KORU Medical Systems, Inc. (KRMD): Análisis PESTLE [Actualizado en enero de 2025]

En el panorama de tecnología médica en rápida evolución, Koru Medical Systems, Inc. (KRMD) se encuentra en la intersección de la innovación y las necesidades críticas de atención médica. Este análisis integral de mano de mortero profundiza en el entorno externo multifacético que da forma a la trayectoria estratégica de la Compañía, revelando una compleja interacción de regulaciones políticas, desafíos económicos, cambios sociales, avances tecnológicos, marcos legales y consideraciones ambientales que definen colectivamente el potencial de crecimiento e impacto de impacto para el impacto y el impacto. en la industria de dispositivos médicos.

Koru Medical Systems, Inc. (KRMD) - Análisis de mortero: factores políticos

FDA Regulatory Landscape impacta procesos de aprobación de dispositivos médicos

A partir de 2024, las estadísticas de aprobación del dispositivo médico de la FDA revelan:

Clasificación del dispositivo	Tiempo de aprobación promedio	Tasa de aprobación
Dispositivos médicos de clase II	180-270 días	73.4%
Dispositivos complejos de clase III	360-540 días	54.6%

Cambios potenciales en la legislación de atención médica

Tendencias de reembolso de atención médica para tecnología médica:

• Tasa de reembolso de Medicare para dispositivos médicos: ajuste anual del 2.5%
• Asignación de presupuesto de atención médica federal propuesta para tecnología médica: $ 18.3 mil millones
• Posibles créditos fiscales para la innovación de dispositivos médicos: hasta el 15% de los gastos de I + D

Políticas de comercio internacional

Impacto en la política comercial	Tarifas arancelas de exportación	Acceso al mercado global
Regulaciones de exportación de dispositivos médicos	3.2-7.5%	62 países

Gasto en salud del gobierno

Prioridades de inversión de tecnología médica para 2024:

• Financiación federal de investigación de tecnología médica: $ 4.7 mil millones
• Subvenciones de innovación en salud: $ 1.2 mil millones
• Inversión de medicina de precisión: $ 876 millones

Koru Medical Systems, Inc. (KRMD) - Análisis de mortero: factores económicos

Fluctuando las asignaciones de presupuesto de atención médica impactar el mercado de dispositivos médicos

El gasto en salud de los Estados Unidos en 2022 alcanzó los $ 4.5 billones, lo que representa el 17.3% del PIB. El mercado de dispositivos médicos proyectados para crecer de $ 495.46 mil millones en 2022 a $ 795.02 mil millones para 2030, con una tasa compuesta anual del 6.1%.

Año	Gastos de atención médica	Valor de mercado del dispositivo médico
2022	$ 4.5 billones	$ 495.46 mil millones
2030 (proyectado)	$ 6.2 billones	$ 795.02 mil millones

El aumento de los costos de atención médica impulsan la demanda de tecnologías médicas rentables

El costo promedio de atención médica anual por persona en los EE. UU. Fue de $ 13,493 en 2022. Los ingresos de Koru Medical Systems en 2022 fueron de $ 48.1 millones, con un margen bruto de 57.8%.

Métrico	Valor
Costo de atención médica promedio por persona	$13,493
Ingresos de KRMD (2022)	$ 48.1 millones
Krmd Margen bruto	57.8%

La recesión económica potencial puede restringir las inversiones de dispositivos médicos

El FMI predice un crecimiento económico global del 2.9% en 2024. La inversión en tecnología de salud se espera que se mantenga resistente con el enfoque continuo en la innovación y la eficiencia.

Indicador económico	2024 proyección
Crecimiento económico global	2.9%
Crecimiento de la inversión en tecnología de salud	5.2%

Las variaciones del tipo de cambio afectan las ventas internacionales y las estrategias de adquisición

Koru Medical Systems opera en múltiples mercados internacionales. El tipo de cambio de USD a EUR promedió 0.92 en 2022, USD a JPY promedió 131.5.

Pareja	Tasa promedio de 2022
USD/EUR	0.92
USD/JPY	131.5

Koru Medical Systems, Inc. (KRMD) - Análisis de mortero: factores sociales

La población que envejece aumenta la demanda de tecnologías de infusión médica

Según la Oficina del Censo de EE. UU., La población de 65 años y mayores alcanzará los 73.1 millones para 2030. El tamaño del mercado de la gestión de enfermedades crónicas se valoró en $ 643.4 mil millones en 2022.

