Company: NDRA
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001654954-25-003612
Chunk: 1

Company: ENDRA Life Sciences Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 1
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 complement our TAEUS technologies and further improve their accuracy; ·Integrating thermo-acoustic technology with conventional ultrasound technologies to simplify, and reduce, the procedure time while reducing user error; and ·Reducing the form factor of TAEUS and making it cost effective.

 4Table of Contents

Fourth, we plan to implement a new low barrier-to-entry, multi-year, subscription-based business model with monthly recurring revenue.  We will retain our traditional direct product sale model with annual upgrade and maintenance fees for customers who may prefer it, but our primary focus will be on the subscription-based approach. In either case, sales are expected to be made by a direct sales force using a value proposition rooted in clinical data supported by results from reference sites.  

We continue to examine the positioning (need, cost, and technical considerations) of our TAEUS platform in the rapidly evolving market for point-of-care assessment of liver fat disease against other opportunities for our platform, such as monitoring of thermo-ablative surgical procedures.

THE IMPORTANCE OF UNDERSTANDING LIVER FAT

The accumulation of fat in the liver, known as hepatic steatosis, or steatotic liver disease (“SLD”), is a key biomarker of metabolic diseases, particularly MASH. MASH is a more severe form of metabolic dysfunction-associated steatotic liver disease (“MASLD”), characterized by liver inflammation and early fibrosis that can progress to cirrhosis, and even hepatocellular carcinoma, and other life-threatening diseases. The presence of excess liver fat is strongly associated with metabolic disorders such as insulin resistance, type 2 diabetes, and hypertension. Additionally, excess liver fat, particularly in the form of MASLD, is considered to be a cardiometabolic risk factor, and studies show statistically significant correlation with increased incidence of kidney disease, cancer, and neurodegenerative disease. 

The excess fat stored in the liver impairs insulin signaling, causing the liver to continue producing glucose even when insulin levels are high, leading to hyperglycemia. This not only worsens type 2 diabetes but also exacerbates inflammation and lipid imbalances, further increasing the risk of cardiovascular disease. Given these widespread effects, reducing liver fat is a crucial strategy for improving metabolic health and preventing disease progression.

GLP-1 receptor agonists, a class of drugs originally developed for type 2 diabetes, have emerged as promising treatments for liver fat reduction and metabolic disease management. These drugs, including semaglutide and tirzepatide, enhance insulin