Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 127

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 127
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 and Israel. Other patent applications in the WO 2017/103924 are in an examination process, which will determine if they
also mature into actual patents. The product covered by WO 2017/103924 uses a ready–for–use formulation technology which
is employed in the final product. WO 2017/103924 also covers a process of manufacturing of GelrinC that avoids the use of acetone,
which may become forbidden under advanced guidelines for products introduced into the body. Therefore, we believe that upon approval
in different territories, additional patents could provide the Company with sufficient protection from completion even after the expiration
dates of the basic patent estate.

GelrinC

The Gelrin technology
utilizes a conjugate of denatured fibrinogen and polyethylene glycol and the intended clinical use of this product is to treat focal
cartilage injuries. These specific conjugate molecules are disclosed and claimed in the earliest patent family of the Company derived
from WO 2005/061018, which are nominally due to expire in December 2025. In various countries, patent term extension or supplementary
protection certificates are available upon receipt of marketing approval to prolong the period of exclusivity of a new medical product.
The earliest patent family of the Company derived from WO 2005/061018 includes patents Nos. US 8,007,774, US 8,858,925, US 9,120,872 and EP 1870115, which are detailed in the table below.

While the first family of
patents form the “basic patent estate” covering the current products of the Company, diligent efforts have been made by the
Company to cover improvements and alternatives. Our “basic patent estate” has expiration date in December 2025. Although the
patents included in this “basic patent estate” are close to expiring, such patents only cover certain components in the Company’s
products. Our additional subsequently granted patents provide supplementary protection, as well as the latest pending patent applications
which cover subsequent improvements in the Company’s products and processes. Furthermore, regulatory approval, when obtained, will
yield certain types of non-patent exclusivities that can maintain the Company’s advantage even after expiration of the earlier “basic
patent estate”.

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We also have additional
subsequent patents that we believe could prevent competitors from entering the market when patents directed to the specific conjugate
molecules expire.