Humedics GmbH has announced that the company has submitted the marketing authorization application for the diagnostic agent necessary for the performance of the LiMAx test. The dossier was submitted in Germany, UK and Austria. 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 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.