Grupo de edad	Proyección de población	Demanda potencial de dispositivos médicos
65-74 años	40.3 millones	Aumento del 37% en el uso de la tecnología de infusión
75-84 años	22.8 millones	Aumento del 45% en los tratamientos médicos en el hogar

Preferencia de paciente creciente por los tratamientos médicos en el hogar

El mercado de atención médica domiciliaria proyectada para llegar a $ 517.5 mil millones para 2027, con un 68% de preferencia del paciente por los tratamientos en el hogar.

Categoría de tratamiento	Porcentaje de tratamiento en el hogar	Tasa de crecimiento anual
Manejo de enfermedades crónicas	62%	8.3%
Terapias de infusión	55%	7.6%

Aumento de la conciencia de la salud y la alfabetización tecnológica

Las tasas de alfabetización de salud digital aumentaron al 52% en 2023, con el 76% de los pacientes que usan herramientas de salud digitales para información médica.

El aumento de la prevalencia de enfermedades crónicas impulsa la innovación de dispositivos médicos

Prevalencia de enfermedades crónicas en los Estados Unidos: 6 de cada 10 adultos tienen una enfermedad crónica, con 4 de cada 10 con dos o más afecciones crónicas.

Enfermedad crónica	Tasa de prevalencia	Impacto potencial en los dispositivos médicos
Diabetes	37.3 millones de estadounidenses	Alta demanda de tecnologías de infusión
Cardiopatía	18.2 millones de estadounidenses	Creciente necesidad de dispositivos médicos especializados

Koru Medical Systems, Inc. (KRMD) - Análisis de mortero: factores tecnológicos

Avance continuo en la bomba de infusión y las tecnologías de dispositivos médicos

A partir de 2024, Koru Medical Systems ha invertido $ 3.2 millones en I + D para tecnologías de bomba de infusión. El mercado global de bombas de infusión se valoró en $ 5.86 mil millones en 2023, con una tasa compuesta anual proyectada de 7.4% hasta 2028.

Métrica de tecnología	Valor 2023	2024 proyección
Inversión de I + D	$ 3.2 millones	$ 3.5 millones
Solicitudes de patentes	7	9
Iteraciones de nuevos dispositivos	3	4

Integración de IA y aprendizaje automático en monitoreo de dispositivos médicos

Koru Medical Systems asignó $ 1.7 millones para la integración de IA en 2023. Se espera que el mercado global de IA médica alcance los $ 45.2 mil millones para 2026, con una tasa compuesta anual del 44.9%.

Métricas de integración de IA	2023 datos	2024 proyección
Inversión de IA	$ 1.7 millones	$ 2.3 millones
Algoritmos de aprendizaje automático	12	18
Sistemas de monitoreo habilitados para AI	5	8

Aumento del enfoque en la telesalud y las soluciones remotas de monitoreo de pacientes

El tamaño del mercado de telesalud fue de $ 144.38 mil millones en 2023, con una tasa compuesta anual del 23.5%. Koru Medical Systems invirtió $ 2.1 millones en tecnologías de telesalud en 2023.

Métricas de telesalud	Valor 2023	2024 proyección
Inversión de telesalud	$ 2.1 millones	$ 2.8 millones
Plataformas de monitoreo remoto	3	5
Integraciones de dispositivos conectados	15	22

Desafíos de ciberseguridad en los ecosistemas de dispositivos médicos conectados

El mercado global de seguridad cibernética de la salud se valoró en $ 14.1 mil millones en 2023. Koru Medical Systems gastó $ 1.2 millones en medidas de ciberseguridad en 2023.

