Koru FreedomEdge Nabs Japanese Regulatory Approval

Koru Medical Systems, a medtech company focused on large volume subcutaneous infusion solutions, recently announced that it has received Japanese regulatory approval for its FreedomEdge System 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.

The system offers patient’s reliability, precision, and a patient-friendly design, making administration of large volume subcutaneous therapies efficient in both at home and in a clinic, according to the company. FreedomEdge is characterized by its compact and portable design, allowing for flexibility in treatment administration.

"We are very pleased to have received regulatory clearance for the FreedomEdge System in Japan," said Linda Tharby, president and CEO of Koru, in a press release. "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."

Commercialization timeline details for the Japanese market have not been disclosed.