Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 8

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 8
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 advantages were effectively demonstrated resulting in our decision to choose GelrinC
as our lead product candidate. In the Pilot Study we completed on 56 patients, it was demonstrated that GelrinC reduced pain significantly
better than the leading gold standard procedure of microfracture. Currently, the Company is conducting a pivotal trial and has recruited
and treated 47 patients for such trial. 41 patients out of the 47 has completed the two-year follow up in this trial. Following the offering,
the Company plans to enroll the remaining 39 patients required in order to submit the pre-market approval application, or PMA, to the
Food and Drug Administration, or the FDA. Having grown out of research from The Technion Israel Institute of Technology, our commitment
to research and innovation is best witnessed by the development we carried out on GelrinC to date from the underlying science and our
close relationship with our founder Professor Dror Seliktar of The Technion, Israel Institute of Technology in Haifa, Israel. We believe
we have the leadership onboard to continue to build our product lines.

In the Pilot Study, 56 patients
who complied with the acceptance and rejection criteria allowed by the FDA (which included age, size of lesion and weight) in need of
cartilage repair were treated with GelrinC for articular cartilage injuries. The improvements observed in the Knee Injury and Osteoarthritis
Outcome Score, or KOOS, and Virtual Analog Scale, or VAS, pain measurement scores taken over two years following the treatment were superior
(100% greater improvement) to those seen with the traditional microfracture procedure, which is considered to be the current “gold
standard”. Additionally, patients continued to report further improvement and greater pain reduction of their knee and associated
problems using GelrinC for four years.

Based on these results, the
FDA granted Regentis an investigational device exemption, or IDE, in September 2016 for our pivotal trial, permitting PMA submission with
two-year follow-up data of 80 patients and with 40 additional patients to be treated thereafter. The pivotal trial that is currently being
conducted in the United States and in Europe, under the FDA’s sanctioned protocol, is an open label study, with one arm only (treatment),
using our own historical control (microfracture). To-date, we have treated 47 patients out of the 80 initial patients.

We intend to develop a pipeline
of products that can be used for