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KORU Medical Systems, Inc. Receives FDA 510(k) Clearance for FREEDOM60® Infusion System With Hizentra® 50 ML Prefilled Syringes
MAHWAH, N.J.--(BUSINESS WIRE)-- KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on
About this update from Koru Medical Systems, Inc.
[{"type":"text","content":" MAHWAH, N.J.--(BUSINESS WIRE)--\nKORU Medical Systems, Inc. (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 subcutaneous infusion solutions that improve quality of life for patients, today announced that it received U.S. Food and Drug Administration (FDA) clearance for use of the FREEDOM60® Infusion System with Hizentra® 50 mL prefilled syringes (PFS).\n\n\n“Being the first and only FDA-cleared infusion system for use with prefilled syringes demonstrates KORU Medical’s continued commitment to enhance the patient experience for all patients self-administering subcutaneous immunoglobulin (SCIg) therapy in the home,” said Linda Tharby, KORU Medical’s President and CEO. “Prefilled syringes are proven to provide a significant improvement in ease of use for all patients, and in administering higher doses of immunoglobulin, including for PIDD and CIDP patients. We are now able to deliver PFS benefits to Hizentra® patients through our FREEDOM™ Infusion System portfolio - the FREEDOM60® Infusion System with 50 mL PFS and the FreedomEdge® with 20 mL PFS. We believe the unlocking of these PFS benefits through use with the FREEDOM™ Infusion System could lead to even greater opportunity to expand SCIg use in the home.”\n\n\nThe FREEDOM™ Infusion System is the first and only infusion system cleared for use with prefilled syringes and, given the majority of patients are prescribed doses of 50 mL or greater, this clearance for FREEDOM60® significantly expands the benefits of PFS use, especially for those diagnosed with conditions requiring significantly higher doses of immunoglobulin. When using prefilled syringes with the FREEDOM™ Infusion System, KORU Medical has demonstrated that patients can experience up to an 80% reduction in drug preparation tasks when compared to using vials.\n\n\nThe FDA approved the Hizentra® 50 mL prefilled syringe in April 2023, and CSL Behring has announced an early 2024 availability. Hizentra® is the most prescribed subcutaneous immunoglobulin and the first to be available in prefilled syringes.\n\n\nAbout KORU Medical Systems\n\n\nKORU Medical Systems develops, manufactures, and commercializes innovative and easy-to-use subcutaneous drug delivery systems that improve...