Press Releases

ABL SA group acquires Berlin based Medtech company Humedics

Berlin, December 2022 – ABL SA acquires the company Humedics Gmbh to extend the use of a robust, well-known, and CE-marked technology intended to be used for liver function measurement.  Financial terms are not disclosed.

Doctor Chalom Sayada, founder of the ABL SA and managing director of the Humedics declared: “We are proud to take over Humedics, and help promoting and expanding such a technology at the international level.”

 

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Reimbursement for the LiMAx® test - MEL Commission includes LiMAx® test in the MEL list 2022

Berlin, April 2022 – The MEL Commission of the Austrian Ministry of Social Affairs has included the LiMAx® test in the MEL list 2022. In the new service catalog, the new group "APG07.02 - Special diagnostics - Gastrointestinal tract 2" was created. Under APG07.02 A, the new service "HL510 - Liver function test with application of a C13-labeled substrate (LE=per session)" is listed - the LiMAx® test, the use of which can be coded with 458 points in an outpatient setting.

The listing was based to a large extent on the results of the Mini Health Technology Assessment conducted in 2019 by the Competence Center for Medical Devices (CCMD). At the time, the institute confirmed the clinical and economic advantage of the LiMAx® system for interventional use in liver surgery and highlighted the non-invasive breath test as particularly innovative.

With the help of the worldwide unique Liver Maximum Capacity Test (LiMAx®), which quantifies the maximum functional capacity of the liver, physicians can specifically examine the liver for possible diseases. The results can be used to better plan interventions on the liver and thus minimize risks for patients.

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Development of the new LiMAx® measurement device for determination of the liver function completed

Berlin, May 2021 – „Liver function measurements have never been so easy" says Andrew Moore, CEO of Humedics GmbH in Berlin. In fact, the technicians at Humedics GmbH have managed to take the LiMAx® measurement device to a new design dimension.

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German Institute for Health Economics and Health Care Research publishes a consensus paper on the possibilities and opportunities of the Humedics LiMAx liver function test in clinical application

Berlin, January 2020 – The consensus paper concludes that application of this novel breath test in the field of liver diagnostics improves patient care and generates economic advantages over existing methods.

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Independent Health Technology Assessment (HTA) confirms: The LiMAx Liver Function Test from Humedics GmbH has both clinical and health economic advantages

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”.

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Humedics LiMAx test: Inter-disciplinary expert panel defines indicators and recommendations for clinical application of the LiMAx liver function test

Berlin, August 18, 2019 – Since a few years, the LiMAx liver function test has increasingly been utilized as a standard liver diagnostic test for non-invasive real-time assessment of metabolic liver function in numerous German, Austrian, and Swiss clinics.

 

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British NICE Institute: Positive assessment of the Humedics LiMAx® test

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.

 

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Independent trial shows accurate staging of liver fibrosis with the LiMAx® test

Berlin, Germany, October 24, 2018 – Humedics GmbH, a specialist in real-time measurement of liver function capacity, announced results of a retrospective study that assessed the diagnostic accuracy of the LiMAx® test in patients with chronic liver disease. Results showed that the test can be a useful method to noninvasively determine hepatic disease severity.

 

 

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Safer liver resection: Perioperative assessment of liver function with the LiMAx® test shortens hospital stay and reduces complications after liver surgery

Berlin, Germany, July 25, 2018 – Humedics GmbH, a specialist in real-time measurement of liver function capacity, announced results of a multicenter randomized controlled clinical trial that clearly shows the benefits of the LiMAx® test in liver surgery. Perioperative use of the LiMAx® test shortens hospital stay by 3 days and significantly reduces the incidence of severe complications after liver surgery.

 

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The LiMAx® liver capacity test is now commercially available in Germany, Austria and the UK

Berlin, Germany, and Paris, France, April 12, 2018 – Humedics GmbH, a specialist in real-time measurement of individual liver function, today announced that the company has received Marketing Authorization for its diagnostic agent LiMAxetin® in two additional countries: Germany and Austria. LiMAxetin® is the diagnostic agent used to perform the LiMAx® test.

 

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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.

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Humedics Announces Appointment of Karsten Damgaard-Iversen as CEO

Reinforcement of senior management team to leverage growth phase of Humedics

Berlin, Germany, May 09, 2017 – The Board of Humedics GmbH is pleased to announce a reinforcement of the senior team of the company with Karsten Damgaard-Iversen (MBA, BScEE), who will take up the role of CEO as of June 1, 2017. Erwin de Buijzer will stay on as managing director (MD) with the title Chief Operations Officer (COO).

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LiMAx test enables better timing of liver surgery for colorectal liver metastatic patients after chemotherapy

Determination of liver function is crucial to assess patient’s eligibility for safe liver resection

Berlin, Germany, November 8, 2016 – Humedics GmbH, a specialist for real-time and mobile measurement of the individual liver function at the bedside of the patient, today announced that two studies show the potential of the LiMAx test to better assess the eligibility of colorectal cancer patients for liver metastases resection after chemotherapy. The LiMAx test was used to explore the effects of oxaliplatin-based chemotherapy on liver function.

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Humedics submits marketing authorization application for the diagnostic agent used with the LiMAx test

Application for marketing authorization of the diagnostic agent 13C-Methacetin Solution for infusion used with the LiMAx test

Berlin, Germany, May 12, 2016 – Humedics GmbH, a specialist for real-time and mobile measurement of the individual liver function at the bedside of the patient, today announced that the company has submitted the marketing authorization application for the diagnostic agent necessary for the performance of the LiMAx test. The dossier was submitted in Germany, UK and Austria.

