Company: RGNT
Filing Date: 2025-03-11
Form Type: F-1
Source: 0001213900-25-022350
Chunk: 65

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-03-11
Form: F-1
Chunk 65
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 in us, and otherwise
materially and adversely affect our reputation and business. Furthermore, the costs of compliance with, and other burdens imposed by,
the laws, regulations, and policies that are applicable to the businesses of our customers or partners may limit the adoption and use
of, and reduce the overall demand for, our products and services. Additionally, if third parties we work with violate applicable laws,
regulations, or agreements, such violations may put the data we have received at risk, could result in governmental investigations or
enforcement actions, fines, litigation, claims, or public statements against us by consumer advocacy groups or others and could result
in significant liability, cause our customers, partners or patients to lose trust in us, and otherwise materially and adversely affect
our reputation and business. Further, public scrutiny of, or complaints about, technology companies or their data handling or data protection
practices, even if unrelated to our business, industry or operations, may lead to increased scrutiny of technology companies, including
us, and may cause government agencies to enact additional regulatory requirements, or to modify their enforcement or investigation activities,
which may increase our costs and risks.

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If we do not obtain and maintain international regulatory registrations, clearances or approvals for our products, we will be unable to market and sell our products outside of the United States.

Sales of our products outside
of the United States are subject to foreign regulatory requirements 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