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.

“The submission of our 510(k) for clearance of the FreedomEDGE® with a subcutaneous oncology biologic is a pivotal milestone for KORU. It sets the foundation for future growth and underscores our strategy to expand KORU’s leadership into the growing drug delivery device market for oncology therapies,” said Linda Tharby, KORU Medical’s President and CEO. “This regulatory filing and expected clearance represents an exciting opportunity to enter a new point of care where we believe our technology can address a meaningful unmet need by improving the administration experience for nurses while supporting greater efficiency in oncology infusion centers.”

KORU Medical anticipates a market entry upon FDA 510(k) clearance.

KORU Medical’s Freedom Infusion System enables, simplifies, and enhances the delivery of large-volume subcutaneous drugs. Supporting drug products with various requirements for viscosity, flow rate, and delivered drug volume, the Freedom System is market proven with:

• 15+ years on the market
• 45,000+ patients and over 2M infusions annually⁴
• 97% adherence rate and 8 on-label Subcutaneous drugs across 30+ countries⁵