Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 166

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 166
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 FDA released its long-awaited update to its LDT policy in the Federal Register. Under these new guidelines, the FDA will phase out enforcement discretion in 5 stages over 4 years allowing labs to adjust to these new requirements in a timely and orderly manner. While grandfathering marketed LDTs and creating a few other exceptions, the FDA will require all new LDTs to be launched according to its new guidelines. On March 31, 2025, a Federal Judge struck down FDA’s final rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). The court ruled that the FDA lacked the statutory authority to classify LDTs — diagnostic tests developed and used within a single laboratory — as medical devices, emphasizing that LDTs are professional medical services, not tangible products subject to FDA regulation. This decision halts the FDA’s plan to phase out its general enforcement discretion over LDTs, which would have introduced new compliance obligations over a four-year period. The court’s ruling underscores that oversight of LDTs falls under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services (CMS), not the FDA. The FDA announced in May 2025 that it will not appeal this decision. If the FDA changes its position on this appeal, and wins on appeal, risks associated with the new landscape of LDTs include but are not limited to:

| ● | DiamiR’s inability to implement quality standards included 
 in the new guidelines                                      |

| ● | DiamiR’s inability to implement all FDA requirements for 
 LDTs                                                     |

| ● | Backlog at the FDA for review of submission |

| ● | Additional regulations being adopted by the FDA |

| ● | Increased timeline to product launch, delaying revenue for the 
 company                                                        |

| ● | Increased regulatory oversight resulting in delays for product 
 launch                                                         |

| ● | Increased costs of product development and regulatory compliance |

| ● | Increase costs may arise from: |

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| ● | More expansive validation study design |

| ● | Hiring additional regulatory compliance talent |

| ● | Hiring additional statistical experts |

| ● | Other unanticipated costs |

Sales of its diagnostic product candidates outside the United States are subject to foreign regulatory requirements governing clinical studies, vigilance reporting, marketing approval, manufacturing, product licensing, pricing and reimbursement. These regulatory requirements vary greatly from country to country. DiamiR may not be able to obtain foreign regulatory approvals on a