Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 122

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 122
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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 microfracture (the current
“gold standard”) procedure efficacy data. The FDA agreed that the data of 80 patients with two-year follow-up data is sufficient
for PMA submission for approval. The primary endpoints are KOOS pain scores and Function in Daily Living, or ADL, scores at 24 months,
with secondary endpoints being, overall KOOS scores and modified MOCART scores at 24 months.

To date, the Company has
treated 47 patients out of the 80 required for submission (41 of which have completed the two-year follow up in this trial). We expect
to complete the pivotal trial within 2.5 years, consisting of six months for the recruitment and treatment of the remaining 33 patients
and two years of follow-up from the treatment of the last patient. We