Humedics Announces Appointment of Karsten Damgaard-Iversen as CEO
Reinforcement of senior management team to leverage growth phase of Humedics
Humedics has made significant progress over the last couple of years. Milestones included ISO certification of the LiMAx device, completion of a phase III clinical trial, submission of the marketing authorization application for the diagnostic agent necessary for the performance of the LiMAx test and the closing of a series C financing round.
The company is now moving into a new phase with the focus shifting to commercialization and a broader international remit. Therefore the time has come to reinforce the management of Humedics as the company is entering this new phase.
Karsten Damgaard-Iversen is an internationally accomplished business professional with over 30 years of global experience in the med-tech industry. He is a proven leader in operational and strategic management positions within large, medium and small healthcare technology companies. Karsten combines strong leadership skills and business acumen with in-depth technical and medical knowledge. He has served as a Board Director at Toshiba of Europe Ltd., Managing Director and Chief Group Executive at Toshiba Medical Systems Europe BV, Managing Director at Toshiba Medical Systems UK Ltd., CEO at SonoCine Inc., VP of International Operations at Fisher Imaging Corporation and Director of Sales & Marketing at Storz Medical AG. Karsten has also directly contributed to the invention and development of specific laser, ultrasound and x-ray based medical products. He holds an MBA from Emory University in Atlanta and a BSc in electronic engineering from Copenhagen University College. He is a Danish National and holds a U.S. Permanent Resident Card.
Karin Dorrepaal, Chair of the Board of Humedics GmbH, stated: “We are very delighted that Karsten joins the Humedics management team as CEO. With his longstanding business experience in the med-tech industry he is the ideal professional to drive forward the company development and the international commercialization of the LiMAx test.” Karsten Damgaard-Iversen commented: “It is a great pleasure for me to join Humedics during this exciting phase of the company's development. I look forward to working with the board, Erwin and all the members of our team to contribute to the future commercial and clinical success of 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.
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.
Erwin de Buijzer MD MBA
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