Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 130

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 130
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ii) | (ii) MACI, an autologous cellular (patient’s own cells) treatment procedures available from Vericel Corp., or Vericel, which is the only commercial offering in the U.S. market. If approved, GelrinC will compete in this market based on its already outlined advantages as an off-the-shelf highly cost-effective product. There are also “modified human tissue” products that are based on allogeneic cartilage matter – BioCartilage, from Arthrex GmbH, which is a paste mixed with PRP (platelet rich plasma or minced cartilage tissue) and Revaflex, a diced cadaver cartilage from ISTO Technologies Inc. These products are often dependent on cadaver tissue and are not frequently used across the patient population. |

While Vericel, Arthrex GmbH
and Revaflex will present us with competition, we believe that these competitors do not hold a significant market share in cartilage repair
which is calculated based on their revenue, amount of procedures they perform annually and the amount of cartilage repair cases currently
in the market. Other potential competitors, although not yet approved for marketing, may succeed in developing products that could directly
compete with GelrinC for market share in cartilage repair, but according to our belief, these other remaining potential competitors are
premature, in terms of research and development, in order for us to determine or evaluate what their potential market share significance
could be. An additional product named Agili-C, which was developed by CartiHeal (acquired by Smith & Nephew in January 2024), has
recently been approved by the FDA. However, to the best of our knowledge, Agili-C has not yet been launched for commercialization.

<div align='center'>80</div>

If our product is approved
in the United States, it is highly likely that we will face competition from Vericel. Vericel’s MACI utilizes a cellular procedure
requiring two surgeries; one for the biopsy taking out a piece of health cartilage for cellular expansion, and a second which occurs approximately
10 - 12 weeks thereafter for reimplantation of the expanded cell population. This procedure costs ~$40,000, with a reported recovery period
of 6 weeks. This is a long, complex procedure especially compared to the ~10 minute procedure for the delivery of GelrinC, which only
involves one surgery.

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