Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 6

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 6
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 deposition of extracellular matrix, leading 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