Company: NDRA
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001654954-25-003612
Chunk: 3

Company: ENDRA Life Sciences Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 3
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 conditions, including obesity, cardiovascular disease, kidney disease, and liver disease. With more than 30 pharmaceutical companies actively developing GLP-1 drugs—and seven of the top 20 pharma companies active in this space—interest in these therapeutics is at an all-time high.

The field is rapidly evolving, with more than 50 active studies of GLP-1 drugs, 30 insulin sensitizers, and 10 to 15 MASH treatments currently in Phase 3 clinical trials. Between 2022 and 2023, the number of clinical trials in this area increased approximately 68%, reflecting the urgent need for effective treatment options. This momentum recently led to the first FDA-approved drug for fatty liver disease, Rezdiffra™, which was granted approval in March 2024. As new therapies emerge, the need for improved diagnostic methods to identify and monitor patients undergoing treatment is critical.

Diagnostic Gaps: The Urgent Need for Improved Liver Fat Detection

Despite significant advancements in therapeutics, the lack of efficient, cost-effective diagnostic tools remains a major challenge. The current non-invasive “gold standard” for liver fat measurement is magnetic resonance imaging (“MRI”), but its high cost, long procedural time, and limited accessibility make it impractical for routine screening. Similarly, liver biopsies, while highly accurate, are invasive, painful, and require specialized medical expertise, limiting their widespread use.

Alternative diagnostic methods such as ultrasound and blood tests also have notable limitations. Ultrasound, though widely available, currently lacks the accuracy needed for detecting liver fat, particularly in individuals with higher body mass indices. Blood tests, while non-invasive, suffer from low precision and reliability, making them insufficient for definitive diagnosis or monitoring treatment progress.

The Future of Liver Fat Diagnosis and Management

With the increasing availability of promising new treatments, the demand for reliable, non-invasive, and cost-effective liver fat diagnostics is greater than ever. The ability to accurately detect and monitor liver fat will be essential in guiding treatment decisions, evaluating therapeutic efficacy, and preventing disease progression. As the medical community continues to prioritize liver fat screening in clinical guidelines, innovation in diagnostic technologies will be key to addressing this growing health crisis.

SLD is no longer a silent epidemic—it is a pressing global health issue that demands immediate attention. With groundbreaking therapies on the horizon and a growing recognition of the disease’s impact, the next crucial step is to bridge the diagnostic gap, ensuring that patients receive timely and effective care before irreversible liver damage occurs.

CURRENT TECHNOLOGY FOR LIVER FAT MEAS