Results from a clinical multicenter trial with HBP-assay published in Critical Care Medicine

Results from a clinical multicenter trial with samples from Emergency
Departments in Sweden, USA and Canada collected during 2011-2014 have been
published online ahead of print by the scientific journal Critical Care Medicine
The study results show that the diagnostic method for assessing Heparin Binding
Protein (HBP) predicts severe sepsis with significantly higher accuracy than
other biomarkers available today. The study demonstrates that the HBP-assay has
the potential to become a significant tool in helping predicting severe sepsis
at emergency departments and infectious disease clinics. For open access to the
publication, please visit:
http://journals.lww.com/ccmjournal/Abstract/publishahead/Heparin_Binding_Protein
_ 
Measurement_Improves_the.97183.aspx

“The results from the IMPRESSED study are promising and Axis-Shield is
developing the HBP testing market globally and is working to attract major
global IVD (In Vitro Diagnostics) players as potential sublicenses. In order to
further strengthen the clinical validity of HBP-assay, Axis-Shield is currently
coordinating additional clinical trials with HBP-assay in the US, Europe, China,
South Korea and India. In addition, we are also developing alternative versions
of the HBP-assay for improved routine clinical applicability.” states Anil
Vasishta, Managing Director, Axis-Shield Diagnostics

”The multicenter trial indicates that the HBP-assay has the potential to become
a valuable tool for Emergency Departments and Infectious Disease clinics for
prediction of severe sepsis.. Hundreds of thousands of lives can potentially be
saved and costly intensive care may be cut through the prediction of severe
sepsis and early treatment”, states Göran Arvidson, CEO of Hansa Medical AB.

Background to the study
The HBP-assay is a novel diagnostic method developed and patented by Hansa
Medical to help predict severe sepsis in patients with infectious disease
symptoms.  Hundreds of thousands of patients die every year due to severe sepsis
as a complication to infections like urinary tract infection and pneumonia.
These infections can be effectively treated with antibiotics in order to prevent
progression to severe sepsis although early prediction of risk patients is
crucial for successful treatment. A seemingly stable infectious disease patient
can within hours develop severe sepsis as manifested through clinical symptoms
like organ failure and circulatory failure. Early prediction and treatment of
risk patients is key to prevent death from severe sepsis.

Study results
The prospective clinical multicenter trial (IMPRESSED-study) involved 759
patients admitted to Emergency Departments in Sweden and the US with infectious
disease symptoms. 674 patients were diagnosed with an infection, of whom 487 did
not have organ dysfunction at enrollment. Of these 487 patients, 141 (29%)
developed severe sepsis within 72 hours. 78% of these patients had elevated
levels plasma-HBP prior to developing severe sepsis. HBP clearly outperformed
those biomarkers available today for diagnosing or predicting severe sepsis
including Procalcitonin, White blood cell count (WBC), CRP, Lactate.
Procalcitonin was increased in 52.5% of the patients developing severe sepsis,
WBC in 57.4%, CRP in 59.3%, and Lactate in 28.1%. Samples from a Canadian
validation cohort of 104 patients confirmed the results of the Sweden/USA study.
The diagnostic accuracy for HBP in predicting severe sepsis in the Canadian
cohort was even higher than in the Sweden/US cohort. The sensitivity was 78% and
the specificity was 95% in predicting severe sepsis among infected patients in
the Canadian cohort.

Commercial development of HBP-assay
Hansa Medical and Axis-Shield Diagnostic Limited signed a collaborative
agreement in 2009 for the commercialization of the HBP-assay. Axis-Shield is
responsible for all clinical trials and further developments of the assay and
Hansa Medical carries certain rights to royalties from Axis-Shield derived from
sales of the HBP-assay as well as milestones payments and minimum royalties.

Need for better tools for prevention of severe sepsis
In the 2013 report “National Inpatient Hospital Costs: The Most Expensive
Conditions by Payer, 2011” the US Department of Health and Human Services
concludes that the most expensive condition treated in hospitals is sepsis,
accounting for $20.3 billion in annual costs for the U.S. healthcare system.
Sepsis represented 5.2 % of the national costs for all hospitalizations in 2011,
resulting in nearly 1.1 million discharges from U.S. hospitals. In a commentary
to the report, The Sepsis Alliance concludes that sepsis alone causes 258,000
deaths annually in the US.

The information in this press release is disclosed pursuant to the Securities
Markets Act or the Financial Instruments Trading Act. The information was
released for public disclosure on August 27, 2015 at 12.40 CET.
For further information, please contact:
Hansa Medical AB
Göran Arvidson, CEO
Mobile: 46 70-390 85 30
E-mail: goran.arvidson@hansamedical.com
www.hansamedical.com
About Hansa Medical AB
Hansa Medical is a biopharmaceutical company focused
on novel immunomodulatory enzymes. Lead project IdeS is an antibody-degrading
enzyme in clinical development, with potential use in transplantation and rare
autoimmune diseases. Other projects include HBP (a market introduced diagnostic
marker for severe sepsis) and EndoS (an antibody-modulating bacterial enzyme in
pre-clinical development). The company is based in Lund, Sweden. Hansa Medical's
share (HMED) is listed on Nasdaq First North in Stockholm with Remium Nordic AB
as Certified Adviser.