Humedics receives patent on method for quantitative liver function analysis based on a breath test
Patent is a milestone for further commercialization of the LiMAx test
The Australian patent AU20062664108 covers an analysis method for determining a functional parameter of an organ using a 13C labeled methacetin solution. “This patent is a milestone for the commercialization of our LiMAx test and the corresponding FLIP device”, says Prof. Dr. Karsten Heyne, co‐founder of Humedics GmbH. “We receive so much positive feedback on this test system from clinical users and, from a company perspective, it is great that the essential part of our proprietary technology is protected by now.”
The underlying principle of the test involves the following steps: At first, a 13C methacetin solution is administered intravenously. Methacetin is metabolized in the liver to paracetamol and 13CO2 and the latter is exhaled in the breath. The exhaled air is collected via a respiratory mask. Subsequent measurement of 13CO2 in a detection device provides a quantitative determination of the liver capacity and thus the liver function.
“Liver surgery and liver transplantation often are very serious interventions” says Dr. Martin Stockmann, co‐founder of Humedics GmbH and co‐owner of the mentioned patent. “It is therefore a high medical need to determine liver function prior to this kind of interventions to better assess the prognosis and also after interventions to monitor recovery.” The LiMAx test fulfills these requirements. Liver diagnostic tests available on the market so far are of limited use for this purpose and do not provide a quantitative liver function analysis. The LiMAx test is a bedside test that can be performed prior, during and subsequent to surgery. And the liver surgeon at Charité – Universitätsmedizin Berlin adds: “In liver surgery the LiMAx test provides added value to make correct therapeutic decisions and to improve therapy control.”
The recently granted patent adds to Humedics’ portfolio of pending and granted patents that secures the economic utilization of the company’s products. A previously granted patent covers the measurement device and a method for analyzing a sample gas by infrared absorption (German Patent No 102009055320) and thus Humedics’ FLIP device for the measurement of exhaled air.
Based in Berlin, Germany, Humedics GmbH is specialised in rapid and accurate liver function measurement using LiMAx®, an innovative technology for analysing exhaled air. The LiMAx® test provides physicians with a method for quantitatively assessing an individual patient’s liver function capacity within minutes. This enables physicians to select treatment strategies and follow disease progression based on up-to-date knowledge of the functional health of the liver.
Current applications, which have already been published in prestigious medical journals, include liver function diagnosis before and after liver transplantation, surgical planning for liver surgery (such as assessing how much liver tissue can be removed without increasing the risk of acute liver failure), and assessment of liver diseases such as fibrosis and cirrhosis. At present, more than 20 studies regarding new indications are being conducted. These include diagnosing and staging of chronic liver diseases such as non-alcoholic steatohepatitis (NASH), as well as selecting, monitoring and managing different oncology treatment options.
These studies, initiated by researchers, have already provided evidence of further potential for the LiMAx® tests. The LiMAx® test is in routine clinical use at more than 30 leading university hospitals in Europe. So far, more than 20,000 LiMAx® tests have been performed. The LiMAx® test is commercially available in Germany, Austria and the UK.