Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 30

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 30
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 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 complete them at all or in a satisfactory or timely manner, which
could delay or prevent us from obtaining regulatory approvals for, or