ENDRA Life Sciences, London Hospital Partner on Ultrasound Study

ENDRA Life Sciences Inc. (ENDRA) is teaming up with King’s College Hospital in London (KCH) to study its non-alcoholic fatty liver disease (NAFLD) assessment tool.

ENDRA’s Thermo-Acoustic Enhanced Ultrasound (TAEUS) is designed to work in concert with 400,000 cart-based ultrasound systems in use globally today. TAEUS measures fat in the liver as a means to assess and monitor NAFLD and inflammation (NASH), chronic liver conditions that affect more than 1 billion people globally, and for which there are no practical diagnostic tools. TAEUS is currently cleared for sale in the European Union, and a 510(k) application has been submitted to the U.S. Food and Drug Administration.

“The current options to assess and monitor liver fat in NAFLD patients, namely MRI and liver biopsy, can be challenging to integrate into clinical practice. There is a pressing need for more practical tools to support and care for patients with this chronic condition,” said Dr. Ashley Barnabas, consultant hepatologist in King’s College Hospital’s Liver Unit.

The collaboration with King’s College Hospital represents the seventh clinical research partnership for ENDRA globally and is a natural progression from the feasibility study conducted by the Robarts Research Institute, which used healthy volunteers to establish the safety and efficacy of the TAEUS technology. The data from the KCH study, along with other ongoing or to-be initiated studies, will be used to bolster the clinical evidence and further establish the clinical utility of the TAEUS ultrasound device in patients with NAFLD. The study will be led by Dr. Barnabas.
 
The goals of the KCH study include:

• Comparing ENDRA’s TAEUS liver device against a baseline measure of liver fat as determined by the current standard of care, MRI-PDFF (magnetic resonance imaging proton density fat fraction).
• Scanning a target of 75 fatty liver patients to contribute additional diversity and volume of patient data.
• Publishing the findings of the study in a peer-reviewed medical journal.
• Providing ENDRA with ongoing clinical feedback on product design and clinical performance.
• Assisting with establishing the clinical value proposition of the TAEUS system in NAFLD to support ongoing commercialization.

“We are thrilled that KCH, a teaching hospital that is world-renowned for pioneering research in liver disease management and transplantation, is evaluating TAEUS as a tool to characterize NAFLD,” said ENDRA Life Sciences CEO Francois Michelon. “We believe this new partnership further advances our commercial strategy as it provides the opportunity to demonstrate the potential clinical utility of TAEUS® and to build on the clinical foundation we have established to date.”
  
NAFLD is a condition closely associated with obesity, diabetes, hepatitis C and certain genetic predispositions in which fat accumulates in the liver. NAFLD affects more than 1 billion people globally and is estimated to cost the U.S healthcare system over $100 billion annually. NAFLD is often asymptomatic and if left untreated, can progress to inflammation (NASH), tissue scarring (fibrosis), cell death (cirrhosis) and liver cancer. By 2025, NAFLD is forecast to be the greatest root cause of liver transplants. The only tools currently available for diagnosing and monitoring NAFLD are impractical: expensive magnetic resonance imaging (MRI) or an invasive surgical biopsy.
 
King’s College Hospital NHS Foundation Trust is one of the U.K.’s largest and busiest teaching hospitals.
 
ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS), a technology being developed to visualize tissue like MRI, but at 1/50th the cost and at the point of patient care. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS , including visualization of tissue temperature during energy-based surgical procedures.