Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 26

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 26
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 to derive most of our revenues from the sales of our GelrinC. Our inability to successfully commercialize this product candidate or any subsequent decline in demand for this product candidate, could severely harm our ability to generate revenues.

We are currently dependent
on the successful commercialization of GelrinC to generate revenues. As a result, factors adversely affecting our ability to successfully
commercialize, or the pricing of or demand for, this product could have a material adverse effect on our financial condition and results
of operations. If we are unable to successfully commercialize or create market demand for GelrinC, we will have limited ability to generate
revenues.

Furthermore, we may be vulnerable
to fluctuations in demand for GelrinC. Such fluctuations in demand may be due to many factors, many of which are beyond our control,
including, among others:

| ● | market                                                                                      
 acceptance of a new product, including healthcare professionals’ and patients’ preferences; |

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| ● | market acceptance of the clinical safety and performance of GelrinC; |

| ● | 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,