Company: RGNT
Filing Date: 2025-02-12
Form Type: DRS/A
Source: 0001213900-25-012299
Chunk: 53

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-02-12
Form: DRS/A
Chunk 53
---
. Depending on the relevant conformity
assessment procedure, the Notified Body would typically audit and examine the technical file and the quality system for the
manufacture, design and final inspection of our devices. The Notified Body issues a certificate of conformity following successful
completion of a conformity assessment procedure conducted in relation to the medical device and its manufacturer and their
conformity with the essential requirements. 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.

<div align='center'>35</div>

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