Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 47

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 47
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 operations are found to be in violation of any of these laws or any other related governmental regulations that may apply to us, we
may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, fines, imprisonment,
disgorgement, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, reputational harm,
additional oversight and reporting obligations if we become subject to a corporate integrity agreement or similar settlement to resolve
allegations of non-compliance with these laws and the curtailment or restructuring of our operations. If any of the physicians or other
healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be
subject to similar actions, penalties and sanctions. Efforts to ensure that our business arrangements comply with applicable healthcare
laws and regulations, as well as responding to possible investigations by government authorities, can be time- and resource-consuming
and can divert a company’s attention from the business.

Healthcare legislative and regulatory reform
measures may have a material adverse effect on our business and results of operations.

Our industry is highly
regulated and changes in law may adversely impact our business, operations, or financial results. The PPACA was a sweeping measure
intended to, among other things, expand healthcare coverage within the United States, primarily through the imposition of health
insurance mandates on employers and individuals and expansion of the Medicaid program. We anticipate that the PPACA, as well as
other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and an additional
downward pressure on the reimbursement our customers may receive for our products. Further, there have been, and there may continue
to be, judicial and Congressional challenges to certain aspects of the PPACA. For example, the U. S. Tax Cuts and Jobs Act of 2017,
or TCJA, includes a provision repealing the tax-based shared responsibility payment imposed by the PPACA on certain individuals who
fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual
mandate.” Any reduction in reimbursement from Medicare and other government programs may result in a similar reduction in
payments from private payers. The implementation of cost containment measures or other healthcare reforms may prevent us from being
able to generate revenue, attain profitability or commercialize our products.

In addition, the delivery
of healthcare in the European Union, including the establishment and operation of health services