KORU Medical Systems, Inc. (KRMD): History, Ownership, Mission, How It Works & Makes Money

As a seasoned financial analyst, I have to ask: is KORU Medical Systems, Inc. (KRMD) the kind of specialized medical technology company that can sustain its impressive momentum in the competitive infusion market?

The company, which develops the patient-centric Freedom Infusion System for large volume subcutaneous infusion, is defintely showing strength, raising its full-year 2025 net revenue guidance to a range of $40.5 million to $41.0 million, representing up to 22% year-over-year growth, and achieving a 30% core business revenue increase in the third quarter alone. You need to understand how a medical device maker with a relatively small market cap of about $175 million (as of November 2025) is carving out a significant niche in home-based therapy and advancing its pipeline into new areas like oncology and orthopedics.

Keep reading to see the history, ownership structure, and precise revenue mechanics behind KORU Medical Systems, and why its focus on the subcutaneous immunoglobulin (SCIg) market is driving such strong financial performance.

KORU Medical Systems, Inc. (KRMD) History

You're looking for the foundation beneath KORU Medical Systems, Inc.'s current market position, and the story starts much earlier than its recent NASDAQ ticker. The company's trajectory, centered on innovative subcutaneous infusion (SCIg) solutions, is a long game of strategic evolution, not a sudden sprint. It began as a small medical device maker and transformed into a publicly traded leader in large-volume, at-home drug delivery, driven by key decisions around branding and pharmaceutical partnerships.

Given Company's Founding Timeline

Year established

The company was established in 1980, originally operating under the name Repro Med Systems, Inc..

Original location

The initial operations were located in New York. Today, the corporate headquarters are in Mahwah, New Jersey.

Founding team members

The company was founded by Andrew I. Sealfon and Adrian W. Zorgniotti. They saw a clear need for better medical infusion solutions outside of a hospital setting.

Initial capital/funding

Specific details on the initial capital and funding for the company's establishment in 1980 are not readily available. What matters more is the long-term capital strategy that followed.

Given Company's Evolution Milestones

Given Company's Transformative Moments

The biggest shifts for KORU Medical Systems, Inc. weren't just product launches; they were strategic pivots that redefined its market. The rebranding in 2019 was more than a cosmetic change; it signaled a renewed commitment to patient-centric, at-home care, moving away from the older Repro Med Systems identity. This focus is defintely what drives their current growth.

The company's strategic focus on its core subcutaneous immunoglobulin (SCIg) business has been paying off, plus the expansion into Pharma Services and Clinical Trials (PST). This dual approach helps mitigate risk and opens new revenue streams, especially with biologics and oncology therapies.

• Rebranding and Ticker Change (2019): The shift to KORU Medical Systems, Inc. and the KRMD ticker on NASDAQ was a clear signal of a new corporate philosophy, focusing on the 'new life' represented by the Koru symbol, directly aligning the brand with patient outcomes.
• Accelerated International Expansion: The third quarter of 2025 showed significant international growth, with international revenue rising 230% year-over-year, even with domestic revenue fluctuating. This suggests successful market share gains and strategic distributor transactions abroad.
• Sustained Profitability Progress: The company reported a net loss of only $0.8 million in Q3 2025, a 51% improvement over the prior year, and achieved positive adjusted EBITDA of $0.09 million. This progress toward sustained profitability is a major structural change for the business.

Here's the quick math: with a market cap of approximately $175 million as of November 2025, and revenue guidance hitting up to $41.0 million for the full year, the market is pricing in significant future growth, betting on the success of their novel therapies pipeline. You can dive deeper into the financial mechanics in Breaking Down KORU Medical Systems, Inc. (KRMD) Financial Health: Key Insights for Investors. Anyway, the constant refinement of the Freedom System and securing new pharmaceutical collaborations are the clear actions driving this positive trend.

KORU Medical Systems, Inc. (KRMD) Ownership Structure

KORU Medical Systems, Inc. (KRMD) is a publicly traded medical technology company, and its ownership structure is notably concentrated, with insiders holding a significant stake-nearly half of the outstanding shares-which is a key factor in understanding its long-term strategy and governance.

KORU Medical Systems' Current Status

KORU Medical Systems is a publicly traded company listed on the NASDAQ Stock Market under the ticker symbol KRMD. This status subjects the company to rigorous reporting requirements by the Securities and Exchange Commission (SEC), ensuring transparency for all investors, from the largest institutions to individual shareholders like you.

