Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 23

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 23
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 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 additional products and procedures to improve GelrinC
implementation and expand our product offerings that reach the market in a timely manner, receive adequate coverage and reimbursement
from third-party payors and provide products that are easier to use, safer, less invasive and more effective than the products and procedures
of our competitors.

We compete with large, diversified
medical device and pharmaceutical companies, including Vericel and others. We also compete with smaller companies similar to us. We also
face potential competition from many different sources, including academic institutions, governmental agencies, and public and private
research institutions.

At any time, these competitors
and other potential market entrants may develop new products, procedures or treatment alternatives that could render our products obsolete
or uncompetitive. In addition, one or more of such competitors may gain a market advantage by developing and patenting competitive products,
procedures or treatment alternatives earlier than we can, obtaining regulatory clear