Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 53

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 53
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 and safety of the device are supported by suitable evidence. If we fail to remain in compliance with applicable
European laws and directives, we would be unable to continue to affix the CE mark to our products, which would prevent us from selling
them within the EEA.

Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the market.

If we receive regulatory
clearance or approval of the GelrinC or other future products, we will remain subject to ongoing and pervasive regulatory requirements
governing, among other things, the manufacture, marketing, advertising, medical device reporting, sale, promotion, import, export, registration,
and listing of devices. For example, we will be required to submit periodic reports to the FDA as a condition of PMA approval. These
reports include information about failures and certain adverse events associated with the device after its clearance. Failure to submit
such reports, or failure to submit the reports in a timely manner, could result in enforcement action by the FDA. Following its review
of the periodic reports, the FDA might ask for additional information or initiate further investigation.

The regulations to which
we are subject are complex and have become more stringent over time. Regulatory changes could result in restrictions on our ability to
continue or expand our operations, higher than anticipated costs, or lower than anticipated sales. Even after we have obtained the proper
regulatory clearance to market a device, we have ongoing responsibilities under FDA regulations and applicable foreign laws and regulations.
The FDA, state and foreign regulatory authorities have broad enforcement powers. Our failure to comply with applicable regulatory requirements
could result in enforcement action by the FDA, state or foreign regulatory authorities, which may include any of the following sanctions:

| ● | untitled letters or warning 
 letters;                    |

| ● | fines, injunctions, consent  
 decrees and civil penalties; |

| ● | recalls, termination of                                             
 distribution, administrative detention, or seizure of our products; |

| ● | customer notifications             
 or repair, replacement or refunds; |

| ● | operating restrictions                                 
 or partial suspension or total shutdown of production; |

| ● | delays in or refusal to                                                                                                                       
 grant our requests for future clearances or approvals or foreign marketing authorization of new products, new intended uses, or modifications 
 to existing products;                                                                                                                         |

| ● | withdrawals or suspensions                                                              
 of product clearances or approvals, resulting in prohibitions on sales of our