KORU Medical Systems, Inc. (KRMD): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la tecnología médica, Koru Medical Systems, Inc. (KRMD) surge como una fuerza pionera, revolucionando la atención al paciente a través de tecnologías innovadoras de bombas de infusión ambulatoria. Su lienzo de modelo de negocio meticulosamente elaborado revela un enfoque estratégico que combina perfectamente la ingeniería médica de vanguardia, las soluciones centradas en el paciente y las sólidas estrategias de penetración del mercado. Al centrarse en el desarrollo avanzado de dispositivos médicos y la prestación de atención médica de precisión, Koru Medical Systems está transformando cómo los profesionales y los pacientes médicos experimentan movilidad, conveniencia y excelencia tecnológica.

Koru Medical Systems, Inc. (KRMD) - Modelo de negocios: asociaciones clave

Fabricantes y proveedores de dispositivos médicos

Koru Medical Systems colabora con los siguientes socios clave de fabricación de dispositivos médicos:

Empresa asociada	Enfoque de asociación	Año establecido
BD (Becton, Dickinson and Company)	Componentes de tecnología de infusión	2018
Medtrónico	Tecnología de la bomba de precisión	2020

Distribuidores de tecnología de salud

Koru Medical Systems mantiene asociaciones de distribución estratégica:

• Henry Schein Medical
• Salud cardinal
• McKesson Corporation

Investigaciones de instituciones y universidades

Institución	Enfoque de investigación	Tipo de colaboración
Universidad de Johns Hopkins	Innovación de tecnología de infusión	Asociación de investigación
Hospital General de Massachusetts	Investigación de aplicaciones clínicas	Ensayos clínicos

Hospitales y centros médicos

Koru Medical Systems se asocia con 47 redes de atención médica importantes en todo Estados Unidos, incluyendo:

• Clínica de mayonesa
• Clínica de Cleveland
• Nyu Langone Health

Socios de cumplimiento regulatorio

Las colaboraciones clave de cumplimiento regulatorio incluyen:

Organización	Área de cumplimiento	Estado de asociación
FDA	Regulaciones de dispositivos médicos	Certificación activa
ISO internacional	Estándares de gestión de calidad	Socio certificado

Koru Medical Systems, Inc. (KRMD) - Modelo de negocio: actividades clave

Investigación y desarrollo de dispositivos médicos

Gastos de I + D para 2023: $ 7.2 millones

Áreas de enfoque de I + D	Asignación de inversión
Tecnología de bomba de infusión ambulatoria	48% del presupuesto de I + D
Sistemas de entrega de medicamentos avanzados	35% del presupuesto de I + D
Integración de software	17% del presupuesto de I + D

Fabricación de infusión y bombas ambulatorias

Capacidad de fabricación anual: 125,000 dispositivos médicos

• Instalación de fabricación primaria: Carlstadt, Nueva Jersey
• Tasa de eficiencia de fabricación: 94.5%
• Tasa de inspección de control de calidad: 100% de las unidades producidas

Prueba de productos y validación clínica

Parámetros de prueba	Métrica
Ensayos clínicos anuales	7-9 estudios
Duración promedio del estudio	18-24 meses
Presupuesto total de pruebas clínicas 2023	$ 3.6 millones

Procesos de aprobación regulatoria

Tasa de éxito de envío de la FDA: 88%

• Línea de aprobación promedio de la FDA: 12-15 meses
• Tamaño del equipo de cumplimiento regulatorio: 12 profesionales
• Presupuesto anual de cumplimiento regulatorio: $ 2.1 millones

Ventas y marketing de tecnologías médicas

Métricas de marketing	2023 datos
Tamaño del equipo de ventas	45 profesionales
Gasto de marketing	$ 4.5 millones
Segmentos de atención médica objetivo	Hospitales, clínicas, atención médica domiciliaria

Koru Medical Systems, Inc. (KRMD) - Modelo de negocios: recursos clave

Talento especializado de ingeniería médica

A partir de 2024, Koru Medical Systems emplea a 143 empleados en total, con aproximadamente 37 dedicados a la ingeniería y los roles de I + D.

Categoría de empleado	Número de empleados	Porcentaje
Total de empleados	143	100%
Ingeniería/personal de I + D	37	25.9%

Tecnología de dispositivos médicos patentados

Koru Medical Systems posee 6 patentes activas de dispositivos médicos Específicamente relacionado con la tecnología de infusión y los sistemas de bombas ambulatorias.

• Plataforma de conductor de la jeringa de la libertad
• Tecnología de infusión ambulatoria de precisión
• Sistemas de entrega médica portátil

Instalaciones de fabricación

La compañía opera un Instalación de fabricación de 12,500 pies cuadrados Ubicado en Newnan, Georgia, EE. UU.