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Use of LiMAx test leads to reduction in post-hepatectomy liver failure and related mortality

Retrospective analysis of 1170 patients shows improved outcomes of partial liver resections after the determination of the patient’s individual operative risk with the LiMAx test.

Berlin, Germany, January 07, 2016 – Humedics GmbH, a specialist for real-time and mobile measurement of the individual liver function at the bedside of the patient, today announced results of a retrospective study investigating the impact of the LiMAx test on clinical patient outcome after hepatectomy. Study results showed that the use of the LiMAx test led to reductions in post-operative liver failure and to a decrease of liver failure related mortality.

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LiMAx test shows reversibility of fatty liver disease after obesity surgery

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

Berlin, Germany, September 1, 2015 – Humedics GmbH, a specialist for real-time and mobile measurement of the individual liver function at the bedside of the patient, today announced results of a clinical study performed at the RWTH Aachen University Hospital. The aim of the study was to assess alterations in liver function capacity with the LiMAx test after bariatric surgery of obese patients. Study results demonstrated that fatty liver disease is reversible after weight reduction and that the LiMAx test is a reliable tool to measure functional liver recovery after obesity surgery.

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Humedics receives ISO 13485 certification

Milestone for market entry of LiMAx test for liver function diagnostics

Berlin, Germany, August 10, 2015 – Humedics GmbH, a specialist for real-time and mobile measurement of the individual liver function at the bedside of the patient, today announced that the company has been certified according to DIN EN ISO 13485. The Quality Management System of the company covers the entire spectrum of processes from design and development, via manufacturing to distribution of its FLIP devices for liver function analysis and corresponding breathing masks. With this certification an important pre-condition for the European marketing of the LiMAx test has been achieved.

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BioMedInvest-II LP joins Humedics Series C financing and increases financing round to 7 million Euro

Berlin, Germany, December 17, 2014 – Humedics GmbH, a specialist for real-time and mobile measurement of the individual liver function at the bedside of the patient, today announced that BioMedInvest-II LP complementary joins the Series C financing round now totaling more than 7 million Euro. Humedics’ business model, products and company development has attracted another international investor.

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Humedics receives Innovation Award Berlin Brandenburg

Award for LiMAx breath test for liver diagnostics

Berlin, Germany, December 6, 2014 – Humedics GmbH, a specialist for real-time and mobile measurement of the individual liver function at the bedside of the patient, today announced that the company was awarded with the Innovation Award Berlin Brandenburg 2014. The prize was awarded for the development of the LiMAx test. This breath test allows for the determination of the individual liver function of patients in real time and represents a revolution in functional liver diagnostics.

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Improved diagnosis of sepsis-related hepatic dysfunction with the LiMAx test

Prospective study showed superior sensitivity and specificity of the LiMAx test compared to traditional tests and its value as predictor of survival

Berlin, Germany, January 23, 2014 – Humedics GmbH, a specialist for real-time and mobile measurement of the individual liver function at the bedside of the patient, today announced the publication of results from a prospective clinical study evaluating the LiMAx test during severe sepsis in comparison with biochemical and indocyanine green tests. Study results demonstrated that the LiMAx test provide an adequate tool to determine early liver dysfunction in sepsis and was found to be a good predictor of survival in septic patients.

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Humedics co‐founder Martin Stockmann awarded with Von‐ Langenbeck Prize for the development of the LiMAx test

Award ceremony at the annual conference of the German Society of Surgery

Berlin, Germany, June 10, 2013 – Humedics GmbH, a specialist for real‐time and mobile measurement of the individual liver function at the bedside of the patient, today announced that PD Dr. Martin Stockmann, co‐founder of Humedics and advisor of the management, was awarded with the highest honor of surgery in Germany, the Von‐Langenbeck Prize of the German Society of Surgery (Deutsche Gesellschaft für Chirurgie).

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Humedics starts LiMAx phase III trial on liver function analysis for severe liver surgery

First patients being included directly after study initiation in Berlin and Jena

Berlin, Germany, February 28, 2013 – Humedics GmbH, a specialist for real-time and mobile measurement of the individual liver function at the bedside of the patient, today announced the start of a clinical phase III trial. The main goal of this study is the early identification of low-risk patients after partial liver resection by the LiMAx test and improvements in patient management based on test results. After the initiation of first study centers in January, first patients already have been enrolled in Berlin and Jena.

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Humedics receives patent on method for quantitative liver function analysis based on a breath test

Patent is a milestone for further commercialization of the LiMAx test

Berlin, Germany, December 5, 2012 ‐ Humedics GmbH, a specialist for real‐time and mobile measurement of the individual liver function at the bedside of the patient, today announced that another key patent protecting Humedics’ proprietary technology has been granted by Australian authorities.

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Humedics appoints Erwin de Buijzer as managing director for marketing and sales

Berlin, Germany, May 4, 2012 - Humedics GmbH, a specialist for real-time and mobile measurement of the individual liver function at the bedside of the patient, today announced that Erwin de Buijzer MD MBA has joined Humedics as managing director to support the further development and strategic positioning of the company.

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Humedics successfully closed its first VC-financing round with Charité Biomedical Fund, VC Fonds Technologie , KfW, HTGF and Ventegis Capital AG

Berlin, Germany, October 10th, 2011 - Humedics GmbH, a specialist for rapid and mobile measurement of the individual liver function at the bedside of the patient, today announced the closing of its first equity financing round. The Charité Biomedical Fund (CBF) managed by Peppermint VenturePartners led this round which included VC Fonds Technologie managed by IBB- Beteiligungsgesellschaft, the ERP Startfonds of the KfW, Ventegis and current investor High-Tech Gründerfonds. The funding enables Humedics to complete the final development and early commercialization of its proprietary and CE-marked diagnostic system to determine the liver function of a patient in real time.

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