Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 154

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 154
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 sales growth. DiamiR’s business model is heavily reliant on the adoption of its products by researchers, clinicians, and healthcare administrators (“Industry Advocates”). These professionals play a critical role in the healthcare ecosystem, influencing both the acceptance and the utilization of new medical technologies. A failure to secure and maintain adoption among these groups poses a significant risk to DiamiR’s operations. New products frequently are subject of slow adoption by healthcare specialists partly due to perceived liability risks and the uncertainty of third-party reimbursement. It is critical to the success of DiamiR’s future sales growth that it continues to work with key opinions leaders in the field, educate healthcare specialists about CogniMIR ®and other assays in development, and demonstrate the clinical utility of its technology. If Industry Advocates do not believe in DiamiR’s products, market acceptance of its products could fail to increase or could decrease, and its business could be harmed. Additionally, a lack of support from Industry Advocates could reduce the rate of coverage and reimbursement by both public and private third-party payors for DiamiR’s products and services, which may further slow the market adoption of its product by physicians, significantly reduce its ability to achieve expected revenues and prevent it from becoming profitable. Slow adoption of DiamiR’s products by Industry Advocates would significantly reduce its ability to achieve expected sales and could prevent it from achieving and maintaining profitability. New product development and clinical validation involves a lengthy and complex process, and DiamiR may be unable to commercialize CogniMIR ® or any other products it may develop on a timely basis, or at all. It takes significant time to fully develop and commercialize CogniMIR ®for risk of early neurodegeneration, and therefore its launch may be delayed or may not be successful. There can be no assurance that CogniMIR ®will be successful in the risk assessment of Mild Cognitive Impairment and early Alzheimer’s disease for a variety of technical and market reasons. DiamiR’s other molecular diagnostic products, which are currently in various stages of early development, will take time to develop and commercialize, if it is able to commercialize them at all. Prior to commercializing any new products, DiamiR’s will need to conduct substantial research and development, including validation studies. DiamiR’s product development efforts involve a high degree of risk and may fail for many reasons, including failure to demonstrate the clinical utility of the product. As DiamiR develops products, it will have to make significant investments in