Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 66

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 66
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 complex, and this or other actual or alleged obligations may be interpreted and applied in a manner
that we may not anticipate or that is inconsistent from one jurisdiction to another and may conflict with other rules or practices including
ours. Further, any significant change to applicable laws, regulations, or industry practices regarding the collection, use, retention,
security, or disclosure of data, or their interpretation, or any changes regarding the manner in which the consent of relevant users for
the collection, use, retention, or disclosure of such data must be obtained, could increase our costs and require us to modify our services
and candidate products, possibly in a material manner, which we may be unable to complete, and may limit our ability to store and process
patients’ data or develop new services and features.

In particular, we will be
subject to U.S. data protection laws and regulations (i.e., laws and regulations that address privacy and data security) at both the federal
and state levels. The legislative and regulatory landscape for data protection continues to evolve, and in recent years there has been
an increasing focus on privacy and data security issues. Numerous federal and state laws, including state data breach notification laws,
state health information privacy laws, and federal and state consumer protection laws, govern the collection, use, and disclosure of health-related
and other personal information. Failure to comply with such laws and regulations could result in government enforcement actions and create
liability for us (including the imposition of significant civil or criminal penalties), private litigation and/or adverse publicity that
could negatively affect our business. For instance, California enacted the California Consumer Privacy Act, or the CCPA, on June 28, 2018,
which took effect on January 1, 2020. The CCPA creates individual privacy rights for California consumers and increases the privacy and
security obligations of entities handling certain personal data. The CCPA provides for civil penalties for violations, as well as a private
right of action for data breaches that is expected to increase data breach litigation. The CCPA may increase our compliance costs and
potential liability, and many similar laws have been proposed at the federal level and in other states.

In addition, we expect to
obtain health information that are subject to privacy and security requirements under HITECH and its implementing regulations. The Privacy
Standards and Security Standards under HIPAA establish a set of standards for the protection of individually identifiable health information
by health plans, health care clearinghouses and certain health care providers, referred to as Covered