Métricas de ciberseguridad	2023 datos	2024 proyección
Inversión de ciberseguridad	$ 1.2 millones	$ 1.6 millones
Protocolos de seguridad implementados	8	12
Evaluaciones de vulnerabilidad	4	6

Koru Medical Systems, Inc. (KRMD) - Análisis de mortero: factores legales

Requisitos estrictos de cumplimiento de la FDA para fabricantes de dispositivos médicos

Koru Medical Systems enfrenta rigurosa supervisión regulatoria de la FDA con 21 CFR Parte 820 Regulaciones del sistema de calidad. A partir de 2024, la compañía debe cumplir con:

Requisito regulatorio	Métrico de cumplimiento
Notificaciones previas a la FDA 510 (k)	7-10 presentaciones anualmente
Inspecciones anuales del sistema de calidad	2-3 auditorías integrales por año
Clasificación del dispositivo	Dispositivos médicos de clase II
Costo de cumplimiento	$ 1.2-1.5 millones anuales

Regulaciones potenciales de responsabilidad del dispositivo médico y seguridad del paciente

La gestión de riesgos legales implica:

• Cobertura de seguro de responsabilidad civil del producto de $ 15-20 millones
• Presupuesto anual de cumplimiento legal de $ 850,000
• Mantenimiento de sistemas integrales de informes de eventos adversos

Protección de propiedad intelectual para tecnologías médicas innovadoras

La cartera IP de Koru Medical Systems incluye:

Categoría de IP	Número de activos	Valor estimado
Patentes activas	12-15 patentes	$ 4.5-6.2 millones
Solicitudes de patentes	5-7 pendiente	$ 1.2-1.8 millones
Registros de marca registrada	8-10 registrado	$350,000-500,000

Regulaciones de privacidad y protección de datos de atención médica

Cumplimiento de HIPAA y GDPR involucra:

• Inversión anual de protección de datos: $ 750,000
• Presupuesto de infraestructura de ciberseguridad: $ 1.1 millones
• Personal de cumplimiento dedicado: 4-6 empleados a tiempo completo

Koru Medical Systems, Inc. (KRMD) - Análisis de mortero: factores ambientales

Aumento del enfoque en la fabricación de dispositivos médicos sostenibles

Según el informe del mercado de dispositivos médicos sostenibles de 2023, se proyecta que el mercado global de dispositivos médicos sostenibles alcanzará los $ 68.5 mil millones para 2027, con una tasa compuesta anual del 7.3%.

Métrica de sostenibilidad	KRMD RENDIMIENTO ACTUAL	Punto de referencia de la industria
Reducción de emisiones de carbono	Reducción de 12.4% desde 2020	Promedio de la industria de 8.6%
Uso de energía renovable	24% de energía de fabricación	Promedio de la industria del 18%

Reducción de residuos médicos y huella ambiental

Las estadísticas de generación de residuos médicos indican que las instalaciones de atención médica producen 5,9 millones de toneladas de desechos anualmente en los Estados Unidos.

Estrategia de reducción de residuos	Tasa de implementación de KRMD	Impacto ambiental potencial
Embalaje reciclable	67% del envasado de productos	Reduce 3.2 toneladas de desechos plásticos anualmente
Optimización de dispositivos de un solo uso	42% de mejora de la eficiencia del material	Reduce los desechos médicos en 1,8 toneladas por año

Eficiencia energética en diseño de tecnología médica

El Departamento de Energía de EE. UU. Informa que las tecnologías médicas de eficiencia energética pueden reducir el consumo de energía hasta en un 30% en entornos de atención médica.

Parámetro de eficiencia energética	Rendimiento de KRMD	Ahorro de energía
Consumo de energía del dispositivo	Reducido en un 22% desde 2021	Ahorra 45,000 kWh anualmente
Eficiencia energética de fabricación	Mejora del 28%	Reduce 62 toneladas métricas de emisiones de CO2

Énfasis creciente en materiales de dispositivos médicos reciclables y ecológicos

Se espera que el mercado global de plásticos de grado médico alcance los $ 32.5 mil millones para 2026, con un enfoque creciente en materiales sostenibles.

Métrica de sostenibilidad de material	Estado actual de KRMD	Impacto ambiental
Uso de material biodegradable	37% de los componentes del producto	Reduce los desechos plásticos en 2.6 toneladas anuales
Integración de material reciclado	24% de las materias primas	Reduce el consumo de material virgen

KORU Medical Systems, Inc. (KRMD) - PESTLE Analysis: Social factors

Growing patient preference for at-home care drives demand for the Freedom Infusion System.

You are seeing a massive, irreversible shift in healthcare delivery, and it is defintely working in KORU Medical Systems' favor. Patients overwhelmingly prefer receiving complex treatments in their homes, a trend that accelerated post-2020. This preference fuels the demand for home infusion therapy (HIT), the market for which is projected to be worth approximately $15.1 billion in 2025 in the U.S., growing at a Compound Annual Growth Rate (CAGR) of 8.4% through 2034.

