KORU Medical Systems, Inc. (KRMD): Business Model Canvas [Dec-2025 Updated]

You're looking for the real engine behind KORU Medical Systems, Inc.'s (KRMD) growth, and honestly, breaking down their Business Model Canvas is the fastest way to see where the value is being built as they push toward their $40.5M-$41.0M revenue guidance for 2025. We're talking about a dual play here: supporting over 45,000 chronic Subcutaneous Immunoglobulin (SCIg) patients with their patient-centric FreedomEdge® system while simultaneously expanding high-margin Pharma Services and Clinical Trials (PST) revenue, which hit $0.58M in Q3 2025 alone. This structure, built on key partnerships with global pharma and a focus on high adherence in the home setting, shows a clear path from device sales to recurring consumable revenue, so let's dive into the nine blocks that map out their strategy for capturing more of the large-volume subcutaneous infusion market.

KORU Medical Systems, Inc. (KRMD) - Canvas Business Model: Key Partnerships

You're looking at the backbone of KORU Medical Systems, Inc.'s growth strategy, which is heavily reliant on deep, strategic alliances rather than just selling pumps off the shelf. These partnerships are what get the Freedom System into the hands of patients receiving novel or expanding subcutaneous therapies. Honestly, for a company of this size, these co-development deals are the primary engine for future revenue visibility.

The core of KORU Medical Systems, Inc.'s partnership strategy involves global pharmaceutical companies for drug-device co-development, especially in the large volume subcutaneous immunoglobulin (SCIg) space. As of the Q3 2025 update, the company highlighted a significant development agreement with a global pharma partner to create next-generation infusion systems for both commercial drugs and clinical programs, focusing on accommodating both vials and prefilled syringes (PFS). This is key because the Freedom System is already market proven with 8 on-label subcutaneous drugs.

The Pharma Services and Clinical Trials (PST) business unit acts as a direct pipeline for these relationships. In the third quarter of 2025, KORU Medical Systems, Inc. announced two new PST collaborations, specifically designed to open doors to new patient populations. Looking across the year, the pipeline has been active; by Q1 2025, there were 15 collaborations in the pipeline with potential for near-to-long-term addition to the Freedom system, and management noted nine active collaborations as of the Q3 2025 call.

The move into orthopedics via ForCast Ortho is a clear diversification play, leveraging the FreedomEDGE® pump for their Wearable Intra-Articular Infusion System (WIIS) to treat periprosthetic joint infection (PJI). This specific entry point targets a rare but serious complication, and the potential infusion volume is substantial, estimated at approximately 140,000 potential infusions. ForCast's lead program, FC001, already has Orphan Drug Designation and Qualified Infectious Disease Program (QIDP) status from the FDA, which de-risks the development pathway for KORU Medical Systems, Inc..

The technology integration with SCHOTT TOPPAC is crucial for the shift to prefilled syringes (PFS). A development agreement signed in early 2025 specifically targets a next-generation system using KORU Medical Systems, Inc.'s infusion technology alongside SCHOTT TOPPAC® polymer syringes. This collaboration is expected to be the first of multiple joint projects. The SCHOTT TOPPAC PFS are designed to meet the need for larger volumes, available in formats from 5mL to 50mL.

For international reach, KORU Medical Systems, Inc. relies on third-party distributors, which is showing massive returns. The Freedom System is currently distributed across 30+ countries. In Q3 2025, international revenue growth was reported at 230%, though management noted this was inflated by stocking orders. This expansion is actively targeting the Out-of-State (OUS) SCIg market, which is valued around $60 million, with KORU Medical Systems, Inc. aiming to increase its share from roughly 10% to 15% up to 20%. A concrete step in this global push was the launch of commercial sales in Japan during 2025.

Here's a quick look at the scale of these partnership-driven activities:

If you're modeling out 2026, the momentum from these alliances is baked into the raised full-year 2025 revenue guidance of $40.5 - $41.0 million, targeting 20% - 22% growth. Finance: draft the Q4 2025 partnership pipeline update by January 15th.

KORU Medical Systems, Inc. (KRMD) - Canvas Business Model: Key Activities

You're looking at the core engine room activities for KORU Medical Systems, Inc. as of late 2025. This is where the rubber meets the road for their revenue projections and pipeline development.

