Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 114

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 114
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80 patients, with an
additional 40 patients to be treated thereafter. The pivotal trial currently being conducted in the United States and Europe. So far,
we have recruited and treated 47 patients out of the required 80 initial patients, under the FDA sanctioned protocol. The protocol is
an open label study, with one arm only (treatment), using our own historical control (microfracture). 41 patients out of the 47 patients
recruited so far have completed the two-year follow up in this trial. We expect to complete the recruitment of patients after the completion
of this offering and by the end of 2025.

Our Market and Opportunity

According to our knowledge,
there is currently no approved off-the-shelf product in the United States for the cartilage repair 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 4 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