Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 122

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 122
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fracture (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 (41 of which have completed the two-year follow up in this trial). 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 (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