Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 66

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 66
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 the FDA in ways that may significantly affect our business and our products. Any new
statutes, regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times
of any future products or make it more difficult to obtain clearance or approval for, manufacture, market or distribute our products.
We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted
or adopted may have on our business in the future. Such changes could, among other things, require: additional testing prior to obtaining
clearance or approval; changes to manufacturing methods; recall, replacement or discontinuance of our products; or additional record
keeping.

The FDA’s and other
regulatory authorities’ policies may change and additional government regulations may be promulgated that could prevent, limit
or delay regulatory clearance or approval of our future products. We cannot predict the likelihood, nature or extent of government regulation
that may arise from future legislation or administrative action, either in the United States or abroad. It is difficult to predict how
these executive actions will be implemented, and the extent to which they will impact the FDA’s ability to exercise its regulatory
authority. If these executive actions impose restrictions on the FDA’s ability to engage in oversight and implementation activities
in the normal course, our business may be negatively impacted. If we are slow or unable to adapt to changes in existing requirements
or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval
or clearance that we may have obtained and we may not achieve or sustain profitability.

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On April 5, 2017, the European
Parliament passed the Medical Devices Regulation (Regulation 2017/745), which repeals and replaces the EU Medical Devices Directive.
Unlike directives, which must be implemented into the national laws of the EEA member states, the regulations would be directly applicable,
i.e., without the need for adoption of EEA member state laws implementing them, in all EEA member states and are intended to eliminate
current differences in the regulation of medical devices among EEA member States. The Medical Devices Regulation, among other things,
is intended to establish a uniform, transparent, predictable and sustainable regulatory framework across the EEA for medical devices
and ensure a high level of safety and health while supporting innovation.

The Medical Devices Regulation
became applicable on May 26, 2021.

Among other