KORU Medical Systems' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by KORU Medical Systems (KRMD).
Over the past two years, KORU Medical Systems has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
FreedomEdge. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
FreedomEdge FDA Regulatory Events
FreedomEdge is a drug developed by KORU Medical Systems for the following indication: Infusion system to deliver pegcetacoplan 20 mL solution.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- FreedomEdge
- Announced Date:
- December 30, 2025
- Indication:
- Infusion system to deliver pegcetacoplan 20 mL solution
Announcement
KORU Medical Systems, Inc announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical's FreedomEDGE® infusion system to subcutaneously administer PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer.1
AI Summary
KORU Medical Systems announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration seeking clearance to use its FreedomEDGE® infusion system to deliver PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf) subcutaneously for HER2-positive breast cancer. The filing is a key step in KORU’s plan to expand FreedomEDGE beyond immunoglobulin treatments into the oncology infusion center market.
The company says subcutaneous delivery can speed drug administration, reduce patient chair time, and support a more efficient care model compared with intravenous infusions. Infusion centers still face nursing challenges such as complex workflows, long setup times, and physical discomfort for patients and staff. FreedomEDGE is designed to provide consistent, controlled large‑volume subcutaneous delivery while simplifying clinical workflows. KORU says the system could improve nursing satisfaction by reducing setup time and physical strain. The company anticipates entering the market after receiving 510(k) clearance.
Read Announcement- Drug:
- FreedomEdge
- Announced Date:
- July 2, 2024
- Indication:
- Infusion system to deliver pegcetacoplan 20 mL solution
Announcement
KORU Medical Systems, Inc announced that its state-of-the-art FreedomEdge® System has received regulatory clearance in Japan for the delivery of multiple drugs, including CSL Behring's Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical's Cuvitru SCIg, and Sobi's Aspaveli paroxysmal nocturnal hemoglobinuria (PNH).
AI Summary
KORU Medical Systems, Inc. announced that its cutting-edge FreedomEdge® System has received regulatory clearance in Japan. This significant milestone allows the system to deliver multiple drugs, including CSL Behring’s Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical’s Cuvitru SCIg, and Sobi’s Aspaveli for paroxysmal nocturnal hemoglobinuria (PNH). The approval means that patients in Japan will have increased access to advanced treatments that are both precise and patient-friendly.
The FreedomEdge® System is designed to provide reliable and efficient delivery of large volume subcutaneous therapies in both home and clinical settings. Its state-of-the-art design offers customizable treatment options tailored to meet the needs of patients and healthcare providers. This regulatory clearance in Japan marks an important step for KORU Medical Systems in broadening access to critical therapies, enhancing patient care outcomes, and strengthening its position in the international market.
Read Announcement
KORU Medical Systems FDA Events - Frequently Asked Questions
As of now, KORU Medical Systems (KRMD) has not received any FDA approvals for its therapy in the last two years.
In the past two years, KORU Medical Systems (KRMD) has reported FDA regulatory activity for FreedomEdge.
The most recent FDA-related event for KORU Medical Systems occurred on December 30, 2025, involving FreedomEdge. The update was categorized as "Provided Update," with the company reporting: "KORU Medical Systems, Inc announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical's FreedomEDGE® infusion system to subcutaneously administer PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer.1"
Currently, KORU Medical Systems has one therapy (FreedomEdge) targeting the following condition: Infusion system to deliver pegcetacoplan 20 mL solution.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:KRMD last updated on 12/31/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