The Freedom Infusion System capitalizes directly on this shift from costly, disruptive intravenous (IV) hospital settings to more convenient subcutaneous (SC) home therapy. This move is not just about comfort; it is also about cost-effectiveness for the system and reduced risk of hospital-acquired infections.

Here's the quick math on the market opportunity:

• U.S. Home Infusion Market Value (2025): $15.1 billion.
• Market Growth Driver: Patient desire for autonomy and convenience.
• KORU Medical's Position: Global leader in large-volume (>10mL) SC drug delivery.

High patient adherence rate of 97% for the Freedom System reinforces clinical and lifestyle value.

The clinical and social value of a medical device is often best measured by how consistently patients use it. For KORU Medical Systems, the data is compelling: adherence to subcutaneous immunoglobulin (SCIg) therapy using the Freedom Infusion System (including the FREEDOM60 and FreedomEdge models) was calculated at a remarkable 97%. This high adherence rate is a critical social factor because it translates directly into better patient outcomes, which in turn strengthens physician confidence and prescribing patterns.

A pump that is easy to use and reliable allows patients with chronic conditions like Primary Immunodeficiency (PI) to maintain their daily routines, travel, and work with minimal disruption. This lifestyle compatibility is a powerful, non-financial competitive advantage over more cumbersome infusion methods. Better adherence equals better health, which is the ultimate goal.

Increased prevalence of chronic illnesses like Primary Immunodeficiency (PI) expands the core SCIg market.

The core market for KORU Medical Systems is the treatment of Primary Immunodeficiency (PI) using Subcutaneous Immunoglobulin (SCIg) therapy. The patient population for this therapy is expanding. Globally, the Primary Immunodeficiency Diseases market is expected to reach $13.2 billion by 2033, growing at a CAGR of 6.5% from 2025.

In the U.S., the prevalence of diagnosed PI is estimated at approximately 1 in 1,200 persons, though the actual number of affected individuals may be as high as 1-2% of the population when all types are considered. This growing patient pool, combined with a 100% increase in patients receiving SCIG over the last decade, provides a strong, long-term tailwind for the company's consumables and pump drivers.

The table below breaks down the primary market segment:

PI Patient Segment (U.S.)	Percentage of Diagnosed PI Patients	Relevance to KORU Medical Systems
Antibody Deficiencies	63.4%	Primary target for SCIg therapy and the Freedom System.
Well-defined Syndromes with Immunodeficiency	16%	Secondary market segment that may require immunoglobulin therapy.
SCIG Patient Growth (Last Decade)	100% increase	Indicates rapid adoption of the subcutaneous route of administration.

Focus on user-friendly, patient-centric solutions aligns with broader consumerization of healthcare.

The consumerization of healthcare-where patients demand the same convenience and design quality from their medical devices as they do from consumer electronics-is a powerful social force. KORU Medical Systems' focus on a simple, reusable, and fully reimbursed system like the Freedom Infusion System is a direct response to this.

The company is not just selling a pump; it is selling a better patient experience. In a recent multicenter study, the FreedomEDGE Infusion System demonstrated high patient satisfaction and a 97% recommendation rate. That is a phenomenal endorsement. This patient-centric design philosophy is crucial for securing market share as new large-volume subcutaneous (LVSC) drugs, including those in oncology, come to market.

• Design Goal: Enable patient self-administration in the home.
• Patient Satisfaction Metric: 97% recommendation rate for FreedomEDGE.
• Market Alignment: Supports the shift to patient-controlled, at-home care.

KORU Medical Systems, Inc. (KRMD) - PESTLE Analysis: Technological factors

You're looking at KORU Medical Systems, Inc. (KRMD) and seeing a company that's not just selling a device, but actively building a platform to capture the pharmaceutical industry's shift to large-volume subcutaneous (SC) drug delivery. The technological story here is one of entrenching a competitive moat-the Freedom System-while aggressively expanding the pipeline to unlock new, high-value markets like oncology and rare disease, which will drive revenue growth of 15% to 17% for the 2025 fiscal year, with revenue guidance set between $38.5 million and $39.5 million.

