Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 23

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 23
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 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 on the GelrinC
hydrogel implant procedure and gain their acceptance of the procedure, develop