KORU Medical Systems announced that the U.S. Food and Drug Administration granted 510(k) clearance for its FreedomEDGE infusion system to administer RYSTIGGO (rozanolixizumab‑noli). The clearance, issued on January 29 2026, allows the company to market RYSTIGGO as a subcutaneous therapy, adding a new drug indication to its Freedom platform.
RYSTIGGO is the only FDA‑approved biologic for adults with generalized myasthenia gravis (gMG) who are anti‑acetylcholine receptor or anti‑muscle‑specific tyrosine kinase antibody positive. The drug is delivered weekly as a 3 ml to 6 ml infusion over 15 to 30 minutes. FreedomEDGE’s large‑volume design—capable of 5 ml to over 50 ml—makes it well suited for RYSTIGGO’s dosing schedule and allows use in both home and ambulatory infusion center settings.
The clearance expands KORU’s addressable market beyond its core immunoglobulin therapies. By adding RYSTIGGO, the company gains access to the gMG patient population, which is estimated to be 30,000–40,000 adults in the United States. The move also positions FreedomEDGE as a versatile platform that can accommodate future biologics, including the recently submitted oncology biologic PHESGO, reinforcing KORU’s strategy to broaden its product portfolio and capture new therapeutic areas.
Financially, KORU reported $39.07 million in revenue for the year ended December 31 2025, a 11.6% three‑year growth rate. Gross margins stood at 62.32%, but the company remains unprofitable with a net margin of –9.5% and an operating margin of –10.28%. The new clearance is expected to generate incremental revenue and improve margin profile as the company leverages its existing manufacturing and distribution infrastructure for RYSTIGGO, potentially offsetting current profitability challenges.
CEO Linda Tharby emphasized the strategic importance of the clearance, stating, “With this new FDA clearance, we are proud to further our leadership in the rapidly growing large‑volume subcutaneous infusion market, with our ninth subcutaneous drug clearance. Expanding from home administration into clinic‑based care highlights the versatility of our Freedom Infusion System to deliver life‑changing therapies wherever patients are treated.” The announcement signals confidence in the company’s platform and its ability to scale into new indications.
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