KORU Medical Systems, Inc. Announces Development Agreement for Next-generation Subcutaneous Immunoglobulin 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 easy-to-use specialty subcutaneous infusion solutions that improve quality of life for patients, today announced a development agreement with a biopharmaceutical manufacturer for KORU Medical to develop and seek regulatory approval for a next-generation infusion system for its subcutaneous immunoglobulin (SCIg) therapy.

“This collaboration is another milestone in our strategy to provide the best infusion experience to SCIg patients,” said Linda Tharby, KORU Medical’s President and CEO. “To receive the full benefit from innovative SCIg medications and new formats like prefilled syringes, patients need an infusion system that is easy to use, fits into their life, and can deliver the drug they’ve been prescribed. KORU Medical has been the first to receive FDA 510(k) clearance for every new SCIg drug approved since 2020. This next-generation infusion system is intended to facilitate easier home therapy, allowing pharmacies to use one pump for their SCIg patients, whether the drug is provided in a vial or prefilled syringe. We’re excited to collaborate with a biopharmaceutical company on this new innovative infusion system.”

About KORU Medical Systems

KORU Medical Systems develops, manufactures, and commercializes innovative and easy-to-use subcutaneous drug delivery systems that improve quality of life for patients around the world. The FREEDOM™ Infusion System currently includes the FREEDOM60^® and FreedomEdge^® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HIgH-Flo Subcutaneous Safety Needle Sets™. The FREEDOM™ Infusion System is used for infusions administered in the home and alternate care settings. 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 those relating to the Company’s development of a next-generation infusion system. Actual results may differ materially from these statements due to potential risks and uncertainties such as, among others, those risks and uncertainties included under the captions "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2022 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, which are 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 November 8, 2023. 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.