22 October 2014 - 22 October 2014 - Israeli diagnostic system developer Exalenz Bioscience Ltd (TLV:EXEN) disclosed Tuesday the initiation of a pivotal study investigating the potential of its BreathID test as a non-invasive tool to diagnose clinically significant portal hypertension (CSPH), the most common complication of cirrhosis which accounts for significant morbidity and mortality in patients with advanced liver disease.

The multinational study will compare the patient-friendly BreathID test to Hepatic Venous Pressure Gradient (HVPG).

Leading medical centres in Europe and the USA will recruit patients with chronic liver disease during the 200-patient first stage of the study. Data gathered during this stage will be used to build the index algorithm to compare the BreathID test with HVPG. Throughout the second stage of the study, which is expected to kick off in 2016, investigators will verify the algorithm.

Once the study is completed, the company plans to submit data to the US FDA for PMA approval.

Prof. J. Bosch, Hospital Clinic, University of Barcelona, Spain, a study investigator and world leader in diagnosing and treating portal hypertension, said he was impressed with the potential of the technology, which is based on measuring different parameters in the patient's breath. He said the technology can certainly become a breakthrough in the non-invasive detection of liver diseases.

Currently, hepatic portal vein hypertension is diagnosed by measuring HVPG, an invasive and expensive test which requires local anaesthesia and the use of contrast material that may harm the kidneys, and exposes the patient to radiation. Furthermore, the test requires a high degree of skill, time and resources that are not available in most medical centres.

Exalenz trusts that the BreathID test will be a non-invasive, rapid, safe and considerably less expensive alternative test for this large market, estimated by the company to be about USD 100 million (EUR 78.582m) . As the cost and complexities of currently available modalities to detect CSPH could be limiting the identification of many CSPH patients, the company believes that the availability of a more convenient breath-based test could eventually increase the market's overall size.

Exalenz Bioscience's CEO, Larry Cohen, said the initiation of the study is a significant milestone in the company's strategic plan to launch a broad portfolio of liver diagnostics based on its patient-friendly BreathID test. Cohen voiced the company's belief that the availability of a less-invasive test will allow clinicians to spot CSPH in a greater number of chronic liver disease patients, while helping reduce healthcare costs.

Exalenz plans to start studies for the diagnosis and monitoring of additional liver indications including NASH (non-alcoholic steateohepatitis), HCC (hepatocellular carcinoma) and ALF (acute liver failure). These will be achieved in part via partnering with companies developing therapies for these diseases.