Hansa Medical AB provided an update following the Company's regulatory interactions with the European Medical Agency (EMA) and the U.S. Food and Drug Administration (FDA) for imlifidase in kidney transplantation. The U.S. Kidney Allocation System was updated in 2014 in order to increase equity in allocation, reduce kidney discard rates and reduce organ/recipient longevity mismatches. While the KAS has improved the possibility for highly sensitized patients to receive a kidney transplant, thousands of highly sensitized patients remain unable to be successfully matched. In September 2018, Hansa successfully completed two Phase 2 clinical studies evaluating imlifidase for kidney transplantation in highly sensitized patients, with imlifidase enabling transplantation in all 35 patients. Imlifidase met all primary and secondary endpoints in each study. Imlifidase has received Fast Track designation from the FDA and has been selected for Priority Medicines (PRIME) by the EMA. Imlifidase has received Orphan Drug Designation from the EMA and FDA.