KORU Medical Systems, Inc. (KRMD): Marketing Mix Analysis [Dec-2025 Updated]

You're looking for a sharp, data-driven breakdown of KORU Medical Systems, Inc.'s market strategy, and honestly, the 4 P's are the perfect lens to map their accelerating growth and pipeline bets. Having spent two decades analyzing med-tech, I can tell you this company is making serious moves, especially with international revenue jumping a massive 230% in Q3 2025 while guiding full-year revenue toward $41.0 million. We'll map out exactly how their core subcutaneous infusion system, coupled with aggressive pharma partnerships, is shaping their Product, Place, Promotion, and Price right now. Dive in to see the concrete actions driving this trajectory.

KORU Medical Systems, Inc. (KRMD) - Marketing Mix: Product

The product element for KORU Medical Systems, Inc. centers on its platform for large-volume subcutaneous infusions, primarily serving the Subcutaneous Immunoglobulin (SCIg) therapy market.

The core offering is the Freedom Syringe Infusion System, which includes the Freedom60® and FreedomEDGE® Syringe Infusion Drivers, Precision Flow Rate Tubing™, and HIgH-Flo Subcutaneous Safety Needle Sets™. This system is market-proven, supporting over 45,000+ patients and facilitating more than 2 million infusions annually across over 30+ countries. The Freedom System first received FDA clearance in 1994.

The system is designed to support drug products with varying requirements for viscosity, flow rate, and delivered drug volume, ranging from 5 mL to 50 mL+ for the FreedomEDGE® and larger volumes for the Freedom60®. The core focus remains on SCIg therapy delivery, with the US SCIg market seeing growth in the 8% to 9% range overall as of late 2025. KORU Medical Systems is targeting to accelerate its overall market share from the mid-teens into the 40% range, which represents a $10 million to $20 million opportunity over the next several years.

The company's financial performance reflects the strength of this product base; full year 2025 revenue guidance was raised to $40.5 million to $41.0 million, representing 20% to 22% year-over-year growth. The core business, driven by the Freedom System and consumables, generated $9.8 million in net revenues in Q3 2025, marking a 30% increase year-over-year.

Pipeline expansion is actively targeting oncology and new rare disease biologics via Pharma Services and Clinical Trials (PST) collaborations. KORU Medical Systems is planning to submit a 510(k) application to the FDA for the FreedomEDGE System's use with a commercialized oncology drug in either Q4 2025 or Q1 2026. A U.S.-based oncology pilot program was launched with over 50 patients across 6 infusion centers. Furthermore, the company announced 2 new PST collaborations in Q3 2025, and a partnership with ForCast Ortho targets approximately 140,000 potential infusions in the orthopedic space.

New consumable and system design focus is showing positive results in usability and comfort metrics, particularly with the FreedomEDGE System in infusion centers. A multicenter evaluation across nine hospitals in Denmark demonstrated significant improvements over manual push techniques:

• 97% recommendation rate for the FreedomEDGE® Infusion System.
• 91% of nurses found the system easier to use.
• 81% of nurses experienced reduced hand strain.
• 73% of patients observed improved comfort.

KORU Medical Systems, Inc. (KRMD) - Marketing Mix: Place

KORU Medical Systems, Inc. (KRMD) employs a distribution strategy centered on both established domestic channels and rapidly expanding international markets for its Freedom Infusion System.

The core distribution model reflects a dual approach:

• US Domestic Market: Core business sales in the U.S.
• Accelerating International Markets: Focus on global share gains, particularly driven by prefilled syringe conversions in Europe.

The primary intended use setting for the Freedom Infusion System is patient self-administration in the home, supported by over 15+ years of use in this setting.

Distribution also supports use in clinical settings, specifically for delivery in an ambulatory infusion center by a healthcare professional.

The financial performance of the international segment in the third quarter of 2025 highlights the acceleration in this area:

This international growth is directly linked to the conversion of the market from vials to prefilled syringes using the Freedom Infusion System.

KORU Medical Systems is targeting significant market share expansion within the Out-of-U.S. (OUS) Subcutaneous Immunoglobulin (SCIg) market, which is valued at approximately $60 million.

• Targeting market share acceleration into the 40% range.
• Current international market share has grown from roughly 10% to 15%-20% of the $60 million OUS SCIg market.
• This acceleration represents a potential opportunity of $10 million to $20 million over the next several years.

The company raised its full-year 2025 net revenues guidance to a range of $40.5 million to $41.0 million, representing year-over-year growth of 20% to 22%.

KORU Medical Systems, Inc. (KRMD) - Marketing Mix: Promotion

You're looking at how KORU Medical Systems, Inc. (KRMD) is communicating its value proposition to the market as of late 2025. Promotion here is heavily weighted toward strategic partnerships and direct engagement with the investment community to support pipeline advancement and market positioning.

