Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 29

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 29
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 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 manage our clinical studies and trials, perform related data collection and analysis, and to enroll patients for our clinical trials, and, as a result, we may face costs and delays that are beyond our control.

We rely on third parties,
such as CROs, clinical investigators and clinical sites, to manage our clinical trials and perform data collection and analysis, and
to enroll patients for our clinical trials. Although we have and expect to continue to have contractual arrangements with these third
parties, we control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies
is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance on such third
parties does not relieve us of our regulatory responsibilities. If such third parties fail to comply with applicable regulatory requirements,
the clinical data generated in our clinical trials may be deemed unreliable and regulatory authorities may require us to perform additional
clinical trials before approving our marketing applications, which would delay the regulatory approval process. Furthermore, we may not
be able to control the amount and timing of resources that these parties devote to our studies and trials or the quality of these resources.
If these third parties fail to properly manage our studies and trials or enroll patients for our clinical trials, we may be unable to