Koru Medical has submitted a 510(k) premarket notification (PMA) to the US Food and Drug Administration (FDA) for its FREEDOM60 syringe infusion system with Hizentra prefilled syringes.
The infusion device FREEDOM60, does not require electricity or batteries and is indicated for use in either home, hospital or ambulatory settings. It is designed to deliver the approved biologics Cutaquig, Cuvitru, Gammagard Liquid, Xembify, and Hizentra. These drugs are used to manage immunodeficiency.
Hizentra, manufactured by CSL Behring, was approved as 50 mL prefilled syringes by the FDA in April 2023.
Syringe controls have become a particular hotbed of innovation in the medical device industry. Their ability to minimise error and provide reliable fluid delivery has meant their use has become popular for treatments that need multiple, repeat doses.
The US company, which is a rebrand of Repro Med Systems from 2019, is listed on NASDAQ. Shares in the company remained stable at market open (10 July) following the announcement.
“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,” said Linda Tharby, KORU Medical’s President and CEO.
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Also in Koru Medical’s device portfolio are its flow rate tubing devices and HIgH-Flo subcutaneous safety needle sets.