GRFS - Repro Med wins FDA clearance to expand use of FREEDOM60 Infusion System

Repro Med Systems (NASDAQ:KRMD) has added ~6.5% in the post-market after announcing the FDA 510(k) clearance for FREEDOM60 Infusion System that would expand its on-label use. Therefore, FREEDOM60 is now authorized for use in two additional subcutaneous immunoglobulin (SCIg) medications: Cutaquig manufactured by Octapharma and Xembify manufactured by Grifols (NASDAQ:GRFS). The FDA decision permitting FREEDOM60 in Xembify and Cutaquig “allows patients and providers additional options for life enhancing subcutaneous immunoglobulin therapy treatment in the home with a system that has broad patient and healthcare worker adoption,” CEO Linda Tharby noted. In November, Repro Med (KRMD) announced the FDA clearance for the use of FreedomEdge infusion pump in Hizentra prefilled syringes. Read more on the company’s Q3 2021 financials that exceeded analysts' revenue expectations.

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Repro Med wins FDA clearance to expand use of FREEDOM60 Infusion System