• The companies, KORU Medical, manufacturer of the proprietary, large-volume, Freedom Infusion System (the “Freedom System”) and SCHOTT Pharma, manufacturer of SCHOTT TOPPAC^® prefillable polymer syringes (PFS), intend to collaborate on optimization of drug delivery in the large volume subcutaneous infusion market.
• When combined with pharma therapies, the joint offering will optimize the ability to administer large volumes of medication subcutaneously and streamline the pharmaceutical drug development process.
• Application of these technologies provide the potential to simplify and de-risk delivery of large volume subcutaneous therapies in both administration by healthcare professionals in a clinic setting or patient self-administration in the home setting.

MAINZ, Germany, & MAHWAH, N.J. / Jun 05, 2024 / Business Wire / SCHOTT Pharma, a pioneer in pharma drug containment solutions and delivery systems, and KORU Medical Systems (NASDAQ: KRMD), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, are joining forces to offer a high-volume subcutaneous drug infusion solution.

“We want to ensure that medications are safe and easy to use for patients and care providers around the world. By combining KORU Medical’s expertise in pump devices with our expertise in large-volume prefillable polymer syringes, we can help improve the time-to-market of infusion therapies while simplifying the subcutaneous drug infusion of large volume drugs,” says Andreas Reisse, CEO of SCHOTT Pharma.

The solution particularly addresses the market for treatments that are administered subcutaneously and require recurring dosing regimens, such as chronic diseases or cancer. The prefillable polymer syringes from SCHOTT Pharma that are used with KORU Medical’s Freedom System are available in large-volume formats from 5mL to 50mL to meet the need for larger infusion volumes and higher drug viscosities.

Andreas Reisse went on to say, “As these two technologies have already demonstrated their ability to solve the subcutaneous immunoglobulin (SCIg) therapy market leader’s transition from vials to PFS, pharmaceutical companies can take comfort in a de-risked development pathway with KORU Medical’s commercialized Freedom System and SCHOTT TOPPAC^® ready-to-use prefillable polymer syringes.”

Linda Tharby, President and CEO of KORU Medical Systems said, “With the shift currently happening in the SCIg market from vials to PFS, patients and health care professionals have already begun utilizing our system in conjunction with SCHOTT Pharma prefillable syringes. As the syringes come prefilled with the exact drug dosage and are capable of being delivered via the FREEDOM60^® and FreedomEdge^® Syringe Infusion Drivers, there are no vial preparation steps needed. This is both a simpler process for patients and reduces the risk of administration errors.” Linda Tharby went on to say, “KORU Medical is very excited to partner with SCHOTT Pharma to simplify drug development for our pharmaceutical partners and facilitate greater success of large volume administration for our patients.”

About SCHOTT Pharma

Human health matters. That is why SCHOTT Pharma designs solutions grounded in science to ensure that medications are safe and easy to use for people around the world. The portfolio comprises drug containment solutions and delivery systems for injectable drugs ranging from prefillable glass and polymer syringes to cartridges, vials, and ampoules. Every day, a team of over 4,600 people from over 60 nations works at SCHOTT Pharma to contribute to global healthcare. The company is represented in all main pharmaceutical hubs with 16 manufacturing sites in Europe, North and South America, and Asia. With over 1,000 patents and technologies developed in-house and a state-of-the-art R&D center in Switzerland, the company is focused on developing innovations for the future. SCHOTT Pharma AG & Co. KGaA is headquartered in Mainz, Germany and listed on the Frankfurt Stock Exchange as part of the SDAX. It is part of SCHOTT AG, which is owned by the Carl Zeiss Foundation. In light of this spirit, SCHOTT Pharma is committed to sustainable development for society and the environment and has the strategic goal of becoming climate-neutral by 2030. Currently, SCHOTT Pharma has over 1,800 customers including the top 30 leading pharma manufacturers for injectable drugs and generated revenue of EUR 899 million in the fiscal year 2023.

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 partnership and patient acceptance of the combination product. 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, 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 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.