Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 134

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 134
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 potential competitors, although not yet approved for marketing, may succeed in developing products that could directly
compete with GelrinC for market share in cartilage repair, but according to our belief, these other remaining potential competitors are
premature, in terms of research and development, in order for us to determine or evaluate what their potential market share significance
could be. An additional product named Agili-C, which was developed by CartiHeal (acquired by Smith & Nephew in January 2024), has
recently been approved by the FDA. However, to the best of our knowledge, 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