Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 121

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 121
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reatment safety of GelrinC, and evaluate the performance and efficacy
of the GelrinC procedure at various time points.

The patient profile of the
pivotal trial’s first 40 patients is highly matched with the control patients’ profile with regard to inclusion and exclusion
criteria and with the patient population of the Pilot Study. A third-party biostatistics analysis of the two patient populations demonstrated
a higher level of matching between historical control patients and those treated so far in the Pivotal Study, when compared to the Pilot
Study, which led them to claim a higher likelihood of success in the outcome for the Pivotal Study.

We have recruited and treated
47 patients for the Pivotal Study out of the 80 required for submission. We intend to recruit the remaining patients subject to financing,
including the closing of this offering. 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).

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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