KORU Medical Submits FDA 510(k) Application for FreedomEDGE Infusion System with Oncology Biologic PHESGO
核心洞察
KORU Medical Systems has submitted a 510(k) premarket notification to the FDA seeking clearance for its FreedomEDGE (搜索) infusion system to subcutaneously administer PHESGO, a co-formulated therapy for HER2+ breast cancer (搜索).
The submission represents a strategic expansion beyond current immunoglobulin indications into the broader oncology infusion center market, addressing unmet needs in nursing workflow and patient comfort.
A multicenter study across nine Danish hospitals demonstrated strong outcomes with the FreedomEDGE (搜索) system, including high nurse and patient satisfaction rates and a 97% recommendation rate.
KORU Medical Systems has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration seeking clearance for its FreedomEDGE (搜索) infusion system to subcutaneously administer PHESGO (pertuzumab/trastuzumab/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer (搜索). The submission marks a pivotal milestone in the company's strategy to expand beyond its current immunoglobulin indications into the broader oncology infusion center market.
Strategic Market Expansion
The regulatory filing represents KORU Medical's entry into the growing oncology drug delivery device market, capitalizing on the increasing shift from intravenous to subcutaneous drug delivery for cancer therapies. This transition allows for faster drug administration and reduced patient chair time, aligning with movement towards more efficient care models.
"The submission of our 510(k) for clearance of the FreedomEDGE (搜索) with a subcutaneous oncology biologic is a pivotal milestone for KORU," said Linda Tharby, KORU Medical's President and CEO. "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."
Addressing Clinical Workflow Challenges
Despite advances in subcutaneous delivery, infusion centers continue to face unmet needs related to nursing satisfaction with drug administration, including workflow complexity associated with treatment protocols, time constraints for setup, and physical discomfort for both patients and nurses during infusions. The FreedomEDGE (搜索) system is designed to address these challenges by enabling consistent, controlled large-volume subcutaneous delivery while supporting more streamlined clinical workflows.
Clinical Evidence and Performance Data
A multicenter study conducted across nine hospitals in Denmark compared the FreedomEDGE (搜索) Infusion System with traditional manual push techniques for short-duration subcutaneous infusion in oncology and immunology settings. The evaluation demonstrated strong outcomes, including high nurse satisfaction, high patient satisfaction, and a 97% recommendation rate.
"The insights from this multicentre study highlight the company's commitment to advancing subcutaneous infusion technologies," said Brent Rutland, KORU Medical's Vice President, Global Medical and Clinical Affairs. "The FreedomEDGE (搜索) System offers a scalable, hands-free alternative that improves workflow efficiency while maintaining patient comfort."
Market-Proven Technology Platform
The Freedom Infusion System has established a strong market presence with over 15 years of clinical experience. The system has treated more than 45,000 patients with over 2 million infusions administered annually across 30+ countries. The platform maintains a 97% adherence rate and supports 8 on-label subcutaneous drugs.
The FreedomEDGE (搜索) system is designed to enable, simplify, and enhance the delivery of large-volume subcutaneous drugs, supporting drug products with various requirements for viscosity, flow rate, and delivered drug volume from 5 mL to 50 mL+. The Freedom System received its first FDA clearance in 1994 and is used for self-administration in the home by patients and delivery in clinical settings by healthcare professionals.
KORU Medical anticipates market entry upon FDA 510(k) clearance, with the regulatory filing expected to support the company's expansion into oncology infusion centers where the technology can address meaningful unmet needs in drug administration efficiency.