Koru Medical Systems, Inc. (KRMD): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage dynamique de la technologie médicale, Koru Medical Systems, Inc. (KRMD) émerge comme une force pionnière, révolutionnant les soins aux patients grâce à des technologies innovantes de pompe à perfusion ambulatoire. Leur toile de modèle commercial méticuleusement conçu révèle une approche stratégique qui mélange de manière transparente l'ingénierie médicale de pointe, les solutions centrées sur le patient et les stratégies de pénétration du marché robustes. En se concentrant sur le développement avancé des dispositifs médicaux et la prestation de soins de santé précis, KORU Medical Systems transforme la façon dont les professionnels de la santé et les patients éprouvent la mobilité du traitement, la commodité et l'excellence technologique.

Koru Medical Systems, Inc. (KRMD) - Modèle d'entreprise: partenariats clés

Fabricants et fournisseurs de dispositifs médicaux

KORU Medical Systems collabore avec les principaux partenaires de fabrication de dispositifs médicaux suivants:

Entreprise partenaire	Focus de partenariat	Année établie
BD (Becton, Dickinson and Company)	Composants de la technologie de perfusion	2018
Medtronic	Technologie de la pompe de précision	2020

Distributeurs de la technologie des soins de santé

Koru Medical Systems maintient des partenariats de distribution stratégique:

• Henry Schein Medical
• Santé cardinale
• McKesson Corporation

Institutions de recherche et universités

Institution	Focus de recherche	Type de collaboration
Université Johns Hopkins	Innovation technologique de perfusion	Partenariat de recherche
Hôpital général du Massachusetts	Recherche d'application clinique	Essais cliniques

Hôpitaux et centres médicaux

Koru Medical Systems s'associe à 47 réseaux de soins de santé majeurs aux États-Unis, notamment:

• Clinique de mayo
• Clinique de Cleveland
• NYU Langone Health

Partenaires de conformité réglementaire

Les principales collaborations de conformité réglementaire comprennent:

Organisation	Zone de conformité	Statut de partenariat
FDA	Règlement sur les dispositifs médicaux	Certification active
ISO International	Normes de gestion de la qualité	Partenaire certifié

Koru Medical Systems, Inc. (KRMD) - Modèle d'entreprise: activités clés

Recherche et développement des dispositifs médicaux

Dépenses de R&D pour 2023: 7,2 millions de dollars

Zones de mise au point R&D	Allocation des investissements
Technologie de pompe à perfusion ambulatoire	48% du budget de la R&D
Systèmes de livraison de médicaments avancés	35% du budget de la R&D
Intégration logicielle	17% du budget de la R&D

Fabrication de perfusion et de pompes ambulatoires

Capacité de fabrication annuelle: 125 000 dispositifs médicaux

• Installation de fabrication principale: Carlstadt, New Jersey
• Taux d'efficacité de la fabrication: 94,5%
• Taux d'inspection du contrôle de la qualité: 100% des unités produites

Tests de produits et validation clinique

Tester les paramètres	Métrique
Essais cliniques annuels	7-9 études
Durée moyenne de l'étude	18-24 mois
Budget total des tests cliniques 2023	3,6 millions de dollars

Processus d'approbation réglementaire

Taux de réussite de la soumission de la FDA: 88%

• Time d'approbation moyenne de la FDA: 12-15 mois
• Taille de l'équipe de conformité réglementaire: 12 professionnels
• Budget annuel de conformité réglementaire: 2,1 millions de dollars

Ventes et commercialisation des technologies médicales

Métriques marketing	2023 données
Taille de l'équipe de vente	45 professionnels
Dépenses de marketing	4,5 millions de dollars
Segments de soins de santé cibles	Hôpitaux, cliniques, soins de santé à domicile

Koru Medical Systems, Inc. (KRMD) - Modèle d'entreprise: Ressources clés

Talent spécialisé en génie médical

En 2024, KORU Medical Systems emploie 143 employés au total, avec environ 37 dédiés à l'ingénierie et aux rôles de la R&D.

Catégorie des employés	Nombre d'employés	Pourcentage
Total des employés	143	100%
Personnel d'ingénierie / R&D	37	25.9%

Technologie des dispositifs médicaux propriétaires

Koru Medical Systems tient 6 brevets de dispositifs médicaux actifs spécifiquement lié à la technologie de perfusion et aux systèmes de pompe ambulatoire.

• Plateforme de conducteur de seringue Freedom
• Technologie de perfusion ambulatoire de précision
• Systèmes de livraison médicale portables

Installations de fabrication

L'entreprise exploite un Installation de fabrication de 12 500 pieds carrés Situé à Newnan, Géorgie, États-Unis.

