Humedics GmBH

Core Technology and Offering: The LiMAx® System

The central product and service offered by Humedics is the LiMAx® test (Liver Maximum Capacity test), a patented, non-invasive, and quantitative diagnostic breath test. The LiMAx system provides a real-time measurement of the functional metabolic capacity of the liver, a critical parameter for patient safety and treatment planning in hepatology and liver surgery.

Products

1. LiMAx® Test Consumables and Diagnostic Drug:

   • 13C-Methacetin Solution: The test requires the intravenous administration of a non-radioactive, isotope-labeled drug, 13C-methacetin. This drug is specifically metabolized exclusively by the liver-specific enzyme Cytochrome P450 1A2 (CYP1A2), which is distributed evenly throughout functional liver tissue. This selective metabolism makes the rate of breakdown a direct, quantifiable marker for the liver's overall metabolic capacity.
   • Breath Mask and Tubing: Disposable components for collecting the patient's exhaled air during the test procedure.

2. FLIP® Detection Device:

   • The Analyzer: FLIP® is the specialized, ultra-sensitive laser system device used to perform the LiMAx test at the patient's bedside (Point-of-Care-Testing).
   • Mechanism: After the injection of 13C-methacetin, the CYP1A2 enzyme in the liver metabolizes it into paracetamol and 13CO2 (carbon dioxide). The 13CO2 is then transported through the blood to the lungs and exhaled. The FLIP® device continuously measures the ratio of the exhaled labeled carbon isotope (13CO2) to the naturally occurring carbon isotope (12CO2). This measurement, which is directly proportional to the patient's actual liver function capacity (the LiMAx value), is displayed in real-time.
   • Mobility and Use: The FLIP® device is designed to be mobile, making it suitable for a variety of clinical settings, including operating rooms, intensive care units (ICUs), emergency rooms, and outpatient stations.

Services and Clinical Applications

Humedics??? technology is applied across various clinical scenarios, offering a predictive and diagnostic tool that traditional liver function markers cannot match. The core service is to provide physicians with the data necessary to stratify patients, refine diagnoses, and personalize treatment plans.

1. Liver Surgery and Resection Planning:

   • Prediction of Postoperative Liver Failure (PHLF): The most critical application is providing a precise risk assessment for Post-Hepatectomy Liver Failure. The LiMAx test quantifies the functional capacity of the liver that will remain after resection, allowing surgeons to determine the safe limit for liver tissue removal, particularly in patients with pre-existing damage like cirrhosis, fibrosis, or chemotherapy-induced injury.
   • Enhanced Recovery Protocols: Implementing the LiMAx® protocol for enhanced recovery has been shown in clinical data to reduce the incidence of major complications, facilitate recovery, and lead to fewer days in intensive care and shorter overall hospitalization.

2. Hepatology and Disease Management:

   • Assessing and Grading Disease Severity: The test is utilized for non-invasive diagnosis and classification of chronic liver diseases. It provides a clear, quantitative stratification of disease severity in patients with conditions such as cirrhosis, alcoholic liver disease, viral hepatitis, and non-alcoholic fatty liver disease (NAFLD/NASH).
   • Alternative to Biopsy: The functional classification provided by the LiMAx value can often be more effective than conventional histological grading and, in many cases, can help avoid the need for an invasive liver biopsy for initial diagnosis and staging.
   • Monitoring Therapy Efficacy: Clinicians use the LiMAx value to monitor the progression of liver disorders or the efficacy of various medical and oncological treatments, including the evaluation of functional improvement after bariatric surgery or the effect of neoadjuvant chemotherapy.

3. Liver Transplantation:

   • Diagnosis and Monitoring: The LiMAx test is used for both pre- and post-transplant assessments to evaluate the health and functional status of the donor liver and monitor the recipient's graft function.

In essence, Humedics GmbH provides a cutting-edge diagnostic platform that shifts liver function assessment from indirect, retrospective blood measurements to a direct, real-time, functional breath test, fundamentally improving patient safety and surgical strategy in complex liver interventions.