FDA Clears KORU Medical’s FREEDOM60 Infusion System With Prefilled Syringes

KORU Medical Systems Inc. has received U.S. Food and Drug Administration (FDA) clearance for use of the FREEDOM60 Infusion System with Hizentra 50 mL prefilled syringes (PFS).
 
“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,” KORU Medical President/CEO Linda Tharby said. “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.”
 
The 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, according to the company. 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.
 
The 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.
 
KORU Medical Systems develops, manufactures, and commercializes subcutaneous drug delivery systems. The FREEDOM Infusion System currently includes the FREEDOM60 and FreedomEdge Syringe Infusion Drivers, Precision Flow Rate Tubing, and HIgH-Flo Subcutaneous Safety Needle Sets. The FREEDOM Infusion System is used for infusions administered in the home and alternate care settings. 
 
Hizentra is a registered trademark of CSL Behring AG, is manufactured by CSL Behring AG, and distributed by CSL Behring LLC.