As of the 2025 fiscal year, the company's market capitalization is approximately $207.06 million, with 46.32 million shares outstanding. This valuation places it firmly within the small-cap medical device space, which often means greater volatility but also higher growth potential if their subcutaneous infusion solutions gain broader market adoption. It's a classic risk/reward trade-off.

KORU Medical Systems' Ownership Breakdown

The ownership breakdown reveals a fascinating dynamic where insiders-the people who actually run the company-control the largest block of shares. This level of insider ownership suggests a strong alignment of interests between management and shareholders, but it also means a smaller float (shares available to the public) and potentially less liquidity.

Here's the quick math on who controls the shares, based on 2025 fiscal year data:

With insiders and institutional investors collectively owning over 88% of the company, the stock's direction is defintely steered by a relatively concentrated group of stakeholders. You can dive deeper into the major holders and their investment theses by Exploring KORU Medical Systems, Inc. (KRMD) Investor Profile: Who's Buying and Why?

KORU Medical Systems' Leadership

The company's strategy is steered by a seasoned executive team, which has seen some key additions in 2025 to bolster its commercial efforts.

The core leadership team, as of November 2025, includes:

• Linda Tharby: President, Chief Executive Officer (CEO), and Director. Appointed in April 2021, Ms. Tharby brings over 25 years of executive experience, including a long tenure at Becton Dickinson (BD), which is crucial for a medtech company.
• Tom Adams: Chief Financial Officer (CFO). He joined KORU Medical Systems with a strong background in the medical device industry, having spent a decade at Integra Life Sciences.
• Adam Kalbermatten: Chief Commercial Officer (CCO). Joining in July 2025, his appointment signals a clear focus on accelerating growth and scaling the business, given his 20+ years of commercial leadership experience, also including a time at BD.

The CEO's total yearly compensation is approximately $1.27 million, with more than half of that tied to bonuses and stock, which aligns her incentives with shareholder returns. A management team with a deep history in medical technology is exactly what you want to see when you're betting on innovation in this sector.

KORU Medical Systems, Inc. (KRMD) Mission and Values

KORU Medical Systems, Inc.'s core commitment extends beyond medical device sales; it is centered on empowering patients with chronic illnesses to live fuller lives through innovative, at-home subcutaneous infusion (SCIg) solutions. This patient-centric approach is the defintely the foundation of their culture and long-term strategy.

The company's mission and values guide their product development-like the FREEDOM Syringe Infusion System-and their business growth, which saw them raise their 2025 revenue guidance to between $38.5 million and $39.5 million. That's a strong signal that their purpose is resonating with the market.

KORU Medical Systems' Core Purpose

KORU Medical develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. They are the global leader in large-volume SCIg drug delivery, supporting over 45,000 chronic and recurring patients annually, with approximately 75% of their revenues being recurring.

Official mission statement

The mission is simple and powerful, focusing on the human outcome of their technology:

• Empower patients with the freedom to truly live.

This means moving treatment out of the clinic and into the home, giving patients the freedom to be wherever they choose, and to simply be themselves. For a financial analyst, this patient focus translates directly into a sticky, recurring revenue base.

Vision statement

While a single, formal vision statement isn't always published, KORU Medical's strategic direction is clear: expand their technology platform to support a much wider range of large-volume subcutaneous drugs beyond the existing $500 million global Immunoglobulin (Ig) market.

• Expand the subcutaneous delivery platform to new drug therapy areas, targeting an additional $2.2 billion in Total Addressable Market (TAM).
• Accelerate growth by submitting two additional commercialized drugs for 510(k) clearance with the Freedom Infusion System by the end of 2025.
• Advance their 'Vision 2026 goals' by expanding product use into infusion clinics alongside home care.

The company's core values-Customer Commitment, One Koru, Operate with Integrity, Pursuit of Excellence, Celebrate the Journey, and Empower & Grow-are the cultural DNA supporting this expansion. You can see how this strategy plays out in Exploring KORU Medical Systems, Inc. (KRMD) Investor Profile: Who's Buying and Why?

KORU Medical Systems' slogan/tagline

The company's core messaging, which is deeply integrated into their mission and product branding, centers on the concept of patient autonomy and simplicity.

• Empowering patients with the freedom to truly live.

The product name, FREEDOM Syringe Infusion System, is the clearest expression of this tagline. It's a powerful, non-jargon phrase that cuts straight to the patient benefit.

KORU Medical Systems, Inc. (KRMD) How It Works

KORU Medical Systems, Inc. operates by developing and commercializing the Freedom Syringe Infusion System, a proprietary platform for patient-centric, large-volume subcutaneous drug delivery, primarily in the home setting. This model generates revenue through the recurring sale of disposable consumables (tubing and needle sets) that accompany the initial sale of the durable infusion pumps.

