Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 64

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 64
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 that vary widely from country to country. Approval procedures vary
among countries and can involve additional testing.

The time required to obtain
approval outside of the United States may differ substantially from that required to obtain FDA approval. In addition, the FDA regulates
exports of medical devices from the United States. While the regulations of some countries may not impose barriers to marketing and selling
our products or only require notification, others require that we obtain the clearance or approval of a specified regulatory body. Complying
with foreign regulatory requirements, including obtaining registrations, clearances or approvals, can be expensive and time-consuming,
and we may not receive regulatory clearances or approvals in each country in which we plan to market our products or we may be unable
to do so on a timely basis. The time required to obtain registrations, clearances or approvals, if required by other countries, may be
longer than that required for FDA clearance or approval, and requirements for 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