Developer Submits 510(k) Premarket Notification for SC Infusion System in HER2+ BC

KORU Medical Systems has submitted a 510(k) premarket notification to the FDA seeking clearance for the utilization of their FreedomEDGE® infusion system to subcutaneously administer a co-formulated therapy–pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo)—for HER2-positive breast cancer, according to a press release.¹

The infusion system enables and simplifies the delivery of subcutaneous treatments. The developer notes that the Freedom System is proven, as shown by its 15-plus years on the market, over 2 million annual infusions, 97% adherence rate, and 8 on-label subcutaneous drugs across various countries.

Notably, the developer anticipates a market entry once the FDA clears the 510(k) submission.

In June 2020, the formulation of pertuzumab, trastuzumab, and hyaluronidase was approved by the FDA for injection under the skin in adult patients with HER2-positive breast cancer that has spread to other parts of the body, and in the treatment of patients with early-stage disease.²

“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,” stated Linda Tharby, president and chief executive officer of KORU Medical Systems, in the press release.¹ “This regulatory filing and expected clearance represent 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.”

The developers also highlighted a retrospective, multicenter survey study titled “Comparing Mechanical Pump and Manual Push for Short-Duration Subcutaneous Infusions: A Nursing Preference Survey Study”, which was shared at the ESID/EHA/SIOPE Focused Symposium 2025.³ The study compared the FreedomEDGE® infusion system with traditional health care provider manual push techniques for short-duration subcutaneous infusions in oncology and immunology settings.

Results demonstrated that 91% of nurses found the system easier to use, with 91% reporting faster setup time, 81% experiencing reduced hand strain, and 97% having increased time for patient interaction. Improved comfort was observed in 73% of patients.Further, 97% of respondents would recommend the FreedomEDGE® infusion system.

Additionally, 64% reported no functionality issues; at least 1 malfunction was experienced by 24% of responders, and 12% observed a temporary slowdown in infusion. The slowdown was consistent with the system’s adaptive flow mechanism, which automatically reduces flow in response to increased pressure at the infusion site and resumes normal flow once pressure decreases. Among the nurses who encountered issues, 59% were confident in their ability to troubleshoot. Reportedly, the rate of malfunctions was “comparable to that of electronic pumps”, the study authors wrote in the poster.⁴

A total of 33 nurses across 9 hospitals in Denmark completed the survey. Those who participated administered subcutaneous infusions regularly and received standardized training on the non-electronic, spring-driven mechanical infusion system before using it in clinical practice.

The survey evaluated ease of use, training clarity, troubleshooting confidence, nurse-patient interaction, and physical comfort for providers and patients.

A separate paper highlighted that large-volume subcutaneous drug delivery can enhance patient outcome through the enabling of self-administration, minimizing hospital visits, and optimizing the treatment process.³

Subcutaneous administration of immunoglobulin therapy also has a favorable safety profile compared with intravenous infusion of the same treatment. Subcutaneous immunoglobulin also results in gradual absorption and release of immunoglobulin therapy, which ultimately reduces systemic adverse effects and the occurrence of adverse effects.

References

1. KORU Medical Systems announces 510(k) submission for clearance of the FreedomEDGE® System with a commercialized oncology biologic. News release. KORU Medical Systems. December 30, 2025. Accessed January 2, 2025. https://tinyurl.com/yc8352hm
2. FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer. FDA. June 29, 2020. Accessed January 2, 2026. https://tinyurl.com/3eze5ejy
3. Majapuro-Hirvonen A, Wilkinson M, Bosshard J, Rutland B. Comparing mechanical pump and manual push for short-duration subcutaneous infusions: A nursing preference survey study. Presented at ESID EHA SIOPE Focused Symposium 2025; November 18-20, 2025; Vienna, Austria.
4. Wu A, Rutland B, Southworth C, Bosshard J, Wall D. The transformative potential of large-volume subcutaneous drug delivery: A discussion of current capabilities and future prospects for pharmaceutical manufacturers. Discover Pharmaceutical Sciences. 2025;1:11. doi:10.1007/s44395-025-00012-6