Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 113

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 113
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 market. GelrinC potentially offers
a solution that gives surgeons a cost-effective product and a simple-to-perform procedure providing patients with sustained pain relief
and functional improvement.

We believe that GelrinC will
offer a cost effective, off-the-shelf product that is simple to use, requiring approximately a 10-minute procedure and from the company’s
experience with patients who have been treated thus far, an average two-week recovery period.

GelrinC is already approved
as a device with a CE mark in Europe, and we plan to look for strategic partners in Europe in connection therewith. With GelrinC, we aim
to develop a product for the treatment of an unmet need for the market of cartilage injuries in the knee. We believe that our product
offers a simple and economic procedure, allowing patients for a comparatively quick recovery with potential for long-term outcomes. In
addition, we have 34 granted patents and 3 pending patent applications covering, in a large number of countries, compositions, delivery
device, surgical and manufacturing features.

Knee cartilage injuries can
be caused either by acute or repetitive trauma due to daily function, including those caused by sports activity. Knee cartilage does not
usually heal by itself when injured. Without treatment, cartilage injuries may progress and cause degeneration of joints, osteoarthritis,
and possibly require total knee replacement. According to an article published in April 2020 on the Harvard Health Publishing of Harvard
Medical School Website, the cartilage repair market in general, is a large sector of orthopedic medicine and currently represents an estimated
overall annual market opportunity of about 750,000 arthroscopic knee operations in the United States at a cost of $4 billion. According
to an article published in PubMed Central (National Library of Medicine), articular cartilage injuries are present in 60% to 66% of knees
undergoing arthroscopy.

The Current Standard of Care – Microfracture Surgery

Currently, the standard of
care procedure for cartilage injuries is microfracture surgery, which involves cleanup of the wound and creation of tiny punctures in
the underlying bone. Because the cartilage produced from microfracture surgery tends to be fibrous, the cartilage is more prone to deterioration
after a short period of time, with such relief from microfracture surgery lasting on average between eight to fourteen months. Unlike
microfracture surgery, treatment using GelrinC does not produce fib