Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 24

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 24
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 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 collaborations; |

| ● | maintain, protect and expand our portfolio of intellectual property rights, including patents, patent applications, trade secrets and know-how; |

| ● | avoid and defend against third-party interference or infringement claims; and |

| ● | attract, hire and retain qualified personnel. |

We
anticipate incurring significant incremental costs associated with commercializing such product candidates. Our expenses could increase
beyond expectations if we are required by the FDA, or other regulatory agencies, domestic or foreign, to change our manufacturing processes
or assays or to perform studies in addition to those that we currently anticipate. Even if we are successful in obtaining additional regulatory
approvals to market our GelrinC or any future product candidates, our revenue earned from such product candidates will be dependent in
part upon the size of the markets in the territories for which we gain regulatory approval for such products, the accepted price for such
products, our ability to obtain reimbursement for such products at any price, whether we own the commercial rights for that territory
in which such products have been approved and the expenses associated with manufacturing and marketing such products for such markets.
Therefore, we may not generate significant revenue from the sale of such products