Business
KORU Medical Systems Signs a Clinical Supply Agreement for Phase 3 Trial with Leading Pharma Partner Using Custom Device for a Novel Subcutaneous Immunoglobulin
MAHWAH, N.J.--(BUSINESS WIRE)-- KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on
About this update from Koru Medical Systems, Inc.
[{"type":"text","content":" MAHWAH, N.J.--(BUSINESS WIRE)--\nKORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, is pleased to announce a clinical supply agreement for a novel subcutaneous immunoglobulin (SCIg) drug entering Phase 3 trials. The custom product developed for this clinical trial under a prior agreement was built off the foundation of the KORU Medical Freedom System and tailored to meet the unique subcutaneous infusion administration specifications of this novel drug.\n\n\nThis significant milestone represents an essential advancement in developing novel therapies for patients with immunological disorders. The Phase 3 trial aims to assess the safety, efficacy, and performance of the SCIg drug in treating various medical conditions, including autoimmune diseases, primary immunodeficiency disorders, and neurological disorders.\n\n\nThe newly developed custom device, designed by KORU Medical's team of experts, includes advanced technology and user-friendly interfaces to enhance patient comfort and ensure precise therapy delivery.\n\n\n“We are proud of our role in developing devices that meet large volume subcutaneous delivery needs, demonstrating KORU Medical’s ability to support our pharmaceutical partners’ drug development process and patient needs,” said Linda Tharby, President and CEO of KORU Medical. \"We are excited to announce the execution of this Phase 3 clinical supply agreement, marking a critical step forward in our commitment to advancing healthcare through innovation. Assuming successful completion and results of the Phase 3 trial, we expect to file a 510k and commercialize with this novel SCIg drug.\"\n\n\nAbout KORU Medical Systems\n\n\nKORU Medical Systems develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The FREEDOM Syringe Infusion System (the “Freedom System”) currently includes the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HIgH-Flo Subcutaneous Safety Needle Sets™. These devices are used for infusions administered in the home and alternate care settings. F...