Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 66

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 66
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 Regulation
became applicable on May 26, 2021.

Among other things, the Medical
Devices Regulation:

| ● | strengthens the rules on                                                          
 placing devices on the market and reinforce surveillance once they are available; |

| ● | establishes explicit provisions                                                                                                 
 on manufacturers’ responsibilities for follow-up regarding the quality, performance and safety of devices placed on the market; |

| ● | improves the traceability                                                                                         
 of medical devices throughout the supply chain to the end-user or patient through a unique identification number; |

| ● | sets up a central database                                                                                                       
 to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU; and |

| ● | provides strengthened rules                                                                                                      
 for the assessment of certain high-risk devices, which may have to undergo an additional check by experts before they are placed 
 on the market.                                                                                                                   |

These modifications may have an effect
on the way we conduct our business in the EEA.

Healthcare reform laws could adversely affect our products and financial condition.

From time to time, legislation
is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory clearance or
approval, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA regulations and guidance are
often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new regulations or
revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of our product candidates.
We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted
or adopted may have on our business in the future. Such changes could, among other things, require:

| ● | changes to manufacturing methods; |

| ● | change in protocol design; |

| ● | additional treatment arm (control); |

| ● | recall, replacement, or discontinuance of one or more 
 of our products; and                                  |

| ● | additional recordkeeping. |

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In addition, in the United
States, there have been a number of legislative and regulatory proposals to change the health care system in ways that could affect our
ability to sell our products profitably. There have been executive, judicial and Congressional challenges to certain aspects of the Affordable
Care Act, or the ACA. Following the enactment of the Tax Act, on December 14, 2018 in a case in the United States District Court for
the Northern