Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 92

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 92
---
 business and reputation.

The collection and use of
personal health data in the EU is governed by the provisions of the data protection derivative and the GDPR. These directives impose several
requirements relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals,
notification of data processing obligations to the competent national data protection authorities and the security and confidentiality
of the personal data. The GDPR also extends the geographical scope of EU data protection law to non-EU entities under certain conditions,
tightens existing EU data protection principles and creates new obligations for companies and new rights for individuals. Failure to comply
with the requirements of the Data Protection Directive, the GDPR, and the related national data protection laws of the EU Member States
may result in fines and other administrative penalties. The GDPR introduces new data protection requirements in the EU and substantial
fines for breaches of the data protection rules. The GDPR regulations impose additional responsibility and liability in relation to personal
data that Kadimastem processes and Kadimastem intends to put in place additional mechanisms ensuring compliance with these and/or new
data protection rules. In addition, other jurisdictions, including Switzerland, 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 Kadimastem’s Reliance on Third Parties

Kadimastem relies 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.

Kadimastem’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
Kadimastem. On the other hand, the recognition of medical insurers for the purchase of products or medical care that will be developed
or provided by Kadimastem, 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