KORU Medical announces FDA clearance for delivery of Hizentra

Repro Med Systems, Inc. dba KORU Medical Systems, a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use specialty infusion solutions that improve quality of life for patients, today announced 510k clearance for use of the KORU Medical FreedomEdge® infusion pump to deliver Hizentra® [immune globulin subcutaneous (human) 20% liquid] 20 mL prefilled syringes. Hizentra® is the most prescribed subcutaneous Ig product and the first to be available in a prefilled syringe format.

“Our patients who use prefilled syringes tell us that their infusions are significantly easier. With the FreedomEdge® they simply place syringes in the pump and infuse, avoiding the drug transfer process that many patients find difficult and stressful. We’re excited to see KORU Medical’s commitment to improve patient satisfaction by getting this important FDA clearance,” said Amy Ehlers, Senior Director of Clinical Programs at NuFactor, a leading specialty infusion pharmacy.

“As the leader in home delivery of subcutaneous immunoglobulin therapy, we are thrilled to add Hizentra® prefilled syringes to our label,” said Linda Tharby, KORU Medical’s Chief Executive Officer. “KORU Medical is committed to improving the patient home infusion experience. The KORU Medical FreedomEdge is the only infusion pump specifically indicated for delivery of a subcutaneous immunoglobulin prefilled syringe product. We will continue to innovate to improve patient comfort and support the innovations developed by our biopharmaceutical relationships such as CSL Behring.” Business Wire