Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 53

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 53
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 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.

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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 or approvals for our products
or to manufacture, market or distribute our products after clearance or approval is obtained.

Our products must be manufactured in accordance with federal, state and foreign regulations, and we could be forced to recall our devices or terminate production if we fail to comply with these regulations.

The methods used in, and
the facilities used for, the manufacture of our products must comply with the Quality System Regulation, or QSR, which is a complex regulatory
scheme that covers the procedures and documentation of the design, testing, production, process controls