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Koru gets regulatory nod in Japan for FreedomEdge infusion tech

Koru gets regulatory nod in Japan for FreedomEdge infusion tech


Koru Medical FreedomEdge infusion system
The FreedomEdge infusion system. [Image from Koru Medical]

Koru Medical Systems (Nasdaq:KRMD) announced today that it received regulatory clearance in Japan for its FreedomEdge infusion system.

Clearance covers 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).

FreedomEdge offers the convenient and efficient administration of large-volume subcutaneous therapies at home and in the clinic. Koru said in a news release that it offers reliability, precision and a patient-friendly design. The company said its latest regulatory milestone “marks a significant advancement in patient care in Japan.”

Koru says FreedomEdge meets the diverse needs of patients and healthcare professionals with customizable features for personalized treatment. It features a compact, portable design that allows for flexibility in administration and effective therapy in various settings.

“We are very pleased to have received regulatory clearance for the FreedomEdge system in Japan,” said Linda Tharby, president and CEO. “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.”

Koru develops, manufactures and commercializes subcutaneous drug delivery systems. Its Freedom platform currently includes the Freedom60 and FreedomEdge syringe infusion drivers, Precision Flow Rate Tubing and HIgH-Flo Subcutaneous Safety Needle Sets.



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