KORU Medical Secures FDA 510(k) Clearance for RYSTIGGO Delivery, Sees $10.9M Q4 Revenue
KORU Medical Systems secured FDA 510(k) clearance to deliver RYSTIGGO (rozanolixizumab-noli) via its FreedomEDGE infusion system, expanding its label to include monoclonal antibody therapies. The company is forecast to report a $0.02 per share loss and $10.89 million in Q4 revenue, up 23.2% year-over-year.
1. FDA Clearance for Rystiggo Delivery
KORU Medical Systems secured FDA 510(k) clearance to deliver RYSTIGGO (rozanolixizumab-noli) via its FreedomEDGE infusion system, marking the first label expansion to include monoclonal antibody therapies. This approval enables commercialization of the system for at-home administration of RYSTIGGO, potentially broadening the addressable market for the device.
2. Q4 Performance Expectations
Analysts forecast KORU Medical to report a $0.02 per share loss and $10.89 million in revenue for the quarter ended December 2025, reflecting a 23.2% year-over-year sales increase and a 33.3% improvement in EPS loss. Consensus estimates have remained unchanged over the past 30 days, providing a stable baseline for assessing actual results and management commentary.