KRMD's 510(k) Submission for FreedomEDGE in Oncology: Strategic Expansion and Unmet Clinical Needs Drive Investment Potential

KORU Medical Systems (KRMD) has taken a pivotal step in its strategic evolution by submitting a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) in December 2025 for its FreedomEDGE® infusion system to deliver PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer according to company announcement. This move marks the company's deliberate expansion into the oncology infusion center market, a sector grappling with significant unmet clinical needs. By leveraging its 15-year-established subcutaneous (SC) infusion technology, KRMD aims to address workflow inefficiencies, staffing challenges, and patient/nurse dissatisfaction, positioning itself for substantial revenue growth and market share capture.

Unmet Clinical Needs in Oncology Infusion Centers

Oncology infusion centers face systemic challenges that hinder operational efficiency and patient care. A 2023 survey revealed that 64% of infusion centers reported staffing shortages as a major obstacle, with nurse-to-patient ratios worsening by 15% year-over-year and patient wait times increasing by 13% according to industry data. Additionally, 40% of centers cited unbalanced appointment schedules-concentrating too many patients midday-as a primary barrier to smooth operations according to a recent survey. These inefficiencies contribute to nurse burnout, delayed treatments, and suboptimal patient experiences.

KRMD's FreedomEDGE system is designed to mitigate these pain points. The device enables hands-free, controlled SC drug delivery, reducing chair time and streamlining clinical workflows. A multicenter study conducted in Denmark demonstrated that 91% of nurses found the system easier to use, with 91% reporting faster setup times according to clinical results. Notably, 70% of nurses using FreedomEDGE in U.S. oncology trials were able to multitask during infusions, a critical advantage in understaffed environments according to trial findings. These findings underscore the system's potential to alleviate workflow bottlenecks and improve nurse satisfaction, directly addressing the sector's most pressing challenges.

Strategic Market Expansion and Technological Advantages

KRMD's pivot into oncology aligns with a broader industry trend: the shift from intravenous (IV) to SC drug delivery for cancer therapies. SC administration offers faster treatment times, reduced hospital stays, and lower risk of complications compared to IV infusions according to market analysis. By securing FDA clearance for FreedomEDGE with PHESGO-a therapy with a well-established market-KRMD can rapidly scale its oncology footprint. The company anticipates market entry by mid-2026, pending 510(k) clearance according to company guidance.

The oncology infusion market itself is poised for growth. While precise 2025 market size figures remain undisclosed, the global oncology market is projected to reach $668.26 billion by 2034, driven by rising cancer incidence and advancements in precision medicine according to market research. KRMD's existing expertise in SC immunoglobulin (SCIG) delivery provides a proven foundation for oncology adoption. With FreedomEDGE already validated for large-volume SC infusions across multiple indications, the company is well-positioned to capitalize on this transition.

Revenue Potential and Financial Momentum

KRMD's recent financial performance reinforces its growth trajectory. In Q3 2025, the company reported $10.4 million in revenue, a 27% year-over-year increase, driven by international expansion and demand for its SCIG solutions according to Q3 earnings. International core revenues surged by 229.6%, reflecting strong adoption of prefilled syringe systems according to financial results. The anticipated FDA clearance for FreedomEDGE in oncology could further accelerate revenue, particularly as the system's efficiency gains attract payers and providers seeking cost-effective solutions.

Moreover, KRMD's partnerships with pharmaceutical companies to expand FreedomEDGE's application to new therapies could unlock additional revenue streams. The company recently announced two new collaborations, broadening the system's reach to diverse patient populations according to press release. These strategic alliances, combined with the oncology market's projected growth, suggest a compelling upside for investors.

Conclusion

KRMD's 510(k) submission for FreedomEDGE represents more than a regulatory milestone-it is a calculated move to address systemic inefficiencies in oncology infusion centers while capitalizing on a $668 billion market. By solving workflow complexities, reducing nurse burnout, and aligning with the shift to SC delivery, the company is poised to capture a significant share of the oncology infusion landscape. With a robust financial foundation and a clear value proposition, KRMD's strategic expansion into oncology presents a compelling case for future revenue growth and stock upside.