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

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 24
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 approved IDE, or the Pivotal
Study, in the United States and Europe. As we have limited clinical experience, our ability to identify potential problems and/or
inefficiencies concerning current and future versions of GelrinC in advance of its use in general and expanded groups of patients
may be limited, and we cannot assure you that actual clinical performances will be satisfactory to support proposed indications and
regulatory approvals and clinical acceptance and adoption, or that its use will not result in unanticipated complications. However,
if the results of such study are not satisfactory, our ongoing Pivotal Study could be delayed. Furthermore, there can be no
assurance that the implementation of our plan will be successful. Furthermore, the results from laboratory, non-clinical and
completed clinical studies, as well as results from our ongoing clinical trials may not be indicative of final clinical results
obtained from our current GelrinC version or future versions of GelrinC on expanded screening populations. In addition, the results
of our clinical trials are subject to human analyses and interpretation of the data accumulated, which could be affected by various
errors due to, among others, lack of sufficient clinical experience with GelrinC, assumptions used in the statistical analysis of
results, interpretation errors in the analysis of the clinical trials results, or due to uncertainty in the actual efficacy of
GelrinC in its current clinical stage. Therefore, the safety and efficacy of GelrinC and the clinical results to date will require
further independent professional validation and require further clinical study. If GelrinC does not function as expected over time,
we may not be able to develop GelrinC at the rate or to the stage we desire, we could be subject to liability claims, our reputation
may be harmed, GelrinC may not achieve regulatory clearances, and GelrinC may not be widely adopted by healthcare providers and
patients.

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We operate in a very competitive business environment, and if we are unable to compete successfully against our existing or potential competitors, our business, financial condition and results of operations may be adversely affected.

Our existing products and
procedures are, and any new products or procedures we develop and commercialize will be, subject to intense competition. The industry
in which we operate is competitive, subject to change and sensitive to the introduction of new products, procedures or other market activities
of industry participants. Our ability to compete successfully will depend on our ability to continue to train surgeons