Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 155

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 155
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 may be adversely affected by healthcare policy changes, including additional healthcare reform and changes in managed healthcare.

Healthcare reform and the
growth of managed care organizations have been considerable forces in the medical diagnostics industry and in recent political discussions.
These forces have placed, and are expected to continue to place, constraints on the levels of overall pricing for healthcare products
and services as well as the coverage available by public and private insurance and thus, could have a material adverse effect on the future
profit margins of its products or the amounts that DiamiR are able to receive from third parties for the licensing of its products. Changes
in the United States healthcare market could also force DiamiR to alter its approach to selling, marketing, distributing and servicing
its products and customer base. In and outside the United States, changes to government reimbursement policies could reduce the funding
that healthcare service providers have available for diagnostic product expenditures, which could have a material adverse impact on the
use of the products DiamiR are developing and its future sales, license and royalty fees and profit margin.

For example, the ACA requires
CMS to reduce payments to hospitals reimbursed under Medicare’s Inpatient Prospective Payment System (“IPPS”) that have
higher than expected readmissions. This and other applicable requirements set forth under the ACA and its current and future implementing
regulations may significantly increase its costs, and/or reduce its customer’s ability to obtain adequate reimbursement for tests
performed with its products, which could adversely affect its business and financial condition. In addition to direct impacts from reimbursement
cuts, revenue from its products could be negatively impacted if reimbursement cuts reduce microbiology budgets. While the ACA is intended
to expand health insurance coverage to uninsured persons in the United States, other elements of the legislation, such as Medicare provisions
aimed at improving quality and decreasing costs, comparative effectiveness research, and pilot programs to evaluate alternative payment
methodologies, make it difficult to determine the overall impact on sales of its products. In addition to uncertainty regarding the impact
of the implementation of the ACA, there have been a number of attempts to challenge the legality of the ACA. Most significantly, on June
17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically
ruling on the constitutionality of the law.

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In recent years, other legislative,
regulatory, and political changes aimed at regulating healthcare delivery in general and clinical laboratory tests in particular have
been