KORU Medical Systems

KORU Medical Submits FDA 510(k) Application for FreedomEDGE Infusion System with Oncology Biologic PHESGO

- KORU Medical Systems has submitted a 510(k) premarket notification to the FDA seeking clearance for its FreedomEDGE infusion system to subcutaneously administer PHESGO, a co-formulated therapy for HER2+ breast cancer. - The submission represents a strategic expansion beyond current immunoglobulin indications into the broader oncology infusion center market, addressing unmet needs in nursing workflow and patient comfort. - A multicenter study across nine Danish hospitals demonstrated strong outcomes with the FreedomEDGE system, including high nurse and patient satisfaction rates and a 97% recommendation rate. - The Freedom Infusion System has over 15 years of market experience with 45,000+ patients and 2 million annual infusions across 30+ countries, achieving a 97% adherence rate.