Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 64

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 64
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in which we expect to operate has established its own data security and privacy legal framework with which we must, and our target customers
will need to, comply, including the rules and regulation mentioned above. We may also need to comply with varying and possibly conflicting
privacy laws and regulations in other jurisdictions. As a result, we could face regulatory actions, including significant fines or penalties,
adverse publicity and possible loss of business.

While we are preparing to
implement various measures intended to enable us to comply with applicable privacy or data protection laws, regulations and contractual
obligations, these measures may not always be effective and do not guarantee compliance. Any failure or perceived failure by us to comply
with our contractual or legal obligations or regulatory requirements relating to privacy, data protection, or information security may
result in governmental investigations or enforcement actions, 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. 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