Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 51

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 51
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ances
or approvals could harm our business.

Furthermore, even if we are
granted regulatory clearances or approvals, they may include significant limitations on the indicated uses for the device or other restrictions
or requirements, which may limit the market for the device.

The FDA can delay, limit
or deny clearance or approval of a medical device for many reasons, including:

| ● | our inability to demonstrate                                                                                                          
 to the satisfaction of the FDA or the applicable regulatory entity or notified body that our product candidates are safe or effective 
 for their intended uses;                                                                                                              |

| ● | the disagreement of the                                                                                                              
 FDA or the applicable foreign regulatory body with the design or implementation of our clinical trials or the interpretation of data 
 from pre-clinical studies or clinical trials;                                                                                        |

| ● | serious and unexpected                                              
 adverse effects experienced by participants in our clinical trials; |

| ● | the data from our pre-clinical                                                                    
 studies and clinical trials may be insufficient to support clearance or approval, where required; |

| ● | our inability to demonstrate                                           
 that the clinical and other benefits of the device outweigh the risks; |

| ● | the manufacturing process                                      
 or facilities we use may not meet applicable requirements; and |

| ● | the potential for approval                                                                                                            
 policies or regulations of the FDA or applicable foreign regulatory bodies to change significantly in a manner rendering our clinical 
 data or regulatory filings insufficient for clearance or approval.                                                                    |

In order to sell our products
in member countries of the European Economic Area, or EEA, our products must comply with the essential requirements of the EU Medical
Devices Directive (Council Directive 93/42/EEC). Compliance with these requirements is a prerequisite to be able to affix the CE mark
to our products, without which they cannot be sold or marketed in the EEA. To demonstrate compliance with the essential requirements
we must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification. Except
for low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can issue a European Community, or
EC, Declaration of Conformity based on a self-assessment of the conformity of its products with the essential requirements of the EU
Medical Devices Directive, a conformity assessment procedure requires the intervention of an organization accredited by a member state
of the EEA to conduct conformity assessments, or a Notified Body. Depending on the relevant conformity assessment procedure, the Notified
Body would typically audit and