KORU Medical Submits FDA 510(k) For FreedomEDGE System To Deliver PHESGO In HER2+ Breast Cancer

KORU Medical Systems, Inc. (NASDAQ:KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical's FreedomEDGE® infusion system to subcutaneously administer PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer.1

The submission represents a key milestone in KORU Medical's strategy to expand the use of the FreedomEDGE® system beyond its current immunoglobulin (Ig) indications and into the broader oncology infusion center market. The increasing shift from intravenous (IV) to subcutaneous (SC) drug delivery for cancer therapies allows for faster drug administration, reduced patient chair time, and aligns with a movement towards a more efficient care model.2

However, despite these advances, infusion centers continue to face unmet needs related to nursing satisfaction with drug administration, including workflow complexity associated with treatment protocol, time constraints for set up and physical discomfort for both patients and nurses during infusions. 3 The FreedomEDGE® system is designed to address these challenges by enabling consistent, controlled large-volume SC delivery while supporting more streamlined clinical workflows.