KORU Medical Systems, Inc. (NASDAQ: KRMD) filed a 510(k) pre‑market notification with the U.S. Food and Drug Administration on December 30, 2025, seeking clearance for its FreedomEDGE infusion system to administer PHESGO (pertuzumab/trastuzumab/hyaluronidase‑zzxf), a HER2‑positive breast‑cancer biologic that is delivered subcutaneously.
The filing marks a strategic pivot for KORU, which has historically focused on immunoglobulin therapies. By adding an oncology biologic to its Freedom platform, the company positions itself to capture a share of the rapidly expanding subcutaneous drug‑delivery market, where oncology is the fastest‑growing application. The shift from intravenous to subcutaneous administration offers faster patient throughput and reduced chair time, benefits that are especially valuable in high‑volume infusion centers.
KORU’s financial performance provides a solid foundation for this expansion. The company reported record revenues and gross profit for full‑year 2024 and posted strong growth in Q3 2025, with revenue up 4% year‑over‑year and a 3% increase from the prior quarter. The robust cash flow and disciplined cost structure give management the flexibility to invest in new therapeutic areas while maintaining profitability.
President and CEO Linda Tharby described the filing as a “pivotal milestone” that “sets the foundation for future growth.” She acknowledged that FDA clearance is still pending but emphasized the company’s confidence in its technology and the growing demand for subcutaneous oncology solutions. Tharby also noted potential headwinds, including the need for additional clinical data and the competitive landscape in the oncology device market.
KORU’s Freedom system has a long history of FDA clearance, having first received approval in 1994 and recently gaining clearance in Japan for the same system in July 2024. The company’s competitive advantage lies in its high‑throughput, nurse‑friendly design, which has achieved a high adherence rate in existing markets. However, the oncology subcutaneous market is crowded, with several established players and new entrants, so KORU will need to differentiate through performance, cost, and integration with oncology workflows.
The 510(k) filing signals a significant shift in KORU’s product strategy and positions the company to tap into a high‑growth market segment. If the FDA grants clearance, the FreedomEDGE system could become a key revenue driver, complementing KORU’s existing portfolio and reinforcing its reputation as a leader in high‑volume subcutaneous delivery solutions.
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