MAHWAH, N.J. / Jun 04, 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 company to initiate a feasibility study with KORU Medical’s Freedom Infusion System (the “Freedom System”) for an FDA and EMA approved subcutaneous oncology biologic drug, that is currently being delivered via a manual syringe administration by a healthcare professional.

The Freedom System is a purely mechanical ambulatory drug delivery device with 11 drugs approved on the label and over 40,000 patients globally. The system is designed to deliver large volumes of biologic medications from 2mL to over 100mL subcutaneously. The Freedom System is capable of allowing patients to self-administer their therapy at home and/or by healthcare professionals in a clinic setting.

Conversion of IV biologics to subcutaneous administration formulations is a growing trend in the oncology market. Evidence suggests subcutaneous administration of oncology therapy simplifies treatment, reduces pressure on hospitals, and improves patients’ quality of life.¹ With the development of new subcutaneous drug therapies, there is an opportunity to develop drug delivery administration solutions which will optimize drug administration for healthcare providers and patients.

“This collaboration presents an exciting, new opportunity to enter the growing oncology subcutaneous biologic market to solve significant unmet needs in the delivery of this life-saving therapy with our patient-centric solutions,” said Linda Tharby, KORU Medical’s President and CEO. Linda Tharby went on to say, “There are multiple subcutaneous oncology biologics currently approved using manual administration with an estimate of over one million global infusions. Upon successful completion of the feasibility study, we anticipate progressing to commercialization of the Freedom System for this drug within the following 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™. 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 those relating to the success of the feasibility study and the commercialization timing of a device for the oncology biologic drug. Actual results may differ materially from these statements due to potential risks and uncertainties such as, among others, results of the feasibility study, 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, 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 June 4, 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.

Reference:

1. Cook G, Ashcroft J, Fernandez M, Henshaw S, Khalaf Z, Pratt G, Tailor A and Rabin N (2023) Benefits of switching from intravenous to subcutaneous daratumumab: Perspectives from UK healthcare providers. Front. Oncol. 13:1063144. doi: 10.3389/fonc.2023.1063144.