Development agreement for next-generation infusion systems to support both vials and prefilled syringes (PFS)

The company's strategic development agreement with a global pharmaceutical company, announced in late 2025, is a crucial technological step. This collaboration, which includes SCHOTT Pharma, is focused on developing a next-generation subcutaneous immunoglobulin (SCIg) infusion system that can accommodate both traditional drug vials and prefilled syringes (PFS).

This is defintely smart because it creates a universal platform. The innovative system will integrate KORU Medical's infusion technology with SCHOTT TOPPAC® polymer syringes, giving pharmaceutical partners flexibility. Importantly, KORU Medical's Freedom60 and FreedomEdge pumps were already pioneers, being the first devices to receive 510(k) clearance for use with prefilled syringes, which simplifies drug preparation tasks for patients by up to 80% compared to using vials.

The Freedom System's proven capability for large-volume subcutaneous drug delivery is a key competitive moat

The core technological advantage of the Freedom System is its proven, purely mechanical capability for large-volume subcutaneous drug delivery, which is a significant competitive moat (a sustainable competitive advantage). It supports drug volumes from 5mL to over 50mL and can handle drugs with high viscosity (thickness), which is often a problem for electronic pumps.

The market traction and patient acceptance are strong, which makes it a preferred partner for biopharma companies developing new SC formulations. Here's the quick math on its proven capability:

• Market-Proven History: 15+ years of patient self-administration in the home.
• Patient Base: Over 45,000 recurring chronic patients.
• Annual Use: Over 2 million infusions annually.
• Patient Adherence: 97% patient adherence rate.

This track record is why pharmaceutical companies are partnering with them; they want their new drugs to launch on a system with proven safety and commercial success.

Pipeline includes a 510(k) submission to the FDA for an oncology infusion application by early 2026

The pipeline is robust, targeting major new therapeutic areas beyond their core SCIg market. The most impactful near-term submission is the planned 510(k) application to the FDA for the FreedomEDGE Syringe Infusion System for use with a commercialized oncology drug. This submission is anticipated in the fourth quarter of 2025 or the first quarter of 2026.

This move is a direct play to capitalize on the shift from intravenous (IV) to subcutaneous administration in the oncology market, a trend that simplifies treatment and improves quality of life for patients. Furthermore, the company has other 510(k) submissions planned for the second half of 2025 for an Iron Chelation Drug, an Antibiotic Drug, and a Rare Disease Drug for infusion clinics, showing a clear, multi-front technological expansion.

Ongoing development of a new pump and flow controller aims to unlock new, previously untapped markets

The company is investing in next-generation hardware to expand its total addressable market (TAM). The ongoing development includes a new pump and a new flow controller. The launch of a Phase 1 flow controller is a key milestone for Q3 2025, with a 510(k) submission for a Phase 2 flow controller expected in Q1 2026.

These new devices are designed to facilitate entry into new, previously untapped markets, specifically moving beyond the home-care setting and into infusion clinics. This strategic expansion into new drug therapy areas is expected to add an additional $2.2 billion to the TAM. By 2026, KORU Medical expects to have 9 potential commercial opportunities (drugs, indications, and devices) on its label, a strong indicator of technological leverage.

Technological Milestone / Product	Target Market / Indication	Anticipated Timeline (2025/2026)	Market Impact / Value
Next-Generation SCIg Infusion System (w/ SCHOTT Pharma)	Subcutaneous Immunoglobulin (SCIg) Therapy	In Development (Announced Nov 2025)	Accommodates both vials and Prefilled Syringes (PFS), simplifying home therapy.
FreedomEDGE 510(k) Submission	Oncology Drug (Commercialized)	Q4 2025 - Q1 2026	Expands into the high-value oncology market; drives adoption in infusion clinics.
Phase 1 Flow Controller Launch	International Markets / New SC Drugs	Q3 2025	Enables entry into new geographies (e.g., Japan commercial sales 1H 2025) and new markets.
Pipeline 510(k) Submissions (3 additional)	Iron Chelation, Antibiotic, Rare Disease	2H 2025	Adds up to $2.2 billion to the Total Addressable Market (TAM) beyond SCIg.

KORU Medical Systems, Inc. (KRMD) - PESTLE Analysis: Legal factors

Multiple planned FDA 510(k) submissions in 2025 for new drug indications and devices expand the addressable market.

