Humedics receives UK Marketing Authorization for its diagnostic agent, LiMAxetin®, and thus achieves full market clearance for the LiMAx® maximum liver capacity test in the UK, - the company’s first in Europe!
The LiMAx® test is now commercially available in the UK
Berlin, Germany, November 21, 2017 – Humedics GmbH, a specialist in real-time measurement of individual liver function at bedside, today announced that the company has received the first Marketing Authorization for its diagnostic agent LiMAxetin®, which is needed to perform the LiMAx® test.
CE Mark for the LiMAx system was obtained in 2015, and application for Marketing Authorization for the diagnostic agent via the Decentralized Procedure in the UK, Austria and Germany, with Germany being the Reference Member State, was submitted in April 2016.
Marketing Authorization for the diagnostic agent LiMAxetin® 4mg/ml solution for injection has now been granted by the UK healthcare authority, MHRA (Medicines and Healthcare Products Regulatory Agency), and additional marketing authorizations in Germany and Austria are expected to follow in short order.
Karsten Damgaard-Iversen, CEO of Humedics GmbH, stated: “This approval is a major milestone not only for Humedics, but also for the medical community of liver experts. In the UK, we will now focus our efforts on achieving a successful commercial launch of the LiMAx® test, while concurrently continuing our work to introduce the LiMAx® test and establish it as the new standard of care for liver function assessment.”
Erwin de Buijzer, COO of Humedics, further commented: “Our company has been pursuing pre- marketing activities for more than two years, and from numerous conversations with medical experts all over the world, we know that the healthcare providers are eagerly awaiting the opportunity to start using the LiMAx® test. Everyone we have spoken to appreciates the profound benefits of this new diagnostic method which enables precise determination of the individual liver function capacity of patients. As an example, when used prior to liver tumor resection and liver transplantation surgery, the LiMAx® test offers important and clinically proven added value, providing physicians with essential guidance and patients with additional safety. The LiMAx® test is already being used and evaluated in 25 top-tier university clinics across Europe and multiple trials in new indications such as the diagnosis of nonalcoholic steatohepatitis (NASH) and measuring the impact of chemotherapy on liver function are ongoing.”
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.