Company: RGNT
Filing Date: 2025-02-12
Form Type: DRS/A
Source: 0001213900-25-012299
Chunk: 57

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-02-12
Form: DRS/A
Chunk 57
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, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.

If GelrinC or our other future
products receive clearance or approval, we will be subject to the FDA’s medical device reporting regulations and similar foreign
regulations, which require us to report to the FDA when we receive or become aware of information that reasonably suggests that one or
more of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were
to recur, it could cause or contribute to a death or serious injury. The timing of our obligation to report is triggered by the date we
become aware of the adverse event as well as the nature of the event. We may fail to report adverse events of which we become aware within
the prescribed timeframe. We may also fail to recognize that we have become aware of a reportable adverse event, especially if it 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.

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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