Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 65

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 65
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, clinical trials and other activities; and/or register their sales representatives. Some states prohibit specified sales and marketing practices, including the provision of gifts, meals, or other items to certain health care providers. |

Efforts to ensure that our
business arrangements with third parties will comply with applicable healthcare laws and regulations involve substantial costs. Additionally,
it is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes,
regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to
be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil,
criminal and administrative penalties, damages, fines, exclusion from government funded healthcare programs, such as Medicare and Medicaid,
and the curtailment or restructuring of our operations. Exclusion, suspension and debarment from government funded healthcare programs
would significantly impact our ability to commercialize, sell or distribute any product. If any of the physicians or other providers or
entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to criminal, civil
or administrative sanctions, including exclusions from government funded healthcare programs.

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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