Company: NDRA
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001654954-25-003612
Chunk: 9

Company: ENDRA Life Sciences Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 9
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 and eligibility requirements, the screening process must cover between 2,500 and 10,000 candidates to meet the required participation levels.

These high screening failure rates contribute to increased costs and extended timelines for clinical trials.

The financial burden of conducting late-stage clinical trials is substantial. One key component of the cost structure is the use of Magnetic Resonance Proton Density Fat Fraction (“MR PDFF”), a diagnostic tool commonly used in metabolic disease studies.  One in three Phase 2 or 3 GLP-1 studies incorporates MR PDFF during the trials.  The cost for CROs to conduct these exams typically falls between $1,500 and $2,500 per patient, with a minimum of two to three exams of each patient required per trial. There is a partial reimbursement, but it’s minimal. These costs underscore the financial considerations that pharmaceutical companies must account for when planning large-scale trials.

High-End Primary Care Networks (Concierge Medicine) 

High-End Primary Care Networks, also known as concierge medicine, are experiencing rapid growth in the U.S., with approximately 20 national and hundreds of regional networks operating 6,500 facilities. These organizations are expanding at a 12% compound annual growth rate (“CAGR”), have an average of 2-3 doctors per facility with approximately 150 patients per doctor. Concierge practices emphasize personalized care, proactive health management, and cutting-edge technology to differentiate themselves from traditional healthcare models.

One area where concierge medicine can further stand out is through advanced metabolic health monitoring, particularly liver fat fraction assessment. Early detection and proactive management of liver fat accumulation can provide significant health benefits, particularly for patients at risk of metabolic disorders, obesity, and diabetes—conditions frequently encountered in concierge practices.

Concierge medicine thrives on offering innovative health solutions that traditional primary care settings may not provide. New technologies are of high interest in this sector, and cost is less of a concern, making our offering an attractive investment for concierge networks. By incorporating liver fat fraction monitoring into routine patient assessments, concierge physicians can:

 ·Offer Personalized Preventative Care: Early detection of liver fat accumulation enables tailored interventions, including lifestyle modifications and pharmaceutical treatments.    ·Enhance Cardiometabolic Risk Management: Since liver health is linked to cardiovascular and metabolic conditions, monitoring liver fat fraction can improve overall patient outcomes.    ·Strengthen Patient Engagement and Retention: Providing access to cutting-edge diagnostic tools reinforces the concierge model’s value proposition, encouraging long-term membership.