Exalenz Bioscience has received humanitarian use device (HUD) designation for its BreathID Methacetin Breath Test (MBT) from the US Food and Drug Administration (FDA).
The BreathID device is used to monitor hepatic metabolism in patients diagnosed with acute liver failure (ALF) and the liver’s ability to eliminate exogenous compounds.
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 provides physicians with valuable information, in combination with other clinical information, to make vital and timely decisions regarding patient status and treatment options, such as the need for liver transplant.
Exalenz plans to initiate discussions with FDA’s Center for Devices and Radiological Health regarding the regulatory requirements for its BreathID MBT Humanitarian Device Exemption (HDE) application.