Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 27

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 27
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 costs or lower than anticipated sales and have a material adverse effect on our reputation, business,
financial condition and results of operations.

In addition, the FDA may change
its marketing authorization policies, adopt additional regulations or revise existing regulations, or take other actions, which may prevent
or delay marketing authorization of any product candidate under development or impact our ability to modify any products authorized for
market on a timely basis. Such changes may also occur in foreign jurisdictions where we intend to market our products. Such policy or
regulatory changes could impose additional requirements upon us that could delay our ability to obtain marketing authorizations or certifications,
increase the costs of compliance or restrict our ability to maintain any marketing authorizations we have obtained. For more information,
see “ Legislative or regulatory reforms in the United States or the EU may make it more difficult and costly for us to obtain
marketing authorizations or certifications for any product candidate or to manufacture, market or distribute any product candidates after
such marketing authorizations or certifications have been obtained. ”

Any product candidates we develop must be
manufactured in accordance with applicable laws and regulations, and we could be forced to recall our devices or terminate production
if we fail to comply with these regulations.

In the United States, the
methods used in, and the facilities used for, the manufacture of medical devices must comply with the FDA’s cGMPs for medical devices,
known as the Quality System Regulation, or QSR, which is a complex regulatory scheme that covers the procedures and documentation of the
design, testing, production, process controls, quality assurance, labeling, packaging, handling, storage, distribution, installation,
servicing and shipping of medical devices. Furthermore, we will be required to verify that our suppliers maintain facilities, procedures
and operations that comply with our quality standards and applicable regulatory requirements. The FDA enforces the QSR through periodic
announced or unannounced inspections of medical device manufacturing facilities, which may include the facilities of subcontractors. Our
product candidates are also subject to similar state regulations and various laws and regulations of foreign countries governing manufacturing.

Our third-party manufacturers
may not take the necessary steps to comply with applicable regulations, which could cause delays in the delivery of product candidate.
In addition, failure to comply with applicable FDA or foreign requirements or later discovery of previously unknown problems with our
products or manufacturing processes could result in, among other things: warning letters or untitled letters; fines, injunctions or civil
penalties; suspension or withdrawal of marketing authorizations or certifications; seizures or