Koru Medical Systems (KRMD) has announced a collaboration with a global pharmaceutical manufacturer to conduct a Phase 3 clinical trial. This trial will investigate an expanded indication for an existing commercialized drug therapy, specifically targeting a rare renal disorder. The study aims to evaluate the safety, efficacy, and performance of the drug in treating complications associated with kidney transplants.
The targeted renal disorder affects an estimated 30,000 patients, with projections indicating a need for approximately 300,000 infusions annually. This collaboration highlights Koru Medical's role in facilitating the development of novel therapies and improving drug delivery methods for patients with rare conditions.
Linda Tharby, President and CEO of Koru Medical, stated, "We continue to see growth in the overall large volume subcutaneous market with multiple new drugs entering clinical trials and several others receiving regulatory approval. With over 2 million infusions administered on the KORU Freedom Infusion System every year, KORU continues to be a leading collaboration partner for large volume subcutaneous drug therapies in both the home and infusion clinic settings."
Koru Medical's Role
The Koru Freedom Infusion System plays a crucial role in this trial, providing a platform for large volume subcutaneous drug delivery. The system is designed for self-administration at home or delivery in ambulatory infusion centers, enhancing patient convenience and adherence.
"Assuming successful completion and results from this Phase III clinical trial, this drug’s expanded indication will give us access to a new patient base and enable the delivery of a therapy to improve the lives of those with rare renal disorder," added Tharby.
About Koru Medical Systems
Koru Medical Systems focuses on developing, manufacturing, and commercializing innovative, patient-centric large volume subcutaneous infusion solutions. Their FREEDOM Syringe Infusion System, which includes the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™, and HIgH-Flo Subcutaneous Safety Needle Sets™, has been used for self-administration in the home by patients and/or delivery in an ambulatory infusion center by a healthcare professional since its initial FDA clearance in 1994. Through its Novel Therapies business, Koru Medical provides products for use by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, is capable of customizing the Freedom System for clinical and commercial use across multiple drug categories.
