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Hansa Medical and Axis-Shield begin multi-centre clinical study of HBP assay for diagnosis of severe sepsis

Regulatory information
Hansa Medical AB (NASDAQ OMX First North:HMED) today announced the start of a major clinical trial of the investigational HBP assay for diagnosis of patients with severe sepsis, in conjunction with development/commercial partner Axis-Shield Diagnostics Limited (LSE:ASD, OSE:ASD) of Dundee, Scotland.

In June 2009, Axis-Shield and Hansa Medical entered a development and licensing agreement regarding HMD-301, Hansa Medicals´ patented method for in vitro diagnostics (IVD) of severe sepsis, based on plasma quantification of the protein HBP. Since the initiation of the development agreement, Axis-Shield has successfully developed a version of the HBP assay which now will be tested in a major clinical trial programme at emergency departments in Sweden and USA. An initial version of the HBP-assay will be launched in the beginning of 2012 upon successful completion of the clinical trial.

“Axis-Shield has developed our original prototype to an assay that is suitable for a pivotal clinical trial and consecutive launch. This optimized assay will now be used in the clinical trial. Initiating this extensive multicentre study has been an important intermediate goal and the enrollment of the first patient in this study is a milestone for this development program.” says Emanuel Björne, CEO at Hansa Medical AB  

Severe sepsis is a life-threatening complication to infection, characterized by organ failure and hypotension and it requires immediate medical attention and treatment. In sepsis, bacteria from a local infection, often pneumonia or urinary tract infections, enter the blood stream and cause a systemic inflammatory state. Severe sepsis is often lethal and in the US, more than 200,000 people die from severe sepsis every year However, for every hour that severe sepsis onset is anticipated with proper treatment, the survival rate increases significantly. The HBP assay under development has the potential to shorten the delay of treatment and save patients from developing severe sepsis.

Hansa Medical is entitled to milestone payments and royalties from Axis-Shield on sales of HBP assays once the test is launched.

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