Company: RGNT
Filing Date: 2025-03-11
Form Type: F-1
Source: 0001213900-25-022350
Chunk: 24

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-03-11
Form: F-1
Chunk 24
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 version we advance through clinical trials may not have favorable results in later clinical trials or receive a regulatory approval.

Clinical failure can occur
at any stage of clinical development. To date, we have performed the Pilot Study involving 56 patients who were treated with GelrinC, and
followed up for up to four years in multiple sites in northern Europe and in Israel. To obtain marketing approval in the United States,
we are currently carrying out an additional pivotal clinical study under an 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,