KORU Medical Systems, Inc.

KORU Medical Systems, Inc. (Nasdaq Capital Market: KORU) develops, manufactures, and commercializes innovative large-volume subcutaneous infusion solutions for drug delivery applications. The company's website is www.korumedical.com.

The company's primary product is the FREEDOM Infusion System, a mechanical drug delivery platform comprising the FREEDOM60 Syringe Driver, FreedomEdge Syringe Driver, HIgH-Flo Subcutaneous Safety Needle Sets, and Precision Flow Rate Tubing. These FDA-cleared devices are designed for self-administration of therapies in home and alternate care settings, with particular focus on subcutaneous immunoglobulin delivery for treating Primary Immunodeficiency Diseases and Chronic Inflammatory Demyelinating Polyneuropathy. The FREEDOM System is also approved for administration of RYSTIGGO, a novel biologic for generalized myasthenia gravis treatment.

KORU operates through three revenue streams: domestic core business covering the United States and Canada, international core operations, and pharma services and clinical trials. The company generates revenue from product sales of syringe drivers, tubing, and needles, as well as non-recurring engineering services and feasibility studies for biopharmaceutical partners developing novel subcutaneous therapies. The company manufactures one hundred percent of pump products at its Mahwah, New Jersey facility and sources consumable supplies from both internal production and Command Medical Products, a contract manufacturer in Nicaragua.

As of December 31, 2025, KORU employed 73 full-time employees, with approximately 48 percent female representation and 38 percent minority representation in the workforce. The company distributes products through nine primary distributors, with three in the United States and six internationally, representing approximately 77 percent of net revenues. One U.S. distributor alone accounts for approximately 29 percent of revenues.

KORU holds 15 U.S. patents and 26 foreign patents protecting its drug delivery systems, with fundamental patents extending through 2039 and beyond. The company maintains an intellectual property portfolio including eight pending U.S. patent applications and 18 foreign patent applications. The company's mechanical infusion approach offers advantages over electronic pumps through lower cost, battery-free operation, and reduced maintenance requirements while maintaining clinical efficacy for subcutaneous drug delivery applications.