KORU Medical Systems, Inc. has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for its FreedomEDGE® infusion system, seeking clearance to use the device with PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf), a subcutaneous co-formulation used to treat HER2-positive breast cancer. The move marks a strategic expansion of the system beyond its original indications in immunoglobulin therapies into the oncology infusion center market

What this signals about subcutaneous biologics and infusion care delivery

The regulatory filing represents more than a device clearance; it underscores a broader industry pivot toward subcutaneous delivery as a scalable, patient-friendly alternative to intravenous infusions in oncology. PHESGO® itself is emblematic of this shift. Co-formulated with hyaluronidase, it allows large volumes of trastuzumab and pertuzumab to be delivered subcutaneously, reducing infusion chair time from 60–150 minutes to 5–8 minutes in some cases.

If cleared, KORU Medical’s FreedomEDGE® could offer oncology providers a non-electric, mechanically controlled device to administer high-viscosity, large-volume biologics with less setup time, consistent flow rates, and greater portability than electric pumps. This aligns with ongoing efforts across cancer centers to optimize workflow, improve patient experience, and reduce nursing burden in high-throughput environments.

Industry observers note that PHESGO® already enjoys widespread adoption due to its fixed-dose combination and speed of administration, particularly in HER2+ breast cancer treatment across both early and metastatic stages. Adding a specialized device platform to improve the subcutaneous delivery experience could further embed SC administration as a standard of care in appropriate patient cohorts.

Why workflow matters more than ever in oncology infusion centers

The potential clearance of FreedomEDGE® for use with PHESGO® comes at a time when infusion centers are under increasing pressure. Staffing shortages, expanded patient volumes, and reimbursement constraints are forcing clinics to look for efficiencies. Mechanical infusion systems like FreedomEDGE® offer a means to deliver consistent drug flow without electricity, complex programming, or high training burdens.

A 2025 nursing preference survey presented at the ESID–EHA–SIOPE Focused Symposium highlighted a clear preference among nurses for mechanically regulated subcutaneous pumps over manual push methods, citing greater consistency, fewer ergonomic challenges, and improved comfort for patients

KORU Medical’s leadership is positioning the FreedomEDGE® system as a means to both simplify and streamline the subcutaneous delivery workflow. Its compatibility with high-viscosity drugs, adjustable flow rate tubing, and high-adherence track record in home immunoglobulin therapy offer some confidence in its applicability in oncology settings. However, industry observers caution that transition from immunology to oncology is not without complexity, given differences in administration protocols, clinical oversight requirements, and reimbursement models.

What this reveals about device-enabled expansion into oncology markets

KORU Medical’s move into oncology is a calculated bet on the convergence of drug formulation innovation and device integration. The Freedom System, which includes the FreedomEDGE® and Freedom60® syringe drivers, has over 15 years of commercial use and supports 2 million infusions annually across 45,000 patients in home-based care, primarily for subcutaneous immunoglobulin delivery

Expanding into oncology marks a transition from home infusion therapy to infusion center-based administration—a materially different care environment. While subcutaneous administration is gaining traction in cancer care, much of the infrastructure remains built around IV protocols. Devices that can integrate into existing nurse-led workflows without adding training burdens or new software requirements may find stronger traction.

However, device adoption in oncology is often tightly coupled with drug-specific co-labeling or co-marketing strategies. In this case, KORU Medical is not the manufacturer of PHESGO®, which is co-developed by Genentech (a member of the Roche Group). The success of the FreedomEDGE® in this setting may depend not only on FDA clearance but also on uptake by providers already familiar with PHESGO®’s subcutaneous regimen.

Regulatory watchers suggest that gaining 510(k) clearance for use with PHESGO® could open doors to similar co-formulated subcutaneous biologics in the pipeline or already approved, including those used in hematologic malignancies, immunotherapy, and autoimmune conditions.

What could slow down adoption even if clearance is granted

While the FDA 510(k) pathway generally offers a clearer regulatory route than de novo or PMA filings, clearance alone does not guarantee adoption. Key challenges include:

Clinical protocols: Infusion centers may be reluctant to alter established administration protocols without head-to-head studies demonstrating superior workflow or patient outcomes.

Reimbursement: Subcutaneous administration of oncology drugs typically involves separate coding and may not incentivize device use unless cost savings or operational benefits are demonstrated.

Manufacturer alignment: Without direct alignment between KORU Medical and biopharma companies developing subcutaneous biologics, there may be limited co-promotion, educational support, or bundled pricing.

Training: While the FreedomEDGE® system requires minimal setup, new devices—especially in oncology—must often pass internal review boards, nursing education checks, and safety committee evaluations before use.

Clinicians tracking the subcutaneous oncology landscape suggest that a major tailwind could come from provider fatigue around intravenous administration logistics, coupled with increased confidence in subcutaneous efficacy and safety data. In that context, devices like FreedomEDGE® may serve as enablers rather than disruptors.

What’s next for KORU Medical as it targets broader infusion markets

Assuming FDA clearance is granted, KORU Medical Systems could position itself as a platform company for large-volume subcutaneous drug delivery across a wide range of therapeutic areas. With eight on-label drugs already supported across more than 30 countries, the infrastructure for global scaling is in place, though oncology demands higher levels of regulatory, safety, and commercial alignment.

The strategy may also tie into KORU Medical’s pharma services and clinical trials division, which already supports customized device adaptations for investigational products. By demonstrating interoperability with commercialized oncology biologics like PHESGO®, the company could attract additional partnerships with biopharma firms seeking user-friendly SC delivery options.

At a time when oncology drug development is rapidly expanding into fixed-dose subcutaneous formats—especially for monoclonal antibodies, bispecifics, and fusion proteins—having a clinically proven, mechanically consistent, and nurse-preferred device may give KORU Medical a unique entry point.

Yet, it remains to be seen whether infusion centers will perceive mechanical delivery systems as operationally superior to manual push or electric pump alternatives, and whether KORU Medical can execute the commercial alignment needed to gain share in a traditionally conservative segment of oncology care.

  510(k) clearance, FreedomEDGE, HER2-positive breast cancer, KORU Medical Systems, medical devices, oncology infusion centers, PHESGO, subcutaneous delivery