“Exalenz is committed to leveraging our proven BreathID platform to innovate new breath-based tests for a broad range of liver and gastrointestinal disorders,” said Raffi Werner, Chief Executive Officer of Exalenz Bioscience. “We are very encouraged by the results of these two clinical trials demonstrating that MBT effectively detects CSPH in NASH patients, which could give clinicians a novel noninvasive tool to improve the management of this growing, complex patient population. We have a strategy in place to bring this innovative test to market with a potential product launch in 2020”.
About MBT
MBT is a simple, noninvasive Point of Care breath-based test in which a patient drinks a half glass of a tasteless solution that is metabolized exclusively in the liver. The patient’s exhaled breath is automatically collected and assayed with the BreathID system to measure the amount of a specific breakdown product of the solution, which reflects the rate of liver metabolism.
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In addition to detecting CSPH in NASH, MBT is being evaluated in monitoring patients with confirmed diagnoses of acute or chronic liver disease. The ability to monitor these patients with a simple, noninvasive test has the potential to radically improve the management and outcomes of patients with an array of liver diseases. Exalenz is also collaborating with pharmaceutical companies to assess the utility of MBT in monitoring response to treatment.
About NASH
More than 8 million people in the United States and Europe are living with advanced non-alcoholic steatohepatitis (NASH), the most severe form of non-alcoholic fatty liver disease (NAFLD) and a major risk factor for liver transplant and the development of primary liver cancer. The incidence of NAFLD is expected to increase more than 21% by 2030, with a concomitant increase of more than 63% in the incidence of NASH in the same period.
About CSPH
Clinically significant portal hypertension (CSPH), a complication of chronic liver disease and cirrhosis in which there is an increase in pressure in the vein that carries blood from the gastrointestinal tract to the liver, is closely associated with an increase in liver related morbidity and mortality. Detecting CSPH in patients with NASH is important for assessing the risk of developing liver complications, initiating therapeutic interventions to reduce portal hypertension and determining the need for additional procedures and/or monitoring. Portal pressure is measured by hepatic venous pressure gradient (HVPG), an invasive, complex and highly operator dependent procedure that exposes the patient to radiation and requires injection of contrast materials.
About Exalenz Bioscience
Exalenz Bioscience develops and markets diagnostic tests and monitoring systems that use the breath to diagnose and help manage gastrointestinal and liver conditions. The company’s flagship BreathID® Hp offers the most efficient and accurate test for detection of H. pylori bacteria, associated with various illnesses including gastric cancer, and is already in use in over 400 U.S. medical centers and major labs across the country. The BreathID 13C-methacetin breath test (MBT) is a sensitive, noninvasive, point of care tool that measures the microsomal function of the liver. Exalenz holds regulatory approvals in Europe, the United States, China and Israel for H. pylori detection and is currently evaluating additional applications of the BreathID platform, including MBT in the detection of CSPH in patients with NASH.
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