Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 119

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 119
---
 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 have already been treated to-date; 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
the use of microfracture historical data, licensed by the Company from TiGenix NV, or TiGenix,
as historical control for the study, thus allowing for a more efficient and less costly trial, which may ultimately lead to a shorter
time to market. See Data “Intellectual Property— Agreement with TiGenix” below.

TiGenix’s study was a Phase III, multicenter, open-label, randomized controlled trial of its intended product, ChondroCelect® in an Autologous Chondrocy