Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 41

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 41
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DTs. We believe the PathsDxTest may not be subject to the FDA’s enforcement of
its medical device regulations and the applicable FDC Act provisions.

However, if and when we utilize
the PathsDxTest technology in the U. S., the FDA may disagree with our assessment that the PathsDxTest falls within
the definition of an LDT and seek to regulate the PathsDxTest as medical devices. If the FDA determines that our products
are subject to such requirements, we could be subject to enforcement action, including administrative and judicial sanctions, and additional
regulatory controls and submissions for the PathsDxTest, all of which could be burdensome.

In the future, certain of
our products or related applications could be subject to additional FDA regulation. Even where a product is not subject to FDA clearance
or approval requirements, the FDA may impose restrictions as to the types of customers to which we can market and sell our products. Such
regulation and restrictions may materially and adversely affect our business, financial condition and results of operations. Other regulatory
regimes that do not currently present material challenges but that could in the future subject to regulations include biosecurity should
our PathsDxTest technology be utilized in the U. S.

In addition, many countries
have laws and regulations that could affect our products and which could limit our ability to sell our products in those countries. The
number and scope of these requirements are increasing. We may not be able to obtain regulatory approvals in such countries or may incur
significant costs in obtaining or maintaining foreign regulatory approvals. For example, the European Union, or EU, is transitioning from
the existing European Directive 98/79/EC on in vitro diagnostic medical devices, or In Vitro Diagnostic Directive (IVDD), to the In Vitro
Diagnostic Device Regulation (EU) 2017/746 (IVDR), which imposes stricter requirements for the marketing and sale of medical devices,
including in the area of clinical evaluation requirements, quality systems and post-market surveillance. The IVDR is expected to become
effective in May 2022. It is likely that we will be impacted by this new regulation, either directly as a manufacturer of IVDs, or indirectly
as a supplier to customers who are placing IVDs in the EU market for clinical or diagnostic use. Complying with the requirements of the
IVDR may require us to incur significant expenditures. Failure to meet these requirements could adversely impact our business in the EU
and other regions that