KORU Medical Systems Receives FDA 510(k) Clearance for Delivery of RYSTIGGO® (rozanolixizumab-noli), Expanding Label for FreedomEDGE® Infusion System

MAHWAH, N.J.--(BUSINESS WIRE)--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 that the Company received U.S. Food and Drug Administration (FDA) clearance for use of the KORU Medical FreedomEDGE® infusion system to deliver RYSTIGGO® (rozanolixizumab-noli), a therapy commercialized globally by UCB, Brussels, Belgium (www.ucb.com).

The clearance for the FreedomEDGE® label includes indicated administration by a healthcare professional, increasing flexibility and access for patients living with generalized myasthenia (gMG). RYSTIGGO® is a novel biologic approved to treat adults with generalized myasthenia gravis (gMG), a rare, chronic autoimmune disorder that affects communication between nerves and muscles.¹ RYSTIGGO® is administered as a weekly infusion of 3mL-6mL of drug over 15-30 minutes for 6 weeks, with subsequent treatment cycles based on clinical evaluation.¹

“With this new FDA clearance, we are proud to further our leadership in the rapidly growing large-volume subcutaneous infusion market, with our ninth subcutaneous drug clearance," said Linda Tharby, KORU Medical’s President and CEO. "Expanding from home administration into clinic-based care highlights the versatility of our Freedom Infusion System to deliver life-changing therapies wherever patients are treated. This clearance aligns with our strategy to extend the Freedom platform to more drug therapies, more settings, and more patients.”

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 from 5mL-50mL+, the Freedom System is market proven with:

• 15+ years of patient self-administration in the home
• 45,000+ patients and over 2M infusions annually²
• 97% adherence rate³ and 9 on-label subcutaneous drugs distributed across 30+ countries

About KORU Medical Systems

KORU Medical Systems develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The Freedom Syringe Infusion System (the “Freedom System”) currently includes the Freedom60® and FreedomEDGE® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HigH-Flo Subcutaneous Safety Needle Sets™. The Freedom System, which received its first FDA clearance in 1994, is used for self-administration in the home by the patient and/or delivery in an ambulatory infusion center by a healthcare professional. Through its Pharma Service and Clinical Trials business, KORU Medical provides products for use by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, is capable of customizing the Freedom System for clinical and commercial use across multiple drug categories. For more information, please visit www.korumedical.com.

Trademark Statement

RYSTIGGO® is a registered trademark of the UCB Group of Companies.

References

1. U.S. Prescribing Information: UCB, Inc. RYSTIGGO® (rozanolixizumab-noli) injection, for subcutaneous use – Prescribing Information. UCB, Inc.; Revised June 2023. Available at: https://www.ucb-usa.com/RYSTIGGO-prescribing-information.pdf. Accessed July 28, 2025.
2. KORU Medical Estimates and Third-Party Data on File
3. Rutland B, Bosshard J, Southworth C. Enhancing Drug Adherence and Patient Outcomes: The Role of SCIG Pump Selection in Subcutaneous Immunoglobulin Therapy for Primary Immunodeficiency Disease. Poster presented at: National Home Infusion Association Annual Conference; March 23-27, 2024; Austin TX.