KORU Medical Plans to Pursue FDA Approval for FreedomEDGE Infusion System in Late 2025 to Early 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 18 2025
0mins
Source: NASDAQ.COM
510(k) Application Submission: KORU Medical Systems plans to submit a 510(k) application to the FDA for its FreedomEDGE Syringe Infusion System in late 2025 or early 2026, seeking clearance for use with a commercial oncology drug.
Infusion System Overview: The FreedomEDGE Infusion System is designed for large-volume subcutaneous drug delivery, proven with over 15 years of use, 45,000 patients, and 2 million annual infusions across more than 30 countries.
Multicenter Study Presentation: KORU Medical will present data from a multicenter study comparing the FreedomEDGE System to manual push techniques at the ESID/EHA/SIOPE Focused Symposium in November 2025, highlighting high satisfaction rates among nurses and patients.
Stock Performance: KRMD's stock has traded between $4.32 and $4.57 over the past year, closing at $4.49, reflecting a 3.94% increase in the latest trading session.
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Analyst Views on KRMD
Wall Street analysts forecast KRMD stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for KRMD is 6.25 USD with a low forecast of 4.00 USD and a high forecast of 8.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Analyst Rating
4 Buy
1 Hold
0 Sell
Strong Buy
Current: 5.520
Low
4.00
Averages
6.25
High
8.00
Current: 5.520
Low
4.00
Averages
6.25
High
8.00
About KRMD
KORU Medical Systems, Inc. is a medical technology company. The Company is focused on developing, manufacturing, and commercializing patient-centric large volume subcutaneous infusion solutions primarily for the subcutaneous drug delivery market. The Company is focused on its mechanical infusion products, the FREEDOM Infusion Systems (FREEDOM System), which include the FREEDOM60 Syringe Driver, the FreedomEdge Syringe Driver, HIgH-Flo Subcutaneous Safety Needle Sets and Precision Flow Rate Tubing. The Company’s infusion devices work together as a system to deliver life-saving therapies to patients with chronic illnesses, such as primary immunodeficiency diseases (PIDD) and chronic inflammatory demyelinating polyneuropathy (CIDP). The FREEDOM System operates at a lower pressure than an electrical, volumetric pump and maintains a balance between what a patient’s subcutaneous tissues can tolerate and what the system delivers.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
KORU Medical Receives FDA Clearance for RYSTIGGO Infusion System
- FDA Approval: KORU Medical has received FDA clearance for the FreedomEDGE® infusion system to deliver RYSTIGGO® therapy to patients with generalized myasthenia gravis, reinforcing the company's leadership in the large-volume subcutaneous infusion market.
- Increased Treatment Flexibility: The approval allows healthcare professionals to provide flexible treatment options in clinical settings, which is expected to significantly enhance patient access to care and improve quality of life.
- Significant Market Potential: RYSTIGGO®, a novel biologic administered weekly at 3mL-6mL over six weeks, with subsequent cycles based on clinical evaluation, demonstrates vast potential in treating chronic autoimmune disorders.
- Strategic Expansion Plans: KORU Medical aims to extend the Freedom platform to more drug therapies and patient populations, further enhancing its market competitiveness and driving future growth and innovation.
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KORU Medical Submits 510(k) for FreedomEDGE® System to Administer PHESGO®
- Market Expansion Milestone: KORU Medical's submission of a 510(k) application aims to utilize the FreedomEDGE® infusion system for subcutaneous administration of PHESGO®, marking a significant step in the company's strategy to penetrate the oncology infusion market, which is expected to enhance market share and meet rising demand.
- Technological Innovation: The system is designed to support large-volume subcutaneous drug delivery, streamlining clinical workflows and is anticipated to significantly improve nursing satisfaction while reducing patient treatment time, thereby enhancing overall treatment efficiency.
- Alignment with Industry Trends: As cancer therapies shift from intravenous to subcutaneous delivery, KORU Medical's technological advancements not only align with this trend but also position the company to potentially lead in the future drug delivery device market.
- Future Growth Potential: KORU Medical anticipates market entry upon FDA approval, which will lay the groundwork for long-term growth in the oncology sector and further solidify its leadership in patient-centric solutions.
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