Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 6

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 6
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 gradually to
the disturbance and finally to loss of the original tissue architecture and function). By GelrinC creating such impenetrable barrier
and thereby preventing the migration of the cells, the cells are forced to take a different route of creating aggregate and contiguous
tissue. Unlike GelrinC, cellular products used by competing companies require a plug of two layers of which the lower layer is a mineral
scaffold, which is a foreign body material that has been engineered to be inserted into the bone tissue even though the bone is often
healthy. Additionally, GelrinC does not have any biological activity. As a result, we believe our product offers a simple and economic
procedure, which we believe will allow patients to recover quickly with potentially long-term outcomes.

Market Opportunities

Knee cartilage injuries can
be caused either by acute or repetitive trauma due to daily function, including those caused by sports activity. Knee cartilage does
not usually heal by itself when injured. Without treatment, cartilage injuries may progress and cause degeneration of joints, osteoarthritis,
and possibly require total knee replacement. Currently, the standard of care procedure for cartilage injuries is microfracture surgery,
which involves cleanup of the wound and creation of tiny punctures in the underlying bone. Microfracture surgery provides only short-term
relief to patients and often requires additional surgical intervention later since the cartilage resulting from this procedure tends
to be fibrous and not as weight bearing as natural hyaline cartilage. Because the cartilage produced from microfracture surgery tends
to be fibrous, the cartilage is more prone to deterioration after a short period of time, with such relief from microfracture surgery
lasting on average between nine to twelve months, according to Medline Plus online health information resource, medical encyclopedia.
Unlike microfracture surgery, treatment using GelrinC does not produce fibrous cartilage, but instead has been shown to grow hyalin cartilage,
which is autologous to the natural cartilage of the patient. While determinations of safety and efficacy are solely within the authority
of the United States Food and Drug Administration, or the FDA, and comparable regulatory bodies, we believe that in our clinical trials,
GelrinC has been shown to have potentially longer-term positive outcomes of up to four years. As evidenced by a pilot study we completed
in 2015 in northern Europe, or the Pilot Study, patients reported greater improvement and pain reduction regarding their knee and associated