Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 168

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 168
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recall or seizure of DiamiR’s products; •corrective field actions for DiamiR’s products; •submission of reports to FDA or other regulatory authorities; •total or partial suspension of production or distribution; •withdrawal or suspension of marketing clearances or approvals; •clinical holds for investigations; •untitled letters or warning letters; •refusal to permit the import or export of DiamiR’s products; •criminal prosecution; and •exclusion or debarment from participation in federal health care programs such as Medicare and Medicaid. Any of these actions, in combination or alone, could prevent DiamiR from marketing, distributing and selling DiamiR’s products. In addition, a product defect or regulatory violation could lead to a government -mandatedor voluntary recall by DiamiR. DiamiR believes that the FDA would request that DiamiR 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.