British NICE Institute: Positive assessment of the Humedics LiMAx® test
Medtech Innovation Briefing (MIB) published by the National Institute for Health and Care Excellence
Point-of-care measurement of the non-invasive breath test emphasised as especially innovative
Possible cost savings to the UK National Health System are addressed
Berlin, April 1, 2019 – The British National Institute for Health and Care Excellence (NICE) has published a Medtech Innovation Briefing on the LiMAx® test. In particular, the briefing emphasises the innovative diagnostic capabilities of this novel breath test technology. The Liver Maximum Capacity (LiMAx®) test enables physicians noninvasively to quantify liver function. The results help provide more accurate diagnoses and thereby improve clinical care of patients.
“We are proud that NICE has confirmed our assessment of the LiMAx® test. The independent expert assessment has shown that this diagnostic innovation can help patients and physicians alike,” adds Humedics GmbH CEO Karsten Damgaard-Iversen on the publication of the Medtech Innovation Briefing.
NICE was founded in 1999 to serve as a special health authority to reduce variation in the availability and quality of NHS treatments and care. The institute assesses clinical efficacy and cost-effectiveness of health technology to ensure fair access for all NHS patients to the treatment they need.
PR-364-00 Press Release NICE Announcement
Medtech Innovation Briefings add to existing NICE guidelines by providing objective information on new and novel medical technology. The information covers a description of the technology as well as its use and potential role in patient treatment.
Many diseases, such as malignant liver tumours, require liver resection – that is, partial removal of the organ. However, this method entails the risk of postoperative liver failure. Consequently, an accurate postoperative prognosis is very important. The LiMAx® test helps doctors improve the medical severity assessment in acute and chronic liver diseases, as well as predicting the postoperative liver function and the risk of liver failure. The NICE Medtech Innovation Briefing also gives this a positive assessment. Owing to decreased post-operative complications and shorter hospital stays the LiMAx® test also holds potential for cost savings, according to the British experts.
According to Karsten Damgaard-Iversen, the technology saves valuable time and resources and enables improved standards of care: “Whether it’s a vital liver transplantation or a conservative treatment, we now have a quick and easy to apply diagnostic tool that allows physicians to offer treatment strategies adapted to the particular disease stage of the individual patient.”
For more details, please go to: www.humedics.eu
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: email@example.com