Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 66

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 66
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 approval policies, adopt additional regulations or revise existing regulations, or take
other actions, which may prevent or delay approval or clearance of our future products under development or impact our ability to modify
our currently cleared products on a timely basis.

In addition, FDA regulations
and guidance are often revised or reinterpreted by 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 E