Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 131

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 131
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 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 amount of $2.34 million that we received from the IIA as of June 30, 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 their intended uses and otherwise meet
the requirements of the FDCA.

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FDA Premarket Clearance and Approval Requirements

Unless an exemption applies,
each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket notification, or
approval of a PMA. Under the FDCA, medical devices are classified into one of three classes—Class I, Class II or Class III—depending
on the degree of risk associated with each medical device and the extent