Strategic Pharma Services and Clinical Trials (PST) Collaborations

KORU Medical Systems is actively promoting its Pharma Services and Clinical Trials (PST) business as a key growth driver. This involves securing agreements with biopharma companies to use the Freedom System in their drug development process. As of the third quarter of 2025, the company announced two new PST collaborations. These collaborations are designed to expand the reach of the Freedom System into new patient populations. Furthermore, a recent partnership with ForCast Ortho entered the orthopedic space, representing an opportunity of approximately 140,000 potential infusions. The company also announced a development agreement for next-generation subcutaneous immunoglobulin (SCIg) infusion systems, supporting the qualification of a system that accommodates both vials and prefilled syringes (PFS).

Here's a quick look at the scale of their current and recent partnership activity:

Active Engagement with the Financial Community

KORU Medical Systems management has been highly visible, actively engaging with the financial community through participation in several key investor conferences in late 2025. This outreach is critical for communicating the raised 2025 revenue guidance of $40.5 million to $41.0 million, representing 20%-22% year-over-year growth. The company also presented data at the ESID/EHA/SIOPE Focused Symposium, held November 18-20, 2025, in Vienna, Austria.

The late 2025 investor engagement schedule included:

• 16th Annual Craig-Hallum Alpha Select Conference: November 18th, 2025
• Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum: November 20th, 2025
• Piper Sandler's 37th Annual Healthcare Conference: December 2nd, 2025

Marketing Emphasis: Subcutaneous Therapy and Prefilled Syringes

The core promotional message centers on enabling the market shift toward subcutaneous (SC) therapy, positioning the Freedom System as the solution for large-volume delivery. CEO Linda Tharby noted that market dynamics continue to support this shift. KORU Medical Systems' Freedom60® and FreedomEDGE® infusion pumps were the first devices to receive 510(k) clearance for use with prefilled syringes (PFS). This focus on PFS is a major differentiator; prior studies showed up to an 80% reduction in drug preparation tasks for patients using PFS with the Freedom system compared to vials. The company is targeting an acceleration of its overall market share from the mid-teens into the 40% range in the $60 million OUS SCIg market over the next several years.

Promotion of New Drug Indications

Promotion efforts are tied directly to pipeline advancement, particularly in oncology. The company is on track for a 510(k) submission to the FDA for oncology market entry expected in Q4 2025 or Q1 2026, with commercial entry anticipated in the second half of 2026. This follows a feasibility study announced for an FDA and EMA approved subcutaneous oncology biologic drug. Furthermore, KORU Medical Systems planned to submit two additional commercialized drugs for 510(k) clearance by the end of 2025. Data supporting the FreedomEDGE System in oncology and immunology settings, from a multicentre study across nine hospitals in Denmark, demonstrated strong outcomes, including a 97% recommendation rate among nurses.

New Chief Commercial Officer Appointment

To accelerate these global commercial and PSD strategies, KORU Medical Systems appointed Adam Kalbermatten as Chief Commercial Officer, effective July 28, 2025. Adam brings over two decades of commercial leadership experience in the medical device and pharmaceutical industries. His mandate includes overseeing global commercial strategy, covering marketing, sales, market access, and pharmaceutical customer engagement. His prior role was Vice President and General Manager of Advanced Drug Delivery Systems at Becton Dickinson (BD).

The CCO's background is being promoted as directly relevant to KORU Medical Systems' current focus:

• Scaling businesses and building high-performing teams
• Deep customer relationships in the market
• Experience with drug-device combination products (as CEO of ZebraSci)

The company is definitely focused on leveraging this new leadership to drive growth.

KORU Medical Systems, Inc. (KRMD) - Marketing Mix: Price

Price, for KORU Medical Systems, Inc., is reflected in the updated financial outlook and the dynamics influencing their Average Selling Price (ASP) across different geographies.

The company has demonstrated pricing power and market traction, leading to an upward revision of its revenue expectations for the current fiscal year.

The current gross margin of 60.2% for the third quarter of 2025 is below the reaffirmed full-year guidance range of 61% to 63%. This compression is directly attributed to strategic shifts in the sales mix.

The current gross margin is impacted by a geographic shift to lower Average Selling Price (ASP) markets, which is a direct consequence of strong international expansion.

• International revenue surged by 230% year-over-year in Q3 2025.
• Domestic core revenues saw a 5.0% decrease in Q3 2025.
• The Q3 2025 gross margin decrease was 320 basis points year-over-year.
• Tariff impacts accounted for approximately 50 basis points of the Q3 margin decrease.

KORU Medical Systems is expecting to achieve positive cash flow from operations for the full year 2025, a key indicator of sustainable financial health.

The company expects future gross margins to improve toward long-range targets through planned efficiencies, even as international growth continues to contribute a higher mix of lower ASP sales in the near term.