Manufacturing and quality control of infusion systems

KORU Medical Systems focuses on the production and ensuring the quality of their Freedom Syringe Infusion System components. The financial performance of this activity is directly reflected in the gross margin figures reported through 2025.

The company reiterated its full-year 2025 gross margin guidance to be in the range of 61% to 63%. To be fair, actual margins have fluctuated based on production mix and external factors; for instance, the Q3 2025 gross margin landed at 60.2%, which was slightly below the Q2 2025 margin of 63.5%. The Q1 2025 margin was 62.8%. Management noted that the Q3 2025 decrease was primarily due to higher manufacturing costs, geographic sales mix, and tariff-related charges, with an expectation for improvement in Q4 2025.

Research and development for new drug indications and devices

R&D is a major component of their operating expenses, driving future recurring revenue streams through new drug compatibility. They are actively working on next-generation hardware and expanding the platform's utility.

KORU Medical Systems announced 2 new Pharma Services and Clinical Trials (PST) collaborations in Q3 2025, adding to their pipeline of opportunities. On the device side, the next-generation pump development has a 510(k) submission expected between Q4 2025 and Q1 2026, and the Phase II flow controller submission is targeted for the first half of 2026. Total operating expenses for the full year 2025, exclusive of stock compensation, are projected to be in the range of $26 million to $27 million, with higher spending anticipated in the second half driven by R&D project work. Still, R&D expenses were lower in Q3 2025 due to severance costs.

Advancing the oncology infusion 510(k) submission

This activity is crucial for tapping into a significant, growing market segment outside of their core immunoglobulin business. They are moving methodically based on clinical data.

The oncology pilot program in the U.S. showed promising results, achieving 100% administration success across five U.S. infusion clinics. Furthermore, 70% of nurses involved in the pilot reported the ability to multitask while administering therapy. This supports their plan to file the 510(k) submission to the FDA either in Q4 2025 or Q1 2026, with commercial market entry anticipated in the second half of 2026. The total addressable market for oncology infusion consumables is projected to grow from approximately $60 million in 2025 to $138 million by 2030.

Global commercialization and international market expansion

Commercialization efforts are heavily weighted toward international growth, which is significantly outpacing domestic revenue gains in 2025. This is a key driver for their raised revenue outlook.

KORU Medical Systems raised its full-year 2025 revenue guidance to $40.5 million to $41.0 million, representing growth of 20% to 22% year-over-year. This momentum is fueled by international expansion; for example, international revenue grew by 230% year-over-year in Q3 2025, with international core revenue reaching $3.70 million in that quarter. International core revenue was $2.4 million in Q1 2025 (a 35.6% increase) and $2.2 million in Q2 2025 (a 33.9% increase). Management has a stated goal to accelerate overall market share from the mid-teens into the 40% range in the SCIg market, which represents a $10 million to $20 million opportunity over the next several years.

The core business, which includes domestic and international product sales, saw a 30% increase year-over-year in Q3 2025, reaching $9.8 million. Domestic revenue actually declined by 5% in Q3 2025.

Managing regulatory clearances (e.g., FDA, international bodies)

Securing and maintaining regulatory clearances is foundational, enabling the commercialization of the Freedom System for new drugs and indications. The system itself has a long history with the FDA.

KORU Medical Systems' Freedom Infusion System first received FDA clearance back in 1994. As part of their pipeline advancement, they submitted a 510(k) ahead of schedule in Q2 2025 for a rare disease biologic. However, another rare disease candidate submission was subsequently pushed to Q1 2026 following an FDA request.

The company is actively pursuing clearances for new drug uses, evidenced by:

• Targeting an oncology 510(k) submission by late 2025/early 2026.
• Submitting for FDA 510(k) clearance for two previously commercialized drugs with the Freedom Infusion System by the end of 2025 (as stated in Q1 2025).

Finance: draft 13-week cash view by Friday.

KORU Medical Systems, Inc. (KRMD) - Canvas Business Model: Key Resources

You're looking at the core assets KORU Medical Systems, Inc. relies on to execute its business plan as of late 2025. These aren't just line items; they are the tangible and intangible foundations supporting their revenue generation.

