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Last 364.70
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As of 10:24 AM 08/27/15 All times are local (Market data is delayed by at least 15 minutes).

exalenz bioscience ltd (EXEN) Snapshot

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08/31/14 - $1,141
52 Week Low
08/24/15 - $251.00
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exalenz bioscience ltd (EXEN) Details

Exalenz Bioscience Ltd. develops and commercializes tools for the diagnosis and management of a range of conditions in the fields of liver health and gastroenterology. It offers BreathID Hp, a urea breath test for diagnosing helicobacter pylori infection; and for post-treatment monitoring of helicobacter pylori infection in adults in the areas of primary care, gastric distress, bariatric surgery, and emergency room and urgent care facilities. The company serves hepatologists, gastroenterologists, bariatric surgeons, urgent care centers, and primary care physicians in Israel and internationally. Exalenz Bioscience Ltd. is based in Modiin, Israel.

exalenz bioscience ltd (EXEN) Top Compensated Officers

Chief Executive Officer
Total Annual Compensation: 1.1M
Chief Financial Officer
Total Annual Compensation: 573.0K
Chief Operating Officer and General Manager
Total Annual Compensation: 658.0K
Vice President of Marketing and Business Deve...
Total Annual Compensation: 564.0K
Vice President of Sales
Total Annual Compensation: 703.0K
Compensation as of Fiscal Year 2014.

exalenz bioscience ltd (EXEN) Key Developments

Exalenz Bioscience Announces Collaboration with Galectin Therapeutics to Use BreathID to Monitor Patients with Cirrhosis Associated with NASH

Exalenz Bioscience announced a collaboration with Galectin Therapeutics to use the BreathID test to monitor patients in a Phase II study evaluating GR-MD-02. GR-MD-02 is an investigational treatment for patients with cirrhosis associated with nonalcoholic steatohepatitis (NASH Cirrhosis). The 156 patient, multicenter, randomized, placebo-controlled, double-blind clinical trial will evaluate the safety and efficacy of GR-MD-O2 for the treatment of liver fibrosis and portal hypertension in patients with NASH Cirrhosis. As part of the study, Exalenz will investigate the clinical utility of BreathID® to follow up the effect of treatment on patients with NASH Cirrhosis, compared to standard medical tests including hepatic venous pressure gradient (HVPG), liver biopsy results, and liver stiffness testing. Exalenz recently received approval from the U.S. Food and Drug Administration (FDA) of an investigational device exemption (IDE) for the trial. During the study, enrolled participants will receive three breath-based tests: the first will be given during the screening stage, the second will be given at week 25 of treatment and the third will be given after the final dose of GR-MD-02. The results of this study will be used to further evaluate the efficacy of BreathID® and to optimize the company's proprietary algorithm for monitoring the progression of NASH Cirrhosis to determine the clinical effectiveness of Galectin Therapeutics' GR-MD-02 treatment among enrolled patients. Exalenz Bioscience expects that the optimized algorithm will continue to be applied to data collected in its other ongoing studies.

Exalenz Bioscience Ltd and Galectin Therapeutics, Inc. Receive FDA Approval for Joint Clinical Trial of Second-Stage of GR-MD-02

Exalenz Bioscience Ltd. announced that it received FDA approval for a joint clinical trial with Galectin Therapeutics Inc. The company's product, the BreathID, will be used to track and diagnose patients in a second-stage clinical trial of GR-MD-02, an experimental treatment for liver cirrhosis caused by NASH (fatty liver disease). Galectin Therapeutics is conducting a multicenter, double-blind, placebo-controlled Phase 2 trial with 156 patients to evaluate the safety and effect of the drug.

Exalenz Bioscience Ltd Launches Clinical Study for Breath-Based Detection of Primary Liver Cancer (HCC)

Exalenz Bioscience announced the initiation of a clinical study designed to investigate its BreathID® test to non-invasively detect primary liver cancer, also known as Hepatocellular Carcinoma (HCC). The 100 patient study, being conducted initially at the 302 Military Hospital of China, with other sites in China expected to be added, will evaluate the efficacy of BreathID for the early detection of HCC, compared to magnetic resonance imaging (MRI). MRI is currently part of the recommended practice guidelines by leading medical organizations including the European Association for the Study of the Liver (EASL) and the American Association for the Study of Liver Diseases (AASLD). Following completion of the study, Exalenz plans to conduct a Pivotal study and submit data to both the U.S. Food and Drug Administration (FDA) and the Chinese Food and Drug Administration (CFDA) in support of marketing approval. The efficacy of the Exalenz breath test for detection of HCC was evaluated in a prior clinical study demonstrating a very high correlation with imaging tests like computed tomography that are currently the standard of care. The company estimates the market value of this test is approximately $380 million in China alone. This study is part of Exalenz's growing clinical pipeline of investigational diagnostic applications for serious liver diseases. In May, the Company announced the initiation of a clinical study evaluating the potential of its BreathID® test to diagnose nonalcoholic steatohepatitis (NASH). Exalenz also has an ongoing pivotal study, launched October 2014, investigating BreathID® as a tool to diagnose Clinically Significant Portal Hypertension (CSPH).


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