Humedics receives UK Marketing Authorization for its diagnostic agent, LiMAxetin®, and thus achieves full market clearance for the LiMAx® maximum liver capacity test in the UK, - the company’s first in Europe!
The LiMAx® test is now commercially available in the UK
Berlin, Germany, November 21, 2017 – Humedics GmbH, a specialist in real-time measurement of individual liver function at bedside, today 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.”
Humedics has developed a breath test based diagnostic system (LiMAx test), which comprises a CE-marked medical device, breath masks and a diagnostic drug. More than 100 million people world-wide suffer from liver diseases (i.e. cirrhosis, hepatitis, fatty liver, metabolic disorders and liver tumors). The LiMAx test enables the clinician to quantitatively determine the individual liver function capacity for a patient within minutes. This allows for selection of treatment strategies that are optimally adapted to the individual patients liver status. Current applications published in highly respected 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 liver failure) and assessment of diseases such as liver cirrhosis. Investigator initiated studies focusing on new indications like oncology, chronic liver disease and nonalcoholic steatohepatitis (NASH) are ongoing. The LiMAx test has been used almost 20,000 times in clinical practice. The phase III multi-center clinical trial required for marketing authorization application for the diagnostic drug has been closed successfully. Humedics has submitted the marketing authorization application for the diagnostic agent, which was developed by Humedics and will be used for performing the LiMAx test, in April 2016.
The underlying principle of the LiMAx test involves the following steps: Firstly, the diagnostic drug solution is administered intravenously and the drug is metabolized in the liver to paracetamol and 13CO2. The latter is exhaled in the breath. The exhaled air is collected via a respiratory mask. Subsequent continuous measurement of 13CO2 in the patients’ breath in the LiMAx device provides a quantitative determination of the liver capacity and thus reflects the liver function.
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