Company: RGNT
Filing Date: 2025-03-11
Form Type: F-1
Source: 0001213900-25-022350
Chunk: 115

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-03-11
Form: F-1
Chunk 115
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 of Harvard
Medical School Website, the cartilage repair market in general, is a large sector of orthopedic medicine and currently represents an
estimated overall annual market opportunity of about 750,000 arthroscopic knee operations in the United States at a cost of $4 billion.
According to an article published in PubMed Central (National Library of Medicine), articular cartilage injuries are present in 60% to
66% of knees undergoing arthroscopy.

The Current Standard of Care – Microfracture Surgery

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. 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 eight to fourteen months. Unlike
microfracture surgery, treatment using GelrinC does not produce fibrous cartilage, but instead has been shown to grow hyalin-like cartilage,
which is the autologous natural cartilage of the patient.

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Competing Therapies for Cartilage Repair

Beyond microfracture surgery,
current commercial therapies for cartilage repair generally involve the use of autologous cells harvested from the patient’s own
healthy tissue. This approach has numerous disadvantages including:

| ● | The need for expensive                                                     
 cell expansion facilities and the requirement for two surgical procedures. |

| ● | The price for such autologous                             
 procedures is approximately $40,000 in the United States. |

| ● | There are also allogeneic                                                                                                             
 cartilage products (BioCartilage and Neo) sourced from cadavers, which, based on our experience, are not preferred by surgeons except 
 for in unique cases.                                                                                                                  |

Due to the complexity, source
and cost of alternatives, orthopedic surgeons with whom we have consulted have expressed a strong preference for a simple, ‘off-the-shelf’
product that can be delivered through a single open or minimally invasive approach. There is also another technology, CartiHeal’s
(acquired by Smith & Nephew in January 2024) Agili-C, which was approved by the FDA in March 2022, that utilizes pre-formed implants
that consist of a two layer plug, of which the lower layer is a mineral/coral