Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 153

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 153
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3); DiamiR also has active accreditation from The College of American Pathologists (CAP Number 7215351) for the Laboratory.
CLIA is a federal law (administered by the Centers for Medicare & Medicaid Services, or CMS) that, in partnership with the states,
regulates clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the
diagnosis, prevention or treatment of disease or impairment of, or assessment of the health of, human beings. CLIA regulations require
clinical laboratories to obtain a certificate commensurate with the type of testing being performed and mandate specific standards in
areas including personnel qualifications, administration, participation in proficiency testing, patient test management and quality assurance.
CLIA certificates must be renewed every two years, and renewal requires undergoing survey and inspection. CLIA and/or state inspectors
may conduct random inspections or conduct inspections as a result of a complaint or reported incident.

miRNA profiling of biospecimens
will be performed at its Laboratory. The failure of DiamiR to maintain it CLIA certification or accreditation appropriate to the type
of testing DiamiR performs, or to comply with CLIA regulations or applicable state licensure requirements could result in adverse regulatory
action that, if not timely corrected, could result in DiamiR being unable to continue offering its testing services, which could adversely
affect its business. Similarly, if DiamiR does not hold state permits or licenses in those states that require them, it may limit its
ability to offer its products and services on a national basis.

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Maintaining adequate sales of DiamiR’s product, if any of its product candidates are approved, may depend on the availability of adequate reimbursement to its customers from third-party payers, including government programs such as Medicare and Medicaid, private insurance plans, and managed care programs.

Maintaining and growing sales
of its approved products depends in part on the availability of adequate coverage and reimbursement of its products by third-party payers,
including government programs such as Medicare and Medicaid, private insurance plans and managed care programs. Hospitals, clinical laboratories
and other healthcare provider customers that may purchase its products generally bill various third-party payers to reimburse all or a
portion of the costs and fees associated with diagnostic tests, including the cost of the purchase of its products. DiamiR’s customers’
access to adequate reimbursement by government and private insurance plans is central to the acceptance of its products. DiamiR may be
unable to