Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 51

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 51
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 letters; fines; injunctions; consent decrees;
civil penalties; customer notifications; termination of distribution; recalls or seizures of products; administrative detention of
medical devices believed to be adulterated or misbranded; delays in the introduction of products into the market; operating
restrictions; total or partial suspension of production; refusal to grant future clearances or approvals for new products, new
intended uses or modifications to our products; withdrawals or suspensions of current approvals, resulting in prohibitions on sales
of our products; and in the most serious cases, criminal prosecution or penalties.

The occurrence of any of these
events would have a material adverse effect on our business, financial condition and results of operations and could result in 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