Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 55

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 55
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 HHS. The FDA and foreign regulatory
agencies regulate, among other things, with respect to medical devices: design, development and manufacturing; testing, labeling, content
and language of instructions for use and storage; clinical trials; product safety; establishment registration and device listing; marketing,
sales and distribution; pre-market clearance and approval; conformity assessment procedures; record keeping procedures; advertising and
promotion; recalls and field safety corrective actions; post-market surveillance, including reporting of deaths or serious injuries and
malfunctions that, if they were to occur, could lead to death or serious injury; post-market approval studies; and product import and
export.

The regulations our product
candidate is subject to are complex and have tended to become more stringent over time. Regulatory changes could result in restrictions
on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales for any approved product.
Failure to comply with applicable regulations could jeopardize our ability to sell our future products, if cleared or approved, and result
in enforcement actions such as: warning or untitled 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,