KORU Medical Systems,a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced that its state-of-the-art FreedomEdge® System has received regulatory clearance in Japan for the delivery of multiple drugs, including CSL Behring’s Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical’s Cuvitru SCIg, and Sobi’s Aspaveli paroxysmal nocturnal hemoglobinuria (PNH).

The regulatory milestone marks a significant advancement in patient care in Japan, providing patients and healthcare providers with access to cutting-edge 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.

"We are very pleased to have received regulatory clearance for the FreedomEdge® System in Japan," said Linda Tharby, President and CEO of KORU Medical. "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.