The intellectual property surrounding the FREEDOM Syringe Infusion System is central. This includes the Freedom60® and FreedomEDGE® Syringe Infusion Drivers, Precision Flow Rate Tubing™, and High-Flo Subcutaneous Safety Needle Sets™. The Freedom System is noted as the only infusion system approved for prefilled syringes.

Operations are anchored by a specialized manufacturing presence in Mahwah, New Jersey. The production environment is a 'Made in the USA with high quality materials in ISO 13485 facility'.

Financially, the Company has been managing its liquidity carefully. As of September 30, 2025, the cash and cash equivalents balance stood at $8.5 million. KORU Medical Systems, Inc. is reiterating its full-year 2025 guidance for an ending cash balance greater than $8.2 million.

The established user base provides a significant foundation for recurring revenue from consumables. The market-proven system supports over 45,000+ patients, who collectively account for over 2 million infusions annually.

Regulatory standing is supported by clearances for use with multiple drugs. The Freedom System is indicated for use with 8 on-label subcutaneous drugs. Furthermore, KORU Medical Systems, Inc. announced plans to submit for FDA 510(k) clearance for 2 commercialized drugs with the Freedom Infusion System™ by year-end 2025.

Here's a quick view of the key quantitative resources as of the latest reported data:

The tangible and intangible assets supporting the platform include:

• - FREEDOM Syringe Infusion System intellectual property and patents.
• - Specialized manufacturing facility in Mahwah, New Jersey.
• - Cash balance targeted to be greater than $8.2 million by year-end 2025.
• - Established base of over 45,000 chronic SCIg patients.
• - Regulatory clearances (510(k)) for multiple on-label drugs, including 8 indicated biologics.

Also, consider the operational metrics that demonstrate resource utilization:

• - Q1 2025 quarterly cash usage was $0.8 million.
• - Q2 2025 cash usage was $0.6 million.
• - Q3 2025 reflected cash generation of $0.4 million.

Finance: draft 13-week cash view by Friday.

KORU Medical Systems, Inc. (KRMD) - Canvas Business Model: Value Propositions

You're looking at the core reasons why patients and providers choose KORU Medical Systems, Inc. (KRMD)'s Freedom System. It's all about making large-volume subcutaneous infusion practical, especially outside the hospital walls.

The primary value is that KORU Medical Systems, Inc. (KRMD) enables large-volume subcutaneous infusion in the home setting. This isn't a small feat; the Freedom System is market-proven, supporting drug delivery volumes from 5 mL to 50 mL+. You can see the adoption scale:

• 15+ years on the market.
• Over 45,000+ patients treated.
• More than 2M infusions annually across 30+ countries.

This patient-centric design directly translates into high compliance, which is a huge win for chronic care management. The system boasts a high 97% adherence rate for subcutaneous immunoglobulin (SCIg) therapy. Considering KORU Medical Systems, Inc. (KRMD) is raising its full-year 2025 revenue guidance to a range of $40.5 million to $41.0 million, this adherence is clearly driving commercial success.

The Freedom System also supports prefilled syringes (PFS) for simplified administration. This is key for reducing steps for the end-user. For instance, the system already has clearance for use with Hizentra 50 mL prefilled syringes, and KORU Medical Systems, Inc. (KRMD) is actively advancing into the oncology space, planning a 510(k) submission to the FDA for use with a commercialized oncology drug in Q4 2025 or Q1 2026. This aligns with the broader PFS market, which is expected to hit USD 13.54 billion by 2030.

When you look at the clinic setting, the FreedomEdge® system allows nurses to multitask, which directly impacts workflow efficiency. We have concrete data from a multicenter nursing preference study comparing the FreedomEdge® Infusion System against traditional manual push techniques for short-duration subcutaneous infusions. Here's the quick math on what nurses reported:

Finally, the system delivers a clear benefit in terms of patient comfort, directly addressing the discomfort associated with manual syringe push. This is a critical differentiator, especially as KORU Medical Systems, Inc. (KRMD) achieved a positive adjusted EBITDA in Q3 2025, showing that better patient experience can also drive financial results. The data shows:

• 81% of nurses experienced less hand pain using FreedomEdge®.
• 73% of nurses observed less patient pain while using the system.

The system's value proposition is clearly anchored in proven patient adherence and tangible workflow improvements for clinicians. Finance: draft 13-week cash view by Friday.

