Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 49

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 49
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, which could materially and adversely affect our business, financial condition, operating results, cash
flows and prospects.

Risks Related to Government Regulation

Our product candidates and operations are subject to extensive government regulation and oversight both in the United States and abroad, and our failure to comply with applicable requirements could harm our business.

GelrinC and possibly other
future products we develop will be regulated by the FDA and the EU Notified Bodies as medical devices. Our product candidate is subject
to extensive regulation in the United States and elsewhere, including by the FDA and its foreign counterparts, the U.S. Department of
Justice, or the DOJ, and the U.S. Health and Human Services-Office of the Inspector General, or the 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