KORU Medical Systems develops, manufactures, and commercializes innovative and easy-to-use subcutaneous drug delivery systems that improve quality of life for patients around the world
KORU Medical Systems seeks FDA approval for Freedom60 Infusion System. (Credit: Ian Talmacs on Unsplash)
KORU 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 has submitted a 510(k) premarket notification submission to the U.S. Food and Drug Administration for the use of its FREEDOM60® Infusion System with Hizentra® 50 mL prefilled syringes.
“This submission is another milestone in KORU Medical’s mission to make subcutaneous therapy radically simpler and easier for patients. Through this application for the use of the Freedom60 Infusion System with Hizentra 50 mL prefilled syringes and our earlier prefilled syringe clearance, we will be able to deliver benefits to all patients who are self-administering subcutaneous immunoglobulin treatment in the home,” said Linda Tharby, KORU Medical’s President and CEO. “Our studies show up to an 80% reduction in drug preparation tasks for patients using prefilled syringes with the FREEDOM™ Infusion System as compared to vials. With market data showing significant uptake in prefilled syringe market growth, this 510(k) submission is another innovation milestone for KORU Medical that will further enhance the patient experience and potentially be an additional growth driver for home subcutaneous therapy.”
The FDA approved the 50 mL Hizentra prefilled syringe in April 2023. Hizentra is the most prescribed subcutaneous immunoglobulin and the first to be available in prefilled syringes.
Source: Company Press Release