KORU Medical Systems said it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration to use its FreedomEDGE infusion system to deliver PHESGO, a HER2-positive breast cancer therapy, subcutaneously rather than intravenously. The filing aims to expand the system’s use in oncology and offer a simpler, more patient-friendly delivery option.
The submission aligns with the company’s strategy to shift from intravenous to subcutaneous drug delivery in oncology. KRMD said FDA clearance would make administration easier for nurses and help infusion centers operate more efficiently.
The 510(k) seeks to validate FreedomEDGE for subcutaneous oncology biologics beyond its current use in immunology. As cancer treatments move toward subcutaneous administration, the system is designed to deliver larger doses under the skin in a controlled manner, reducing patient chair time and easing physical strain on nurses. FDA clearance would indicate the system meets oncology requirements for controlled flow rates, larger volumes and consistent delivery performance.
Following the announcement, KORU shares fell 6.1% at yesterday’s close. Over the past six months the stock has climbed 58.9%, compared with a 1.1% rise for the industry and a 14.1% increase for the S&P 500. KRMD’s market capitalization is about $280.7 million.
Successful clearance and commercialization would expand KRMD’s addressable market by establishing a subcutaneous delivery platform for oncology biologics, enabling the company to enter a larger cancer care market and potentially improve workflow and efficiency for infusion centers, nurses and patients.
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