Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 54

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 54
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, quality assurance, labeling,
packaging, handling, storage, distribution, installation, servicing and shipping of medical devices.

Furthermore, we are 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 products 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 our products. In
addition, failure to comply with applicable FDA or state 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 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