Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 70

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 70
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 such registrations, clearances or approvals may significantly
differ from FDA requirements. If we modify our products, we may need to apply for additional regulatory clearances or approvals before
we are permitted to sell the modified product. In addition, we may not continue to meet the quality and safety standards required to maintain
the authorizations that we have received. If we are unable to maintain our authorizations in a particular country, we will no longer be
able to sell the applicable product in that country.

Regulatory clearance or approval
by the FDA does not ensure registration, clearance or approval by regulatory authorities in other countries, and registration, clearance
or approval by one or more foreign regulatory authorities does not ensure registration, clearance or approval by regulatory authorities
in other foreign countries or by the FDA. However, a failure or delay in obtaining registration or regulatory clearance or approval in
one country may have a negative effect on the regulatory process in others.

Legislative or regulatory reforms in the United States or the EU may make it more difficult and costly for us to obtain regulatory clearances or approvals for our products or to manufacture, market or distribute our products after approval is obtained.

From time to time, legislation
is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulation of medical devices.
In addition, the FDA may change its clearance and 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