The submission covers the use of the Freedom60 infusion system with the Hizentra 50 mL prefilled syringe.
In January, Koru inked a development agreement with a manufacturer of subcutaneous immunoglobulin therapy (SCIg). The deal sought to garner regulatory clearance for Freedom Infusion System with an SCIg prefilled syringe. Mahwah, New Jersey-based Koru received FDA approval for the 50 mL Hizentra prefilled syringe in April 2023.
According to the company, Hizentra is the most prescribed subcutaneous immunoglobulin. It’s also the first to be made available in prefilled syringes, Koru said in a news release.
Koru President and CEO Linda Tharby called the submission “another milestone” in Koru’s mission. The company aims to make subcutaneous therapy “radically simpler and easier for patients.” Clearance for the Freedom60 infusion system with the Hizentra prefilled syringe could bring benefits to self-administered subcutaneous immunoglobulin treatment in the home.
“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,” Tharby said. “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.”
Koru develops, manufactures and commercializes subcutaneous drug delivery systems. Its Freedom platform currently includes the Freedom60 and FreedomEdge syringe infusion drivers, Precision Flow Rate Tubing and HIgH-Flo Subcutaneous Safety Needle Sets.
Uses for Koru’s devices include at-home infusions and alternate care settings.
