ENDRA reveals enhanced Strategy to enable the early detection and management of metabolic diseases facilitated by emerging GLP-1 therapies

ENDRA Life Sciences has revealed a new strategic direction to develop and deploy its Thermo-Acoustic Enhanced UltraSound system (TAEUS) as a biomarker solution for the early detection and management of metabolic diseases in patients being treated with glucagon-like peptide-1 (GLP-1) drugs and other metabolic dysfunction-associated steatohepatitis (MASH) therapies.

“Steatotic liver disease (SLD) is on the rise and represents an enormous health burden that affects over two billion people globally and approximately one-third of the US 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,” said Alexander Tokman, Chief Executive Officer of ENDRA. “We believe our TAEUS technology is uniquely 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, as described below:

• Identified new target customer segments. As part of the revised market strategy, TAEUS Liver will target four markets:

• Pharmaceutical companies and clinical research organizations to assist in the efficient screening and monitoring of subjects for GLP-1 and related clinical trials;

• Concierge medical practices to assist in screening patients for obesity, diabetes, cardiovascular risk factors and liver disease, as well as monitoring responses to lifestyle changes and drug therapies;

• Bariatric and metabolic clinics for managing obesity, detecting metabolic disorders and monitoring responses to therapies; and

• Primary care and internal medicine practices to 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 anticipates that 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. In order 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 the development and commercialisation of TAEUS for its initial indication to measure liver fat. These expanded applications include temperature monitoring for ablation therapies, vascular and tissue perfusion.