KORU Medical makes and sells the FREEDOM Infusion System, a mechanical pump used to deliver large-volume drugs subcutaneously at home or in infusion clinics. The system includes two syringe driver pumps (FREEDOM60 and FreedomEdge), proprietary needle sets (HIgH-Flo), and flow-rate tubing, which together form a complete drug delivery platform. The core use case is subcutaneous immunoglobulin (SCIg) therapy — primarily for patients with Primary Immunodeficiency Disease (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) — which are chronic conditions requiring recurring, typically weekly, infusions. KORU estimates it serves roughly 45,000 chronic SCIg patients. The business model is a classic razor/razorblade structure: pumps are a one-time purchase, but consumables (needle sets and tubing required for every infusion) drive roughly 85% of economics. Gross margins are consistently above 60%. KORU sells through distributors, who supply specialty pharmacies and home infusion providers. KORU reports three segments: Domestic Core (U.S. and Canada, the largest), International Core (primarily Europe, the Middle East, and Japan), and Pharma Services and Clinical Trials (PST), which generates lumpy, non-recurring revenue from engineering services and clinical trial supply agreements. Growth is driven by expanding the domestic SCIg patient base, growing international share (particularly as European markets shift to prefilled syringe formats that favor KORU's mechanical system over electronic pumps), and expanding the platform to support large-volume subcutaneous delivery of non-SCIg drugs, including oncology drugs administered in infusion clinics.
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