Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 29

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 29
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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 clearances or approvals more rapidly than we can or selling
competitive products at prices lower than ours. If medical research were to lead to the discovery of alternative therapies or technologies
that improve or cure tissue regeneration as an alternative to surgery, the use of pharmaceuticals or breakthrough bio-technological innovations
or therapies, our profitability could suffer through a reduction in sales