Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 17

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 17
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 size of any markets
in which our products and product candidates receive approval and our ability to achieve sufficient market acceptance, pricing, reimbursement
from third-party payors for our products and product candidates. Further, the operating losses that we incur may fluctuate significantly
from quarter to quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good indication
of our future performance. Other unanticipated costs may also arise.

We have not generated any revenue from product sales and may never be profitable.

While
our GelrinC has been approved as a device with a CE mark in Europe since August 2017, we have not yet begun to commercialize our products
and have never generated any revenue from product sales. Our ability to generate revenue and achieve profitability mainly depends on
our ability to find a marketing partner for Europe after we scale-up our manufacturing and prepare our GelrinC product for launch. In
parallel, we need to receive the necessary regulatory approvals to commercialize 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