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KORU Medical Announces FDA Clearance for Delivery of Hizentra® Prefilled Syringes
KORU Medical’s Freedom Edge becomes the only device specifically cleared for delivery of subcutaneous Ig prefilled syringes CHESTER, N.Y.--(BUSINESS WIRE)--
About this update from Koru Medical Systems, Inc.
[{"type":"text","content":"\nKORU Medical’s Freedom Edge becomes the only device specifically cleared for delivery of subcutaneous Ig prefilled syringes\n\n CHESTER, N.Y.--(BUSINESS WIRE)--\nRepro Med Systems, Inc. dba KORU Medical Systems (NASDAQ: KRMD) (\"KORU Medical\" or the \"Company\"), 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.\n\n“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.\n\n“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.”\n\nAbout KORU Medical Systems\n\nKORU Medical Systems develops, manufactures, and commercializes innovative and easy-to-use specialty infusion solutions that improve quality of life for patients around the world. The FREEDOM Syringe Infusion System currently includes the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HIgH-Flo Subcutaneous Safety Needle Sets™. These devices are used for infusions administered in the home and alternate care settings. For more information, please visit www...