Press release

LiMAx test shows reversibility of fatty liver disease after obesity surgery

Clinical study provides evidence for functional liver recovery after weight loss.

The prevalence of overweight and obesity has increased dramatically in recent years. Approximately half or more than half of the Western world’s population is overweight or obese. The hepatic manifestation of the metabolic syndrome is nonalcoholic fatty liver disease (NAFLD), which is presently considered to be the most common liver disease in Western countries. NAFLD may progress to nonalcoholic steatohepatitis (NASH) and liver fibrosis. Both, NAFLD and NASH are reversible when effective weight reduction can be achieved. However, current noninvasive approaches to diagnosis, staging, and management of NAFLD and NASH are deficient.

Bariatric surgery provides long-term weight loss and improvement of obesity-associated liver diseases. In a prospective cohort study from October 2011 to May 2014, morbidly obese individuals receiving bariatric surgery were investigated for functional liver recovery. Liver function was determined by the LiMAx test preoperatively, 6 and 12 months postoperatively.
Investigator Prof. Ulf Neumann, Department of General, Visceral and Transplantation Surgery, RWTH Aachen University Hospital, said: “We applied the LiMAx test to assess the liver function of morbidly obese patients and to monitor the functional liver recovery after bariatric surgery. The non-invasive LiMAx breath test validly determines liver function capacity. It may avoid the inaccuracy seen with blood parameters and the risks of invasive liver biopsies which, moreover, do not necessarily reflect the liver function. Our study results show that LiMAx values correlate to the NAFLD activity score (NAS). Thus, the LiMAx test is an interesting method to diagnose and monitor NAFLD and NASH.”
Study results showed that the mean liver function capacity significantly increased from preoperatively severely impaired values to normal values within 6 months after surgery and further improved over the period of the survey with a final measurement after one year.

Erwin de Buijzer, CEO of Humedics GmbH, stated: “The study at the Aachen University Hospital clearly demonstrated the usefulness of our LiMAx test in obesity-related liver diseases and represents the first study to noninvasively assess the impact of weight loss on changes in the liver function. The dramatic increase of obesity and obesity-associated diseases is a major problem in the Western world. We are very pleased to provide physicians with a novel diagnostic test to better assess obesity patients and to monitor disease course and therapy success.”

The LiMAx test, together with the corresponding FLIP device and the diagnostic drug offers a clinically proven significant added value for patients with liver diseases and liver surgery.

Original publication:
OBES SURG
DOI 10.1007/s11695-015-1664-0

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ILCA 2015, International Liver Cancer Association 9th Annual Conference. September 4-6, 2015. Paris,
France; www.ilca2015.org
Please visit us at booth No. 8.

ESOT, 17th Congress of the European Society for Organ Transplantation, September 13-16, 2015,
Brussels, Belgium; http://esot2015.esot.org
Please visit us at booth No. 29.

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About Humedics

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.

LiMAx® Test

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. 

Humedics Contact:

Humedics GmbH

Erwin de Buijzer MD MBA

Marie-Elisabeth-Lüders Str. 1

10625 Berlin

Phone:                 +49 30 590083240

E-Mail:                 info@limaxtest.com

Homepage:        www.limaxtest.com

PR Contact:

Almut Gebhard

Strategische Kommunikation

Hasenheide 56

10967 Berlin

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Mobile                 +49 (0)174 3017754

E-Mail:                 ag@almutgebhard.de