KORU Medical Systems Announces Agreement for Next-Generation Subcutaneous Immunoglobulin Infusion System

By: KORU Medical Systems, Inc. via Business Wire

February 06, 2025 at 16:05 PM EST

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 signing of an agreement with a global pharmaceutical company. The agreement is intended for KORU Medical to develop and seek regulatory clearance for a next-generation subcutaneous immunoglobulin (SCIg) therapy infusion system for use with a commercialized drug therapy.

Additionally, the project will include a close collaboration with SCHOTT Pharma and is expected to be the first of multiple joint projects with SCHOTT, allowing KORU Medical to develop a platform infusion system that can integrate with both a vial and prefilled syringe. The innovative system will be developed using KORU Medical’s infusion technology along with SCHOTT TOPPAC® prefillable polymer syringes (PFS).

“This collaboration marks another milestone in our strategy to provide the most convenient infusion experience to SCIg patients,” said Linda Tharby, President and CEO of KORU Medical. “To receive the full benefit from innovative SCIg medications, including new formats like prefilled syringes, patients need an infusion system that is easy to use, fits into their lifestyles, and can efficiently deliver the drug they have been prescribed. This next-generation infusion system is intended to facilitate easier home therapy, whether the drug is dispensed via a vial or prefilled syringe. We are excited that this project includes a close collaboration between KORU and SCHOTT Pharma.”

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 Novel Therapies 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.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including but not limited to collaboration and future Company projects with SCHOTT. Actual results may differ materially from these statements due to potential risks and uncertainties such as those risks and uncertainties included under the captions "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023 which is on file with the SEC and available on our website at www.korumedical.com/investors and on the SEC website at www.sec.gov. All information provided in this release and in the attachments is as of February 6, 2025. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. We undertake no duty to update this information unless required by law.