KORU Medical Systems' Product/Service Portfolio

The company's value proposition centers on its core infusion technology, which is then extended through strategic partnerships with pharmaceutical companies to enable new drug therapies.

KORU Medical Systems' Operational Framework

The operational framework is built to support a high-margin, recurring revenue model centered on the Freedom System's disposable components, which is the defintely the core of the business. The company focuses on manufacturing user-friendly, high-quality devices and then distributing them globally.

• Manufacturing and Quality: KORU Medical designs and manufactures the infusion drivers and consumables, ensuring stringent quality standards and regulatory compliance. The gross margin is robust, with full-year 2025 guidance set between 61% and 63%.
• Distribution and Sales: Products reach the end-user through a combination of direct sales, a network of distributors, and partnerships with pharmaceutical companies. This hybrid approach allows for deep penetration in the core U.S. market and rapid expansion internationally.
• Value Creation: The company creates value by shifting complex, time-consuming intravenous (IV) infusions, which typically require a clinic visit, to simpler, patient-administered subcutaneous (SC) infusions at home. This lowers healthcare costs and dramatically improves patient quality of life and mobility.
• Financial Discipline: The company is focused on operational efficiency, projecting to achieve positive cash flow from operations for the full fiscal year 2025 and an ending cash balance of at least \$8.2 million.

KORU Medical Systems' Strategic Advantages

The company's market success, which is expected to drive full-year 2025 revenue guidance to between \$40.5 million and \$41.0 million, is rooted in a few key differentiators that are hard for competitors to replicate quickly.

• Established Patient-Centric Platform: The Freedom System has been FDA-cleared since 1994, giving it a long-standing, trusted position in the large-volume subcutaneous infusion market, particularly for Primary Immunodeficiency.
• High-Growth International Expansion: KORU Medical is aggressively converting the European market to prefilled syringes, which drove international revenue growth of 230% in the third quarter of 2025. They are targeting to accelerate their overall market share from the mid-teens into the 40% range in the OUS SCIg market.
• Novel Therapies Pipeline: The Pharma Services and Clinical Trials segment is a strategic hedge, allowing the company to partner with biopharma to enable new drugs using the Freedom platform. They are on track for a 510(k) submission for a new oncology drug application in Q4 2025 or Q1 2026, which taps into a significant oncology infusion consumables market projected to grow from approximately \$60 million in 2025.
• Recurring Revenue Base: The high-margin consumables that patients must use with the durable pump create a sticky, recurring revenue stream, which provides financial stability and predictability.

For a deeper dive into who is backing this strategy, you should check out Exploring KORU Medical Systems, Inc. (KRMD) Investor Profile: Who's Buying and Why?

KORU Medical Systems, Inc. (KRMD) How It Makes Money

KORU Medical Systems, Inc. primarily generates revenue through a classic razor-razor blade model, selling reusable infusion pumps (the razor) and the high-margin, recurring disposable administration sets and needles (the blade) used for subcutaneous immunoglobulin (SCIg) therapy and other large-volume infusions.

KORU Medical Systems, Inc.'s Revenue Breakdown

The company's revenue is split into two main streams: the dominant Core SCIg Business, which drives recurring sales, and the strategic Pharma Services and Clinical Trials (PST) segment. Based on the third quarter of 2025's net revenues of $10.4 million, here is how the business breaks down.

Business Economics

KORU Medical Systems' financial engine is built on the high-volume, recurring nature of its consumables. Honestly, the reusable Freedom Infusion Systems are the entry point; the disposable sets are the cash flow driver. This model means over 75% of the company's revenue is recurring, which is defintely a strong point for stability.

• Recurring Consumables: The business thrives on the weekly or bi-weekly use of disposable HIgH-Flo Subcutaneous Safety Needle Sets and Precision Flow Rate Tubing for chronic conditions like Primary Immunodeficiencies (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
• High Gross Margin: The full-year 2025 gross margin guidance is tight, expected to be between 61% and 63%. This high margin, typical of the medical device space, provides a substantial buffer to cover operating expenses.
• Pricing Power: The specialized nature of their large-volume subcutaneous (SCIg) delivery system, which allows for faster, more comfortable home infusions, gives them pricing power, especially as pharmaceutical companies shift to pre-filled syringe formats.
• International Expansion: The core business saw a massive 230% surge in international revenue in Q3 2025, driven by stocking orders and prefill conversions, which is a clear sign of successful geographic diversification offsetting a temporary 5.0% domestic decline due to distributor inventory adjustments.

