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Diagnostic device for liver failure on FDA fast track

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Friday, February 17th, 2012

Liver failure can have cataclysmic implications. “Most liver patients are chronic patients,” notes Steven Eitan, CEO of Israel’s Exalenz Bioscience, a small, Modi’in-based company that has developed the world’s first non-invasive diagnostic device for acute liver failure.

No similar device exists anywhere, which is what prompted the US Food and Drug Administration (FDA) to grant Exalenz’s breakthrough technology “humanitarian use device” (HUD) designation in September, so the company may get its product to market quickly. “There are a few thousand acute liver failure patients every year in the US alone,” says Eitan. “This alternative clearance pathway could be shorter than the normal path to market, which will enable us to provide physicians with a new tool for this condition.”

Eitan expects that the HUD designation will help Exalenz establish relationships with liver and GI physicians in the United States, which will be beneficial when future applications for the system are launched into this market. “If we are successful, this will be the first time physicians can start using this system. It’s currently only used for clinical liver studies. Last year we launched the first series of FDA-cleared tests in the US and Israel. In addition, we’re working on a pipeline of other tests,” says Eitan.

Supporting other organs

Acute liver failure (ALF), a rare condition in which there is rapid deterioration of liver function in previously normal individuals, often requires liver transplantation if not treated early enough. The liver supports almost every organ in the body, and mortality rates among ALF patients are high.

Exalenz’s BreathID MBT device monitors the liver’s metabolism capabilities by continuously measuring subtle changes in the carbon levels of an ALF patient’s exhaled breath. “It’s a combination of a device and drug – but the drug is not for treatment, rather as a diagnostic device,” Eitan explains. “Right now there is no non-invasive function test available. The choices are either a blood test or a biopsy, each of which has its own drawbacks. There are millions of patients worldwide with no way of diagnosing and monitoring their condition,” says Eitan.

He sees tremendous potential for the product. “The market exists – but there’s no solution for the market right now. Non-invasive devices exist for monitoring the functioning of the heart or lungs, for example, but for the liver there’s no such thing.”

Managing disease through breath analysis

Exalenz (formerly BreathID) develops and markets unique systems that can monitor subtle changes in exhaled breath to extract vital diagnostic information – enabling medical specialists to identify and manage specific digestive and liver conditions at the point of care.

The company’s proprietary core technology enables medical specialists to identify and manage digestive and liver conditions with unprecedented ease, precision and patient comfort. The technology uses a clinically proven, sophisticated laser-like light source to pinpoint real-time changes in carbon isotope ratios with a high degree of accuracy. Covered by 55 patents worldwide, with others pending, the company’s flagship product is the BreathID System. It enables assessment of liver function, gastric function and the detection of Helicobacter pylori bacteria, and is currently sold in the US (for H. pylori only), Europe, Israel and Asia.

Established in 2006 as a spinoff of Ordion Bioscience, Exalenz has grand plans of becoming a worldwide leader in the field of non-invasive tests by providing accurate, breath test-based, point-of-care disease management solutions for a broad range of GI and liver disorders, says Eitan. “We have proven, commercial technology and there are already about 150 medical centers in the US, Italy, Japan and Israel using our technologies.” Major investors include Israeli businessman Mori Arkin, the Hadassah Medical Center and the Migdal insurance group.

“We grew to 45 people over the past year, about 15 of them based in the US,” says Eitan. “My board is telling me that the feedback has been excellent. Customers in the US say they’ve never seen a relatively small company doing so much. In the coming years, we want to develop many tests so that a GP will be able select the tests he needs. We also want to expand to other countries, while remaining heavily invested in R&D.”