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1. The Insulet (Omnipod) for at-home immunoglobulin (IG) infusions.

2. A specialized Becton Dickinson (BD) focused on home-based subcutaneous drug delivery systems.

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• FREEDOM Syringe Drivers (Infusion Pumps): These are medical devices used for subcutaneous delivery of medications, primarily for immunoglobulin therapy in home or clinic settings.
• Precision Flow Rate Tubing: Specialized tubing designed to provide accurate and consistent flow rates for medications delivered via their infusion pumps.
• Subcutaneous Needle Sets: A range of needle sets used for comfortable and effective subcutaneous infusion, compatible with their pump systems.

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Major Customers of KORU Medical Systems (KRMD)

KORU Medical Systems (KRMD) primarily operates on a business-to-business (B2B) model, selling its medical devices, such as the FREEDOM Infusion System, to other companies rather than directly to individual patients. These customer companies then distribute or dispense KORU's products to patients requiring subcutaneous immunoglobulin (SCIg) therapy.

While KORU Medical Systems' financial disclosures indicate significant customer concentration (e.g., their top three customers accounted for approximately 64% of total revenue in 2023), the company does not publicly disclose the specific names of these major customer companies in its regulatory filings (such as its annual 10-K report) or other official investor communications.

Based on their descriptions in SEC filings, KORU Medical Systems' primary categories of customers are:

• Specialty pharmacies
• Distributors
• Home health providers

These entities acquire KORU's infusion systems and related disposables to serve patients receiving home infusion therapies.

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Linda Tharby, Chief Executive Officer and President

Ms. Tharby has served as KORU Medical Systems' Chief Executive Officer and President since April 2021. She has over 25 years of executive leadership experience in building and leading global organizations that develop and commercialize products and service innovations. Prior to joining KORU Medical Systems, Ms. Tharby spent 24 years with Becton Dickinson (“BD”). She was a member of BD's Executive Leadership team that transformed the company from an $8 billion medical supplies company to an $18 billion global medical technology company. During her time at BD, she held numerous global business leadership roles, including Chief Customer Experience Officer, Chief Human Resources Officer, Executive Vice President and President of Life Sciences, Group President of Pre-Analytical Systems and Biosciences, Worldwide President of Diabetes Care, and Vice President/General Manager of Pharmaceutical Systems. Ms. Tharby also brings enterprise change and integration experience, including her role as Chief Human Resources Officer through BD's $24 billion acquisition and integration of C.R. Bard in 2017.

Thomas Adams, Chief Financial Officer

Mr. Adams has been the Chief Financial Officer at KORU Medical Systems since August 2023. He previously served as the Vice President of Financial Planning Analysis from November 2021 to August 2023 and as Interim Chief Financial Officer from July 2022 to July 2023. Mr. Adams has over 20 years of finance and accounting experience in the medical technology and pharmaceutical sector. Before joining KORU Medical Systems, he spent 10 years at Integra LifeSciences in progressively senior finance roles, with his last position as Senior Director of Finance for a $500M commercial business unit. Prior to Integra, Mr. Adams worked at Pfizer as Director of Finance from 2000 to 2011. He began his career at Ernst & Young in the audit function.

Christopher Pazdan, Chief Operating Officer

Mr. Pazdan was promoted to Chief Operating Officer, effective July 18, 2024. He joined KORU Medical Systems in September 2021 and previously served as Senior Vice President of Operations. Mr. Pazdan has over two decades of experience in the medical technology and pharmaceutical sectors. Prior to KORU, he held positions at Abbott Laboratories and Becton Dickinson (BD), among others.

Adam Kalbermatten, Chief Commercial Officer

Mr. Kalbermatten was appointed Chief Commercial Officer, effective July 28, 2025. He brings over two decades of commercial leadership experience in the medical device and pharmaceutical industries. Prior to KORU Medical Systems, Mr. Kalbermatten served as Vice President and General Manager, Advanced Drug Delivery Systems, at Becton Dickinson (BD). He also previously served as Chief Executive Officer of ZebraSci, a drug-device combination product development firm, where he led a successful turnaround and growth strategy that resulted in the company's acquisition by BD. Earlier in his career, Adam held global leadership roles at Terumo Medical Corporation.

