Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 350

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 350
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 validate DiamiR’s tests, especially with respect to treatment benefit; •Attract and retain skilled personnel; •Protect DiamiR’s products and technology with patents; •Assure the quality of DiamiR’s LDTs produced under FDA and CLIA guidelines; •Assure that the CLIA lab where tests are produced continue to maintain all appropriate licenses; and •Meet necessary regulatory requirements. Payment and reimbursement The principal groups that DiamiR expects to pay for its molecular testing services include: •Biopharmaceutical companies conducting clinical trials; •Clinical centers, including memory, brain health and geriatric centers that will pay negotiated rates for their clinicians’ test orders; •Commercial third -partypayors, based on existing or novel Current Procedural Terminology (CPT) and/or PLA codes; •Government and private payors, with whom DiamiR plans to initiate a dialog and to submit relevant applications as soon as feasible; and •Patients and at -riskindividuals who pay co -payments, deductibles and other amounts that DiamiR is unable to collect from their health insurers. After this offering, DiamiR plans to expand its team with reimbursement and regulatory experts, and DiamiR will work diligently towards securing reimbursement based on current regulations. DiamiR plans on creating a clinical dossier compromised of peer -reviewpublications on the following 4 key areas: 1.Analytical Validation — The assay correctly and reproducibly tests for specific analytes/targets 2.Clinical Validation — The assay’s target analytes rule -inor rule -outa disease 3.Clinical utility — The test results in changes with physician behavior or patient treatment 4.Cost -effectivenessand economic health benefits — The test saves the healthcare system money, either by reducing unnecessary treatment, improving outcomes or other measures. A robust clinical dossier is a critical tool for successful reimbursement discussions with payors. DiamiR’s management team has experience with, and understands the process, and will focus its efforts to gain insurance coverage in a timely manner. 212 Accurate early diagnostics of AD will improve effectiveness of future cost of care for AD. The current cost of care for AD and AD related issues is estimated to be around $345B annually and is expected to reach $1Trillion by 2050. ____________ * https: // www.alz.org / media / Documents /alzheimers -facts - and-figures .pdf Strategies and products designed for early identification of AD are key