Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 26

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 26
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 ● | development of similarly                    
 cost-effective products by our competitors; |

| ● | development delays of GelrinC; |

| ● | adverse medical side effects                                                                   
 suffered by patients using GelrinC, whether actually resulting from the use of GelrinC or not; |

| ● | changes in regulatory policies     
 toward tissue repair technologies; |

| ● | changes in regulatory approval,                       
 clearance requirements and licensure for our product; |

| ● | third-party claims of intellectual 
 property infringement;             |

| ● | budget constraints and                                                                       
 the availability of reimbursement or insurance coverage from third-party payors for GelrinC; |

| ● | adverse responses from                                     
 certain of our competitors to the offering of GelrinC; and |

| ● | the shelf life of GelrinC. |

If healthcare professionals do not recommend our product to their patients, GelrinC may not achieve market acceptance and we may not become profitable.

If healthcare professionals,
including physicians, do not recommend or prescribe our product to their patients, GelrinC may not achieve market acceptance and we may
not become profitable. In addition, physicians have historically been slow to change their medical diagnostic and treatment practices
because of perceived liability risks arising from the use of new products. Delayed adoption of GelrinC by healthcare professionals could
lead to a delayed adoption by patients, as well as government and private third-party payors. Healthcare professionals may not recommend
GelrinC until certain conditions have been satisfied including, among others:

| ● | there is sufficient long-term                                                                                             
 clinical and health-economic evidence to convince them to alter their existing tissue repair methods and recommendations; |

| ● | there are recommendations                                                                               
 from prominent physicians, educators and/or associations indicating that GelrinC is safe and effective; |

| ● | we obtain favorable data                               
 from clinical and health-economic studies for GelrinC; |

| ● | reimbursement or insurance                                            
 coverage from government and private third-party payors is available; |

| ● | healthcare professionals                                                                                    
 obtain required approvals and licensures for the handling, storage, dispensing and disposal of GelrinC; and |

| ● | healthcare professionals                          
 become familiar with the complexities of GelrinC. |

We cannot predict when, if
ever, healthcare professionals and patients may adopt the use of GelrinC. Even if favorable data is obtained from clinical and health-economic
studies for the regulatory approval of GelrinC, there can be no assurance that prominent physicians would endorse it or that future clinical
studies