KORU Medical Systems (NASDAQ: KRMD) is a medical device company that develops, manufactures, and commercializes large volume subcutaneous drug delivery products, operating from its headquarters in Mahwah, New Jersey. Revenue comes from three streams: domestic core (U.S. and Canada), international core, and pharma services and clinical trials, all generated through product sales of the FREEDOM Infusion System and related consumables. Primary end markets are immunoglobulin therapy for Primary Immunodeficiency Diseases and Chronic Inflammatory Demyelinating Polyneuropathy. The company operates in a single market, infusion, and competes against large medical device companies with broader product lines as well as specialized device makers. Most consumables are assembled and packaged in Nicaragua, with contract manufacturer Command producing approximately 85% of consumables as of the FY2024 10-K filed 2026-03-12. KRMD is classified as a smaller reporting company and non-accelerated filer. The company holds a leased 43,975 square foot facility in Mahwah, New Jersey used for headquarters and in-house manufacturing, under a lease expiring August 31, 2032.

Revenue model

Transactional product sales across three segments: domestic core (U.S. and Canada), international core, and pharma services and clinical trials. Products sold to specialty pharmacies, ambulatory service providers, and hospitals, which bill third-party payers including Medicare, Medicaid, private insurance, and managed care plans.

Products and services

FREEDOM Infusion System, including FDA-cleared pump and consumable components (needle sets and tubing sets) for subcutaneous drug delivery, primarily used for immunoglobulin administration in PIDD and CIDP patients. Pharma services and clinical trials represent a third revenue segment as disclosed in the FY2024 10-K.

Customers and end markets

Direct customers are specialty pharmacies, ambulatory service providers, and hospitals. End patients are primarily those receiving subcutaneous immunoglobulin therapy for Primary Immunodeficiency Diseases and Chronic Inflammatory Demyelinating Polyneuropathy. Reimbursement from Medicare, Medicaid, private insurance, and managed care plans is a key demand driver.

Value-chain role

Device developer, in-house manufacturer (Mahwah, New Jersey facility), and commercial seller. Contract manufacturer Command provides subassemblies for all consumables and manufactures, assembles, and packages approximately 85% of consumables as of the FY2024 10-K filed 2026-03-12.

Geographic exposure

Primary market is U.S. and Canada (domestic core). International core segment represents a secondary revenue stream. EU market subject to MDR compliance deadline of December 2028. Manufacturing operations for consumables based in Nicaragua.

Competitors

Large medical device companies offering electronic volumetric pumps, Elastomeric infuser pump manufacturers, Mechanical drug delivery device makers, Novel drug delivery and formulation technology companies

Source: SEC 10-K, filed 2026-03-12

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