Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 50

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 50
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shareholders losing their entire investment.

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We may not receive, or may be delayed in receiving, the necessary clearances or approvals for our future products, and failure to timely obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business.

In the United States, before
we can market a new medical device, or a new use of, new claim for or signification modification to an existing product, we must first
receive approval of a PMA from the FDA. Clinical data are sometimes required to support substantial equivalence. In the process of obtaining
PMA approval, the FDA must determine that a proposed device is safe and effective for its intended use based, 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