KORU Medical Eyes Oncology Market with Cancer Drug Delivery System

MAHWAH, N.J. – December 30, 2025 – KORU Medical Systems has taken a significant step toward entering the lucrative oncology market, announcing today its submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA). The submission seeks clearance for its FreedomEDGE® infusion system to be used with PHESGO®, a widely used subcutaneous therapy for HER2-positive breast cancer.

This move signals a pivotal strategic expansion for the medical technology company, which has historically focused on treatments for immune deficiencies. If cleared, the approval would position KORU’s established technology at the forefront of a major shift in cancer care: the move away from time-consuming intravenous (IV) infusions toward faster, more efficient subcutaneous (SC) drug delivery.

The Shift from Vein to Skin in Cancer Treatment

The landscape of cancer therapy is undergoing a quiet revolution. For decades, the image of a cancer patient was tied to long hours spent in a clinic, tethered to an IV drip. Now, a growing number of biologic drugs, including powerful cancer treatments, are being reformulated for subcutaneous delivery—an injection into the tissue just beneath the skin.

This transition offers profound benefits for patients and healthcare systems alike. Research shows that switching from IV to SC administration can dramatically reduce treatment time. In some cases, infusions that once took several hours can be completed in minutes. For example, studies on SC versions of the cancer drug trastuzumab have shown potential time savings of up to 330 minutes per administration. This allows patients to reclaim significant portions of their lives, reducing the overall burden of treatment. Patients often report a "huge life improvement," expressing a desire to "want their time back" from the infusion chair.

Beyond convenience, the benefits are clinical and economic. Subcutaneous delivery is often associated with a lower risk of infusion-related reactions compared to IV methods. For healthcare providers and hospitals, the efficiency gains are substantial. Faster administration frees up valuable chair time in busy oncology infusion centers, allowing more patients to be treated. Economic analyses have estimated that SC delivery can lead to non-drug cost savings of 45% to 54% per administration, stemming from reduced drug preparation time, less medical waste, and optimized use of staff resources.

A Strategic Leap into a New Market

For KORU Medical Systems, this FDA submission is more than just a new product application; it represents a calculated pivot into the multi-billion dollar oncology sector. The company's Freedom Infusion System has been a reliable workhorse in the subcutaneous immunoglobulin (SCIg) market for over 15 years, serving more than 45,000 patients annually. With this foundation of expertise in large-volume subcutaneous delivery, KORU is now leveraging its proven technology to tap into a much larger and rapidly growing field.

This strategic move comes at a time of strong financial momentum for the company. KORU reported revenue of $33.65 million in 2024, a nearly 18% increase from the previous year, and has projected further growth of 20-22% for 2025. This performance has not gone unnoticed by investors, with the company's stock (NASDAQ: KRMD) surging nearly 70% over the past six months. Analyst sentiment is overwhelmingly positive, with an average "Strong Buy" rating and confidence in the company's growth trajectory.

Linda Tharby, KORU Medical’s President and CEO, emphasized the importance of the submission in the company's press release. “The submission of our 510(k) for clearance of the FreedomEDGE® with a subcutaneous oncology biologic is a pivotal milestone for KORU. It sets the foundation for future growth and underscores our strategy to expand KORU’s leadership into the growing drug delivery device market for oncology therapies,” she stated.

Improving the Infusion Experience for Patients and Nurses

While PHESGO® is already an SC drug, KORU Medical aims to solve a different problem: the administration experience itself. In busy oncology clinics, nurses face challenges related to workflow complexity, time constraints, and the physical discomfort that can arise from manual "push" injections of large-volume drugs. KORU's FreedomEDGE® system is a mechanical pump designed to address these unmet needs.

The system provides a consistent, controlled flow rate, which can enhance patient comfort and ensure the drug is delivered according to precise specifications. This automation streamlines the process for nurses, freeing them from the need to perform a manual injection that can take several minutes. A pilot study of KORU's oncology system highlighted its appeal to healthcare professionals, with 97% of participating nurses indicating a preference for the device over manual methods.

"This regulatory filing and expected clearance represents an exciting opportunity to enter a new point of care where we believe our technology can address a meaningful unmet need by improving the administration experience for nurses while supporting greater efficiency in oncology infusion centers,” Tharby added in her statement. By simplifying the delivery of a critical therapy for HER2-positive breast cancer, which affects 15-20% of all breast cancer patients, the system has the potential to improve both the standard of care and the quality of life for a significant patient population.

The Regulatory Path and Market Outlook

KORU Medical is seeking clearance through the FDA's 510(k) pathway, the most common regulatory route for medical devices in the United States. This process requires the company to demonstrate that its device is "substantially equivalent" to a legally marketed predicate device. While the FDA's official goal is to review such submissions within 90 days, the timeline can be extended if the agency requests additional information.

Assuming a successful review, KORU Medical anticipates a market entry soon after receiving FDA clearance. The company's focus on improving the administration of existing SC oncology drugs like PHESGO® could give it a strong foothold in infusion centers looking to optimize their operations. With several other high-profile cancer drugs also available in or transitioning to subcutaneous formulations, the market for reliable, large-volume delivery devices is poised for significant growth.

This initial step with a breast cancer therapy could pave the way for the FreedomEDGE® system to be used with a wider range of oncology biologics in the future, solidifying KORU Medical's transformation from a niche player in immunology to a key innovator in the broader landscape of modern cancer treatment.