Exalenz Bioscience Ltd. (TASE:EXEN) announced that the Humanitarian Device Exemption (HDE) application for the company’s BreathID non-invasive diagnostic device intended to treat acute liver failure has been approved by the US Food and Drug Administration (FDA).
The FDA defines a Humanitarian Use Device (HUD) as a device intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. An HDE application is submitted to FDA to obtain approval for an HUD. Obtaining Humanitarian use device (HUD) status implies that the device will be exempted from undergoing an efficacy trial, thus significantly decreasing the duration of the FDA approval process as well as cost, provided the device meets FDA requirements.
In a trial comprising several dozen patients at Kings College in London and at Hadassah Medical Organization in Jerusalem, Exalenz demonstrated the efficacy of the BreathID device in diagnosing acute liver failure. Lives can be saved and unnecessary liver transplants can be avoided by early diagnosis provided by the device.
According to Exalenz, the device could be expanded for its use in a wide range of applications, if it meets the FDA requirements successfully.
The BreathID device was approved by the FDA last week for a clinical trial involving the early diagnosis of a type of liver cancer known as Hepatocellular Carcinoma.
By early afternoon, Exalenz shares slipped 1.4% to NIS 0.71, giving a market cap of NIS 96 million.