KORU Medical Systems

KORU Medical Systems

KORU Medical Systems, incorporated in 1994 and headquartered in Mahwah, New Jersey, manufactures the FREEDOM Infusion System, a mechanical pump cleared by the FDA for subcutaneous immunoglobulin administration. The company was originally founded as Repro Med Systems before rebranding to reflect its core therapeutic focus. CEO Linda Tharby joined from Becton Dickinson where she led the medication delivery solutions business, signaling a push by the board to professionalize sales and expand beyond the original founder-led era. The firm operates a razor-and-blade model: it sells durable infusion pumps at low margins to seed an installed base, then derives recurring revenue from single-use disposable administration sets. Its primary market is chronic immunoglobulin therapies for primary immunodeficiency diseases and chronic inflammatory demyelinating polyneuropathy. KORU has also pursued label expansions into other large-volume injectables, including certain oncology supportive-care drugs and rare disease biologics. Key commercial partners have historically included CSL Behring and Takeda, which co-promote the device in specific therapy corridors. Its geographic footprint covers the United States and a patchwork of distributor relationships across Europe and Japan. As a publicly listed micro-cap, KORU does not disclose assets under management and operates as an operating company rather than an investment vehicle. Total headcount has hovered below 100 employees across its New Jersey headquarters and remote commercial teams. In 2022, the firm secured a novel 510(k) clearance for the FREEDOM60 Infusion System for use with an expanded label of biologics, which marked the company's most significant regulatory milestone since Tharby's arrival. The company has no family-office wealth origin, no separate philanthropic vehicle, and does not engage in fund commitments or principal investing. KORU's structural differentiator lies in its concentrated regulatory moat within a niche infusion hardware segment. Competing against large diversified medical-device manufacturers, KORU has defended its position by maintaining deep compatibility with specific high-cost biologic regimens, a strategy that ties switching costs directly to the drug's administration protocol rather than the pump's price point. This vendor-lock dynamic through 510(k) labeling, rather than raw hardware superiority, defines the company's economic posture.