MAHWAH, N.J. / Mar 11, 2024 / Business Wire / KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced a collaboration with a global pharmaceutical manufacturer to initiate a feasibility study with KORU’s Freedom Infusion System for an already commercialized rare disease therapy.

Upon successful completion of the feasibility study, KORU Medical intends to develop a customized Freedom System that will deliver this large volume therapy via subcutaneous administration. Healthcare providers administer this rare disease drug in the growing ambulatory infusion center (AIC) and ambulatory infusion suite (AIS) setting in the United States and the hospital setting in the European Union.

“We are excited to continue our leadership in large volume subcutaneous infusion within a new rare disease biologic therapy and new therapeutic settings, such as AICs and AISs,” said Linda Tharby, KORU Medical’s President and CEO. “Expansion of our use case from home subcutaneous administration into these new settings demonstrates the versatility and flexibility of the KORU Medical Freedom Infusion System in delivering life-changing therapies wherever patients are being treated. Upon success of the feasibility study, we expect to submit the device for FDA clearance within the next 12 months.”

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^™. These devices are 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 customized Freedom System, submission of a device for FDA clearance, entry into AICs and AISs, and continuing leadership in large volume subcutaneous infusion. Actual results may differ materially from these statements due to potential risks and uncertainties such as, among others, success of the feasibility study, agreement with the pharmaceutical manufacturer with respect to customization of the system, successful development of the system, obtaining regulatory clearances, and by 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 September 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 March 5, 2024. 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.