Ultrasound technology company ENDRA Life Sciences Inc. in Ann Arbor is partnering with King’s College Hospital (KCH) in London, England on a clinical study of ENDRA’s Thermo-Acoustic Enhanced Ultrasound (TAEUS) device for assessing non-alcoholic fatty liver disease (NAFLD).
“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, a condition that impacts more than 1 billion people globally,” says Francois Michelon, CEO of ENDRA Life Sciences. “It’s an honor for ENDRA to partner with another leading NHS trust. 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.”
This project 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. Ashley Barnabas, consultant hepatologist in the liver unit at King’s College Hospital.
“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,” says Barnabas. “There is a pressing need for more practical tools to support and care for patients with this chronic condition.”
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.
TAEUS currently is cleared for sale in countries that recognize the CE mark, including those in the European Union, and a 510(k) application has been submitted to the U.S. Food and Drug Administration.
