KORU Medical Systems, Inc. has submitted a 510(k) premarket notification to the United States Food and Drug Administration seeking clearance for the use of its FreedomEDGE infusion system to administer PHESGO, the fixed-dose subcutaneous formulation of pertuzumab, trastuzumab, and hyaluronidase-zzxf used for HER2-positive breast cancer. The regulatory filing marks the company’s first formal attempt to expand beyond immunoglobulin therapies and enter the oncology infusion center market with a device-based solution.

Why the oncology pivot marks a strategic shift in KORU Medical’s platform ambition

The FreedomEDGE system is already well-established in immunoglobulin delivery, but its adaptation to oncology therapy represents a significant platform extension. PHESGO, developed by F. Hoffmann-La Roche Ltd., is approved as a rapid subcutaneous injection alternative to intravenous pertuzumab and trastuzumab. KORU Medical is now seeking to build on this evolution by proposing a mechanical delivery system that offers more standardized control and workflow compatibility compared to manual push methods.

This strategic pivot positions the New Jersey-based medical technology company within a broader trend toward decentralization and simplification of biologic drug administration. Oncology infusion centers face growing pressure to reduce patient chair time, nurse workload, and cost per treatment. A subcutaneous infusion platform that enables hands-free operation and consistent large-volume delivery could potentially transform a range of current administration models, especially if it secures FDA clearance for oncology indications.

Industry observers note that this move represents more than just an incremental extension. While the use of FreedomEDGE with immunoglobulin therapies is mature and broadly adopted, applying it in an oncology setting with a subcutaneous biologic marks a new regulatory and clinical challenge. KORU Medical is attempting to turn a specialty delivery system into a multi-indication platform that could be paired with other subcutaneous cancer therapies in the future.

Clinical usability data from Denmark hints at strong nurse and patient support

KORU Medical’s platform momentum has been partly anchored by its recent multicenter usability study across nine hospitals in Denmark. The study, conducted in oncology and immunology infusion settings, compared the FreedomEDGE infusion system with traditional manual push administration techniques for short-duration subcutaneous infusions. According to the findings, more than 90 percent of nurses reported easier setup, reduced hand strain, and improved ability to interact with patients. Meanwhile, 73 percent of patients noted improved comfort during infusion, and nearly all nursing respondents recommended the system for broader use.

Although the study did not include clinical efficacy endpoints, its results offer important qualitative insights into the operational advantages of the platform. In a care setting where nursing burnout and workflow bottlenecks are rising, such advantages may prove more decisive for adoption than marginal improvements in speed or drug utilization efficiency.

From a regulatory perspective, the company has built a narrative of user-led validation. Presenting these results at the ESID/EHA/SIOPE Focused Symposium 2025 was a calculated step toward aligning FreedomEDGE with the clinical and academic communities that influence standard-of-care evolution in Europe and beyond.

Device-drug pairing introduces regulatory complexity under 510(k)

The 510(k) route to FDA clearance requires KORU Medical to demonstrate that its FreedomEDGE system is substantially equivalent to existing legally marketed devices. However, by pairing the device with a specific oncology biologic, the company enters a regulatory grey zone that blends device clearance with combination product logic. The PHESGO biologic is already approved for fixed-dose subcutaneous injection, typically administered manually in an outpatient setting. Transitioning it to mechanical infusion requires new compatibility data, infusion profile validation, and possibly human factor testing.

Regulatory experts tracking device-biologic interfaces believe KORU Medical’s case could become a reference point for future 510(k) submissions involving oncology drugs. While several SC delivery devices exist for immunoglobulin, few mechanical platforms have been evaluated at scale with subcutaneous oncology therapies. The outcome of this submission may influence how regulators draw boundaries between off-label accessory use and formal combination product designation in oncology delivery.

Success will also depend on how closely the FreedomEDGE system mimics existing approved administration techniques. If the infusion profile, needle configuration, and delivery speed align with labeled recommendations for PHESGO, the FDA may view the device as functionally equivalent. However, any meaningful deviation in delivery duration or patient experience could trigger additional scrutiny or even delay market entry.

Subcutaneous oncology delivery is growing, but the device layer remains fragmented

Subcutaneous delivery of oncology biologics has expanded in recent years, driven by patient preference, payer interest in reduced costs, and logistical efficiencies for clinics. Biologics such as rituximab, daratumumab, and PHESGO are now available in subcutaneous formulations, many supported by recombinant human hyaluronidase to facilitate absorption.

However, despite these advances, the delivery device landscape remains fragmented. Manual push injections remain the default, even when they involve large-volume, high-viscosity formulations that require extended injection times and can strain both patients and providers. Infusion centers report recurring workflow problems, including nurse fatigue, inconsistent injection rates, and difficulty maintaining patient comfort.

KORU Medical’s entry into this space, if successful, could reshape the standard operating procedures for biologic administration. Mechanical infusion systems allow for controlled, standardized delivery without requiring nurse presence for the entire duration, freeing staff to manage multiple patients simultaneously. This is particularly relevant as oncology centers adapt to higher treatment volumes and tighter resource allocation.

Industry analysts suggest that the FreedomEDGE system’s real promise lies not just in enabling subcutaneous infusion, but in redefining its operational footprint within clinical environments. By decoupling therapy from full nurse supervision and allowing scalable, protocol-driven administration, mechanical infusion systems could push the oncology field closer to the care-at-home model already emerging in other chronic disease areas.

Reimbursement and real-world integration remain key hurdles

Even with FDA clearance, the path to wide adoption will depend on payer receptivity, provider training, and real-world cost-efficiency metrics. Many infusion centers operate on narrow margins and are slow to introduce new devices that disrupt established workflows or reimbursement models. While mechanical infusion may offer long-term efficiencies, short-term onboarding costs can be a deterrent, especially in smaller or underfunded oncology practices.

Compatibility with existing tubing, syringe formats, and safety needle sets will also matter. KORU Medical’s Freedom System, which includes the FreedomEDGE and Freedom60 syringe drivers along with proprietary flow rate tubing, is already approved in multiple settings. However, adaptation for oncology may require formulation-specific adjustments that introduce logistical friction.

The company has emphasized its readiness to customize the FreedomEDGE system for clinical and commercial deployment across multiple drug categories. Its pharma services arm supports clinical trials, suggesting a roadmap toward broader label expansion once the oncology use case gains initial traction. But until the FDA offers formal clearance and payers align reimbursement pathways, commercial scale remains aspirational.

What the oncology community will watch next

The oncology delivery field has often been slower to adopt new devices compared to other specialties due to the high stakes of cancer therapy, entrenched hospital protocols, and the complexity of treatment regimens. What happens with the FreedomEDGE submission could influence how future drug-device integrations are evaluated and introduced.

If cleared, KORU Medical may become the first to establish a 510(k)-cleared, large-volume subcutaneous infusion system for oncology biologics in the United States. That milestone could open the door for new delivery innovations around other SC cancer therapies, particularly those in development for home-based or decentralized care.

Until then, regulatory watchers, oncology pharmacists, and nurse administrators will be looking closely at three key issues: whether the FDA grants clearance without requiring combination product classification, how early adopters respond to training and usability workflows, and whether the FreedomEDGE platform demonstrates measurable gains in infusion center efficiency without compromising safety or treatment adherence.

KORU Medical’s bet is that device-led workflow redesign, not just drug innovation, will define the next generation of oncology care.

  FDA 510(k), FreedomEDGE, HER2-positive breast cancer, infusion centers, KORU Medical Systems, oncology drug delivery, pertuzumab trastuzumab hyaluronidase, PHESGO, subcutaneous infusion