What KORU MEDICAL SYSTEMS does

KORU Medical Systems, Inc. (NASDAQ: KRMD) is a Mahwah, New Jersey-based medical device company founded in 1980 that develops and manufactures the FREEDOM Infusion System, an integrated platform for large-volume (≥10 mL) subcutaneous drug delivery. The system centers on two FDA 510(k)-cleared mechanical syringe drivers — the Freedom60 (60/50 mL syringe compatibility) and the FreedomEDGE (30/20 mL and prefilled syringe compatibility) — combined with proprietary HIgH-Flo Subcutaneous Safety Needle Sets (26- and 24-gauge) and Precision Flow Rate Tubing. The devices operate without batteries or electricity at lower pressure than electronic volumetric pumps, and Freedom60 also carries EU MDR 2017/745 certification enabling commercialization across the European Union. KORU sells both directly and through a network of nine distributors (three U.S., six international), with specialty pharmacies, home infusion providers, and biopharmaceutical companies as primary sales contacts.

The company's core end-market is subcutaneous immunoglobulin (SCIg) therapy for patients with Primary Immunodeficiency Diseases (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), served through a recurring patient base of more than 55,000. Revenue is structured across three streams: domestic core product sales (68.1% of 2025 revenue, $28.0M, +11% YoY), international core product sales (26.5%, $10.9M, +80% YoY), and pharma services and clinical trials (5.5%, $2.3M) including non-recurring engineering (NRE) fees from biopharma partners. KORU has been actively expanding its labeled drug-device combinations beyond immunoglobulin — gaining FDA clearance for RYSTIGGO (rozanolixizumab-noli, generalized myasthenia gravis) in early 2026 and submitting 510(k) for PHESGO (HER2+ breast cancer) in late 2025 — supported by co-development partnerships with biopharmaceutical companies.

Manufacturing of consumables (~85%) is outsourced to Command Medical Products in Nicaragua, with finished goods warehoused in Miami, Florida; the company does not perform in-house consumable manufacturing, which is a structural cost and supply-chain consideration. The platform is protected by 15 U.S. and 26 foreign patents (with key patents extending to 2039 and beyond), and Freedom60/FreedomEDGE each hold drug-specific 510(k) clearances (K200176, K214045, plus RYSTIGGO label expansion). The company employs 73 people as of December 31, 2025, and generated $41.1M in 2025 revenue (+22% YoY) with positive adjusted EBITDA of $0.6M, a $3.1M swing from the prior year. A planned CEO transition from Linda Tharby to Adam Kalbermatten (effective July 1, 2026) and the December 2025 appointment of Eric Schiller as CTO are the most recent material governance changes.

Name

KORU MEDICAL SYSTEMS

Legal name

KORU Medical Systems, Inc.

Website

https://korumedical.com

Company type

Public

Founded year

1980

Operating status

Operating

Headcount range

51–100 employees

Short description

KORU Medical Systems (NASDAQ: KRMD) designs and manufactures the FDA-cleared FREEDOM Infusion System — portable mechanical syringe drivers and subcutaneous needle/tubing accessories — used primarily to deliver immunoglobulin therapies to patients with PIDD and CIDP, with growing applications in oncology and neurology.

Ownership category

akta.pro rank

Product category

Medical Infusion Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Measuring, Dispensing, and Other Pumping Equipment Manufacturing (333914)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Infusion Pumps (Ambulatory/Stationary) (HLAHAIAF)

akta.pro secondary industry

Infusion Sets, Catheters & Pump Consumables (HLAHAIAH)

Keywords

• Subcutaneous infusion systems
• Medical syringe drivers
• Immunoglobulin delivery devices
• Drug-device combination products
• Home infusion equipment

