Monday, November 5, 2018

Liver Meeting® 2018- Exalenz to Present Positive Clinical Data for Breath ID® in NASH cirrhosis patients

Exalenz to Present Positive Clinical Data for the Breath ID® 13C-Methacetin Breath Test System at the Liver Meeting® 2018

MODI’IN, Israel and MANASQUAN, N.J., Nov. 05, 2018 (GLOBE NEWSWIRE) -- Exalenz Bioscience Ltd. (TASE: EXEN), a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, today announced that the Company will present positive data from a Phase 2 trial, conducted by Galectin Therapeutics in NASH cirrhosis patients (ie the NASH-CX trial), utilizing its BreathID® 13C-Methacetin Breath Test (MBT) System in patients with compensated non-alcoholic steatohepatitis (NASH).

The poster presentation is titled “The Noninvasive Point of Care MBT Accurately Predicts Decompensation Events Better Than MELD in Compensated (MELD <15) Nash Cirrhotics” (#1337) will be presented at the Liver Meeting® 2018 on November 10 at 2:00 PM PT / 5:00 PM ET. The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), is being held November 9 - 13, 2018 in San Francisco. The lead author is Naga Chalasani, MD, Associate Dean for Clinical Research and a Professor of Medicine at the Indiana University School of Medicine.

“Results of this study indicate that the MBT has the potential to predict liver decompensation in patients with compensated NASH cirrhosis, which may enable earlier intervention and improved management of these patients,” said Raffi Werner, Chief Executive Officer of Exalenz Bioscience. “We believe that these results add to the growing body of data supporting the MBT as an important alternative to more invasive detection methods and support our strategy to advance this innovative test to the market, potentially launching the product 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.

In addition to evaluating MBT to monitor NASH patients, it is also being developed to detect CSPH in the advanced NASH patient population, as well as in monitoring patients with confirmed diagnoses of acute liver failure (ALF). The ability to monitor patients with a simple, noninvasive test has the potential to radically improve the management and outcomes of patients with an array of liver diseases.

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.

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