Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 119

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 119
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 the cartilage cells. This pre-formed implant requires special fitting and drilling into the bone and related cartilage lesion
and in order to accommodate the lower layer of the implant (the scaffold), the surgeon must drill down into the underlying bone even though
the bone is often healthy. It is worthwhile mentioning that a minute fraction of patients present themselves with bone involvement while
an overwhelming majority have only cartilage injuries.

Our Strategy

We aim to provide patients
with safe, effective, simple, lasting treatments that are cost effective. With our lead product, GelrinC, patients may be treated for
cartilage injuries in the knee with an off-the-shelf product by a short and simple procedure that is highly cost effective.

Our first priority is to complete
patient enrollment and required follow-up of our GelrinC pivotal trial on the critical path to FDA approval. Upon completion of this
offering, we plan to continue our pivotal clinical trial, as we move toward FDA approval.

| ● | We aim to complete our GelrinC pivotal trial, and if successful, we plan to apply for PMA marketing approval. |

| ● | If and when GelrinC is approved for commercial sale, we intend to market the product in the United States with a strategic partner. Our reimbursement strategy will be to obtain a Current Procedural Terminology, or CPT, code based on articles of innovation. In addition, we intend to capitalize on the opportunity and carry out post-approval trials in a number of additional injuries including elbow, wrist and ankle, in an effort to become the cartilage leader in this market. |

| ● | We have obtained a CE mark for marketing approval for GelrinC in Europe and plan to look for a strategic partner in connection therewith, in parallel to seeking FDA approval. |

| ● | We plan to build on our Gelrin platform technology to broaden our product base. Our Gelrin family of products is a unique one that can be used for other injuries and we intend to develop a pipeline of products that can be used for additional tissue regeneration opportunities. |

Our Solution – Cartilate Regeneration Through Stimulating the Body’s Natural healing Process

Gelrin is a family of hydrogels
that derive their unique physical and chemical properties from polymer chains crosslinked with trace quantities of denatured protein.
In the body, Gelrin is eroded and resorbed over time through a pre-programmed and controlled gradual surface degradation process, meaning
that the GelrinC implant covers the entire wound, so