US-based medical technology company KORU Medical Systems has secured regulatory approval for its FreedomEdge syringe infusion system in Japan.
The infusion system is indicated for the delivery of multiple drugs, including CSL Behring’s Hizentra, Takeda’s Cuvitru SCIg, and Sobi’s Aspaveli.
According to KORU Medical, the regulatory approval marks a significant advancement in patient care in Japan.
It provides patients and healthcare providers with access to new treatment options for subcutaneous immunoglobulin (SCIg) therapy and paroxysmal nocturnal haemoglobinuria (PNH).
The FreedomEdge system offers convenient and effective administration of large-volume subcutaneous therapies at home and in the clinic, said the medical technology company.
KORU Medical president and CEO Linda Tharby said: “We are very pleased to have received regulatory clearance for the FreedomEdge System in Japan.
“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 is a medical technology company focused on the development, manufacturing, and commercialisation of patient-centric large-volume subcutaneous infusion solutions.
According to the company, FreedomEdge is designed to meet the diverse needs of patients and healthcare professionals, offering customisable features for personalised treatment.
Its compact and portable design allows for flexibility in treatment administration, enabling patients to manage their therapy effectively in various settings.
The device features a highly accurate constant pressure system that meets ISO accuracy standards and automatically slows down when the pressure in the sites increases.
Furthermore, the FreedomEdge system is convenient for patients, has no unnecessary alarms and noise, doesn’t need batteries or electricity, and is easy to check infusion progress.
