and unexpected adverse device effects experienced by participants in our clinical trials;  

  the data from our preclinical studies and clinical trials may be insufficient to support clearance, de novo classification, approval or certification, where required;  
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  our inability to demonstrate that the clinical and other benefits of the device outweigh the risks;  

  the manufacturing process or facilities we use may not meet applicable requirements; and  
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  the potential for marketing authorization or certification policies or regulations of the FDA or applicable foreign regulatory bodies to change significantly in a manner rendering our clinical ...  

Subject to the transitional
provisions and in order to sell our products in member states of the EU, our products must comply with the general safety and performance
requirements of the EU Medical Devices Regulation (Regulation (EU) No 2017/745), which repeals and replaces the EU Medical Devices Directive
(Council Directive 93/42/EEC) and the Active Implantable Medical Devices Directive (Council Directive 90/385/EEC).