KORU Medical Systems, Inc. (KRMD) - Canvas Business Model: Customer Relationships

The relationship KORU Medical Systems, Inc. cultivates with its customers centers on enabling patient self-administration and securing deep, long-term ties with pharmaceutical developers.

Dedicated clinical support for patient self-administration is foundational, as the Freedom Infusion System allows patients to self-administer therapies at home or in ambulatory settings. This patient-centric approach is evidenced by the strong performance in the core business, which saw domestic revenue increase by 16.4% in Q1 2025, driven by new patient starts and market share gains within existing accounts. The overall SCIg market growth KORU Medical Systems is operating within is estimated to be in the 8% to 9% range overall as of late 2025.

Direct sales force engagement with healthcare providers directly fuels the recurring revenue base. While domestic revenue saw a 5% decline in Q3 2025, this was set against a backdrop of significant international acceleration. The core business revenue, which includes domestic and international product sales, still grew 30% year-over-year in Q3 2025, reaching $9.8 million. This engagement is crucial for capturing share in the domestic SCIg market, which is KORU Medical Systems' largest recurring revenue base.

Long-term collaboration with pharmaceutical partners (PST) is a key growth driver, diversifying relationships beyond traditional SCIg. In Q2 2025, Pharma Services and Clinical Trials revenues reached $900,000, marking a 42.1% increase over the prior year, driven by clinical trial orders. The company announced two new PST collaborations in Q3 2025, expanding the reach of the Freedom System into new patient populations.

High-touch support for complex large-volume drug delivery is demonstrated by the active pipeline development. KORU Medical Systems is progressing in collaboration with 1 of 7 identified oncology drugs, aiming for a 510(k) submission by the end of 2025 or Q1 2026. Furthermore, the company entered the orthopedic space via a recent partnership with ForCast Ortho, targeting approximately 140,000 potential infusions. The clinical pipeline itself includes more than 95 drugs exceeding 10 mL across the pharma landscape.

The financial metrics reflecting the success of these customer-facing strategies as of Q3 2025 include:

The focus on international expansion and new collaborations is clearly shifting the revenue mix. International revenue growth accelerated significantly, with management projecting that international market share could nearly double over the next short period, driven mostly by prefills.

The company's operational success in supporting these relationships is reflected in its profitability metrics for Q3 2025:

• Adjusted EBITDA was positive at $0.09 million.
• Net loss narrowed to $0.8 million.
• Ending cash balance was $8.5 million.
• Gross margin for the quarter was 60.2%.

Management has long-range plans to push margins to 65% plus.

KORU Medical Systems, Inc. (KRMD) - Canvas Business Model: Channels

You're looking at how KORU Medical Systems, Inc. gets its infusion solutions-the Freedom Infusion System and consumables-into the hands of patients and providers. The channel strategy is clearly bifurcated between a strong domestic push and an aggressively growing international footprint.

Domestically, the primary channel relies on a direct sales force in the United States, targeting the shift from intravenous (IV) hospital settings to subcutaneous (SC) therapy in outpatient and home settings. This channel supports the core subcutaneous immunoglobulin (SCIg) business, which, as of Q1 2025, was serving approximately 45,000 chronic patients who generated over 2 million annual infusions. The direct effort translates into solid domestic core revenue; for example, in the second quarter of 2025, domestic core revenues hit \$7.1 million, marking a 15.3% increase year-over-year.

Internationally, KORU Medical Systems relies on a network of international distributors across 30+ countries, though the exact number isn't explicitly stated in the latest filings, the growth suggests significant reach. This channel is showing explosive growth; for instance, international core revenues reached \$2.2 million in Q2 2025, a 33.9% jump from the prior year. To be fair, some of that growth can be lumpy; Q3 2025 saw international revenue grow by 230% year-over-year, but management noted this was inflated by 'outsized stocking orders' and a distributor transaction. Still, the underlying trend is strong, with Q1 2025 international revenue up 36% year-over-year to \$2.4 million.

