Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 57

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 57
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 is not reported to us as an adverse event or if it is an adverse event that is unexpected or removed in time from the use of the product.
If we fail to comply with our reporting obligations, the FDA or other regulatory bodies could take action, including warning letters,
untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our device clearance
or approval, seizure of our products or delay in clearance or approval of future products.

<div align='center'>39</div>

The FDA and foreign regulatory
bodies have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design
or manufacture of a product or in the event that a product poses an unacceptable risk to health. The FDA’s authority to require
a recall must be based on a finding that there is reasonable probability that the device could cause serious injury or death. We may
also choose to voluntarily recall a product if any material deficiency is found. A government-mandated or voluntary recall by us 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 may require, or we may decide, that we will need to obtain
new clearances or approvals for the device before we may market or distribute the corrected device. Seeking such clearances 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.

Companies are required to
maintain certain records of recalls and corrections, even if they are not reportable to the FDA. We may initiate voluntary withdrawals
or corrections for our products in the future that we determine do not require notification of the FDA. If the FDA 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