Patient recruitment completed in Phase II clinical study with IdeS in kidney transplantation

Hansa Medical AB (publ) today announced that the last patient, in the ongoing
Phase II study at Uppsala University Hospital and Karolinska University Hospital
in Huddinge, has been treated with IdeS and subsequently transplanted.
Highlights about the Phase II Clinical Study:

  · Recruitment completed with 10 patients included.
  · All 10 patients have been transplanted following treatment with IdeS.
  · The Phase II clinical study is a single arm, open label study.
  · The study primarily evaluates safety and tolerability of the candidate drug
IdeS in sensitized kidney transplantation patients.
  · The study is also aimed at identifying an IdeS dose that results in anti-HLA
antibody levels acceptable for transplantation within 24 hours from dosing.

“We are excited to have all of the included patients of the Phase II study in
Sweden transplanted following treatment with IdeS and we are looking forward to
see the results after follow-up,” stated Göran Arvidson, President and CEO of
Hansa Medical AB (publ).

The patients are followed for six months after transplantation for safety and
kidney function.  Results from the study are expected in Q4 2016.

Additionally, a US phase II study initiated by Professor Stanley Jordan is
ongoing at Cedars Sinai Medical Center, Los Angeles. The US study is
investigating IdeS in combination with high dose intravenous gamma globulin and
anti-CD20 treatment. This study will include 10-20 patients and the patients
will be followed for six months after transplantation.

In the beginning of April 2016, the US Food and Drug Administration (FDA)
cleared Hansa Medicals IND application for IdeS in kidney transplantation.  This
enables Hansa Medical to start the next clinical study in the US scheduled to
begin soon with the aim to complete recruitment in H1 2017.

The information in this press release is disclosed pursuant to the Swedish
Securities Markets Act and/or the Swedish Financial Instruments Trading Act. The
information was released for public disclosure on April 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 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.