FDA Grants Humanitarian Use Designation for BreathID MBT Device for Acute Liver Failure

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Exalenz Bioscience permitted to pursue marketing authorization for the ALF monitoring indication under a Humanitarian Device Exemption (HDE) application.

Exalenz Bioscience Ltd. is pleased to announce that the US Food and Drug Administration (FDA) has granted the company’s request for humanitarian use device (HUD) designation for the BreathID® Methacetin Breath Test (MBT) device when used to monitor hepatic metabolism in patients diagnosed with acute liver failure (ALF). As a result of FDA’s designation, Exalenz is permitted to pursue marketing authorization for the ALF monitoring indication under a Humanitarian Device Exemption (HDE) application.

Acute liver failure (ALF) is a rare condition in which there is rapid deterioration of liver function in previously normal individuals. Liver transplantation is frequently required and mortality rates among ALF patients are high. The BreathID MBT device monitors the liver’s ability to eliminate exogenous compounds in ALF patients. The device works in conjunction with a marker specifically targeted to challenge hepatic metabolism and that can be measured in the breath of an ALF patient. The device is intended to monitor hepatic metabolism in patients diagnosed with ALF, and to provide the physician with valuable information, in combination with other clinical information, to make timely and vital decisions regarding patient status and treatment options, such as the need for liver transplant.

Under the HUD designation, the BreathID MBT for monitoring hepatic metabolism in ALF patients is intended for a condition which affects fewer than 4,000 people in the United States each year. HUD devices are reviewed by FDA under an HDE application, which is similar to a PMA but requires substantiation of safety and probable benefit, rather than a full effectiveness demonstration as would be required for a PMA. HDEs are also subject to a shorter FDA review time frame of 75 days rather than 180 days for a PMA. The potential for a shorter review process is to help encourage the availability of devices for rare conditions like ALF.

With the HUD designation in place, the company plans to soon initiate discussions with FDA’s Center for Devices and Radiological Health regarding the regulatory requirements for the BreathID MBT HDE. The company is hopeful that prior clinical experience with the use of the device at Kings College in London and Hadassah Medical Center in Israel will help support the company’s HDE application.

The Company wishes to clarify that at this time it has no knowledge about what data FDA will require to support future approval of the HDE, nor is there certainty that the company will be successful in ultimately obtaining HDE approval, or under what timeframe.

About Exalenz Bioscience
Exalenz Bioscience develops and markets medical equipment for breath testing for the purposes of diagnosis and management of digestive system and liver conditions. The company sells the BreathID® System together with proprietary disposable test kits. The BreathID® System has been proven effective for clinical use in the task of identifying the presence of H. pylori bacteria and is presently undergoing clinical tests for use in the field of liver function, liver cirrhosis, and digestive disturbances. Exalenz holds regulatory approvals in Europe and the U.S. for some of the applications and the company is currently in process of applying for approvals for additional applications.

This news release contains “forward-looking statements.” Statements in this press release, which are not purely historical, are forward-looking statements and include statements concerning the Company’s business outlook or future economic performance, anticipated revenues, expenses or other financial items; plans and objectives related thereto; and assumptions or expectations relating to any future events, conditions, performance or other matters. Forward-looking statements are subject to risks, uncertainties and factors including, but not limited to, changing customer demands, changing regulatory requirements, customer acceptance of the Company's products, the impact of competitive products and pricing, dependence on existing management, that technology may not function as expected and general economic conditions. The Company assumes no obligation to update the information in this release.

For more details:
U.S. Contact: Sean Hanlon, Vice President, Marketing, 617-794-6936
Investor Relations Contact: Eran Gabay, Gelbert Kahane, Investor Relations, +972-54-246-7278


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Sean Hanlon
Exalenz Bioscience
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