Especificación de la instalación	Detalles
Ubicación	Newnan, Georgia
Espacio de fabricación total	12,500 pies cuadrados
Certificación ISO	ISO 13485: 2016

Cartera de propiedades intelectuales

A partir del año fiscal 2023, Koru Medical Systems mantiene:

• 6 patentes activas
• 3 solicitudes de patentes pendientes
• Inversión total de propiedad intelectual: $ 2.1 millones

Equipo de control y prueba de calidad

La compañía utiliza equipos de prueba avanzados valorados en aproximadamente $ 1.5 millones, incluido:

• Instrumentos de calibración de precisión
• Cámaras de pruebas ambientales
• Sistemas de prueba de compatibilidad electromagnética

Categoría de equipo	Valor estimado
Instrumentos de calibración	$450,000
Prueba de cámaras	$650,000
Sistemas de prueba de compatibilidad	$400,000

Koru Medical Systems, Inc. (KRMD) - Modelo de negocio: propuestas de valor

Tecnologías avanzadas de bomba de infusión ambulatoria

La tecnología del conductor de la jeringa de libertad de Koru Medical Systems permite la entrega precisa de medicamentos ambulatorios con las siguientes especificaciones:

Especificación tecnológica	Métrico
Precisión de la infusión	± 2% a caudales especificados
Duración de la batería	Hasta 24 horas operación continua
Peso	Aproximadamente 4.5 onzas
Vida útil del dispositivo	5+ años

Mejora de la movilidad del paciente y la conveniencia del tratamiento

Las ventajas de movilidad clave incluyen:

• Dispositivo portátil que pesa menos de 5 onzas
• Capacidades de conectividad inalámbrica
• Compatible con múltiples tipos de medicamentos
• Diseñado para el uso ambulatorio de pacientes

Precisión mejorada de suministro de medicamentos

Métrica de precisión	Actuación
Precisión de la tasa de flujo	± 2% en rangos especificados
Detección de oclusión	Sistema de alerta inmediata
Intervalos programables	Incrementos de 0.1 ml/hora

Soluciones de dispositivos médicos rentables

Métricas financieras que demuestran rentabilidad:

• Costo promedio del dispositivo: $ 1,250 por unidad
• Ahorros de atención médica estimados: $ 3,500 por paciente anualmente
• Tasas de readmisión hospitalarias reducidas en un 22%

Innovación en la salud centrada en el paciente

Parámetro de innovación	Métrico de rendimiento
Calificación de satisfacción del paciente	4.7/5
Tasa de adopción clínica	68% en clínicas especializadas
Cartera de patentes	12 patentes activas de dispositivos médicos

Koru Medical Systems, Inc. (KRMD) - Modelo de negocios: relaciones con los clientes

Equipos directos de soporte de ventas

A partir del cuarto trimestre de 2023, Koru Medical Systems mantiene un equipo de ventas directo dedicado de 37 profesionales que se especializan en ventas de dispositivos médicos. El equipo cubre múltiples regiones geográficas en los Estados Unidos.

Métrica del equipo de ventas	Cantidad
Representantes de ventas totales	37
Experiencia promedio de ventas	8.5 años
Cobertura geográfica	48 estados

Servicio al cliente técnico

Koru Medical Systems proporciona un servicio técnico al cliente a través de múltiples canales con métricas de respuesta específicas.

• Línea directa de soporte técnico 24/7
• Tiempo de respuesta promedio: 17 minutos
• Representantes de servicio al cliente: 22
• Interacciones anuales de servicio al cliente: 4.562

Recursos de capacitación en productos en línea

La compañía ofrece plataformas integrales de capacitación digital para profesionales médicos.

Recurso de capacitación	Detalles
Módulos de capacitación en línea	47 módulos interactivos
Participación anual del usuario	2.345 profesionales médicos
Tasa de finalización de capacitación	92%

Consulta profesional médico

Koru Medical Systems emplea 15 especialistas clínicos que brindan servicios de consulta médica directa.

• Especialistas clínicos con títulos médicos avanzados: 12
• Duración de consulta promedio: 43 minutos
• Tasa de cumplimiento de la solicitud de consulta: 96%

Soporte y mantenimiento del producto continuo

La compañía proporciona infraestructura integral de soporte de productos para sus dispositivos médicos.

Métrico de soporte	Cantidad
Contratos de mantenimiento anual	1,237
Tiempo de respuesta promedio para el mantenimiento	4.2 horas
Calificación de satisfacción del cliente	4.7/5

Koru Medical Systems, Inc. (KRMD) - Modelo de negocios: canales

Fuerza de ventas directa

A partir del cuarto trimestre de 2023, Koru Medical Systems mantiene un equipo de ventas directo de 37 representantes de ventas dirigidos a hospitales, clínicas e instalaciones médicas en todo Estados Unidos.

