KORU Medical Systems Announces Development Agreement for Innovation in Subcutaneous Immunoglobulin Infusion Systems

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MAHWAH, N.J.--(BUSINESS WIRE)--Nov 4, 2025--

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 easy-to-use patient-centric large volume subcutaneous infusion solutions, today announced a development agreement with a global pharmaceutical company. The agreement allows for broad collaboration on next-generation infusion systems in subcutaneous immunoglobulin (SCIg) therapy for both commercial drugs and clinical programs.

The agreement is for KORU Medical to support the qualification of an infusion system that can accommodate both vials and prefilled syringes (PFS). KORU Medical’s Freedom60® and FreedomEDGE® infusion pumps were the first devices to be 510(k) cleared for use with prefilled syringes. The innovative system will be developed using KORU Medical’s infusion technology along with SCHOTT TOPPAC® polymer syringes.

“ We are proud of our role in developing devices that meet large-volume subcutaneous drug delivery needs, reflecting KORU’s deep commitment to supporting our pharmaceutical partners and the patients they serve,” said Linda Tharby, President and CEO of KORU Medical. “This partnership represents an important step forward in simplifying treatment for people living with immunodeficiency disorders and advancing healthcare through innovation.”

KORU Medical’s FREEDOM Syringe 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 annually 1
• 97% adherence rate and 8 on-label subcutaneous drugs 2
• Distributed across 30+ countries

About KORU Medical Systems

KORU Medical develops, manufactures, and commercializes innovative and patient-centric 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 Services 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.

References

1. KORU Medical Estimates and Third-Party Data on File
2. 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.

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CONTACT: Investor Contact:

Louisa Smith

[email protected]

KEYWORD: NEW JERSEY UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: MEDICAL SUPPLIES HEALTH FDA MEDICAL DEVICES CLINICAL TRIALS PHARMACEUTICAL BIOTECHNOLOGY

SOURCE: KORU Medical Systems, Inc.

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PUB: 11/04/2025 04:05 PM/DISC: 11/04/2025 04:05 PM

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