Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 119

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 119
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 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).

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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 osteoarthritis, or OA. It holds 42 items in
five separately scored subscales: KOOS Pain, KOOS Symptoms, Function in daily living, or KOOS ADL, Function in Sport and Recreation,
or KOOS Sport/Rec, and knee-related Quality of Life, or KOOS QOL (Roos and Lohmander 2003). The score above is presented in percentages.

The MOCART score is a
9-part and a 29-item scoring system, resulting in a final cartilage repair tissue score between 0 and 100 points; 0 points represents
the worst imaginable score, while 100 points represent the best imaginable score. When patients measure pain, they sometimes fill out
reports with subjective answers, and therefore we also use an MRI criterion (i.e., MOCART) to measure pain, which provides an objective
pain score response calculation. A P-value is a statistical measurement used to validate a hypothesis against observed data. A P-value
measures the probability of obtaining the observed results, assuming that the null hypothesis is true. The lower the P-value, the greater
the statistical significance of the observed difference. A P-value of P<0.05 is deemed statistically significant, as there is less
than a 5% probability the results are random.

<div align='center'>73</div>

Ongoing Pivotal Trial

To obtain marketing approval
in the United States, we are currently carrying out a pivotal clinical trial for PMA in multiple sites in the United States, Europe and
Israel under an FDA approved investigational device exemption, or IDE