Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 51

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 51
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 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 examine the technical file and the quality system for the manufacture, design and final inspection of
our devices. The Notified Body issues a certificate of conformity following successful completion of a conformity assessment procedure
conducted in relation to the medical device and its manufacturer and their conformity with the essential requirements. This certificate
entitles the manufacturer to affix the CE mark to its medical devices after having prepared and signed a related EC Declaration of Conformity.

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As a general rule, demonstration
of conformity of medical devices and their manufacturers with the essential requirements must be based, among other things, on the evaluation
of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically, a manufacturer
must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks,
and any adverse events, are minimized and acceptable when weighed against