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Hansa Medical AB announces cooperation with Cedars-Sinai Medical Center’s Comprehensive Transplant Center and US transplantation expert Stanley Jordan

Regulatory information
Hansa Medical AB has initiated a cooperation with Cedars-Sinai Medical Center’s Comprehensive Transplant Center and US transplantation expert Stanley Jordan. Dr Jordan will be a scientific and medical advisor and assist the company in the development of IdeS in transplantation. He will also be the chairman of the US advisory board for IdeS in transplantation. An IND for IdeS has been submitted and a Letter to Proceed has been received from the FDA.

Dr Stanley Jordan is Director of Kidney Transplantation and Transplant Immunology, Kidney and Pancreas Transplant Center and Director of Division of Pediatric and Adult Nephrology at Cedars Sinai Medical Center, Los Angeles, USA. Dr Jordan’s focus is on immunology and transplantation and his work has focused primarily on improving transplantation for highly HLA sensitized patients.

Dr Jordan has performed extensive research funded by dozens of research grants and awards, including National Institutes of Health controlled clinical trials in kidney transplantation. Dr Jordan has written hundreds of articles in scientific journals and authored about two dozens book chapters. He has been appointed by the National Institutes of Health's National Institute of Allergy and Infectious Diseases to advise Congress on the safety and efficacy of intravenous gammaglobulin products. He also assisted NIH/NIAID to develop research priorities for kidney transplantation for the 21st century. Dr. Jordan is a member of national and international professional societies and has served on the editorial boards of numerous professional journals.

Dr Jordan graduated from the University of North Carolina, Chapel Hill and completed pediatric internship and residency at the University of California, Los Angeles. He completed three fellowships in pediatric nephrology at UCLA, in experimental pathology in the Department of Immunology at Scripps Clinic and Research Foundation, and in dialysis and transplantation at Children's Hospital of Los Angeles. He is board certified in pediatrics, pediatric nephrology and diagnostic laboratory immunology.

About IdeS
IdeS, a unique molecule with a novel mechanism, is a bacterial enzyme that cleaves human IgG antibodies. IdeS degrades all IgG specifically, swiftly and efficiently. IdeS has been tested for safety and efficacy in numerous in vitro and in vivo models. During 2013, a phase I clinical trial on 29 healthy subjects was conducted, demonstrating IdeS as efficacious and well tolerated with a favorable safety profile. During 2014, a phase II clinical trial in sensitized patients awaiting kidney transplantation was initiated, to be reported during 2015. In addition to transplantation, IdeS has potential indications within a variety of rare autoimmune diseases including anti-GBM disease. IdeS is protected by several patents and has been published in numerous peer review journals.

About sensitized patients
Approximately one third of the several hundred thousands of patients waiting for organ transplantation are sensitized to human leukocyte antigen (HLA). These patients have developed antibodies to HLA primarily as the result of allo-immunisation from previous transplantations, blood transfusions or pregnancies. Antibodies to HLA hamper the identification of a suitable donor and HLA-antibodies that react to a potential donor (i.e. a positive cross-match test) are a direct contraindication to transplantation because of the risk of antibody-mediated rejection. Consequently, sensitized patients have extended waiting times on dialysis and risk never being transplanted, despite highest priority. End-stage renal disease patients can be maintained on dialysis However, kidney transplantation is the treatment-of-choice since the patient’s life expectancy and quality of life is dramatically increased and there are substantial cost-savings associated with transplantation compared to dialysis.

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 February 5, 2015 at 08.30.