Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 50

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 50
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 trade secrets or other proprietary information of the former employers. An inability to
incorporate technologies, features or other intellectual property that are important or essential to our products could have a material
adverse effect on our business and competitive position, and may prevent us from selling our products. In addition, we may lose valuable
intellectual property rights or personnel. Even if we are successful in defending against these claims, litigation could result in substantial
costs and could be a distraction to management. Any litigation or the threat thereof may adversely affect our ability to hire employees
or contract with independent sales representatives. A loss of key personnel or their work product could hamper or prevent our ability
to commercialize our products, 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