Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 269

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 269
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 insurance companies, as tests that are not reimbursed most likely will not gain uptake in the marketplace. To garner coverage and have a test deemed medically necessary, payors will typically require additional studies, including Clinical Utility studies aimed at demonstrating how a test changes patients’ treatment and/or physician behavior. For example, a test with high clinical utility may prevent unnecessary surgeries or help physicians choose the right therapeutic regimen for or recommend an important lifestyle change to a patient, when absent that test, a different treatment course, with worse results would be adopted. While DiamiR plans on conducting Clinical Utility studies for its CogniMIR ®, at this time DiamiR has no assurances that insurance companies will cover its tests and if they do, how much they will pay for DiamiR’s tests. While coverage and contracting discussions with insurance company typically take ~12 to 18 months, DiamiR cannot provide an estimated timeline, or guarantee of a positive outcome for these activities at this time due to the nature of the reimbursement process and rules regarding same. The timing of estimated completion dates noted in the table above is based on DiamiR’s best estimate at this time, however, these dates are subject to change and potential delays based on changes in DiamiR’s priorities and on factors outside of DiamiR control, such as supply chain disruptions, clinical study results, and other factors discussed in the Risk Factors section are possible. DiamiR also has no control over the regulatory regime that currently governs or will govern the products in the future and therefore cannot estimate whether or not DiamiR will need to comply with any future regulations that could delay the commercialization of its products. For all of DiamiR’s pipeline products DiamiR plans on utilizing the LDT path to market. DiamiR previously published proof-of-concept data for the Pulmonary and GI panels (“Analysis of organ-enriched microRNAs in plasma as an approach to development of Universal Screening Test: feasibility study”, by Sheinerman KS et al. J Transl Med 11:304 2013, PMID: 24330742). 162 miRNAs are Powerful and Patient-Friendly Biomarkers DiamiR is an active participant in the burgeoning field of microRNA (miRNA) biomarkers. miRNA biomarkers have already been used in clinical assays in the oncology, and evidence of their utility in brain health and Alzheimer’s space has been growing every year since 2010. According to data compiled from pubmed.gov in 1Q