Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 133

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 133
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.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 of manufacturer and regulatory control needed to ensure its
safety and effectiveness. Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness
can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions
of the QSR, facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling,
advertising, and promotional materials. Class II devices are subject to the FDA’s General Controls, and special controls as
deemed necessary by the FDA to ensure the safety and effectiveness of the device. These special controls can include performance standards,
post-market surveillance, patient registries and FDA guidance documents.

While most Class I devices
are exempt from the 510(k)