Company: RGNT
Filing Date: 2025-03-11
Form Type: F-1
Source: 0001213900-25-022350
Chunk: 113

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-03-11
Form: F-1
Chunk 113
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become subject to significant inflationary pressures, we may not be able to fully offset such higher costs through hedging transactions.
Our inability or failure to do so could harm our business, financial condition and results of operations.

Foreign Currency Exchange Risk

Currency fluctuations could
affect us through increased or decreased costs, mainly for goods and services acquired outside of Israel. Currency fluctuations did not
have a material effect on our results of operations during the six months ended June 30, 2024 and the year ended December 31, 2023 and
the year ended December 31, 2022.

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BUSINESS</div>

Overview

Regentis Biomaterials Ltd.
is a regenerative medicine company dedicated to developing innovative tissue repair solutions that restore the health and enhance quality
of life of patients. Our current efforts are focused on orthopedic treatments using our Gelrin platform based on degradable hydrogel
implants to regenerate damaged or diseased tissue (inflamed cartilage and bone tissue). Gelrin is a unique hydrogel matrix of polyethylene
glycol diacrylate (a polymer involved in tissue engineering) and denatured fibrinogen (a biologically inactivated protein that normally
has a role in blood clotting). Our lead product is GelrinC, a cell-free, off-the-shelf hydrogel that is cured into an implant in the
knee for the treatment of painful injuries to articular knee cartilage.

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 we believe, gives surgeons a cost-effective product and a simple-to-perform procedure providing patients with sustained
pain relief and functional improvement. 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 our product offers a simple, and economic procedure, allowing patients for a comparatively
quick recovery with potentially 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.

In the Pilot Study, 56 patients
were treated with GelrinC for articular cartilage injuries