Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 162

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 162
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, 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 laws also mandate
proficiency testing for laboratories licensed under the laws of each respective State regardless of whether such laboratories are located
in California, Maryland, New York or Rhode Island. If DiamiR is unable to obtain or maintain its CLIA certificate for its laboratory,
whether as a result of revocation, suspension or limitation, DiamiR would no longer be able to perform its current clinical services on
samples from those States, which could have a material adverse effect on its business, financial condition and results of operations.
If DiamiR were to lose its licenses issued by States where it is required to hold licenses, if such licenses expired or were not renewed,
or if it failed to obtain and maintain a State license that it is required to hold, it may be subject to significant fines, penalties
and liability, and may be forced to cease testing (if Connecticut) or cease testing specimens from those States (