Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 134

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 134
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 Agili-C has not yet been launched for commercialization.

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If our product is approved
in the United States, it is highly likely that we will face competition from Vericel. Vericel’s MACI utilizes a cellular procedure
requiring two surgeries; one for the biopsy taking out a piece of health cartilage for cellular expansion, and a second which occurs approximately
10 - 12 weeks thereafter for reimplantation of the expanded cell population. This procedure costs ~$40,000, with a reported recovery period
of 6 weeks. This is a long, complex procedure especially compared to the ~10 minute procedure for the delivery of GelrinC, which only
involves one surgery.

| (1) | Represents the market cap as of November 27, 2024. Vericel’ product, Maci, net revenues for first half of 2024. |

Research Grants

Grants under the Israeli Encouragement of Industrial and Development Law

Our research and development
efforts have been financed in part through royalty-bearing and non-royalty-bearing grants in an aggregate principal amount of $2.34 million
that we received from the IIA as of December 31, 2024. With respect to the royalty-bearing grants, we are committed to pay royalties
at a rate between 3% and 4.5% on sales proceeds from our products that were developed under IIA programs up to the total amount of grants
received, linked to the U.S. dollar and bearing interest at an annual rate of SOFR applicable to U.S. dollar deposits.

Grant from the European Commission

We received an approval from
the EU through EASME, for our participation in research and development activities. Pursuant to such approval, the EASME will fund research
and development expenses of up to total approved budget of approximately 2,185,190 EUR as part of the Horizon 2020 Research and Innovation
Framework Programme.

Government Regulation

Our products and our operations
are subject to extensive regulation by the FDA and other federal and state authorities in the United States, as well as comparable authorities
in foreign jurisdictions. Our products are subject to regulation as medical devices in the United States under the Federal Food, Drug,
and Cosmetic Act, or the FDCA, as implemented and enforced by the FDA.

United States Regulation

The FDA regulates the development,
design, non-clinical and clinical research, manufacturing, safety, efficacy