Brent Boucher, Vice President of Global Medical Affairs

Mr. Boucher brings more than 25 years of experience in Medical Affairs to KORU Medical Systems. Prior to joining KORU, Brent was with Baxter Healthcare as a Senior Medical Science Liaison and, most recently, with La Jolla Pharmaceutical Company as a Senior Director, Health Outcomes. He has helped launch 7 vaccines, 4 drugs, and 1 device.

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• The increasing market trend towards high-concentration subcutaneous immunoglobulin (SCIg) formulations combined with the potential for new, integrated drug-device delivery systems from pharmaceutical companies. As drug manufacturers develop higher-concentration products, they may also invest in proprietary delivery solutions such as specialized auto-injectors, large-volume patch pumps, or pre-filled syringe systems specifically designed for their drugs, which could diminish the market for general-purpose infusion pumps like those offered by KORU Medical Systems.
• The development and adoption of novel, non-pump-based subcutaneous drug delivery technologies. Innovations such as advanced large-volume patch pumps, sustained-release implants, or next-generation auto-injectors could offer patients a more convenient, discreet, or simplified experience for administering chronic therapies, potentially disrupting the market for traditional portable subcutaneous infusion pump systems.

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KORU Medical Systems (NASDAQ: KRMD) anticipates several key drivers to fuel its revenue growth over the next two to three years:

1. Sustained Growth in the Global SCIg Market and Market Share Expansion: KORU Medical Systems expects continued growth in the global subcutaneous immunoglobulin (SCIg) market, estimated to be in the 8% to 10% range. The company has consistently demonstrated its ability to outpace the overall SCIg market in its core domestic business and aims for ongoing domestic and international market share gains.

2. Expansion of the Flow Controller Product Line: The company has identified the expansion of its flow controller product line as a significant contributor to future revenue.

3. Entry into New International Markets: KORU Medical Systems is strategically expanding its geographic footprint, with a notable entry into the Japanese market planned for the first half of 2025. This, along with accelerating international growth in existing and new markets, is expected to drive revenue.

4. Novel Therapies Collaborations and New Drug Pipeline: KORU Medical Systems is actively pursuing and securing collaborations with pharmaceutical companies to enable the delivery of new drug therapies on its FREEDOM platform. The company plans to submit additional commercialized drugs for 510(k) clearance for use with its Freedom Infusion System and has a pipeline of nine commercial opportunities spanning the end of 2025 to the end of 2026. These collaborations are expected to bring new drugs and indications onto KORU's label.

5. Expansion into New Therapeutic Settings: KORU Medical Systems is exploring and executing on opportunities to expand the use case of its Freedom Infusion System beyond home subcutaneous administration. This includes a feasibility study to enter ambulatory infusion centers (AICs) and ambulatory infusion suites (AISs) in the United States, as well as hospital settings in the European Union, for commercialized rare disease therapies. This strategic move aims to capitalize on the shift from intravenous (IV) hospital settings to subcutaneous (SC) therapy in diverse care environments.

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Share Repurchases

• KORU Medical Systems authorized a stock repurchase program of up to $10 million in November 2020. This program was set to expire on December 31, 2021.

Share Issuance

• In June 2020, KORU Medical Systems commenced an underwritten public offering of common stock. The net proceeds were intended for general corporate purposes, including commercial expansion, clinical trials, pharmaceutical initiatives, gross margin enhancement, and new product innovations.
• The company's additional paid-in capital increased from $47,018,707 as of December 31, 2023, to $49,581,303 as of December 31, 2024. This further increased to $50,277,053 as of March 31, 2025.
• As of June 2025, the issuance of stock for the trailing twelve months was reported as $0.00 million.

Inbound Investments

• No information available regarding large strategic investments by third-parties or private equity firms directly into KORU Medical Systems during the specified period.

Outbound Investments

• No information available regarding KORU Medical Systems making strategic investments in other companies during the specified period.

Capital Expenditures

• KORU Medical Systems expects less than $2 million in investing activities and capital expenditures for new production lines for the remainder of 2025.