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Presentation at ASN Kidney Week 2018 Highlights Stable Renal Function at up to 24 Months Following Transplantation Enabled by Imlifidase

Regulatory information
Lund, Sweden, October 26, 2018- Hansa Medical AB (NASDAQ Stockholm:HMED), the leading biopharma company focusing on inhibition of immunoglobulin G (IgG)-mediated immunopathologies, today announced that data on imlifidase (previously known as IdeS), the Company’s IgG cleaving enzyme, was highlighted in a presentation at the American Society of Nephrology (ASN) Kidney Week 2018, being held October 23-28, 2018 in San Diego, USA.

The presentation, titled IdeS in Highly Sensitized Patients, was presented at ASN Kidney Week 2018 by Stanley C. Jordan, M.D., Director of Kidney Transplantation and Transplant Immunology at the Kidney and Pancreas Transplant Center at Cedars-Sinai Medical Center, Los Angeles, USA on Thursday, October 25, 2018. The presentation described results from the U.S. investigator initiated Phase 2 study demonstrating continued stable renal function over time in long term follow up, up to 24 months after transplantation enabled by imlifidase.

The trial was a single-arm, open-label study designed to assess the safety and efficacy of imlifidase in deceased donor kidney transplantation. Dr. Jordan was the lead investigator in this U.S. investigator-initiated study, which enrolled 17 patients with donor specific antibodies at the Kidney and Pancreas Transplant Center at Cedars-Sinai Medical Center, Los Angeles, USA. As previously disclosed, imlifidase enabled kidney transplantation in all 17 patients. Patients reaching 6, 12 and 24 months post transplant to date showed estimated glomerular filtration rate (eGFR) comparable to non-sensitized patients.

“In long term follow up, imlifidase continues to demonstrate a compelling safety and efficacy profile for patients with previous immunological barriers to kidney transplantation, with patients showing stable renal function at up to 24 months.” said Dr. Jordan. “In the absence of transplantation, patients are confronted with long-term dialysis, which is associated with high morbidity and mortality. Imlifidase has the potential to shift the paradigm for these patients and allow access to a life-saving procedure.”

“These data presented at ASN provide further evidence of imlifidase’s ability to enable kidney transplantation through the rapid and effective inhibition of IgG,” said Soren Tulstrup, President and Chief Executive Officer of Hansa Medical AB.

This is information that Hansa Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below at 08:00am CEST on October 26, 2018.