Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 8

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 8
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 data at two years. Additionally, patients continued to report further improvement and
greater pain reduction of their knee and associated problems using GelrinC for four years. See “Business – Clinical Development of GelrinC – Completed Pilot Study” below.

Beyond microfracture surgery,
current commercial therapies for cartilage repair 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.

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Strategy & Solution

We aim to provide patients
with safe, effective, simple, and 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 we believe will be cost effective.
We believe that our Gelrin technology platform may also provide a solution to osteoarthritis and other cartilage injuries related to
the ankle, wrist, and elbow.

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. Gelrin
can be 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 light. It can also be introduced into narrow bone crevices or large spaces, open or closed.

GelrinC is specifically designed
for the repair of articular cartilage defects in the knee caused by acute trauma or repetitive use. We believe that GelrinC will offer
a cost effective, off-the-shelf product that will be simple to use, requiring approximately a 10-minute procedure and a two-week recovery
period.

Research and Clinical Development

We believe that the cartilage
repair market is in need for an off-the-shelf solution, which it currently lacks. GelrinC, being an off-the-shelf product, requiring
a short procedure, believed by us to be easy to use by the surgeon and having efficient economics answer those needs very effectively.
In both pre-clinical and clinical studies, all of these advantages were effectively demonstrated resulting in our decision to choose
GelrinC as our lead product candidate. In the Pilot Study we completed on 56 patients,