Company: RGNT
Filing Date: 2025-03-11
Form Type: F-1
Source: 0001213900-25-022350
Chunk: 119

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-03-11
Form: F-1
Chunk 119
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 like the ankle, wrist, and elbow. |

| ● | GelrinV – Novel intra-articular                                                                                                  
 injectable gel, long-lasting with pro-healing capabilities. It is a thermo-responsive, hydrophobic polymer, which is injected as 
 a thin liquid, and turns into a thick gel at body temperature. Targeted for treatment of moderate osteoarthritis.                |

Clinical Development of GelrinC

Completed Pilot Study

In medical devices, the efficacy
trial first tested on larger groups of patients is 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