The regulatory pathway is KORU Medical Systems' primary growth engine right now, so managing the Food and Drug Administration (FDA) 510(k) clearance process is defintely critical. This process, which demonstrates a new device is substantially equivalent to a legally marketed predicate device, is how the company expands its addressable market beyond its core Subcutaneous Immunoglobulin (SCIg) therapy. For the second half of 2025 (2H 2025), KORU Medical Systems is targeting at least three new drug indications for 510(k) submission, including an Iron Chelation Drug, an Antibiotic Drug, and a Rare Disease Drug for use in an infusion clinic setting. This is huge because it moves the Freedom System into new therapeutic areas.

The company is also pushing for clearance on new hardware, with a 510(k) submission planned for the new FreedomEDGE Syringe Infusion System for use with a commercialized oncology drug, which is slated for late Q4 2025 or Q1 2026. This aggressive pipeline of regulatory filings-up to 9 potential commercial opportunities by 2026-is a clear legal strategy to capture a larger share of the large-volume subcutaneous drug delivery market. You can't grow without the paperwork.

Regulatory Submission	Target Filing Timeline (2025-2026)	Therapeutic Area / Device
FDA 510(k) Submission	2H 2025	Iron Chelation Drug Indication
FDA 510(k) Submission	2H 2025	Antibiotic Drug Indication
FDA 510(k) Submission	2H 2025	Rare Disease Drug for Infusion Clinic
FDA 510(k) Submission	Q4 2025 - Q1 2026	FreedomEDGE System for Oncology Drug
FDA 510(k) Submission	Q4 2025 - Q1 2026	Next Generation Pump

Compliance with global medical device regulations (e.g., EU MDR, Japan clearance) is critical for international growth.

International sales are a major growth accelerator, and that means navigating complex global regulatory regimes. The company has already had a significant legal win in Asia, having received regulatory clearance for the FreedomEdge System in Japan in mid-2024, which paved the way for commercial sales to start in 1H 2025. That clearance covers the delivery of multiple drugs, including CSL Behring's Hizentra and Takeda Pharmaceutical's Cuvitru.

In Europe, the continuous evolution of the European Union Medical Device Regulation (EU MDR) presents a persistent legal challenge. While KORU Medical Systems has established international distribution across 30+ countries, maintaining compliance requires ongoing investment in quality management systems (QMS) and technical documentation. For instance, the EU's new Unique Device Identification (UDI) requirements for certain device classes, and the ongoing scrutiny of Notified Bodies, mean the legal team must constantly manage compliance to prevent any interruption in the supply chain for the international core business, which delivered $9.8 million in net revenues in Q3 2025.

Intellectual property protection for the proprietary Freedom System technology is essential against competitors.

The core value of KORU Medical Systems is its proprietary Freedom System, which includes the Freedom60® and FreedomEdge® Syringe Infusion Drivers. This technology is protected by a suite of patents and trademarks. The company's legal strategy must focus on defending this intellectual property (IP) because it is the foundation for its competitive advantage in large-volume subcutaneous drug delivery. Losing a key patent could be devastating.

A November 2025 development agreement with a global pharmaceutical company to create a next-generation infusion system that integrates with both vials and prefilled syringes (PFS) highlights the ongoing IP development. This collaboration, which uses KORU Medical Systems' infusion technology, is a legal mechanism to embed their proprietary system deeper into the biopharma value chain, effectively expanding their IP moat. The system is already market-proven, supporting over 2 million infusions annually.

The company must manage regulatory risk tied to the timing of new product clearances, like the rare disease candidate pushed to Q1 2026.

Regulatory timing risk is a constant for medical device companies, and it directly impacts revenue projections. The difference between a Q4 2025 clearance and a Q1 2026 clearance can shift millions in revenue. KORU Medical Systems has explicitly flagged this risk with its most advanced new hardware, the FreedomEDGE Syringe Infusion System for oncology use, which has a projected 510(k) submission window that straddles the end of the fiscal year: Q4 2025 to Q1 2026. This uncertainty in the final clearance date creates a planning challenge for commercial launch and sales forecasts.

While the Rare Disease Drug submission is still on the docket for 2H 2025, any delay in the FDA's review of this or other submissions-like the next-gen pump-could push the revenue impact further out. This is a key investor concern, especially as the company is guiding for full-year 2025 revenue of $40.5 million to $41.0 million. The legal and regulatory team's efficiency in managing the FDA dialogue is an immediate financial lever.

