Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 118

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 118
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 that can be delivered through a single open or minimally invasive approach. There is also another technology, CartiHeal’s
(acquired by Smith & Nephew in January 2024) Agili-C, which was approved by the FDA in March 2022, that utilizes pre-formed implants
that consist of a two layer plug, of which the lower layer is a mineral/coral material that has been shaped to be inserted into a hole
drilled into bone, which part is expected to assimilate with the bone, and the upper layer part is a scaffold intended to serve as a growth
host for 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