Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 114

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 114
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rous cartilage, but instead has been shown to grow hyalin-like cartilage,
which is the autologous natural cartilage of the patient.

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Competing Therapies for Cartilage Repair

Beyond microfracture surgery,
current commercial therapies for cartilage repair generally involve the use of autologous cells harvested from the patient’s own
healthy tissue. This approach has numerous disadvantages including:

| ● | The need for expensive cell expansion facilities and the requirement for two surgical procedures. |

| ● | The price for such autologous procedures is approximately $40,000 in the United States. |

| ● | There are also allogeneic cartilage products (BioCartilage and Neo) sourced from cadavers, which, based on our experience, are not preferred by surgeons except for in unique cases. |

Due to the complexity,
source and cost of alternatives, orthopedic surgeons with whom we have consulted have expressed a strong preference for a simple,
‘off-the-shelf’ product 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