KORU Medical Systems, Inc. KRMD

Company Overview

KORU Medical Systems, Inc. is a U.S.-based medical technology company focused on the development, manufacture, and commercialization of infusion solutions for subcutaneous drug delivery. The company operates within the broader healthcare and medical device industries, with a primary emphasis on specialty infusion therapy. KORU’s products are designed to facilitate the administration of biologic medications and immune globulin therapies in home-based and ambulatory care settings. The company’s core revenue drivers include its infusion pump systems, consumable infusion sets, and related accessories used in chronic therapy treatments.

KORU’s primary platform is its wearable and portable subcutaneous infusion technology, including the FREEDOM infusion system product line. The company serves pharmaceutical manufacturers, specialty pharmacies, home infusion providers, hospitals, and patients requiring long-term infusion therapy. KORU has positioned itself around the growing trend toward home-based care and patient self-administration, particularly for chronic immune deficiencies and neurological conditions treated with subcutaneous immunoglobulin (SCIg). Originally founded as Repro-Med Systems, Inc., the company later rebranded to KORU Medical Systems to reflect its broader strategic focus on patient-centric infusion technologies and pharmaceutical partnerships.

Business Operations

KORU generates revenue primarily through sales of its FREEDOM Infusion System, including mechanical infusion pumps, precision flow rate tubing, needle sets, and consumable accessories. The company’s business model includes recurring revenue from disposables and consumables associated with ongoing patient therapies. Its products are regulated medical devices marketed primarily for subcutaneous infusion applications, particularly immunoglobulin therapies. The company also supports pharmaceutical companies pursuing subcutaneous formulations of biologic drugs, positioning its delivery systems as enabling technologies for drug administration outside traditional clinical environments.

Operations are centered in the United States, with manufacturing and corporate activities primarily conducted domestically, while commercial distribution extends internationally through distributors and healthcare partners. KORU has expanded relationships with specialty pharmacies, infusion providers, and pharmaceutical manufacturers to support drug-device combination opportunities. The company maintains intellectual property related to infusion mechanics and flow control technologies and has emphasized regulatory compliance and quality systems aligned with FDA and international medical device standards.

Strategic Position & Investments

KORU’s strategic direction has focused on expanding adoption of subcutaneous delivery methods as healthcare systems increasingly shift toward decentralized and home-based care models. Growth initiatives have included strengthening pharmaceutical collaborations, expanding indications for subcutaneous biologic therapies, and increasing international commercial penetration. The company has also invested in next-generation infusion technologies intended to improve ease of use, precision dosing, and patient adherence. Management has highlighted the long-term opportunity associated with biologic drugs transitioning from intravenous to subcutaneous administration.

The company has pursued operational investments in manufacturing capabilities, product development, and commercial infrastructure to support scalable growth. KORU’s strategy also includes supporting clinical and regulatory pathways for pharmaceutical partners using its infusion platforms in drug-device combination programs. While KORU is smaller in scale than major diversified medical device manufacturers, it occupies a specialized niche within chronic infusion therapy, particularly in SCIg delivery. Public disclosures indicate continued emphasis on recurring consumable revenue and strategic alignment with specialty biologic therapies.

Geographic Footprint

KORU Medical Systems is headquartered in Mahwah, New Jersey, and maintains a primary operational footprint in the United States. The company markets its infusion products domestically through direct commercial relationships and healthcare distribution networks serving specialty pharmacies, home infusion providers, and clinical institutions. The U.S. market remains the company’s largest source of revenue, particularly due to demand associated with immunoglobulin therapies and chronic care management.

Internationally, KORU distributes products across selected regions in Europe, Asia-Pacific, the Middle East, and other global healthcare markets through third-party distributors and strategic commercial partnerships. The company’s international presence reflects broader growth in home infusion therapy adoption and increasing use of subcutaneous biologic administration globally. Although its operational scale outside the United States is smaller relative to domestic activity, international expansion remains an identified strategic growth area in company filings and investor communications.

Leadership & Governance

KORU Medical Systems operates under a corporate governance structure led by an executive management team and board of directors focused on medical device commercialization, operational scalability, and long-term healthcare market expansion. Leadership has emphasized innovation in patient-focused infusion delivery, strategic pharmaceutical partnerships, and expansion within chronic biologic therapies. The company’s governance framework aligns with U.S. public company standards and reporting obligations under the SEC.

Key executives include:

• Linda Tharby – President and Chief Executive Officer
• Tom Adams – Chief Financial Officer
• Leanne Kelly – Chief Commercial Officer
• Dan Vuksanovich – Chief Operating Officer

The company’s leadership strategy has centered on expanding recurring revenue streams, strengthening operational execution, and increasing penetration in the specialty infusion market. Public company disclosures and investor materials indicate a continued focus on disciplined growth, product innovation, and collaboration with pharmaceutical manufacturers developing subcutaneous therapies.