Humedics GmbH, a specialist in real-time measurement of individual liver function at bedside, 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.”