Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 122

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 122
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 called a pilot study. We carried out the Pilot Study on 56 patients that were treated
with GelrinC and followed up for up to four years in multiple sites in Northern Europe and Israel. The primary efficacy endpoints were
changes from baseline for overall KOOS scores and KOOS pain subscale at 18 months and the primary efficacy end points were met. No serious
adverse events were observed in the completed Pilot Study. In addition to pre-clinical studies we conducted for GelrinC, the Pilot Study
we carried out was the sole study we used in order to obtain approval of GelrinC as a medical device in Europe in 2017. The near and long-term
improvements in KOOS and VAS scores which are the commonly used scales with which pain is measured and the imaging diagnostic measurements
of MRI, MOCART taken, were superior to those seen with the traditional microfracture procedures, which microfracture results were used
in both the Pilot study and current ongoing pivotal trial (referenced below), and these results continued to improve over the four years
follow up period. Presented hereunder are the main findings from these trials. At two years, the resultant KOOS score for GelrinC provided
an improvement of about 100% greater pain reduction than that of historical microfracture procedure data, as seen in Pilot Study Data
figure chart below where we received a KOOS score of about 28 for GelrinC at two years, with microfracture having a KOOS score of about
14 at two years. Microfracture is considered the “gold standard” among the various commonly used procedures for the treatment
of these patients. Based on MRI images, the MOCART qualitative score for GelrinC has reached a score over 80, within 24 months. After
two years, the resultant KOOS score for GelrinC continued to show improvement over the course of an additional 24 months (so far, 44 patients
out of the 56 patients followed up at 18 months and 42 out of 56 patients followed up at 24 months; about 80% and 75% of the initial 56
patients, respectively).

<div align='center'>72

Pilot Study Data</div>

The KOOS is a patient-reported
outcome measurement instrument, developed to assess the patient’s opinion about their knee and associated problems. The KOOS evaluates
both short-term and long-term consequences of knee injury and