KORU Medical Submits 510(k) for FreedomEDGE® System to Administer PHESGO®
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 30 2025
0mins
Should l Buy KRMD?
Source: Newsfilter
- 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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Analyst Views on KRMD
Wall Street analysts forecast KRMD stock price to rise
5 Analyst Rating
4 Buy
1 Hold
0 Sell
Strong Buy
Current: 3.900
Low
4.00
Averages
6.25
High
8.00
Current: 3.900
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 Presents Research at ONS Congress on Infusion Solutions
- Research Findings Presentation: KORU Medical showcased its latest research at the Oncology Nursing Society Congress, demonstrating that 100% of doses were successfully administered with the FreedomEDGE® infusion system across four community infusion centers, significantly enhancing patient safety and efficacy in drug administration.
- Reduced Nurse Strain: The study revealed that nurses experienced significantly less strain after implementing pump-assisted or tubing-needle set-assisted drug administration, allowing them to multitask during 80% of pump infusions, thereby improving overall care quality and efficiency.
- High Satisfaction Levels: Both nurses and patients reported high satisfaction levels with the FreedomEDGE® system, scoring 4.85/5 and 4.92/5 respectively, indicating a substantial positive impact on patient experience and care quality, which further strengthens KORU Medical's competitive position in the market.
- Global Recognition and Expansion: KORU Medical's Freedom system has received approval in over 30 countries and supports more than 3 million infusions annually, showcasing its widespread acceptance in patient self-administration and clinical settings, with potential for further market share expansion through ongoing innovation.
See More
KORU Medical Systems Q1 2026 Earnings Call Highlights
- Leadership Transition: CEO Linda Tharby announced her departure effective July 1, with Adam Kalbermatten succeeding her, indicating a stable leadership transition aimed at ensuring ongoing business growth and strategic execution.
- Performance Highlights: The company reported Q1 2026 revenue of $11.8 million, representing a 22% year-over-year growth, with a gross margin of 61.5%, despite pressures from rising production costs and tariffs, showcasing the company's competitive position and profitability.
- Market Outlook: KORU reiterated its full-year 2026 revenue guidance of $47.5 million to $50 million, with expectations for a heavier revenue weighting in the second half, reflecting confidence in new market and product opportunities while factoring in geopolitical risks in the Middle East.
- Product Development Dynamics: KORU has eight active non-Ig drug opportunities in development, expected to yield over 6 million annual infusions, although the decision to remove vancomycin from the pipeline indicates a strategic shift in resource allocation.
See More
Phreesia Shares Surge 5.1% Driven by Investor Optimism
- Significant Price Increase: Phreesia's stock surged 5.1% in the last trading session to close at $11.77, with trading volume significantly exceeding normal levels, indicating heightened market confidence in its future performance.
- Investor Confidence Boost: Pale Fire Capital SE purchased 1,602,505 shares of Phreesia between March 17 and 19 for approximately $18.3 million, increasing its total holdings to 7,648,829 shares, which further bolstered market optimism about the company.
- Strong Earnings Expectations: Phreesia is expected to report quarterly earnings of $0.09 per share, reflecting a year-over-year increase of 181.8%, with revenues projected at $126.37 million, up 15.2% from the previous year, showcasing the company's growth potential.
- Market Focus: Although the consensus EPS estimate has remained unchanged over the past 30 days, research indicates a strong correlation between earnings estimate revisions and stock price movements, prompting investors to closely monitor Phreesia's future performance.
See More
KORU Medical Systems Secures EU Certification for Freedom60 Infusion Pump
- EU Certification Milestone: KORU Medical Systems' Freedom60® Infusion Pump has achieved certification under the EU Medical Devices Regulation, marking a significant step towards commercialization in the EU market, which is expected to enhance the company's competitive position in Europe.
- Enhanced Product Flexibility: The Freedom60 and FreedomEDGE® infusion systems support both 50 mL and 20 mL prefilled syringes, providing clinicians and patients with greater dosing flexibility, thereby improving patient treatment experiences and adherence.
- Optimized Patient Experience: The increasing adoption of prefilled syringes simplifies the subcutaneous immunoglobulin (SCIg) therapy process by reducing medication handling steps, decreasing overall treatment burden, and enhancing patient confidence and independence in home therapy.
- Market Demand Response: CEO Linda Tharby emphasized that as prefilled syringes become more widely adopted, patients are increasingly seeking simplified treatment solutions, and the Freedom60 and FreedomEDGE systems are designed to meet this need, aiming to improve patients' quality of life.
See More
KORU Medical Systems Q4 2025 Earnings Call Highlights
- CEO Transition Plan: KORU Medical Systems' CEO Linda Tharby announced her retirement effective June 30, with Adam Kalbermatten set to become President on March 15 and CEO on July 1, ensuring continuity and stability in the company's strategic direction.
- Significant Revenue Growth: The company reported Q4 2025 revenue of $10.9 million, reflecting a 23% year-over-year increase, marking three consecutive quarters of over 20% revenue growth, with full-year revenue reaching $41.1 million, a 22% rise from 2024, indicating strong market demand and execution.
- International Market Expansion: The International Core business grew 71% in Q4 and 80% for the full year, with Tharby highlighting an increase in market share in Europe from 10% to 20%, and the expectation of adding 1 to 2 new markets each quarter, further driving revenue growth.
