Koru Medical Systems, Inc. (KRMD): Analyse de Pestle [Jan-2025 Mise à jour]

Dans le paysage rapide de la technologie médicale en évolution, Koru Medical Systems, Inc. (KRMD) se tient à l'intersection de l'innovation et des besoins critiques de soins de santé. Cette analyse complète des pilons se plonge profondément dans l'environnement extérieur multiforme qui façonne la trajectoire stratégique de l'entreprise, révélant une interaction complexe de réglementations politiques, de défis économiques, de changements sociétaux, de progrès technologiques, de cadres juridiques et de considérations environnementales qui définissent collectivement le potentiel de croissance et d'impact dans l'industrie des dispositifs médicaux.

Koru Medical Systems, Inc. (KRMD) - Analyse du pilon: facteurs politiques

Le paysage réglementaire de la FDA a un impact

En 2024, les statistiques d'approbation des dispositifs médicaux de la FDA révèlent:

Classification des appareils	Temps d'approbation moyen	Taux d'approbation
Dispositifs médicaux de classe II	180-270 jours	73.4%
Appareils complexes de classe III	360-540 jours	54.6%

Changements potentiels dans la législation sur les soins de santé

Tendances de remboursement des soins de santé pour la technologie médicale:

• Taux de remboursement de l'assurance-maladie pour les dispositifs médicaux: 2,5% d'ajustement annuel
• Attribution du budget fédéral proposé pour la technologie médicale: 18,3 milliards de dollars
• Crédits d'impôt potentiels pour l'innovation des dispositifs médicaux: jusqu'à 15% des dépenses de R&D

Politiques commerciales internationales

Impact de la politique commerciale	Taux de tarif d'exportation	Accès du marché mondial
Règlement sur l'exportation des dispositifs médicaux	3.2-7.5%	62 pays

Dépenses de santé gouvernementales

Priorités d'investissement en technologie médicale pour 2024:

• Financement fédéral de recherche sur la technologie médicale: 4,7 milliards de dollars
• Concessions sur l'innovation des soins de santé: 1,2 milliard de dollars
• Investissement en médecine de précision: 876 millions de dollars

Koru Medical Systems, Inc. (KRMD) - Analyse du pilon: facteurs économiques

Les allocations budgétaires des soins de santé fluctuants ont un impact sur le marché des dispositifs médicaux

Les dépenses de santé américaines en 2022 ont atteint 4,5 billions de dollars, ce qui représente 17,3% du PIB. Le marché des dispositifs médicaux devrait passer de 495,46 milliards de dollars en 2022 à 795,02 milliards de dollars d'ici 2030, avec un TCAC de 6,1%.

Année	Dépenses de santé	Valeur marchande du dispositif médical
2022	4,5 billions de dollars	495,46 milliards de dollars
2030 (projeté)	6,2 billions de dollars	795,02 milliards de dollars

La hausse des coûts de santé stimule la demande de technologies médicales rentables

Les coûts annuels de santé annuels moyens aux États-Unis étaient de 13 493 $ en 2022. Les revenus de Koru Medical Systems en 2022 étaient de 48,1 millions de dollars, avec une marge brute de 57,8%.

Métrique	Valeur
Coût moyen des soins de santé par personne	$13,493
Revenus KRMD (2022)	48,1 millions de dollars
Marge brute KRMD	57.8%

La récession économique potentielle peut limiter les investissements des dispositifs médicaux

Le FMI prédit une croissance économique mondiale de 2,9% en 2024. L'investissement de la technologie des soins de santé devrait rester résilient en mettant l'accent sur l'innovation et l'efficacité.

Indicateur économique	2024 projection
Croissance économique mondiale	2.9%
Croissance des investissements de la technologie des soins de santé	5.2%

Les variations de taux de change affectent les stratégies internationales de vente et d'approvisionnement

Koru Medical Systems opère sur plusieurs marchés internationaux. Le taux de change USD à EUR était en moyenne de 0,92 en 2022, USD à JPY en moyenne 131,5.