Headquarters

HQ city

Mahwah

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Operations, Supply Chain, Personnel, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Domestic Core Revenue: Sales of syringe drivers, tubing and needles (Product Revenue) for delivery of subcutaneous drugs FDA-cleared for use with FREEDOM System in US and Canada. Primary delivery for immunoglobulin to treat Primary Immunodeficiency Diseases (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). In 2025, domestic core revenue was $27,992,436 representing 68.1% of total revenue with 11.0% year-over-year growth.
2. International Core Revenue: Sales of infusion systems outside the US and Canada. In 2025, international core revenue was $10,881,183 representing 26.5% of total revenue with 80.0% year-over-year growth. Six distributors outside the U.S.
3. Pharma Services and Clinical Trials: Product Revenue for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in drug development process. Also includes non-recurring engineering services (NRE) revenues for customizing FREEDOM System for clinical and commercial use across multiple drug categories. In 2025, revenue was $2,253,747 representing 5.5% of total revenue.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels7 records

Core offering

KORU Medical Systems designs, develops, and manufactures the FREEDOM Infusion System — an integrated platform of portable mechanical syringe drivers (Freedom60 and FreedomEDGE) and consumable accessories (HIgH-Flo Subcutaneous Safety Needle Sets, Precision Flow Rate Tubing) for large-volume subcutaneous drug delivery of ≥10ml. The system is FDA 510(k) cleared and EU MDR certified, enabling self-administration of immunoglobulin therapies and specialty pharmaceuticals in home, alternate-site, and clinical infusion settings.

Product overview

KORU Medical Systems offers the FREEDOM Infusion System, an integrated platform of portable mechanical infusion devices and accessories designed for large-volume subcutaneous drug delivery (≥10ml). The system consists of two syringe drivers (FREEDOM60 for 60/50mL syringes and FreedomEDGE for 30/20mL and prefilled syringes), HIgH-Flo Subcutaneous Safety Needle Sets, Precision Flow Rate Tubing, and Precision Flow Rate Controller. The devices are portable, battery-free, and operate at lower pressure than electronic pumps. The system is FDA 510(k) cleared for delivery of multiple immunoglobulin therapies (Hizentra, Cuvitru, Xembify, Empaveli, Gammagard Liquid, Cutaquig) for PIDD and CIDP, RYSTIGGO for generalized myasthenia gravis, and is being expanded into oncology through PHESGO administration clearance.

Differentiator

Problem solved

Functional benefit

Brands

• Freedom60: FREEDOM60 Syringe Driver - FDA-cleared syringe infusion system for subcutaneous drug delivery
• FreedomEDGE
• HIgH-Flo Subcutaneous Safety Needle Sets
• Precision Flow Rate Tubing
• Freedom Infusion System

Products and services

• FREEDOM60 Syringe Driver A mechanical syringe driver (pump) compatible with standard 60/50mL syringes. The portable, battery-free device operates at lower pressure than electronic volumetric pumps and is FDA 510(k) cleared and EU MDR certified for delivery of subcutaneous immunoglobulin therapies including Hizentra, Cuvitru, Xembify, and other SCIg treatments.
• FreedomEDGE Syringe Driver A syringe driver compatible with standard 30mL and 20mL syringes as well as prefilled syringes. FDA 510(k) cleared for delivery of RYSTIGGO (rozanolixizumab-noli) for generalized myasthenia gravis and indicated for subcutaneous administration of immunoglobulin therapies. Real-world study at community infusion centers showed 100% successful dose administration.
• HIgH-Flo Subcutaneous Safety Needle Sets Safety needle sets designed for subcutaneous self-administration. Available in 26-gauge and 24-gauge sizes with unique design elements and safety mechanisms for comfortable, safe patient use at home or in clinical settings. Approximately 85% manufactured by Command Medical Products under a CMO supply agreement.
• Precision Flow Rate Tubing
• Prefilled Syringe Compatibility Prefilled syringe adapter compatibility for the Freedom60 and FreedomEDGE systems. Prefilled syringe formats reduce preparation steps, minimize medication handling, and decrease overall treatment burden compared to traditional vial-based administration for subcutaneous immunoglobulin therapy.
• Precision Flow Rate Controller
• FREEDOM Infusion System An integrated platform comprising the FREEDOM60 and FreedomEDGE syringe drivers, HIgH-Flo Subcutaneous Safety Needle Sets, and Precision Flow Rate Tubing. Designed for large-volume subcutaneous infusion (≥10ml) primarily for immunoglobulin delivery to treat PIDD and CIDP, as well as specialty pharmaceutical therapies including RYSTIGGO and emerging oncology applications.
• Pharma Services and Clinical Trials (NRE)

Quantifiable outcome

• 100% successful dose administration with FreedomEDGE in real-world infusion clinic settings
• +4 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Three partnerships are on record, tiered core.

