Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 121

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 121
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| ● | 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
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 Chondrocyte Implantation procedure compared to the procedure of microfracture in the repair of symptomatic cartilage lesions of the knee. In that study, 51 participants were treated with characterized chondrocyte (cell) implantation, or CCI, and 61 participants were treated with microfracture as the control. The primary end-points in that study were histology and KOOS. Historical data is commonly used by agreement of the FDA and is so identified in the Code of Federal Regulations. The FDA agreed to allow the Company to use this data in our Phase III study after reviewing the TiGenix data and after observing that other companies were abstaining from doing cartilage repair clinical trials due to recruitment difficulties. Patients who complain about knee pain may suffer from one or multiple knee pathologies (e.g., ACL, meniscus or cartilage lesions), a fact that is making recruitment very difficult in search of patients who have only cartilage lesions and thus requiring recruitment and screening of many patients in order to remain with the required number of patients who have just the one cartilage injury.In our unique trial design, GelrinC efficacy is compared to historical micro