The LiMAx® liver capacity test is now commercially available in Germany, Austria and the UK
Following approval in the UK in 2017, Humedics has now also received Marketing Authorization for its diagnostic agent, LiMAxetin®, in Germany and Austria.
Berlin, Germany, and Paris, France, April 12, 2018 – Humedics GmbH, a specialist in real-time measurement of individual liver function, today announced that the company has received Marketing Authorization for its diagnostic agent LiMAxetin® in two additional countries: Germany and Austria. LiMAxetin® is the diagnostic agent used to perform the LiMAx® test.
The application for Marketing Authorization for the diagnostic agent LiMAxetin® 4mg/ml solution for injection via the decentralized procedure in the UK, Austria and Germany, with Germany being the Reference Member State, was submitted in April 2016. The UK healthcare authority MHRA granted Marketing Authorization already in October 2017 and this was followed in January 2018 by the Austrian authority AGES. With the German Marketing Authorization by BfArM in March 2018 the first wave of marketing approvals has now been successfully achieved.
Karsten Damgaard-Iversen, CEO of Humedics GmbH, stated "We are very pleased to announce this good news here in Paris at the International Liver Congress as these approvals in the UK, Germany and Austria represent major milestones not only for Humedics, but also for the medical community of liver experts in these key markets in Europe. We are convinced that these approvals will further accelerate the process of our LiMAx® test becoming the new gold standard for liver function assessment and quantification."
Erwin de Buijzer, COO of Humedics, further commented: "We are currently focusing significant efforts on the further market introduction of the LiMAx® test and we are experiencing rapidly growing interest. During the past quarter, this has already resulted in multiple contracts being closed with university clinics that are now implementing our unique liver function capacity test into their clinical routines. The LiMAx® test offers important and clinically proven added value, providing hepatologists, oncologists, radiologists and liver surgeons with previously unavailable quantitative guidance for diagnostic and therapy decisions as well as delivering additional patient safety and improved care."
The LiMAx® test is already being used in over 30 top-tier university clinics across Europe and over 20 trials in new indications such as the diagnosis of chronic liver diseases like non-alcoholic steatohepatitis (NASH) and the improvement of treatment decisions in liver oncology are ongoing. These investigator initiated trials impressively demonstrate the further potential of the LiMAx® test.
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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.