Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 53

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 53
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 This certificate entitles the manufacturer to affix the CE mark to its medical devices
after having prepared and signed a related EC Declaration of Conformity.

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As a general rule, demonstration
of conformity of medical devices and their manufacturers with the essential requirements must be based, among other things, on the evaluation
of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically, a manufacturer must
demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and
any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made
about the performance and safety of the device are supported by suitable evidence. If we fail to remain in compliance with applicable
European laws and directives, we would be unable to continue to affix the CE mark to our products, which would prevent us from selling
them within the EEA.

Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the market.

If we receive regulatory clearance
or approval of the GelrinC or other future products, we will remain subject to ongoing and pervasive regulatory requirements governing,
among other things, the manufacture, marketing, advertising, medical device reporting, sale, promotion, import, export, registration,
and listing of devices. For example, we will be required to submit periodic reports to the FDA as a condition of PMA approval. These reports
include information about failures and certain adverse events associated with the device after its clearance. Failure to submit such reports,
or failure to submit the reports in a timely manner, could result in enforcement action by the FDA. Following its review of the periodic
reports, the FDA might ask for additional information or initiate further investigation.

The regulations to which we
are subject are complex and have become more stringent over time. Regulatory changes could result in restrictions on our ability to continue
or expand our operations, higher than anticipated costs, or lower than anticipated sales. Even after we have obtained the proper regulatory
clearance to market a device, we have ongoing responsibilities under FDA regulations and applicable foreign laws and regulations. The
FDA, state and foreign regulatory authorities have broad enforcement powers. Our failure to comply with applicable regulatory requirements
could result in enforcement action by the FDA, state or foreign regulatory authorities, which may include any of the following sanctions:

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