ENDRA Life Sciences (NASDAQ:NDRA) is partnering with King’s College Hospital, London (KCH) for a clinical study of ENDRA’s Thermo-Acoustic Enhanced Ultrasound (TAEUS) device for assessing non-alcoholic fatty liver disease (NAFLD).
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, 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.
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 KCH.
“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,” ENDRA CEO, Francois Michelon, said in a statement.
TAEUS has CE mark clearance and a 510(k) application has been submitted to the FDA.
Earlier this year, Hepion Pharmaceuticals (NASDAQ:HEPA) signed a collaboration agreement with ENDRA to incorporate TAEUS as an add-on technology to support Hepion’s patient screening and biomarker measurement during the upcoming Phase 2b study of CRV431 in NASH.