Monday, July 15, 2024

Subcutaneous Infusion Delivery Enhanced as Koru FreedomEdge Gains Japanese Regulatory Approval

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Subcutaneous infusion solutions are the specialty of Koru Medical Systems, a medtech company that recently announced receiving Japanese regulatory approval for its FreedomEdge System. This system is designed for the delivery of multiple drugs, including CSL Behring’s Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical’s Cuvitru SCIg, and Sobi’s Aspaveli for paroxysmal nocturnal hemoglobinuria.

The FreedomEdge System offers reliability, precision, and a patient-friendly design, making the administration of large volume subcutaneous therapies efficient both at home and in clinical settings. Its compact and portable design allows for flexibility in treatment administration, providing patients with more options for their care routines. The system’s ease of use and portability are significant advantages for patients who require regular infusions, enhancing their overall treatment experience.

Subcutaneous Infusion Milestone: Koru’s FreedomEdge System Gains Japanese Regulatory Clearance

“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.”

The Japanese approval of the FreedomEdge System is a major milestone for Koru Medical Systems, reflecting the company’s dedication to providing innovative and patient-centric healthcare solutions. By entering the Japanese market, Koru aims to expand its global footprint and provide more patients with access to advanced subcutaneous infusion technologies. This regulatory approval is expected to open new opportunities for collaboration with healthcare providers and other stakeholders in Japan, fostering a broader adoption of subcutaneous infusion therapies.

Subcutaneous

Subcutaneous Infusion Gains Recognition: FreedomEdge System’s Approval Highlights Efficacy for Large Volume Therapies

Moreover, the FreedomEdge System’s approval highlights the growing recognition of subcutaneous infusion as a viable and effective method for delivering large volume therapies. As healthcare systems worldwide continue to seek efficient and patient-friendly treatment options, the FreedomEdge System is poised to play a crucial role in meeting these needs. The system’s ability to deliver multiple types of medication with precision and ease is particularly valuable for patients with chronic conditions that require ongoing treatment.

Koru Medical Systems’ focus on innovation and patient care is evident in the design and functionality of the FreedomEdge System. By providing a solution that simplifies the infusion process and enhances the patient’s quality of life, Koru is addressing a critical need in the healthcare market. The company’s commitment to expanding access to its technologies globally is a testament to its vision of improving patient outcomes through advanced medical solutions.

In summary, the Japanese regulatory approval of the FreedomEdge System marks a significant achievement for Koru Medical Systems. It enables the company to offer its state-of-the-art subcutaneous infusion technology to a broader patient population in Japan, thereby enhancing the delivery of critical therapies. With this approval, Koru continues to demonstrate its leadership in the medtech industry and its dedication to improving healthcare delivery through innovative and patient-friendly solutions.

 

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Resource: Business Wire, July 02, 2024

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