Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 52

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 52
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or requirements, which may limit the market for the device.

The FDA can delay, limit or
deny clearance or approval of a medical device for many reasons, including:

| ● | our inability to demonstrate to the satisfaction of the FDA or the applicable regulatory entity or notified body that our product candidates are safe or effective for their intended uses; |

| ● | the disagreement of the FDA or the applicable foreign regulatory body with the design or implementation of our clinical trials or the interpretation of data from pre-clinical studies or clinical trials; |

| ● | serious and unexpected adverse effects experienced by participants in our clinical trials; |

| ● | the data from our pre-clinical studies and clinical trials may be insufficient to support clearance or approval, where required; |

| ● | our inability to demonstrate that the clinical and other benefits of the device outweigh the risks; |

| ● | the manufacturing process or facilities we use may not meet applicable requirements; and |

| ● | the potential for approval policies or regulations of the FDA or applicable foreign regulatory bodies to change significantly in a manner rendering our clinical data or regulatory filings insufficient for clearance or approval. |

In order to sell our
products in member countries of the European Economic Area, or EEA, our products must comply with the essential requirements of the
EU Medical Devices Directive (Council Directive 93/42/EEC). Compliance with these requirements is a prerequisite to be able to affix
the CE mark to our products, without which they cannot be sold or marketed in the EEA. To demonstrate compliance with the essential
requirements we must undergo a conformity assessment procedure, which varies according to the type of medical device and its
classification. Except for low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can issue a
European Community, or EC, Declaration of Conformity based on a self-assessment of the conformity of its products with the essential
requirements of the EU Medical Devices Directive, a conformity assessment procedure requires the intervention of an organization
accredited by a member state of the EEA to conduct conformity assessments, or a Notified Body. 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.