Humedics submits marketing authorization application for the diagnostic agent used with the LiMAx test
Application for marketing authorization of the diagnostic agent 13C-Methacetin Solution for infusion used with the LiMAx test
After the successful closing of the clinical phase III study with the LiMAx test in September 2015, Humedics submitted the application for marketing authorization of the diagnostic agent in April 2016. Submission was performed via the Decentralized Procedure in Germany, UK and Austria, with Germany being the reference member state.
The “Fast-track LiveR” Trial with the investigational diagnostic agent 13C-Methacetin Solution for infusion was set up to demonstrate the positive impact of LiMAx test on patient management and diagnostic thinking related to postoperative management in patients undergoing partial liver resection.
Erwin de Buijzer, CEO of Humedics GmbH, stated: “After the successful closing of our phase III study we focused all of our efforts on preparing the marketing authorization dossier. This submission represents a breakthrough for the commercialization of our LiMAx test.”
The recent submission for marketing authorization represents another milestone in the dynamic development of the company. After closing a series C financing round end of 2014 and the successful CE certification of the FLIP medical device in 2015, Humedics’ team now focusses on the preparation of a successful European market entry of the diagnostic agent for the LiMAx test.
The LiMAx test, in combination with the corresponding FLIP device and the diagnostic drug offers a clinically proven significant added value for patients with liver diseases and liver surgery. The LiMAx test is already being used in 17 top-tier university clinics in Europe.
Fast-track LiveR Trial
Fast-track LiveR was a prospective, randomized, controlled, multi-centric, phase III study for the early identification of low-risk patients after partial liver resection with the LiMAx test. The LiMAx test determines the actual liver function in real-time. The test includes the application of the diagnostic investigational medicinal product, 13C-Methacetin Solution for infusion and a breath test involving the use of Humedics’ FLIP device for measurement and analysis. 148 patients with different types of liver tumors and designated for open liver surgery were included in the study. Two study arms had been set up; each enrolling more than 70 patients. The LiMAx group was subject to a perioperative patient management according to the fast-track procedure. This included a pre- and postsurgical analysis of the liver function with the LiMAx test. In the control group the perioperative patient management was performed according to current clinical standards. The trial was conducted at six study centers in Germany and was completed in September 2015.
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.