Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 30

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 30
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 could occur
as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects, labeling or design deficiencies,
packaging defects or other deficiencies or failures to comply with applicable regulations. Product defects or other errors may occur in
the future.

Depending on the corrective
action we take to redress a product’s deficiencies or defects, the FDA or foreign regulatory bodies may require, or we may decide,
that we will need to obtain new marketing authorizations or certifications for the device before we may market or distribute the corrected
device. Seeking such clearances, certifications or approvals may delay our ability to replace the recalled devices in a timely manner.
Moreover, if we do not adequately address problems associated with our devices, we may face additional regulatory enforcement action,
including FDA warning letters, product seizure, injunctions, administrative penalties or civil or criminal fines or similar actions by
the foreign regulatory bodies.

Companies are required to
maintain certain records of recalls and corrections, even if they are not reportable to the FDA or foreign regulatory authorities. We
may initiate voluntary withdrawals or corrections for our products in the future that we determine do not require notification of the
FDA or foreign regulatory authorities. If the FDA or foreign regulatory authorities disagrees with our determinations, it could require
us to report those actions as recalls and we may be subject to enforcement action. A future recall announcement could harm our reputation
with customers, potentially lead to product liability claims against us and negatively affect our sales. Any corrective action, whether
voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management
from operating our business and may harm our reputation and financial results.

The misuse or off-label use of our product
candidates, if authorized or certified for marketing, may harm our reputation in the marketplace, result in injuries that lead to product
liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion
of these uses, any of which could be costly to our business.

Any marketing authorization
or certification we may receive for a product candidate will be limited to specified indications for use. We plan to train our sales and
marketing personnel, as well as any direct sales force which may be hired in the future, to not promote our devices for uses outside of
the FDA (or foreign regulatory authorities)-authorized or -certified indications for use, known as “off-label uses.” We cannot,
however, prevent a physician