The distribution network feeds directly into key points of care, which include home healthcare providers and specialty pharmacies, where chronic patients manage their own subcutaneous infusions, and also ambulatory infusion centers and hospital settings for initial setup and specific treatments. The company is actively expanding its reach by securing prefilled tender wins in established markets and entering new geographic markets. Furthermore, the Pharma Services and Clinical Trials segment acts as a specialized channel, generating \$0.9 million in net revenues in Q2 2025, a 42.1% increase, driven by product sales for clinical trials.

Here's a quick look at how the revenue streams broke down in the second quarter of 2025, showing the relative contribution of these channels:

The focus on expanding the system's use beyond the core SCIg market is evident in their pipeline development, which directly influences future channel opportunities. You should track these milestones closely:

• Currently managing 15 pharmaceutical collaborations in progress.
• Targeting 9 commercial opportunities by 2026.
• These future opportunities represent a combined addressable market of \$2.7 billion.
• The company is targeting 30-40% market share in the international SCIg TAM, up from an estimated 10% share in Q1 2025.

The success of the direct sales force and distributor network is tied to securing new drug indications for the Freedom Infusion System; for example, the system is indicated for use with the expanded indication of Empaveli® for C3G and Primary IC-MPGN treatment. Finance: draft 13-week cash view by Friday.

KORU Medical Systems, Inc. (KRMD) - Canvas Business Model: Customer Segments

You're looking at the core groups KORU Medical Systems, Inc. serves with its large volume subcutaneous infusion solutions as of late 2025. This isn't just about one disease; it's about enabling drug delivery across several complex chronic conditions and clinical needs.

The primary focus remains on the established patient base requiring Subcutaneous Immunoglobulin (SCIg) therapy, which is a significant driver of the recurring revenue model. This segment is supported by the fact that the underlying US SCIg market is growing at an estimated 10-11% annually. KORU Medical Systems has a market-proven system that supports 8 on-label SC drugs.

The scale of the existing patient base using the Freedom Infusion System is substantial, showing deep penetration in this chronic care area. Here's a quick look at the usage metrics as of late 2025:

The total addressable market opportunity KORU Medical Systems is targeting is estimated at $2.3B. A portion of this, specifically for Vancomycin, Deferoxamine, and Oncology applications, is quantified at $1.8B.

The customer base is segmented across several key areas, which is reflected in their reported revenue streams through the third quarter of 2025. The core business, which includes chronic SCIg patients transitioning to home care, is the largest component, though its domestic segment saw a temporary dip.

• Chronic patients requiring Subcutaneous Immunoglobulin (SCIg) therapy.
• Patients with Primary Immunodeficiency Diseases (PIDD) and CIDP.
• Biopharmaceutical companies needing drug delivery systems for clinical trials.
• Oncology infusion clinics for large-volume subcutaneous drugs.

The revenue breakdown from the third quarter ended September 30, 2025, shows how these segments translate financially. The company raised its full-year 2025 net revenues guidance to between $40.5 million and $41.0 million.

For the third quarter of 2025, the revenue contribution from the different business lines was:

The significant growth in International Core Revenues, up 229.6% in Q3 2025, suggests strong adoption by international distributors and pharma partners, likely related to prefill syringe conversions. The Pharma Services and Clinical Trials segment, which serves biopharma companies, generated $0.6 million in Q3 2025, despite a slight year-over-year decrease of 4.4%. This segment supports the pipeline, as KORU Medical Systems is tracking 7 potential commercial opportunities by 2026, and there are 18+ large-volume SC drugs in development by major Pharma companies.

The Freedom System is designed to support drug volumes ranging from 5mL-50mL+, making it adaptable for the expansion into infusion clinics for large-volume subcutaneous drugs, particularly in oncology and rare disease indications.

Finance: review the Q3 2025 revenue mix against the full-year guidance of $40.5 - $41.0 million by next Tuesday.

KORU Medical Systems, Inc. (KRMD) - Canvas Business Model: Cost Structure

You're looking at the cost side of the KORU Medical Systems, Inc. equation, which is heavily influenced by manufacturing efficiency and pipeline investment. Honestly, the numbers from the third quarter of 2025 give us a clear snapshot of where the costs landed recently.

Cost of goods sold (COGS) for manufacturing infusion systems is directly tied to the gross margin performance. For the third quarter ended September 30, 2025, KORU Medical Systems, Inc. reported net revenues of $10.4 million and a gross profit of $6.3 million. This means the COGS for that quarter was approximately $4.1 million ($10.4M revenue minus $6.3M gross profit). The full-year 2025 gross margin guidance remains targeted in the 61% to 63% range, which is a key metric for managing the cost of the Freedom System components.

