Company: RGNT
Filing Date: 2025-02-12
Form Type: DRS/A
Source: 0001213900-25-012299
Chunk: 19

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-02-12
Form: DRS/A
Chunk 19
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 our GelrinC in the United States. We do not know when,
or if at all, we will generate any such revenue. Our ability to generate future revenue from product sales will depend heavily on our
success in many areas, including but not limited to:

| ● | complete research and development                                                                    
 of our Gelrin hydrogel platform and any future product candidates in a timely and successful manner; |

| ● | complete our pivotal clinical                        
 study in the United States. and Europe successfully; |

| ● | obtain FDA approval for 
 our GelrinC product     |

| ● | obtain regulatory and marketing      
 approval for any product candidates; |

| ● | maintain and enhance a                                                                                                                   
 commercially viable, sustainable, scalable, reproducible and transferable manufacturing process for our GelrinC product and our hydrogel 
 platform and any future product candidates that is compliant with current good manufacturing practices, or cGMPs;                        |

| ● | establish and maintain                                                                                                           
 supply and, if applicable, manufacturing relationships with third parties that can provide, in both amount and quality, adequate 
 products to support development and the market demand for our Gelrin hydrogel platform and any future product candidates, if and 
 when approved;                                                                                                                   |

| ● | identifying, assessing,                             
 acquiring and/or developing new product candidates; |

| ● | launch and commercialize                                                                                                               
 any product candidates for which we obtain regulatory and marketing approval, either directly by establishing a sales force, marketing 
 and distribution infrastructure, and/or with collaborators or distributors in the United States, Europe and other potential markets    
 that we will target;                                                                                                                   |

| ● | accurately identifying                                                    
 demand for our Gelrin hydrogel platform or any future product candidates; |

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| ● | expose and educate physicians                               
 and other medical professionals to the use of our products; |

| ● | obtain market acceptance                                                                                             
 of our Gelrin hydrogel platform and any future product candidates from the medical community and third-party payors; |

| ● | ensure our product candidates                                                                                                       
 are approved for reimbursement from governmental agencies, health care providers and insurers in jurisdictions where they have been 
 approved for marketing;                                                                                                             |

| ● | address any competing technological                                                                                              
 and market developments that impact our Gelrin hydrogel platform and any future product candidates or their prospective usage by 
 medical professionals;                                                                                                           |

| ● | negotiate favorable terms                                                                                                            
 in any collaboration, licensing or other arrangements into which we may enter and perform our obligations under such