KORU Medical Systems Signs a Clinical Supply Agreement for Phase 3 Trial with Leading Pharma Partner Using Custom Device for a Novel Subcutaneous Immunoglobulin

MAHWAH, N.J.--(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, is pleased to announce a clinical supply agreement for a novel subcutaneous immunoglobulin (SCIg) drug entering Phase 3 trials. The custom product developed for this clinical trial under a prior agreement was built off the foundation of the KORU Medical Freedom System and tailored to meet the unique subcutaneous infusion administration specifications of this novel drug.

This significant milestone represents an essential advancement in developing novel therapies for patients with immunological disorders. The Phase 3 trial aims to assess the safety, efficacy, and performance of the SCIg drug in treating various medical conditions, including autoimmune diseases, primary immunodeficiency disorders, and neurological disorders.

The newly developed custom device, designed by KORU Medical's team of experts, includes advanced technology and user-friendly interfaces to enhance patient comfort and ensure precise therapy delivery.

“We are proud of our role in developing devices that meet large volume subcutaneous delivery needs, demonstrating KORU Medical’s ability to support our pharmaceutical partners’ drug development process and patient needs,” said Linda Tharby, President and CEO of KORU Medical. "We are excited to announce the execution of this Phase 3 clinical supply agreement, marking a critical step forward in our commitment to advancing healthcare through innovation. Assuming successful completion and results of the Phase 3 trial, we expect to file a 510k and commercialize with this novel SCIg drug."

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 11, 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.