Press release

Berlin, 20/11/2019

The Austrian Competence Center for Medical Devices (CCMD) has conducted a Mini Health Technology Assessment to identify and analyze the clinical and economic benefits, as well as the potential clinical risks of the LiMAx system from Humedics GmbH. The institute confirms the clinical and health economic advantages of the LiMAx system for interventional use in liver surgery and highlights the noninvasive breath test as particularly innovative. The unique Liver Maximum Capacity Test (LiMAx) quantifies the functional health of the liver, thereby enabling the planning of better and safer interventional liver procedures. The HTA further concludes that the LiMAx system is a convenient and easy-to-implement way to reduce the cost of treatments associated with liver surgery. “For example, with 100 liver surgeries per year in a hospital, the use of the LiMAx system can save at least € 215,900 per year”.

"We are pleased and encouraged that this HTA confirms the validity and healthcare impact of our clinical study data, as well as many of our own assessments of the potential benefits of the LiMAx test. This evaluation by independent experts shows that our unique diagnostic tool, which can measure the functional capacity of the liver in real time, not only helps patients and physicians alike, but also rewards the clinics and hospitals that choose to deploy the LiMAx test by providing them with considerable economic benefits”, says Karsten Damgaard-Iversen, Managing Director and Chief Executive Officer of Humedics GmbH, commenting on the publication of the CCMD Mini-HTA.

The HTA also investigated the non-interventional diagnostic use of the LiMAx test where published clinical study data show a wide range of use cases such as the diagnosis of non-alcoholic steatohepatitis, the detection of fibrosis/cirrhosis and the prediction of mortality. However, the HTA concludes that despite the promising results of these mainly retrospective studies, the clinical usefulness of the LiMAx system in non-interventional diagnostics cannot currently be confirmed with a sufficient level of evidence and that additional studies are needed. “We are aware of the need for additional study data in other areas of clinical application of the LiMAx test, and we are therefore pleased that a large number of Investigator Initiated Trials (IITs) are currently ongoing, studying the utility and performance of our test in non-surgical areas such as transcutaneous liver interventions (e.g. SIRT, TACE & TIPPS), the diagnosis of NASH, LiMAx vs. Biopsy, monitoring of chronic liver diseases and chemotherapy toxicity”, Damgaard-Iversen further commented.

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Liver diseases lead to approximately two million deaths per year worldwide. Currently available diagnostic options often prove to be of limited use for the exact measurement of liver function or for the prediction of various pathologies associated with the liver. A novel form of determining global liver function is the LiMAx test (Maximum Liver Function Capacity), which measures the metabolism of an intravenously administered solution (13C-methacetin) in the exhaled air of the patient. As no Health Technology Assessment for this test procedure has so far been conducted, the aim of this Mini Health Technology Assessment was to systematically evaluate and analyse the clinical evidence and the economic benefits of the LiMAx test.

Numerous diseases, such as malignant liver tumours, require the removal of parts of the liver, a so-called liver resection. In surgical management, the use of the LiMAx system leads to safer procedures and a reduction in postoperative intensive care unit days and hospital days. The economic cost-benefit analysis confirms the economic efficiency of the LiMAx system for use in surgical management, as costs savings between € 4.51 and € 23.54 for every Euro spent can be realized. In addition, the LiMAx system features further clinical benefits such as for example reduced occurrence of postoperative liver failure and mortality and therefore, it can be recommended for application in everyday clinical routine.

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To obtain a copy of the CCMD Mini HTA, please contact us at info@limaxtest.com.

For further information about Humedics and the LiMAx test please visit www.humedics.eu