Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 122

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 122
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 in the outcome for the Pivotal Study.

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We have recruited and
treated 47 patients for the Pivotal Study out of the 80 required for submission (41 of which have completed the two-year follow up in
this trial). We intend to recruit the remaining patients subject to financing, including the closing of this offering and by the end
of 2025. We are now performing follow-up testing of the treated patients. No serious adverse events have been observed in the pivotal
trial. We expect to complete the recruitment of patients by the end of 2025, and we further expect to submit our PMA by the end of 2027.

Research and Development

Having grown out of research
from The Technion Israel Institute of Technology, our commitment to research and innovation is best witnessed by the development we carried
out on GelrinC to-date from the underlying science and our close relationship with our founder Professor Dror Seliktar of The Technion.
We believe we have the expertise onboard to continue to build our product lines, including advancing future products and additional applications
(such as GelrinP).

Intellectual Property

Our success will depend in
part on obtaining and maintaining patents, trade secrets and other intellectual property and protection of our technology, current and
future product candidates and methods used to develop and manufacture them. We cannot be sure that any of our currently pending patent
applications or with respect to any patent applications that we file in the future will be granted, nor can we be sure that our existing
patents or any patents that may be granted to us in the future will be sufficient to protect our technology or will not be challenged,
invalidated or circumvented. Our success also depends on our ability to operate our business without infringing, misappropriating or
otherwise violating any patents and other intellectual property or proprietary rights of third parties.

The scope of patent protection
for the major products that are already approved for marketing and/or in development by the Company include granted or issued patents.
The main composition of matter patents claim protein-polymer conjugates of an extracellular matrix protein (e.g. fibrinogen) or a serum
protein, (e.g., albumin) covalently bound to a synthetic polymer (e.g. polyethylene glycol, polaxamer), as well as uses of these compositions
for treating cartilage injuries or osteoarthritis and scaffolds formed from these conjugates. Additionally, there is a family of