The PST segment, while small at 5.8% of Q3 2025 revenue, is a strategic play. It involves customizing the Freedom System for biopharmaceutical companies' clinical trials and new drug development, essentially seeding the market for future core revenue when those drugs gain commercial approval and require their infusion system. The two new PST collaborations announced in Q3 2025 are a leading indicator of future growth.

KORU Medical Systems, Inc.'s Financial Performance

The company is firmly on a path toward profitability, showing strong top-line growth and improved operational efficiency in 2025. Management raised its full-year 2025 net revenue guidance to a range of $40.5 million to $41.0 million, representing a growth of 20% to 22% year-over-year.

• Revenue Growth: Year-to-date revenue through Q3 2025 hit $30.2 million, a 22% increase over the same period in 2024.
• Net Loss Improvement: The GAAP net loss for Q3 2025 was significantly reduced to ($0.8) million, a 51% improvement compared to the prior year period.
• Positive Adjusted EBITDA: The company achieved a positive adjusted EBITDA of $0.09 million in Q3 2025, demonstrating operating leverage and a major step toward sustained profitability.
• Cash Position: KORU Medical Systems generated $0.4 million in cash during Q3 2025, ending the quarter with a cash balance of $8.5 million, and is reiterating guidance for positive cash flow from operations for the full year 2025.

The business is scaling, but still not profitable on a GAAP basis; you see the net loss, but you also see the positive cash flow and Adjusted EBITDA, which means the underlying operations are generating cash. The next step is to monitor the Q4 2025 results to see if they hit the $41.0 million revenue target and keep the gross margin in the 61%-63% range as they promised. For a deeper dive into who is betting on this growth, check out Exploring KORU Medical Systems, Inc. (KRMD) Investor Profile: Who's Buying and Why?

KORU Medical Systems, Inc. (KRMD) Market Position & Future Outlook

KORU Medical Systems is positioned as a critical enabler in the shift toward home-based care, specifically for large volume subcutaneous infusion (SCIg), with a strong domestic base and aggressive international expansion plans. The company's future outlook hinges on capturing new drug indications through its Novel Therapies pipeline, aiming for full-year 2025 net revenues of $40.5 million to $41.0 million, a projected growth of 20% to 22% year-over-year.

You can see the Mission Statement, Vision, & Core Values of KORU Medical Systems, Inc. (KRMD) drive this focus on patient-centric, at-home care. Honestly, that market tailwind-moving treatment from the hospital to the home-is a powerful structural advantage for them right now.

Competitive Landscape

In the large volume subcutaneous infusion device space, KORU Medical Systems' Freedom Syringe Infusion System holds a leading position in the U.S. subcutaneous immunoglobulin (SCIg) market, competing primarily against electronic pumps and other delivery systems. The company's core mechanical pump technology offers a distinct, patient-preferred alternative to the more complex electronic pumps (e-pumps) often used in other infusion therapy areas.

Opportunities & Challenges

The company is actively executing a strategy to diversify revenue beyond its core SCIg business, which is smart, but doing so introduces new execution risks. For example, while Q3 2025 net revenues hit $10.4 million, the gross margin dipped to 60.2% from the prior year, partially due to higher manufacturing costs and tariffs.

Here's a quick map of the near-term landscape:

Industry Position

KORU Medical Systems operates in the large volume subcutaneous drug delivery niche, a segment of the broader infusion pump market projected to be worth $16.66 billion in 2025. The company's unique value proposition lies in its simple, mechanical Freedom System, which is highly preferred for patient self-administration of large-volume drugs like SCIg at home, boasting a proven 97% adherence rate across over 45,000 patients.

• SCIg Device Leadership: KORU Medical Systems is the domestic leader in the conventional pump segment of the SCIg market, which itself accounted for 48.67% of the overall SCIg market revenue share in 2024.
• Pharma-Device Integration: The company's technology is cleared for use with eight on-label SCIg drugs from five major pharmaceutical manufacturers, making it a critical partner in the drug delivery ecosystem.
• Future Focus: The strategic shift is toward next-generation infusion systems that can accommodate both vials and prefilled syringes (PFS), a key convenience trend in the market, to capture more of the growing subcutaneous drug delivery market.

What this estimate hides is the risk of large pharmaceutical companies developing their own proprietary, facilitated subcutaneous delivery systems, which could bypass KORU's device entirely in the long run. Finance: monitor the cost of goods sold (COGS) and tariff impact closely to ensure the gross margin returns to the 61% to 63% target range by year-end.