Renaud Maloberti
Chief Commercial Officer (CCO), ENDRA Life Sciences
A new non-invasive approach to identifying levels of liver fat could deliver an important boost in the fight against liver disease.
Early diagnosis is key to helping combat liver disease.
Changes in lifestyle can prevent the condition becoming serious and developing into NAFLD (non-alcoholic fatty liver disease) or NASH (non-alcoholic steatohepatitis).
However, early monitoring of the liver for excess fat is not always straightforward and the acknowledged gold standard approach of MRI-PDFF (proton density fat fraction) scan is costly, while the alternative of biopsies are uncomfortable and invasive for the patient.
Because of the nature of liver problems, diagnosis can often come too late for effective interventions to be implemented without resorting to more drastic and invasive treatments.
The scale of the problem is significant, according to Renaud Maloberti, Chief Commercial Officer of ENDRA Life Sciences, who says NAFLD affects well over one billion people worldwide.
“If not diagnosed and treated it can progress to liver inflammation (a.k.a NASH), cirrhosis, liver cancer and conditions that can ultimately lead to a patient requiring a liver transplant. Liver disease is also closely associated with diabetes and cardiovascular disease,” he adds.
Non-invasive liver assessment
ENDRA has developed a unique solution to help advance liver disease diagnosis with its TAEUS® product offering rapid, non-invasive, point-of-care liver disease assessment. TAEUS stands for Thermo Acoustic Enhanced Ultrasound and is a unique technology using a hybrid combination of radio frequency and ultrasound to characterise tissue.
The TAEUS probe, when placed on the patient’s skin for 1.2 seconds, provides a numerical reading to assess the amount of liver fat. Physicians can characterise tissue and non-invasively evaluate NAFLD.
“Liver disease is growing rapidly, due our lifestyles and a host of other causes, including diabetes,” continues Mr Maloberti. “It’s a progressive, often asymptomatic disease, which can lead to much more expensive care issues from a healthcare system standpoint – like a liver transplant.”
Lifestyle changes
Early assessment can either rule out NAFLD or allow for lower cost interventions such as lifestyle changes or, in the near future, targetted drug therapies.
“Clinical literature indicates that anybody with more than 5%-6% liver fat, needs to be monitored,” he continues. “Since there is no convenient way to monitor NAFLD, people tend to find the problem when the disease is already in the more advanced stages.”
With a rich pipeline of drugs in development to fight liver disease, he believes simple, point-of-care diagnostics will be essential to screen-in patients and monitor the effectiveness of those therapies for patients.
ENDRA’s new TAEUS product has CE certification in Europe. TAEUS has not yet been approved for sale in the US. Clinical evaluation at six sites in the United States and Europe are comparing its performance with MRI-PDFF in 75-100 patients at each location, with the aim of deploying it clinically in 2021.
For more information visit: www.ENDRAinc.com