Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 124

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 124
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 cartilage injury.In our unique trial design, GelrinC efficacy is compared to historical microfracture (the current “gold
standard”) procedure efficacy data. The FDA agreed that the data of 80 patients with two-year follow-up data is sufficient for PMA
submission for approval. The primary endpoints are KOOS pain scores and Function in Daily Living, or ADL, scores at 24 months, with secondary
endpoints being, overall KOOS scores and modified MOCART scores at 24 months.

To date, the Company has treated
47 patients out of the 80 required for submission. We expect to complete the pivotal 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.

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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