Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 123

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 123
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 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 criteria (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. The number of patients, with 24 months follow-up, required for
PMA submission is 80, with an additional 40 patients to be treated afterward. Currently, the Company is midway in enrolling patients in
this trial which was initiated in November 2017 and expects to complete the recruitment of patients by the end of 2025.

The advantages gained with
the GelrinC IDE:

| ● | Fewer patients to screen and enroll, creating a faster, more efficient trial; |

| ● | Microfracture (control) results already known; |

| ● | Confidence based on same product, same clinical protocol, and the same control as the 56 patient Pilot Study compared to the 80 patients required for the pivotal trial for PMA submission; |

| ● | 47 of the 80 patients in the pivotal trial