Company: RGNT
Filing Date: 2025-02-12
Form Type: DRS/A
Source: 0001213900-25-012299
Chunk: 118

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-02-12
Form: DRS/A
Chunk 118
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 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 also consequences of primary oste