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.
Humedics has developed a breath test based in vivo diagnostic system (the LiMAx® test), which comprises a CE-marked medical device, breathing masks and a diagnostic drug. The LiMAx® test enables the clinician to quantitatively determine the individual liver function capacity of a patient within minutes. This allows for selection of treatment strategies and disease monitoring optimally adapted to the individual patients’ liver status. Current clinical applications, studies of which have already been published in highly respected peer-reviewed scientific journals, include diagnosis of the liver function before and after liver transplantation, liver surgery planning (e.g. assessment of the amount of liver to be resected without potentially increasing the risk of acute liver failure) and assessment of diseases such as liver fibrosis and cirrhosis. 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. The LiMAx® test is already being used in over 30 top-tier university clinics across Europe and more than 20,000 tests have already been performed. The LiMAx® test is commercially available in Germany, Austria and the UK.
Based on the specific metabolic action of the liver enzyme CYP1A2, which is expressed in all functioning hepatocytes, performing the LiMAx® test is a simple procedure. The diagnostic drug solution is administered intravenously, and the liver immediately starts to metabolize the drug into low dose paracetamol and 13CO2 (non-radioactive). The latter is exhaled in the breath, collected via a respiratory mask and guided to the LiMAx® system where, within 1-2 minutes following the injection, the LiMAx® IR laser spectroscopy system allows real-time and very precise quantification of the increase in 13CO2 content. The resulting LiMAx® value, measured in micrograms per kilo body weight per hour, is a reliable and repeatable measure of the maximum functional capacity of the liver.
Dr. Ralf Kohnen
Marie-Elisabeth-Lüders Str. 1
Tel.: +49 30 59008 3240 E-mail: firstname.lastname@example.org