Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 177

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 177
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iamiR initiate a voluntary
recall if a test was defective or presented a risk of injury or gross deception. Regulatory agencies in other countries have similar authority
to recall devices because of material deficiencies or defects in design or manufacture that could endanger health. Any recall would divert
management attention and financial resources, could expose DiamiR to product liability or other claims (including contractual claims from
parties to whom it sells products) and harm DiamiR’s reputation with customers.

The use of DiamiR’s diagnostic products by DiamiR’s customers
is also affected by the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) and related federal and state regulations
that provide for regulation of laboratory testing. CLIA is intended to ensure the quality and reliability of clinical laboratories in
the United States by mandating specific standards in the areas of personnel qualifications, administration, participation in proficiency
testing, patient test management, quality assurance, quality control and inspections. Current or future CLIA requirements or the promulgation
of additional regulations affecting laboratory testing may prevent some laboratories, hospitals, providers or other customers with laboratories
from using some or all of DiamiR’s diagnostic products.

If DiamiR fails to comply with federal, state and foreign laboratory licensing requirements, DiamiR could lose the ability to perform its tests or experience disruptions to its business.

DiamiR is subject to CLIA regulations, a federal law that regulates
commercial clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the
diagnosis, prevention or treatment of any disease, or impairment of, or the assessment of the health of, human beings. CLIA regulations
mandate specific personnel qualifications, facilities layout, quality systems, inspections and proficiency testing. CLIA certification
is also required in order for DiamiR to be eligible to bill federal and state healthcare programs (Medicare and Medicaid), as well as
many private third-party payers, for its molecular diagnostic tests. To renew these certifications, DiamiR is subject to bi-annual inspections.
Moreover, CLIA inspectors may make random inspections of its clinical laboratory. DiamiR is also required to maintain a CT State licenses
to conduct testing in its New Haven, Connecticut laboratory. In addition, its laboratory is required to be licensed by certain states,
including Pennsylvania, California, Maryland, New York and Rhode Island. New York law requires DiamiR to obtain test-specific
approval before offering its tests as LDT. California, Maryland, New York and Rhode Island