Company: RGNT
Filing Date: 2025-02-12
Form Type: DRS/A
Source: 0001213900-25-012299
Chunk: 121

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-02-12
Form: DRS/A
Chunk 121
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 trial within 2.5 years, consisting of six months
for the recruitment and treatment of the remaining 33 patients and two years of follow-up from the treatment of the last patient. We 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.

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