Company: RGNT
Filing Date: 2025-02-12
Form Type: DRS/A
Source: 0001213900-25-012299
Chunk: 24

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-02-12
Form: DRS/A
Chunk 24
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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, financial condition and results of operations may be adversely affected.

Our