• Command Medical Products, Inc.coreOthers · 19 November 2025Contract manufacturing organization (CMO) providing subassemblies for all consumables (needle and tubing sets). Manufactures, assembles and packages approximately 85% of KORU's consumables. Operations in Nicaragua with finished goods stored in Miami, Florida. Amended Supply Agreement signed November 2025.
• Development Agreement Partner (Subcutaneous Immunoglobulin)coreStrategic or Co-development Partner · 4 November 2025Development agreement for innovation in subcutaneous immunoglobulin infusion systems. Focus on advancing SCIg delivery technology and expanding product capabilities.
• UCB PharmacoreStrategic or Co-development PartnerKORU received FDA 510(k) clearance for delivery of RYSTIGGO (rozanolixizumab-noli) with FreedomEDGE Infusion System. RYSTIGGO is a novel biologic for treatment of generalized myasthenia gravis developed by UCB.

Scale indicators10 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• West Pharmaceutical Services: West manufactures elastomeric components, prefilled syringe systems, and drug delivery devices for injectable therapies; comparable to KORU in serving subcutaneous biologic drug-device combination products.
• Insulet Corporation: Insulet's Omnipod tubeless insulin pump is a wearable subcutaneous drug delivery system; comparable to KORU's Freedom System in the patient self-administration and wearable drug delivery category.
• ICU Medical: ICU Medical (which acquired Smiths Medical) manufactures infusion pumps, IV sets, and needle-free connectors for hospital and specialty infusion, directly overlapping with KORU's mechanical infusion pump platform.
• Terumo Corporation: Terumo manufactures drug delivery devices including prefillable syringes, injection systems, and infusion products; comparable to KORU in subcutaneous drug-device combination offerings and Adam Kalbermatten's prior employer.

Others

• Halozyme Therapeutics: Halozyme licenses its ENHANZE subcutaneous drug delivery technology to major pharma (Roche, BMS, Pfizer, J&J, AbbVie, argenx); comparable to KORU as an enabling subcutaneous delivery platform for biologic partners.
• Stevanato Group: Stevanato manufactures drug containment, drug delivery devices, and prefillable syringe systems serving biopharma; comparable to KORU's prefilled syringe compatibility and consumables franchise.

Broad incumbents

• Baxter International: Baxter offers IV pumps, infusion sets, and home infusion therapy services overlapping with KORU's infusion pump and consumable business, particularly in clinical and home care settings.
• Becton Dickinson (BD): BD is a diversified medical technology leader with extensive drug delivery, infusion, and prefilled syringe systems; comparable to KORU's subcutaneous infusion platform and was home to CEO Linda Tharby and CCO Adam Kalbermatten.

Emerging players

• Tandem Diabetes Care: Tandem manufactures specialty insulin pumps for diabetes management; comparable to KORU in miniaturized, patient-friendly specialty infusion pump design, though addressing insulin rather than biologics.
• Ypsomed Holding: Ypsomed manufactures injection and infusion systems including pen injectors and patch pumps for self-administration of biologics; directly comparable to KORU in subcutaneous self-administration device platforms for pharma partners.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/korumedical
• YouTubeyoutube.com/channel/UCvMytb_74xGs8f7ajk7M7yQ
• Facebookfacebook.com/korumedical
• LinkedInlinkedin.com/company/korumedical
• Instagraminstagram.com/korumedical

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about KORU MEDICAL SYSTEMS