Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 60

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 60
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Changes in laws or regulations relating to data protection, or any actual or perceived failure by us to comply with such laws and regulations or our privacy policies, could materially and adversely affect our business or could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.

We expect to receive health
information and other highly sensitive or confidential information and data of patients and other third parties (e.g., healthcare providers
who refer GelrinC to patients), which we expect to compile and analyze. Collection and use of this data might raise privacy and data
protection concerns, which could negatively impact our business. There are numerous federal, state and international laws and regulations
regarding privacy, data protection, information security, and the collection, storing, sharing, use, processing, transfer, disclosure,
and protection of personal information and other data, and the scope of such laws and regulations may change, be subject to differing
interpretations, and may be inconsistent among countries and regions we intend to operate in (e.g., the United States, the EU and Israel),
or conflict with other laws and regulations. The regulatory framework for privacy and data protection worldwide is, and is likely to
remain for the foreseeable future, uncertain and 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,