Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 115

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 115
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. 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 the cells that naturally want to migrate to the damaged tissue in situations where
there is nothing holding them back or preventing them from migration, are unable to migrate due to the GelrinC implant and are controlled,
which allows for the receding implant to allow the surrounding cells to regenerate the cartilage in a controlled and synchronous process.
The body of this receding mass acts to stimulate the body’s natural healing process, by guiding the migration and organization of
cells involved in tissue repair doing so in a gradual process over time. Gelrin is applied in liquid form allowing it to completely fill
the entire tissue defect and is then cured into a rubbery implant by the use of ultraviolet, or UV, light. It can be introduced into narrow
bone crevices or large spaces, open or closed.

GelrinC is specifically designed
for the