KORU Medical Systems, Inc. (NASDAQ: KRMD)

KORU Medical develops, manufactures and commercializes innovative patient centric large volume subcutaneous infusion solutions for the subcutaneous drug delivery market. The company’s core products are the FREEDOM Infusion System, which includes the FREEDOM60 Syringe Driver, the FreedomEdge Syringe Driver, HIgH Flo Subcutaneous Safety Needle Sets and Precision Flow Rate Tubing. These mechanical devices operate without batteries or electricity and are used primarily for delivering immunoglobulin to treat Primary Immunodeficiency Diseases and Chronic Inflammatory Demyelinating Polyneuropathy.

KORU Medical generates revenue from product sales of its infusion system components and from service agreements. Product revenue comes from sales of syringe drivers, tubing and needle sets to customers in the United States and Canada (domestic core) and to international markets (international core). Additionally, the company earns pharma services and clinical trials revenue by providing feasibility or early stage trial support and non recurring engineering services such as product adaptation, testing and regulatory assistance to biopharmaceutical firms developing new subcutaneous therapies.

The company operates through the following segments:.

• Pharma services and clinical trials: This segment provides product revenue for feasibility studies, clinical trials and non recurring engineering services including product innovation, testing and registration to help biopharmaceutical companies prepare and customize the FREEDOM System for commercial use across multiple drug categories.

Within the subcutaneous infusion market, KORU Medical holds a leading position, particularly as the market leading delivery system in the United States for immunoglobulin therapies. Its mechanical pumps compete with electronic volumetric pumps, elastomeric pumps and other mechanical devices, offering advantages such as no requirement for batteries or electricity, lower operating pressure, ease of use and lower total cost of ownership. These attributes support patient self administration and appeal to home infusion and specialty pharmacy settings.

The company serves specialty pharmacies, home infusion providers, medical device distributors and biopharmaceutical companies. Its products are used by patients receiving immunoglobulin therapy and by clinical sites conducting trials of new subcutaneous drugs.