MAHWAH, N.J. / Oct 31, 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, this week presented data demonstrating nursing preference for the use of the KORU FreedomEdge® Infusion System to administer subcutaneous oncology infusions in the clinic setting. The results of the case study were presented at the PODD 2024 Conference on October 28, 2024, in Boston, Massachusetts.

The objective of the Nursing Preference Study was to assess time spent with patients, impact on nursing and patient comfort, and overall nurse preference when comparing manual syringe administration versus mechanical pump administration with the KORU FreedomEdge® Infusion System during subcutaneous oncology biologic drug infusions. The study was conducted by KORU Medical across 6 hospitals in Denmark with 33 nurses administering more than 3,000 infusions of a >10mL oncology drug with an average administration time of approximately 10 minutes.

• Increased Patient Interaction: 97% of nurses reported having more time to interact with patients while using the KORU FreedomEdge® Infusion System versus manual syringe administration

• Reduced Nurse Discomfort: 81% of nurses experienced less hand pain while using the KORU FreedomEdge® Infusion System compared to manual syringe administration

• Ease of Use: 91% of nurses found the KORU FreedomEdge® Infusion System easier to use, with a shorter setup time compared to manual syringe administration

• Reduced Patient Discomfort: 73% of nurses observed less patient pain during infusions with the KORU FreedomEdge® Infusion System​ versus manual syringe administration

• Recommended by Nurses: 97% of nurses would recommend the KORU FreedomEdge® Infusion System over manual syringe administration, citing ease of use and reduced discomfort as key reasons​

Subcutaneous formulation of formerly intravenous biologics is a growing trend with oncology pharmaceutical manufacturers. There are five greater-than-5mL biologic oncology drugs that have been cleared for in-clinic administration by healthcare professionals for an estimated one million global infusions.^1,2 Evidence indicates that subcutaneous administration of oncology therapy simplifies treatment protocol, reduces pressure on hospitals, and improves patients’ quality of life.³ As further development of subcutaneous drug therapies increases, the optimization of drug administration has created a significant opportunity for drug delivery solutions like the KORU FreedomEdge® Infusion System.

“The growing prevalence of large-volume subcutaneous oncology drug therapies has the potential to create challenges in the clinical setting for the manual push method, particularly related to limiting workflow as a result of hands-on administration time required,” said Linda Tharby, President and CEO of KORU Medical. “Nurses are required to apply continuous manual pressure on syringes containing highly viscous drugs for a nearly-10-minute administration time.”

Ms. Tharby continued, “KORU’s FreedomEdge® Infusion System represents an alternative that may address these concerns and simplify the drug delivery experience. We are pleased that the results of this study demonstrate that KORU’s FreedomEdge® Infusion System is widely preferred by nurses and expect to file for FDA clearance of our system with an oncology biologic in 2025.”

About KORU Medical Systems

KORU Medical 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. All statements that are not historical fact are forward-looking statements and can be identified by words such as “expect,” “will,” "believe" and "potential". 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, 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 October 31, 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.

References:

1. Third party data source on file
2. Third party data source on file
3. 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.