Koru Medical gets 510k clearance for delivery of Rystiggo

KORU Medical (KRMD) “announced that the Company received U.S. Food and Drug Administration clearance for use of the KORU Medical FreedomEDGE(R) infusion system to deliver RYSTIGGO, a therapy commercialized globally by UCB, Brussels, Belgium. The clearance for the FreedomEDGE(R) label includes indicated administration by a healthcare professional, increasing flexibility and access for patients living with generalized myasthenia (gMG). RYSTIGGO(R) is a novel biologic approved to treat adults with generalized myasthenia gravis (gMG), a rare, chronic autoimmune disorder that affects communication between nerves and muscles. RYSTIGGO(R) is administered as a weekly infusion of 3mL-6mL of drug over 15-30 minutes for 6 weeks, with subsequent treatment cycles based on clinical evaluation.”