Japanese Regulatory Clearance Granted to KORU Medical’s FreedomEdge System

KORU Medical Systems Inc.’s FreedomEdge System has received regulatory clearance in Japan for the delivery of multiple drugs, including Hizentra subcutaneous immunoglobulin (SCIg), Cuvitru SCIg, and Aspaveli paroxysmal nocturnal hemoglobinuria (PNH).

The regulatory milestone provides patients and healthcare providers in Japan with access to treatment options for Subcutaneous Immunoglobulin therapy (SCIg) and Paroxysmal Nocturnal Hemoglobinuria (PNH). The FreedomEdge System, known for its reliability, precision, and patient-friendly design, offers convenient and efficient administration of large volume subcutaneous therapies at home and in the clinic, KORU Medical claims.

“We are very pleased to have received regulatory clearance for the FreedomEdge System in Japan,” KORUM Medical President/CEO Linda Tharby said. “This accomplishment underscores our commitment to advancing healthcare solutions that enhance patients’ lives worldwide and further strengthens KORU’s expansion into international markets. With the approval of the FreedomEdge System in Japan, we are proud to broaden access to critical therapies, empowering patients and healthcare providers with a reliable and user-friendly drug delivery platform.”

The FreedomEdge System is designed to meet the diverse needs of patients and healthcare professionals, offering customizable features for personalized treatment experiences. Its compact and portable design allows for flexibility in treatment administration, enabling patients to manage their therapy effectively in various settings.

KORU Medical Systems develops, manufactures, and commercializes patient-centric large volume subcutaneous infusion solutions. 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. The Freedom System, which received its first U.S. Food and Drug Administration clearance in 1994, is used for self-administration in the home by the patient and/or delivery in an ambulatory infusion center by a healthcare professional. The company is headquartered in Mahwah, N.J.