Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 123

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 123
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 believe that we will be in position to recruit the remaining required
33 patients across multiple centers within this time frame, subject to funding from this offering. Our expected timeline takes into consideration
that we have already built the study infrastructure, recruited the sites, and finalized agreements with hospitals and institutional review
boards. Since most of this is done and the sites are more available having done the two-year follow up, we believe that they will be
able to more efficiently rejoin the recruitment process.

The primary objectives for
the pivotal trial are to evaluate the 6, 12, 18 and 24-month post-treatment 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.

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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