Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 120

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 120
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te 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. 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 believe
that we will be in position to recruit the remaining required 33 patients across multiple centers within this time frame, subject to funding
from this offering. Our expected timeline takes into consideration that we have already built the study infrastructure, recruited the
sites, and finalized agreements with hospitals and institutional review boards. Since most of this is done and the sites are more available
having done the two-year follow up, we believe that they will be able to more efficiently rejoin the recruitment process.

The primary objectives for
the pivotal trial are to evaluate the 6, 12, 18 and 24-month post-t