Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 54

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 54
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; suspension or withdrawal of approvals; seizures or recalls of our products; total or partial suspension of production
or distribution; administrative or judicially imposed sanctions; the FDA’s refusal to grant pending or future clearances or approvals
for our products; clinical holds; refusal to permit the import or export of our products; and criminal prosecution of us, our suppliers
or our employees.

Any of these actions could
significantly and negatively affect supply of our products. If any of these events occurs, our reputation could be harmed, we could be
exposed to product liability claims and we could lose customers and experience reduced sales and increased costs.

The misuse or off-label use of our products 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.

Advertising and promotion
of our future products that obtains approval in the United States may be heavily scrutinized by the FDA, the DOJ, the HHS, state attorneys
general, members of Congress, and the public. In addition, advertising and promotion of any future product that obtains approval outside
of the United States will be heavily scrutinized by comparable foreign regulatory authorities.

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We expect that, if cleared
or approved, our products, including the GelrinC, will be cleared by the requisite regulatory authorities for specific indications. We
expect to train our marketing personnel and direct sales force to not promote our devices for uses outside of the FDA-approved indications
for use, known as “off-label uses.” We cannot, however, prevent a physician from using our devices off-label, when in the
physician’s independent professional medical judgment he or she deems it appropriate. There may be increased risk of injury to
patients if physicians attempt to use our devices off-label. Furthermore, the use of our devices for indications other than those approved
by the FDA or approved by any foreign regulatory body may not effectively treat such conditions, which could harm our reputation in the
marketplace among healthcare providers and patients.

If the FDA or any state or
foreign regulatory body determines that our promotional materials or training constitute promotion of an off-label use, it could request
that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance or imposition
of an untitled letter, which is used for violators that do not necessitate a