Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 56

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 56
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 in part, on extensive data,
including, but not limited to, technical, pre-clinical, clinical trial data, manufacturing and labeling data. The PMA process is typically
required for devices that are deemed to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices.

Modifications to products
that are approved through a PMA application generally require FDA approval. The PMA approval can be expensive, lengthy and uncertain.
The process of obtaining a PMA is costly and uncertain and generally takes from one to three years, or even longer, from the time the
application is submitted to the FDA. In addition, a PMA generally requires the performance of one or more clinical trials. Despite the
time, effort and cost, a device may not be approved or cleared by the FDA. Any delay or failure to obtain necessary regulatory clearances
or approvals could harm our business.

Furthermore, even if we are
granted regulatory clearances or approvals, they may include significant limitations on the indicated uses for the device or other restrictions
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