We've updated our Privacy Policy to make it clearer how we use your personal data.

We use cookies to provide you with a better experience. You can read our Cookie Policy here.

Advertisement
Humedics Submits Marketing Authorization Application
News

Humedics Submits Marketing Authorization Application

Humedics Submits Marketing Authorization Application
News

Humedics Submits Marketing Authorization Application

Read time:
 

Want a FREE PDF version of This News Story?

Complete the form below and we will email you a PDF version of "Humedics Submits Marketing Authorization Application"

First Name*
Last Name*
Email Address*
Country*
Company Type*
Job Function*
Would you like to receive further email communication from Technology Networks?

Technology Networks Ltd. needs the contact information you provide to us to contact you about our products and services. You may unsubscribe from these communications at any time. For information on how to unsubscribe, as well as our privacy practices and commitment to protecting your privacy, check out our Privacy Policy

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.

Advertisement