Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 114

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 114
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 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. The improvements observed in the KOOS and VAS pain measurement scores taken
over two years were superior (100% greater improvement) to those seen with the traditional microfracture (the current “gold standard”)
procedure. Additionally, patients continued to report further improvement and greater pain reduction of their knee and associated problems
using GelrinC for four years.

Based on these results, the
FDA has granted Regentis an IDE for our pivotal trial, permitting PMA submission with two-year follow up data of 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