Hansa Medical initiates pivotal multicenter study in the US with IdeS for treatment of refractory highly sensitized kidney patients

Hansa Medical AB (publ) today announced that the company sponsored pivotal
multicenter study in the US with IdeS in refractory highly sensitized patients
is open for recruitment.
The single arm Phase II study will include approximately 20 highly sensitized
patients awaiting kidney transplantation, who are refractory to currently
available desensitization strategies. The patients in this new study have either
failed on previous attempts of desensitization or the currently available
methods are considered insufficiently effective.

The study is entitled "A Phase II Study to Evaluate the Efficacy of IdeS (IgG
endopeptidase) to Desensitize Transplant Patients with a Positive Crossmatch
Test" with the short name Highdes. The primary objective of the study is to
assess the efficacy of IdeS in creating a negative crossmatch test. The trial
will also evaluate safety, kidney function and immunogenicity during the 6-month
follow-up period. The aim is to complete recruitment of approximately 20
patients over a 12-month period. The recruitment of patients has been initiated
at Cedars-Sinai Medical Center in Los Angeles.

"The initial evaluation of the results in the ongoing Phase II studies with IdeS
in Sweden and the U.S. verifies our strong belief in the potential of IdeS as a
safe, fast and highly effective desensitization treatment. We are excited that
we have initiated a fully Hansa Medical sponsored US study with the ambition to
recruit patients in immediate need of desensitization”, commented Göran
Arvidson, President and CEO of Hansa Medical AB.

Study results could potentially form the basis for filing a Biologics License
Application, i.e. an application to the US Food and Drug Administration (FDA)
for authorization to commercialize IdeS in the US.

Hansa Medical is currently evaluating the possibility to add European sites to
this now initiated study in order to support the regulatory process at the
European Medicines Agency, EMA, for marketing authorization of IdeS in the
European market.

This study was cleared by the FDA in April 2016. More information about this
trial in refractory highly sensitized patients is available at
www.clinicaltrials.gov under the identifier NCT02790437.

The information in this press release is disclosed pursuant to the EU Market
Abuse Regulation. The information was released for public disclosure through the
agency of the contact person below on July 19, 2016 at 08.30 CET
For further information, please contact:
Hansa Medical AB
Göran Arvidson, CEO
Mobile: 46 70-633 30 42
E-mail: goran.arvidson@hansamedical.com
www.hansamedical.com
About refractory highly sensitized patients
Approximately one third of the kidney patients that require dialysis are
sensitized to human leukocyte antigens (HLA). The presence of antibodies that
react with a potential donor organ is a significant barrier to transplantation
due to the risk of acute antibody mediated rejection. Sensitized patients in
general have an increased waiting time for transplantation. Depending on level
of HLA-immunization, some sensitized patients can be transplanted with treatment
procedures using plasmapheresis or intravenous gamma globulin at some
specialized clinics. Refractory highly sensitized patients are highly sensitized
patients that have either failed on previous attempts of desensitization or in
whom effective desensitization using currently available methods is highly
unlikely.

About IdeS
IdeS, a unique molecule with a novel mechanism, is an enzyme that specifically
cleaves human IgG antibodies. During 2013, a Phase I clinical trial including 29
healthy subjects was conducted, demonstrating IdeS as efficacious and well
tolerated with a favorable safety profile. During 2014, a Phase II study in 8
sensitized patients awaiting kidney transplantation was conducted. Data from the
study show that IdeS is effective in reducing anti-HLA antibody levels in highly
sensitized patients to levels acceptable for transplantation. The efficacy and
safety of IdeS in transplantation are currently investigated in two on-going
clinical trials in sensitized kidney patients in Sweden and in the U.S. In
addition to transplantation, IdeS has potential applications in a variety of
rare autoimmune diseases. IdeS is protected by several patents and results of
studies with IdeS have been published in a number of peer reviewed scientific
journals.

About Hansa Medical AB
Hansa Medical is a biopharmaceutical company focusing on novel immunomodulatory
enzymes. The lead project IdeS is an antibody-degrading enzyme in clinical
development, with potential use in transplantation and rare autoimmune diseases.
Additional projects focus on development of new antibody modulating enzymes, as
well as HBP, a diagnostic biomarker for prediction of severe sepsis at emergency
departments that is already introduced on the market. The company is based in
Lund, Sweden. Hansa Medical’s share (ticker: HMED) is listed on Nasdaq
Stockholm.