KORU Medical Systems has secured the 510(k) clearance from the US Food and Drug Administration (FDA) to use the FREEDOM60 Infusion System with Hizentra 50ml prefilled syringes (PFS).

The Nasdaq-listed firm is engaged in the development, production, and commercialisation of subcutaneous drug delivery devices.

The FREEDOM Infusion System is said to be the first and only infusion system authorised for use with prefilled syringes, considering that most patients are prescribed doses of 50ml or more.

According to KORU Medical Systems, the FDA clearance for FREEDOM60 significantly expands the benefits of using prefilled syringes, particularly for those diagnosed with conditions that need considerably higher doses of immunoglobulin.

FREEDOM60 is designed for subcutaneous infusion in various settings, such as the home, hospital, or ambulatory environments. It is said to have a highly precise constant pressure system, a travel pouch to promote patient independence, and operates without the need for batteries or electricity.

Besides, the infusion system is designed ergonomically which makes it easy to grasp and turn, said the company. The system can be filled from 1ml to 50ml and has a spring-loaded syringe holder that locks the syringe into the pump and maintains proper syringe orientation.

KORU Medical Systems president and 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 50ml PFS and the FreedomEdge with 20ml 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.”

KORU Medical Systems said that by utilising prefilled syringes with the FREEDOM Infusion System, patients can significantly ease their drug preparation tasks, with potential reductions of up to 80% compared to using vials.

The Hizentra 50ml prefilled syringe was authorised by the FDA in April 2023. CSL Behring, a biopharmaceutical firm focused on plasma-derived and recombinant therapeutic products, stated that the syringe will be available in early 2024.