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Clinical research results with HMD-301 published in Clinical Infectious Diseases

28 Sep 2009, 08:00
Regulatory information
The scientific journal Clinical Infectious Diseases (DOI: 10.1086/605563) has published clinical research results showing that elevated levels of the biomarker HBP, Heparin-Binding Protein, is a prominent tool for prognosis of severe sepsis in infectious disease patients. Early identification of patients at high risk of developing severe sepsis and septic chock makes it possible for the physician to initiate intravenous fluid replacement and proper broad-spectrum antibiotic treatment well in advance to the onset of life threatening clinical symptoms.

The clinical study was carried out at the Infectious Disease Clinic at Lund University Hospital including 233 patients with fever and suspected or proven infection. Of the 233 patients, 70 patients developed severe sepsis. The study shows that quantification of HBP in blood is a better method than any other available method for identification of high risk patients within 12 hours prior to the onset of devastating clinical symptoms.Severe sepsis is a life threatening complication to a local infection with high mortality. In sepsis, bacteria from a local infection, often pneumonia or urinary tract infections, reaches the blood stream and elicits a systemic inflammatory response that puts the patient in life threatening danger. The consequence of this inflammatory response is ultimately organ failure. Severe sepsis is per definition sepsis plus organ failure.Severe sepsis is an increasing problem primarily at Intensive Care Units and approximately 8 million patients are admitted to ICUs annually in USA and Western Europe. Also, patients with infectious diseases entering the Emergency Departments risk developing severe sepsis. Treatment and monitoring of sepsis patients puts significant burden on the health care providers and in the EU, the cost of intensive care treatment of sepsis patients is estimated to 7.6 billion USD. Severe sepsis is a severe condition with high mortality. In the US more than 200.000 patients decease from sepsis. In order to increase the chances of for sepsis patients to survive, it is necessary to identify high risk patients early in order to initiate correct treatment or change present treatment. HMD-301 is Hansa Medicals patented method for quantification of HBP under co-development with British diagnostic company Axis-Shield plc. In June 2009, Hansa Medical and Axis-Shield entered an exclusive and worldwide collaboration agreement for development and commercialization of HMD-301. Together, the parties will optimize the diagnostic method and then initiate further clinical validation during 2010. It is anticipated that the diagnostic method will enter the market in late 2011. The market is estimated to 3 million analyses per year and Hansa Medical will receive royalties from Axis-Shield from net sales of HBP-assays.For more information, please contact:Hansa Medical ABEmanuel Björne, CEOMobile: +46 707 175477E-mail: