Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 121

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 121
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 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'>75</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 required 80 patients                                                                                                          
 in the pivotal trial have already been recruited and treated to-date (41 of which have completed the two-year follow up in this trial); 
 and                                                                                                                                     |

| ● | The enrollment profile                                                                                                         
 of the first 47 patients in the pivotal trial is highly matched with the control patients’ profile, which we believe indicates 
 a high likelihood of success in the outcome for the pivotal trial.                                                             |

The FDA has allowed the Company