Research and development (R&D) for pipeline expansion is managed carefully against operating expenses. Total operating expenses for the third quarter of 2025 were $7.1 million, an increase of 3.5% over the prior year period. Within that, R&D expenses were noted as being lower due to severance costs in the prior year and lower project spend in the current period. This suggests R&D spending is being tightly controlled while the company focuses on commercial execution and new collaborations, such as the two new Pharma Services and Clinical Trials (PST) collaborations announced.

Sales, General, and Administrative (SG&A) expenses fall under that total operating expense umbrella. The increase in total operating expenses to $7.1 million in Q3 2025 was primarily driven by increases in compensation and benefits related to higher bonus accruals because of higher revenues, plus legal fees. The sales force expansion and general overhead are baked into this figure as KORU Medical Systems, Inc. drives domestic and international adoption of its subcutaneous infusion solutions.

Manufacturing costs, tariffs, and supply chain inflationary pressures are definitely weighing on current margins. The Q3 2025 gross margin came in at 60.2%, down 320 basis points year-over-year. Management attributed this decrease to higher manufacturing costs, the geographic sales mix shifting toward international markets which carry lower Average Selling Prices (ASPs), and tariff-related charges estimated at approximately 50 basis points. Still, management expects margin improvement in the fourth quarter of 2025.

Here's a quick look at the key financial figures impacting the cost structure as of late 2025:

Aiming for long-term gross margin of 65% plus, defintely, is a stated goal for KORU Medical Systems, Inc. While the 2025 guidance is set between 61% and 63%, management has long-range plans to achieve margins exceeding 65%. This push toward higher profitability relies on several factors:

• - Continued success in converting international markets to higher-margin prefilled syringe utilization.
• - Realizing efficiencies from lower project spend in R&D translating into lower overall operating costs.
• - Mitigating the impact of tariffs and supply chain inflation through sourcing adjustments or price realization.
• - Expanding the mix toward higher-margin revenue from Pharma Services and Clinical Trials (PST) collaborations.

The company is focused on maintaining disciplined spending, evidenced by achieving positive adjusted EBITDA of $0.09 million in Q3 2025 and reiterating the expectation of positive cash flow from operations for the full year 2025. Finance: draft Q4 2025 expense forecast by next Tuesday.

KORU Medical Systems, Inc. (KRMD) - Canvas Business Model: Revenue Streams

You're looking at how KORU Medical Systems, Inc. actually brings in the money, which is key for understanding their valuation and near-term stability. The revenue structure is built around a mix of recurring supplies and capital equipment sales, plus a growing services component.

The core of the revenue generation relies on the ongoing use of their infusion systems, which means the sale of consumables like tubing and needles generates recurring revenue. This is the annuity stream supporting the initial sale of the drivers, which are the Freedom60® and FreedomEdge® infusion pumps.

Here's a quick look at the most recent reported quarterly figures and the full-year outlook, which shows strong momentum heading into the end of 2025.

The Pharma Services and Clinical Trials (PST) segment is showing growth, with management announcing two new PST collaborations in the third quarter, expanding the opportunity to reach new patient populations. The core subcutaneous immunoglobulin (SCIg) business remains the bedrock, showing strength driven by international expansion and global share gains.

You can see the components that make up the revenue stream based on the Q3 2025 results:

• Sale of consumables (tubing, needles) generating recurring revenue.
• Sale of Freedom60® and FreedomEdge® infusion pumps (drivers).
• Pharma Services and Clinical Trials (PST) revenue (Q3 2025: $0.58M).
• Full-year 2025 revenue guidance: $40.5M-$41.0M.
• Core SCIg business revenue (Q3 2025: $9.82M domestic/international).

The company raised its full-year 2025 revenue guidance to a range of $40.5 million to $41.0 million, which reflects year-over-year growth of 20% to 22%. This updated guidance shows confidence despite some headwinds, like a 5% year-over-year decline in domestic core revenue in Q3, which was tied to distributor inventory actions. Finance: draft 13-week cash view by Friday.