KORU Medical Expands FreedomEDGE System Label with FDA Clearance for RYSTIGGO Delivery

Event summary

  • KORU Medical received FDA 510(k) clearance for its FreedomEDGE infusion system to deliver UCB's RYSTIGGO (rozanolixizumab-noli).
  • RYSTIGGO is approved for treating generalized myasthenia gravis (gMG), a rare autoimmune disorder.
  • This is KORU Medical's ninth subcutaneous drug clearance, expanding its presence in the large-volume subcutaneous infusion market.
  • The clearance allows for administration by healthcare professionals, increasing flexibility for gMG patients.

The big picture

This FDA clearance solidifies KORU Medical's position in the rapidly growing large-volume subcutaneous infusion market. The ability to deliver RYSTIGGO in both home and clinic settings aligns with broader industry trends toward flexible, patient-centric care solutions. With over 45,000 patients and 2 million infusions annually, KORU Medical is well-positioned to capitalize on the increasing demand for subcutaneous drug delivery systems.

What we're watching

Market Expansion
How KORU Medical will leverage this clearance to penetrate the clinic-based care segment.
Strategic Alignment
Whether KORU Medical can sustain its strategy of extending the Freedom platform to more drug therapies.
Competitive Dynamics
The pace at which KORU Medical can secure additional drug clearances to maintain its leadership in the subcutaneous infusion market.

Related topics

Regulatory Approval Medical Devices