Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 28

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 28
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 can complete the development and commercialization
of our technology, our future products and our services, including our GelrinC product candidate and platform technology, whether we can
manufacture GelrinC on a commercial scale in such amounts and at such costs as we anticipate, and whether we can achieve market acceptance
of our products, services and business models. We may never generate any revenue or operate on a profitable basis. Even if we achieve
profitability, we may not be able to sustain it.

Clinical failure can occur at any stage of clinical development. Our clinical experience to date does not necessarily predict future results and may not have revealed certain potential limitations of the technology and potential complications from GelrinC and may require further clinical validation. Any product 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