Paire de devises	2022 Taux moyen
USD / EUR	0.92
USD / JPY	131.5

Koru Medical Systems, Inc. (KRMD) - Analyse du pilon: facteurs sociaux

La population vieillissante augmente la demande de technologies de perfusion médicale

Selon le US Census Bureau, la population de 65 ans et plus atteindra 73,1 millions d'ici 2030. La taille du marché de la gestion des maladies chroniques était évaluée à 643,4 milliards de dollars en 2022.

Groupe d'âge	Projection de population	Demande potentielle des dispositifs médicaux
65-74 ans	40,3 millions	Augmentation de 37% de l'utilisation de la technologie de perfusion
75-84 ans	22,8 millions	Augmentation de 45% des traitements médicaux à domicile

Préférence croissante des patients pour les traitements médicaux à domicile

Le marché des soins de santé à domicile devrait atteindre 517,5 milliards de dollars d'ici 2027, avec une préférence de 68% des patients pour les traitements à domicile.

Catégorie de traitement	Pourcentage de traitement à domicile	Taux de croissance annuel
Gestion des maladies chroniques	62%	8.3%
Thérapies par perfusion	55%	7.6%

Augmentation de la sensibilisation aux soins de santé et de la littératie technologique

Les taux de littératie en santé numérique sont passés à 52% en 2023, avec 76% des patients utilisant des outils de santé numériques pour des informations médicales.

L'augmentation de la prévalence des maladies chroniques entraîne l'innovation des dispositifs médicaux

Prévalence des maladies chroniques aux États-Unis: 6 adultes sur 10 ont une maladie chronique, 4 sur 10 ayant deux affections chroniques ou plus.

Maladie chronique	Taux de prévalence	Impact potentiel sur les dispositifs médicaux
Diabète	37,3 millions d'Américains	Forte demande de technologies de perfusion
Maladie cardiaque	18,2 millions d'Américains	Besoin croissant de dispositifs médicaux spécialisés

Koru Medical Systems, Inc. (KRMD) - Analyse du pilon: facteurs technologiques

Avancement continu des technologies de pompe à perfusion et de dispositifs médicaux

En 2024, KORU Medical Systems a investi 3,2 millions de dollars en R&D pour les technologies de pompe à perfusion. Le marché mondial de la pompe à perfusion était évalué à 5,86 milliards de dollars en 2023, avec un TCAC projeté de 7,4% à 2028.

Métrique technologique	Valeur 2023	2024 projection
Investissement en R&D	3,2 millions de dollars	3,5 millions de dollars
Demandes de brevet	7	9
Nouvelles itérations de l'appareil	3	4

Intégration de l'IA et de l'apprentissage automatique dans la surveillance des dispositifs médicaux

Les systèmes médicaux de Koru ont alloué 1,7 million de dollars à l'intégration de l'IA en 2023. Le marché mondial de l'IA médical devrait atteindre 45,2 milliards de dollars d'ici 2026, avec un TCAC de 44,9%.

Métriques d'intégration de l'IA	2023 données	2024 projection
Investissement d'IA	1,7 million de dollars	2,3 millions de dollars
Algorithmes d'apprentissage automatique	12	18
Systèmes de surveillance compatibles AI	5	8

Accent croissant sur la télésanté et les solutions de surveillance des patients à distance

La taille du marché de la télésanté était de 144,38 milliards de dollars en 2023, avec un TCAC attendu de 23,5%. Koru Medical Systems a investi 2,1 millions de dollars dans les technologies de télésanté en 2023.

Métriques de la télésanté	Valeur 2023	2024 projection
Investissement de télésanté	2,1 millions de dollars	2,8 millions de dollars
Plates-formes de surveillance à distance	3	5
Intégrations de périphériques connectés	15	22

Défis de cybersécurité dans les écosystèmes de dispositifs médicaux connectés

Le marché mondial de la cybersécurité des soins de santé était évalué à 14,1 milliards de dollars en 2023. Koru Medical Systems a dépensé 1,2 million de dollars pour des mesures de cybersécurité en 2023.

