Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 132

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 132
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 the United States.Arthroscopy. 2021;37(12):3499–3506.e1. |

| (3) | Market Cap as of May 1, 2025.                                                                                                                                                                         
 Net revenues of $46.3M for MACI in first quarter of Fiscal Year 2025 (https://investors.vcel.com/news-releases/news-release-details/vericel-reports-first-quarter-2025-financial-results-and-raises). |
| (4) | https://www.smith-nephew.com/en/news/2024/01/10/20240110---sn-completes-acquisition-of-novel-cartilage-regeneration.                                                                                  |

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, labeling, packaging, storage, installation, servicing, recordkeeping,
premarket clearance or approval, adverse event reporting, advertising, promotion, marketing and distribution, and import and export of
medical devices to ensure that medical devices distributed domestically are safe and effective for