Company: RGNT
Filing Date: 2025-03-11
Form Type: F-1
Source: 0001213900-25-022350
Chunk: 54

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-03-11
Form: F-1
Chunk 54
---
 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 products; |

| ● | FDA refusal to issue certificates                                                 
 to foreign governments needed to export products for sale in other countries; and |

| ● | criminal prosecution. |

Any of these sanctions could
result in higher than anticipated costs or lower than anticipated sales and have a material adverse effect on our reputation, business,
financial condition and results of operations.

<div align='center'>36</div>

In addition, the FDA or state
or foreign authorities may change their clearance and approval policies, adopt additional regulations or revise existing regulations,
or take other actions, which may prevent or delay clearance or approval of our future products under development on a timely basis. Such
policy or regulatory changes could impose additional requirements upon us that could delay our ability to obtain new clearances or approvals,
increase the costs of compliance or restrict our ability to maintain any approvals we are able to obtain. Legislative or regulatory reforms
in the United States or the EU may make it more difficult and costly for us to obtain regulatory clearances