- Optimistic 2026 Outlook: The company anticipates 2026 revenue guidance of $47.5 million to $50 million, representing 15% to 22% growth, with plans for positive adjusted EBITDA and cash flow, reflecting confidence in future market opportunities and strategic positioning.
See More
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.
See More
KORU Medical Presents Research at ONS Congress on Infusion Solutions
- Research Findings Presentation: KORU Medical showcased its latest research at the Oncology Nursing Society Congress, demonstrating that 100% of doses were successfully administered with the FreedomEDGE® infusion system across four community infusion centers, significantly enhancing patient safety and efficacy in drug administration.
- Reduced Nurse Strain: The study revealed that nurses experienced significantly less strain after implementing pump-assisted or tubing-needle set-assisted drug administration, allowing them to multitask during 80% of pump infusions, thereby improving overall care quality and efficiency.
- High Satisfaction Levels: Both nurses and patients reported high satisfaction levels with the FreedomEDGE® system, scoring 4.85/5 and 4.92/5 respectively, indicating a substantial positive impact on patient experience and care quality, which further strengthens KORU Medical's competitive position in the market.
- Global Recognition and Expansion: KORU Medical's Freedom system has received approval in over 30 countries and supports more than 3 million infusions annually, showcasing its widespread acceptance in patient self-administration and clinical settings, with potential for further market share expansion through ongoing innovation.
See More
KORU Medical Systems Q1 2026 Earnings Call Highlights
- Leadership Transition: CEO Linda Tharby announced her departure effective July 1, with Adam Kalbermatten succeeding her, indicating a stable leadership transition aimed at ensuring ongoing business growth and strategic execution.
- Performance Highlights: The company reported Q1 2026 revenue of $11.8 million, representing a 22% year-over-year growth, with a gross margin of 61.5%, despite pressures from rising production costs and tariffs, showcasing the company's competitive position and profitability.
- Market Outlook: KORU reiterated its full-year 2026 revenue guidance of $47.5 million to $50 million, with expectations for a heavier revenue weighting in the second half, reflecting confidence in new market and product opportunities while factoring in geopolitical risks in the Middle East.
- Product Development Dynamics: KORU has eight active non-Ig drug opportunities in development, expected to yield over 6 million annual infusions, although the decision to remove vancomycin from the pipeline indicates a strategic shift in resource allocation.
See More
Phreesia Shares Surge 5.1% Driven by Investor Optimism
- Significant Price Increase: Phreesia's stock surged 5.1% in the last trading session to close at $11.77, with trading volume significantly exceeding normal levels, indicating heightened market confidence in its future performance.
- Investor Confidence Boost: Pale Fire Capital SE purchased 1,602,505 shares of Phreesia between March 17 and 19 for approximately $18.3 million, increasing its total holdings to 7,648,829 shares, which further bolstered market optimism about the company.
- Strong Earnings Expectations: Phreesia is expected to report quarterly earnings of $0.09 per share, reflecting a year-over-year increase of 181.8%, with revenues projected at $126.37 million, up 15.2% from the previous year, showcasing the company's growth potential.
- Market Focus: Although the consensus EPS estimate has remained unchanged over the past 30 days, research indicates a strong correlation between earnings estimate revisions and stock price movements, prompting investors to closely monitor Phreesia's future performance.
See More
KORU Medical Systems Secures EU Certification for Freedom60 Infusion Pump
- EU Certification Milestone: KORU Medical Systems' Freedom60® Infusion Pump has achieved certification under the EU Medical Devices Regulation, marking a significant step towards commercialization in the EU market, which is expected to enhance the company's competitive position in Europe.
- Enhanced Product Flexibility: The Freedom60 and FreedomEDGE® infusion systems support both 50 mL and 20 mL prefilled syringes, providing clinicians and patients with greater dosing flexibility, thereby improving patient treatment experiences and adherence.
- Optimized Patient Experience: The increasing adoption of prefilled syringes simplifies the subcutaneous immunoglobulin (SCIg) therapy process by reducing medication handling steps, decreasing overall treatment burden, and enhancing patient confidence and independence in home therapy.
- Market Demand Response: CEO Linda Tharby emphasized that as prefilled syringes become more widely adopted, patients are increasingly seeking simplified treatment solutions, and the Freedom60 and FreedomEDGE systems are designed to meet this need, aiming to improve patients' quality of life.
See More
KORU Medical Systems Q4 2025 Earnings Call Highlights
- CEO Transition Plan: KORU Medical Systems' CEO Linda Tharby announced her retirement effective June 30, with Adam Kalbermatten set to become President on March 15 and CEO on July 1, ensuring continuity and stability in the company's strategic direction.
- Significant Revenue Growth: The company reported Q4 2025 revenue of $10.9 million, reflecting a 23% year-over-year increase, marking three consecutive quarters of over 20% revenue growth, with full-year revenue reaching $41.1 million, a 22% rise from 2024, indicating strong market demand and execution.
- International Market Expansion: The International Core business grew 71% in Q4 and 80% for the full year, with Tharby highlighting an increase in market share in Europe from 10% to 20%, and the expectation of adding 1 to 2 new markets each quarter, further driving revenue growth.
- Optimistic 2026 Outlook: The company anticipates 2026 revenue guidance of $47.5 million to $50 million, representing 15% to 22% growth, with plans for positive adjusted EBITDA and cash flow, reflecting confidence in future market opportunities and strategic positioning.
See More
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.
See More