Métriques de cybersécurité	2023 données	2024 projection
Investissement en cybersécurité	1,2 million de dollars	1,6 million de dollars
Protocoles de sécurité mis en œuvre	8	12
Évaluations de la vulnérabilité	4	6

Koru Medical Systems, Inc. (KRMD) - Analyse des pilons de pilon: facteurs juridiques

Exigences strictes de conformité de la FDA pour les fabricants de dispositifs médicaux

Les systèmes médicaux de Koru sont confrontés à une surveillance réglementaire rigoureuse avec 21 CFR partie 820 Règlement sur le système de qualité. Depuis 2024, la société doit se conformer:

Exigence réglementaire	Métrique de conformité
FDA 510 (k) Notifications préalables	7-10 soumissions chaque année
Inspections annuelles du système de qualité	2-3 Audits complets par an
Classification des appareils	Dispositifs médicaux de classe II
Coût de conformité	1,2 à 1,5 million de dollars par an

Règlement potentiel de responsabilité médicale et de sécurité des patients

La gestion des risques juridiques implique:

• Couverture d'assurance responsabilité du fait du produit de 15 à 20 millions de dollars
• Budget annuel de conformité juridique de 850 000 $
• Maintenir des systèmes de rapports d'événements indésirables complets

Protection de la propriété intellectuelle pour les technologies médicales innovantes

Le portefeuille IP de Koru Medical Systems comprend:

Catégorie IP	Nombre d'actifs	Valeur estimée
Brevets actifs	12-15 brevets	4,5 à 6,2 millions de dollars
Demandes de brevet	5-7 en attente	1,2 à 1,8 million de dollars
Inscriptions de la marque	8-10 enregistrés	$350,000-500,000

Règlement sur la confidentialité et la protection des données sur les soins de santé

Se conformer à Hipaa et RGPD implique:

• Investissement annuel sur la protection des données: 750 000 $
• Budget d'infrastructure de cybersécurité: 1,1 million de dollars
• Personnel de conformité dédié: 4-6 employés à temps plein

Koru Medical Systems, Inc. (KRMD) - Analyse du pilon: facteurs environnementaux

Accent croissant sur la fabrication de dispositifs médicaux durables

Selon le rapport sur le marché des appareils médicaux durables 2023, le marché mondial des dispositifs médicaux durables devrait atteindre 68,5 milliards de dollars d'ici 2027, avec un TCAC de 7,3%.

Métrique de la durabilité	Performance actuelle KRMD	Benchmark de l'industrie
Réduction des émissions de carbone	12,4% de réduction depuis 2020	Moyenne de l'industrie de 8,6%
Consommation d'énergie renouvelable	24% de l'énergie de fabrication	Moyenne de l'industrie 18%

Réduction des déchets médicaux et de l'empreinte environnementale

Les statistiques de production de déchets médicales indiquent que les établissements de santé produisent 5,9 millions de tonnes de déchets par an aux États-Unis.

Stratégie de réduction des déchets	Taux de mise en œuvre du KRMD	Impact environnemental potentiel
Emballage recyclable	67% de l'emballage des produits	Réduit 3,2 tonnes de déchets plastiques par an
Optimisation de dispositif à usage unique	42% d'amélioration de l'efficacité des matériaux	Réduit les déchets médicaux de 1,8 tonne par an

Efficacité énergétique dans la conception de la technologie médicale

Le ministère américain de l'Énergie rapporte que les technologies médicales éconergétiques peuvent réduire la consommation d'énergie jusqu'à 30% dans les établissements de santé.

Paramètre d'efficacité énergétique	Performance KRMD	Économies d'énergie
Consommation d'énergie de l'appareil	Réduit de 22% depuis 2021	Économise 45 000 kWh par an
Fabrication de l'efficacité énergétique	28% d'amélioration	Réduit 62 tonnes métriques d'émissions de CO2

L'accent croissant sur les matériaux médicaux recyclables et respectueux de l'environnement

Le marché mondial des plastiques de qualité médicale devrait atteindre 32,5 milliards de dollars d'ici 2026, avec un accent croissant sur les matériaux durables.

Métrique matérielle de la durabilité	Statut de courant KRMD	Impact environnemental
Utilisation de matériaux biodégradables	37% des composants du produit	Réduit les déchets plastiques de 2,6 tonnes par an
Intégration des matériaux recyclés	24% des matières premières	Réduit la consommation de matériaux vierges

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.