ENDRA Life Sciences Deploys TAEUS Tech to Improve Metabolic Disease Detection

ENDRA Life Sciences Inc. is developing and deploying its Thermo-Acoustic Enhanced UltraSound (TAEUS) system as a biomarker solution to detect and manage metabolic diseases earlier in patients being treated with glucagon-like peptide-1 (GLP-1) drugs and other metabolic dysfunction-associated steatohepatitis (MASH) therapies.

ENDRA’s management has thoroughly evaluated the company’s technical capabilities and go-to-market strategy for TAEUS Liver and determined this new target market opportunity is far larger and more viable than its prior focus on hepatology and radiology markets, noting that metabolic diseases are an upstream phenomenon that lead to multiple risk factors including those specific to liver diseases. With this pivot toward metabolic health, ENDRA’s revised mission is to develop and market an accurate, simple-to-use, inexpensive, point-of-care test—essentially a “blood pressure cuff”—for assessing and managing steatotic liver disease (SLD).

“SLD is on the rise and represents an enormous health burden that affects over 2 billion people globally and approximately one-third of the U.S. population. As GLP-1 therapies continue to be embraced to treat metabolic risk factors such as obesity, type 2 diabetes and cardiovascular disease, there is an unmet need for a cost-effective, simple-to-use and accurate point-of-care test,” ENDRA Life Sciences CEO Alexander Tokman said. “We believe our TAEUS technology is positioned to fill this gap and meet the needs of providers, patients, and payers. Our development efforts are now focused on refining TAEUS’ design for this use as we continue to collect crucial clinical data to support our future De Novo regulatory filing with the FDA.”

Highlights of this strategy include new target customer segments, enhanced TAEUS features to improve its adoption and a realignment of the business model:

• Identification of new target customer segments. As part of the revised market strategy, TAEUS Liver will target four markets:
  1. Pharmaceutical companies and clinical research organizations will assist in the efficient screening and monitoring of subjects for GLP-1 and related clinical trials.
  2. Concierge medical practices will help screen patients for obesity, diabetes, cardiovascular risk factors and liver disease, as well as monitoring responses to lifestyle changes and drug therapies.
  3. Bariatric and metabolic clinics for managing obesity, detecting metabolic disorders and monitoring responses to therapies.
  4. Primary care and internal medicine practices will screen patients for metabolic diseases related to obesity, diabetes and hypertension, as well as cardiovascular risk factors, and to monitor responses to lifestyle changes and drug therapies.

The Company expects patients prescribed GLP-1 therapies will be managed primarily by these providers, rather than hepatologists.

• Redefined and redesigning TAEUS Liver device to improve its scalability and adoption into new target markets. To meet market requirements as a biomarker solution, ENDRA will further TAEUS’ development to be more accurate, simpler to use, and more ergonomic, as well as scalable and more cost effective. As a result, ENDRA’s management has developed a multi-generational product plan to include 1) new artificial intelligence features to improve accuracy, 2) full integration of thermo-acoustic and ultrasound technologies in a single device to simplify clinical workflow and reduce procedural time, and 3) a reduction in the device’s form factor and a decrease in manufacturing cost. All of these changes are deemed necessary for greater adoption of TAEUS Liver in the new target markets, and particularly in the very large primary care market segment.
• Introducing a subscription-based sales model. Once commercially available, ENDRA expects to offer TAEUS through a monthly subscription-based sales model with no upfront capital expenditures to reduce the barrier to entry and maximize customer uptake. ENDRA intends to deploy a small direct sales force that will leverage TAEUS’ value proposition as evidenced by clinical results from current and additional evaluation sites.
• Extend TAEUS applicability beyond liver health. To increase the value and versatility of TAEUS’ patented thermoacoustic technology, ENDRA will develop several additional high-value applications, following TAEUS’ development and commercialization for its initial indication to measure liver fat. These expanded applications include temperature monitoring for ablation therapies, vascular and tissue perfusion.

SLD is often asymptomatic and not easily detectable at the early stages, and represents a global health crisis affecting more than 2 billion people worldwide including over 100 million in the United States. Despite its prevalence and severe health implications, there remains a significant gap in dependable, affordable and easily accessible point-of-care tools to accurately detect and monitor liver fat. As the number of people with SLD continues to rise, its impact on public health and healthcare systems is becoming more evident, particularly as it is strongly linked to metabolic syndrome and a range of chronic conditions such as obesity, type 2 diabetes, cardiovascular disease, and even liver cancer.

ENDRA Life Sciences developed Thermo-Acoustic Enhanced UltraSound, a technology being developed to assess tissue fat content and monitor tissue ablation during minimally invasive procedures, at the point of patient care. TAEUS is focused on measuring liver fat as a means to assess and monitor steatotic liver disease and metabolic dysfunction-associated steatohepatitis, chronic liver conditions for which there are no practical diagnostic tools.