Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 34

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 34
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 service, our products, business, reputation and operating
results could be adversely affected. In addition, poor quality of service by third-party service providers could result in liability claims
and litigation against us for damages or injuries.

Our business plan relies on certain assumptions about the market for our product, however, the size and expected growth of our addressable market has not been established with precision and may be smaller than we estimate, and even if the addressable market is as large as we have estimated, we may not be able to capture additional market share.

Our estimates of the addressable
market for our current products and future products are based on a number of internal and third-party estimates and assumptions. While
we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and our estimates may not be correct.
However, the projected demand for our products could materially differ from actual demand if our assumptions regarding these trends and
acceptance of our products by the medical community prove to be incorrect or do not materialize, or if non-surgical treatments or other
surgical techniques gain more widespread acceptance as a viable alternative to using GelrinC. In addition, even if the number of tissue
regeneration sufferers who elect to undergo tissue repair surgery, and the Gelrin hydrogel implant procedure in particular, increases
as we expect, technological or medical advances could provide alternatives to address tissue regeneration and reduce demand for tissue
regeneration implant surgery. As a result, our estimates of the addressable market for our current or future products and procedures may
prove to be incorrect. Further, one component of our growth strategy is our direct to patient education program, which we expect will
help us educate additional tissue regeneration patients about our products and procedures; however, these patient engagements may not
be as successful at educating potential surgical candidates as we expect. Thus, even if the total addressable market for our current and
future products and procedures is as large as we have estimated, we may not be able to penetrate the existing market to capture additional
market share for the reasons discussed in this “Risk Factors.”. If the actual number of tissue regeneration sufferers who
would benefit from our products, the price at which we can sell future products or the addressable market for our products is smaller
than we estimate, or if the total addressable market is as large as we have estimated but we are unable to capture additional market share,
it could have a material adverse effect on our business, financial condition and results of operations.

We depend on third parties to