|[May 21, 2014]
Exalenz Bioscience Expands Its Breath Testing Technology into the Potential Billion Dollar Liver Diagnostic Market
JERSEY CITY, N.J. --(Business Wire)--
Exalenz Bioscience's (TASE: EXEN) Board of Directors has approved
pursuing the development of liver diagnostics in four medical
indications: Clinically Significant Portal Hypertension (CSPH),
Nonalcoholic Steatohepatitis (NASH), Hepatocellular Carcinoma (HCC), and
Acute Liver Failure (ALF).
Exalenz, which develops and markets unique diagnostic and monitoring
systems for the diagnosis and management of digestive tract and liver
diseases, reports today that the company's Board of Directors has
approved a strategic and tactical plan, expanding and accelerating the
company's activity in the field of liver diagnostics.
Exalenz is expected to commence its pivotal Phase III trial in the third
quarter of 2014, for the diagnosis of clinically significant portal
hypertension (CSPH). Working with the FDA, Exalenz has developed an
approach to the diagnosis of CSPH comparing breath testing to HVPG
(Hepatic Vein Venus Pressure) that will be submitted with the conclusion
of the clinical study. CSPH is considered the accepted indication for
liver cirrhosis severity assessment. The market potential for the
developed diagnostic test is estimated by Exalenz at 100 million USD a
Since several companies are presently at the clinical stages of
developing drugs for NASH (Nonalcoholic Steatohepatitis) and are
actively seeking a non-invasive test for diagnosis and follow up,
Exalenz has started discussions with some of these companies, for the
purpose of integrating its diagnostic, non-invasive test for NASH. In
the United States, 20-30% of the population suffers rom fatty liver
disease and 5-6% suffer from a development of liver inflammation and/or
damage to the liver tissue (NASH). The studies performed by the company
to date (Phase IIa) demonstrate high correlation between the results of
the Exalenz breath test and liver biopsy. The company estimates the
market for this indication at $2.6B.
Liver cancer is the sixth most common cancer in the world, third in
cancer mortality rate, with high prevalence in China. Exalenz will be
starting a Phase II clinical trial in China for the diagnosis of liver
cancer (HCC) in the second half of 2014. The efficacy of the Exalenz
breath test for detection of HCC was tested in an initial clinical study
and was found to have a very high correlation with imaging tests (MRI or
CT). The company estimates the market value of this test at 380 million
USD, in China alone.
The company is planning to participate in a multi-center NIH funded
study for monitoring of acute liver failure patients (ALF).
Larry Cohen (News - Alert), the CEO of Exalenz, said, "We are excited about our Board's
decision to renew and accelerate the liver diagnostic program in Exalenz
and are determined to pursue the potential of our unique BreathID
technology in a number of indications. The Exalenz breath test has shown
early evidence of efficacy as a diagnostic and a follow up tool for
liver patients in a non-invasive, convenient and valuable manner for
both patients and the healthcare industry."
"Furthermore," says Larry, "our track record in penetrating the H.
pylori breath testing market into hundreds of medical centers in the US,
indicates our ability to bring these exciting applications to the
In addition, the company reported a 40% growth in sales in Q1, 2014, of
the BreathID Hp system for the detection of H. pylori, and�aims for an
over 50% growth in 2015.
These activities are expected to strengthen the business and competitive
position of Exalenz and create an infrastructure for the company's
commercial launch in liver testing for the future.
Exalenz Bioscience develops diagnostic and monitoring systems that use
the breath to diagnose and help manage GI and liver conditions. The
company's flagship BreathID Hp product detects the presence of the H.
pylori bacteria, the cause of various illnesses including gastric
cancer. Exalenz holds regulatory approvals in Europe, the US and Israel
for H. pylori detection, and is currently in the process of obtaining
approvals for additional applications.
Forward-looking information: estimates made by the company included in
this publication are considered forward-looking information and there is
no assurance that said information will be realized. Company estimates
are based on various business assumptions, experience and professional
information. These estimates may not be realized, in whole or in part,
or may be realized in a manner significantly different from that
anticipated by the company, for various reasons, including reasons not
within the control of the company.
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