Métrico de canal de ventas	2023 datos
Representantes de ventas directas totales	37
Cobertura geográfica	Estados Unidos
Ciclo de ventas promedio	4.2 meses

Distribuidores de equipos médicos

Koru Medical Systems se asocia con 12 distribuidores de equipos médicos especializados en todo el país.

• Acuerdos de distribución estratégica con redes regionales de suministro médico
• Asociaciones que cubren 48 estados
• Tasa de comisión de distribuidores: 12-15%

Plataformas de comercio electrónico en línea

La compañía utiliza dos canales principales de ventas en línea con $ 2.3 millones en ingresos digitales en 2023.

Plataforma en línea	2023 Ingresos digitales
Sitio web de la empresa	$ 1.4 millones
Plataformas de suministro médico de terceros	$900,000

Conferencias médicas y ferias comerciales

Koru Medical Systems participó en 17 conferencias médicas en 2023, generando aproximadamente $ 780,000 en ventas directas.

• Conferencias a la que asistieron: 17
• Ingresos generados por la conferencia total: $ 780,000
• Ingresos promedio por conferencia: $ 45,882

Redes de proveedores de atención médica

La compañía ha establecido relaciones con 243 redes de proveedores de atención médica, que representan la base de clientes potenciales.

Tipo de red	Número de redes
Redes hospitalarias	127
Clínicas especializadas	86
Instituciones de investigación	30

Koru Medical Systems, Inc. (KRMD) - Modelo de negocios: segmentos de clientes

Hospitales y centros médicos

Tamaño del mercado para posibles clientes del hospital: 6.129 hospitales en los Estados Unidos a partir de 2023.

Tipo de hospital	Número total	Penetración potencial del mercado de Koru
Hospitales comunitarios	4,752	35.6%
Hospitales sin fines de lucro	2,873	42.1%

Proveedores de atención médica en el hogar

Agencias de salud en el hogar total en los Estados Unidos: 12.422 a partir de 2022.

• Agencias de salud en el hogar certificadas por Medicare: 9.815
• Proveedores privados de salud en el hogar: 2,607

Instalaciones de atención ambulatoria

Instalaciones de atención ambulatoria total en los Estados Unidos: 41,285 a partir de 2023.

Tipo de instalación	Número de instalaciones
Centros quirúrgicos	5,687
Centros de atención urgente	11,523

Clínicas médicas especializadas

Clínicas médicas de especialidad total en los Estados Unidos: 28,456 a partir de 2023.

• Clínicas de oncología: 3,245
• Clínicas de hematología: 1.876
• Centros de infusión: 4,532

Profesionales médicos individuales

Número total de médicos activos en los Estados Unidos: 1.073.616 a partir de 2022.

Grupo especializado	Número de profesionales
Oncólogos	14,680
Hematólogos	6,542
Especialistas en infusión	8,234

Koru Medical Systems, Inc. (KRMD) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Koru Medical Systems reportó gastos de I + D de $ 7.3 millones, lo que representa el 19.2% de los ingresos totales.

Año fiscal	Gastos de I + D	Porcentaje de ingresos
2023	$ 7.3 millones	19.2%
2022	$ 6.8 millones	18.5%

Costos de fabricación y producción

Los costos totales de fabricación para 2023 fueron de $ 12.5 millones, con un desglose de la siguiente manera:

• Costos de material directo: $ 5.2 millones
• Costos laborales directos: $ 3.8 millones
• Sobrecoss de fabricación: $ 3.5 millones

Inversiones de ventas y marketing

Los gastos de ventas y marketing para 2023 totalizaron $ 9.6 millones, lo que representa el 25.3% de los ingresos totales.

Categoría de gastos	Cantidad
Personal de ventas	$ 4.2 millones
Campañas de marketing	$ 3.1 millones
Feria y eventos	$ 1.3 millones
Marketing digital	$ 1.0 millones

Gastos de cumplimiento regulatorio

Los costos de cumplimiento regulatorio para 2023 ascendieron a $ 2.9 millones, lo que incluye:

• Cumplimiento de la FDA: $ 1.5 millones
• Sistemas de gestión de calidad: $ 0.8 millones
• Pruebas clínicas y validación: $ 0.6 millones

Gestión de gastos generales operativos

La sobrecarga operativa para 2023 fue de $ 6.2 millones, distribuida en varias funciones administrativas:

Categoría de gastos generales	Cantidad
Gastos administrativos generales	$ 2.7 millones
Infraestructura	$ 1.5 millones
Gestión de instalaciones	$ 1.2 millones
Servicios profesionales	$ 0.8 millones

Koru Medical Systems, Inc. (KRMD) - Modelo de negocios: flujos de ingresos

Venta de productos de dispositivos médicos

Koru Medical Systems reportó ingresos totales de $ 17.6 millones para el año fiscal 2023, con ventas de productos de dispositivos médicos que representan una porción significativa.

