KORU Medical Shares Surge On FDA Approval For FreedomEdge Infusion Pump

The FDA gave 510k clearance to Repro Med Systems Inc dba KORU Medical Systems KRMD FreedomEdge infusion pump.
The approval comes for the delivery of Hizentra [immune globulin subcutaneous (human) 20% liquid] 20 mL prefilled syringes.
Hizentra is indicated for primary immune deficiency (Pl) in patients 2 years and older and as maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
The Company posted Q3 sales of $6.0 million, (0.7)% Y/Y lower. Adjusted net revenue grew 9%, with growth in all business areas; domestic core driven by pumps, international was driven by consumables.
The gross margin was 57.9%, a decline from the prior year of 64.8%, driven by delays in the transition to the second manufacturing facility.
Net loss was $(1.1) million, compared with net income of $0.2 million.
Price Action: KRMD shares are up 8.51% at $3.06 during the premarket session on the last check Thursday.