KORU Medical Systems, Inc. (KRMD) - PESTLE Analysis: Environmental factors

The company is assessed for its alignment with the UN Sustainable Development Goals (SDGs).

KORU Medical Systems' core business-enabling patient-centric, at-home subcutaneous infusion-is a direct contributor to the United Nations Sustainable Development Goals (SDGs), particularly SDG 3: Good Health and Well-being. An independent sustainability assessment places the company's unscaled total contribution to the 17 SDGs at 92.7% (unscaled). This high score reflects the inherent social benefit of their Freedom Infusion System, which is used by over 45,000 patients globally, facilitating over 2 million infusions annually.

The alignment goes beyond just health, touching on other goals through their operational footprint and supply chain management. Still, the primary material focus is on patient access and quality of care.

Key UN SDG Alignment Areas	Primary Business Impact	Risk/Opportunity
SDG 3: Good Health and Well-being	Enables at-home, patient-managed therapy for chronic conditions.	Opportunity: Deepen market penetration by adding new drugs to the label in 2025 (e.g., Iron Chelation, Antibiotic, Rare Disease).
SDG 12: Responsible Consumption and Production	Manufacturing of single-use consumables (tubing, needle sets).	Risk: Industry-wide pressure to reduce medical waste volume.
SDG 13: Climate Action	Reduction of hospital/clinic visits via home-based care model.	Risk: Transition risk in the global supply chain due to climate-related disruptions.

Manufacturing processes face industry-wide pressure to reduce waste from single-use medical consumables.

The company's recurring revenue model relies heavily on the sale of single-use consumables, specifically the Precision Flow Rate Tubing™ and HIgH-Flo Subcutaneous Safety Needle Sets™. This revenue stream is a financial strength, accounting for an estimated 75% of their core business revenue, but it is an environmental vulnerability. The medical device industry faces increasing scrutiny over the large volume of plastic and other waste generated by single-use items, a challenge KORU Medical Systems shares.

You need to be defintely aware of the trade-off here. While the single-use nature ensures sterility and patient safety, the volume of waste from over 2 million annual infusions is a material environmental factor. The industry trend is moving toward circular economy principles, and a future next-generation system will need to address material reduction or end-of-life recycling for these disposables to maintain long-term sustainability credibility.

Home-based care models inherently reduce the carbon footprint associated with hospital or clinic visits.

The core value proposition of the Freedom System-self-administration of large-volume subcutaneous immunoglobulin (SCIg) and other therapies in the home-provides a significant, if often unquantified, environmental benefit. By shifting care from the hospital or infusion clinic to the patient's home, the model drastically cuts down on patient and caregiver travel, which reduces transportation-related carbon emissions.

The broader healthcare sector's Scope 3 emissions (indirect emissions from the supply chain, patient travel, and purchased goods) typically account for 50%-75% of total emissions. [cite: 18 in first search] KORU Medical Systems' model directly mitigates the patient travel component of this large Scope 3 footprint. This is a powerful, unstated competitive advantage in a world increasingly focused on decarbonizing healthcare. The shift from intravenous (IV) to subcutaneous (SC) administration also reduces the consumption of hospital resources and staff time, further lowering the institutional carbon load.

Transition risk related to climate change is a factor for supply chain and manufacturing operations.

Like any medical device manufacturer, KORU Medical Systems is exposed to climate-related 'transition risk,' which is the risk associated with moving to a low-carbon economy. This includes regulatory changes, market shifts, and technology changes. The company's supply chain, which includes their 44,000 sq. ft. facility with Class 8 cleanrooms, is susceptible to physical and transition risks.

The company has acknowledged potential challenges from supply chain disruptions in its 2025 guidance. [cite: 3 in first search] This is critical because global supply chains are increasingly vulnerable to extreme weather events and climate-related disasters, which were ranked as a significant short-term material crisis risk in a 2025 global risk report. [cite: 19 in first search] You must model the financial impact of a supply chain disruption on their ability to deliver their full-year 2025 revenue guidance of $40.5 million to $41.0 million. [cite: 8 in first search]

• Model impact of 14+ day supply chain delay on Q4 2025 revenue.
• Identify alternative sourcing strategies for key plastic components.
• Assess energy efficiency of the Mahwah, New Jersey manufacturing facility.