Categoría de productos	Ingresos anuales	Porcentaje de ingresos totales
Sistema de infusión de jeringa de la libertad	$ 12.3 millones	70%
Bomba de jeringa de precisión	$ 3.5 millones	20%
Otros dispositivos médicos	$ 1.8 millones	10%

Contratos de mantenimiento de equipos recurrentes

Los ingresos por contrato de mantenimiento para 2023 totalizaron $ 1.2 millones, lo que representa un crecimiento del 5-7% del año anterior.

• Valor promedio de contrato de mantenimiento anual: $ 450- $ 750 por dispositivo
• Contratos de mantenimiento activos totales: 1.650
• Tasa de renovación del contrato: 85%

Consumibles y ventas de accesorios

Los consumibles y las ventas de accesorios generaron $ 2.4 millones en ingresos para 2023.

Tipo consumible	Venta anual
Conjuntos de jeringas desechables	$ 1.6 millones
Kits de accesorios	$ 0.8 millones

Tarifas de servicio de capacitación y apoyo

Los servicios de capacitación y apoyo contribuyeron con $ 0.7 millones a los ingresos de la compañía en 2023.

• Costo promedio de la sesión de capacitación: $ 250- $ 500
• Ingresos de capacitación en línea: $ 0.3 millones
• Ingresos de capacitación en el sitio: $ 0.4 millones

Ingresos de expansión del mercado internacional

Las ventas internacionales alcanzaron los $ 3.5 millones en 2023, lo que representa el 20% de los ingresos totales de la compañía.

Región geográfica	Ingresos internacionales	Porcentaje de ventas internacionales
Europa	$ 1.8 millones	51%
Asia-Pacífico	$ 1.2 millones	34%
Medio Oriente y África	$ 0.5 millones	15%

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:

Metric	FreedomEdge® Result	Comparison to Manual Push
Ease of Use	91% found it easier to use	N/A
Workflow Efficiency	97% reported increased time for patient interaction	Implies multitasking capability
Setup Time	91% reported faster setup time	N/A
Recommendation Rate	97% would recommend the system	N/A

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:

Metric	Value (Q3 2025)	Context/Driver
Total Net Revenues	$10.4 million	Second consecutive quarter over $10 million
International Core Revenue Growth (YoY)	230%	Attributed to stocking orders and prefill conversions
Pharma Services and Clinical Trials Revenue (Q2 2025)	$900,000	Represents diversification beyond SCIg
Overall 2025 Revenue Guidance (Raised)	$40.5 million to $41.0 million	Represents 20% - 22% year-over-year growth
Targeted Overall Market Share Increase	Mid-teens into the 40% range	Represents a $10 million to $20 million opportunity

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:

Channel/Segment	Q2 2025 Net Revenue (Millions USD)	Year-over-Year Growth
Domestic Core Business	\$7.1	15.3%
International Core Business	\$2.2	33.9%
Core Business Total	\$9.3	19%
Pharma Services and Clinical Trials	\$0.9	42.1%
Total Net Revenues	\$10.2	21%

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:

Metric	Value
Recurring Chronic Patients	45,000+
Annual Infusions Annually	Over 2M
Patient Adherence Rate	97%
System Lifespan (Razor)	3+ years
Countries of Distribution	30+

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:

Revenue Segment	Q3 2025 Revenue (USD)	Year-over-Year Change
Domestic Core Revenues	$6.1 million	-5.0%
International Core Revenues	$3.7 million	229.6%
Pharma Services and Clinical Trials Net Revenues	$0.6 million	-4.4%

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:

Metric	Q3 2025 Actual	FY 2025 Guidance/Target
Total Net Revenues	$10.4 million	$40.5 million to $41.0 million
Gross Profit	$6.3 million	Implied Range: $24.705 million to $25.83 million
Gross Margin	60.2%	61% to 63%
Total Operating Expenses	$7.1 million	Not explicitly guided, but positive cash flow from operations is expected.
Ending Cash Balance	$8.5 million (as of Sept 30)	Greater than $8.2 million

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.

Revenue Component	Q3 2025 Amount
Total Net Revenues (Q3 2025)	$10.4 million
Core SCIg Business Revenue (Domestic/International) (Q3 2025)	$9.82 million
Pharma Services and Clinical Trials (PST) Revenue (Q3 2025)	$0.58 million

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.