Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 125

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 125
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 put in place additional mechanisms ensuring compliance with these and/or new data protection rules. In addition,
other jurisdictions, are currently discussing or implementing regulations similar to GDPR. Changes to these European privacy
regulations (and similar regulations in other jurisdictions) and unsuccessful compliance may be onerous and adversely affect its
business, financial condition, prospects, results of operations and reputation.

Risks Related to the Combined Company’s
Reliance on Third Parties

The combined company’s reliance on
third party expenses reimbursement related to its products by insurance companies, pursuant to eligibility criteria that may be changed,
as well as fluctuations of indemnity amounts that may impair its ability to sell its products and may affect its business outcomes which
are determined by both the Israeli government and by insurance companies.

The combined company’s
activity is influenced by a policy of health insurers regarding its eligibility to participate and cover its expenses, or reimbursement,
known in Israel as the “ Healthcare Basket.” The degree of participation or coverage (full or partial) for the purchase of
products or medical treatment developed or provided by it may affect its activities and the sales potential and business outcomes for
the combined company. On the other hand, the recognition of medical insurers for the purchase of products or medical care that will be
developed or provided by the combined company, for the purpose of reimbursing expenses, is expected to increase demand for its products
and services in its target markets. The entitlement to reimbursement is determined from time to time by health insurance companies, both
private insurance companies and public insurance companies, in accordance with considerations that go beyond the scope of the combined
company’s influence. A change to the reimbursement criteria or non-confirmation of eligibility for expenses reimbursement related
to its products, as well as fluctuations of indemnity amounts for substitute and complementary diagnostic tests may assist or impair its
ability to sell the combined company’s products and may affect its business outcomes.

The combined company may be materially adversely
affected if there is an imbalance in global logistics, which may cause disruptions to its transport, storage and distribution operations,
negatively impacting the costs related thereto.

The combined company’s
operations are dependent upon uninterrupted transportation, storage and distribution of its products. Transportation, storage or distribution
of its products could be partially or completely, temporarily or permanently shut down as the result of any number of circumstances that
are not within its control, such as:

  catastrophic events;  

  strikes or other labor difficulties;  

  disruption in the global supply chain, including container  

  war and other