Spécification de l'installation	Détails
Emplacement	Newnan, Géorgie
Espace de fabrication total	12 500 pieds carrés
Certification ISO	ISO 13485: 2016

Portefeuille de propriété intellectuelle

Depuis l'exercice 2023, KORU Medical Systems maintient:

• 6 brevets actifs
• 3 demandes de brevet en instance
• Investissement total de propriété intellectuelle: 2,1 millions de dollars

Équipement de contrôle de la qualité et de test

L'entreprise utilise des équipements de test avancés évalués à approximativement 1,5 million de dollars, y compris:

• Instruments d'étalonnage de précision
• Chambres de test environnemental
• Systèmes de test de compatibilité électromagnétique

Catégorie d'équipement	Valeur estimée
Instruments d'étalonnage	$450,000
CHAMBRES DE TEST	$650,000
Systèmes de test de compatibilité	$400,000

Koru Medical Systems, Inc. (KRMD) - Modèle d'entreprise: propositions de valeur

Technologies avancées de pompe à perfusion ambulatoire

La technologie du conducteur de la seringue Freedom System de Koru Medical Systems permet une livraison précise de médicaments ambulatoires avec les spécifications suivantes:

Spécifications technologiques	Métrique
Précision de perfusion	± 2% à des débits spécifiés
Durée de vie de la batterie	Jusqu'à 24 heures opérationnelles continues
Poids	Environ 4,5 onces
Durée de vie de l'appareil	Plus de 5 ans

Amélioration de la mobilité et de la commodité du traitement des patients

Les avantages clés de la mobilité comprennent:

• Appareil portable pesant moins de 5 onces
• Capacités de connectivité sans fil
• Compatible avec plusieurs types de médicaments
• Conçu pour une utilisation ambulatoire des patients

Précision de livraison de médicaments améliorée

Métrique de précision	Performance
Précision de débit	± 2% entre les gammes spécifiées
Détection d'occlusion	Système d'alerte immédiat
Intervalles programmables	Incréments de 0,1 ml / heure

Solutions de dispositifs médicaux rentables

Les mesures financières démontrant la rentabilité:

• Coût moyen de l'appareil: 1 250 $ par unité
• Économies de santé estimées: 3 500 $ par patient par an
• Réduction des taux de réadmission de l'hôpital de 22%

Innovation de santé centrée sur le patient

Paramètre d'innovation	Métrique de performance
Évaluation de satisfaction des patients	4.7/5
Taux d'adoption clinique	68% entre les cliniques spécialisées
Portefeuille de brevets	12 brevets de dispositifs médicaux actifs

Koru Medical Systems, Inc. (KRMD) - Modèle d'entreprise: relations avec les clients

Équipes de soutien aux ventes directes

Depuis le quatrième trimestre 2023, Koru Medical Systems maintient une équipe de vente directe dédiée de 37 professionnels spécialisés dans les ventes de dispositifs médicaux. L'équipe couvre plusieurs régions géographiques à travers les États-Unis.

Métrique de l'équipe de vente	Quantité
Représentants des ventes totales	37
Expérience de vente moyenne	8,5 ans
Couverture géographique	48 États

Service client technique

KORU Medical Systems fournit un service client technique via plusieurs canaux avec des mesures de réponse spécifiques.

• Hotline de support technique 24/7
• Temps de réponse moyen: 17 minutes
• Représentants du service à la clientèle: 22
• Interactions annuelles sur le service à la clientèle: 4 562

Ressources de formation des produits en ligne

L'entreprise propose des plateformes de formation numérique complètes pour les professionnels de la santé.

Ressource de formation	Détails
Modules de formation en ligne	47 modules interactifs
Engagement annuel des utilisateurs	2 345 professionnels de la santé
Taux d'achèvement de la formation	92%

Consultation professionnelle médicale

KORU Medical Systems emploie 15 spécialistes cliniciens fournissant des services de consultation médicale directes.

• Spécialistes cliniques titulaires de diplômes médicaux avancés: 12
• Durée moyenne de la consultation: 43 minutes
• Taux de réalisation des demandes de consultation: 96%

Assistance et maintenance des produits en cours

La société fournit une infrastructure complète de soutien aux produits pour ses dispositifs médicaux.

Métrique de soutien	Quantité
Contrats de maintenance annuels	1,237
Temps de réponse moyen pour la maintenance	4,2 heures
Évaluation de satisfaction du client	4.7/5

Koru Medical Systems, Inc. (KRMD) - Modèle d'entreprise: canaux

Force de vente directe

Depuis le quatrième trimestre 2023, Koru Medical Systems maintient une équipe de vente directe de 37 représentants commerciaux ciblant les hôpitaux, les cliniques et les installations médicales à travers les États-Unis.

Métrique du canal de vente	2023 données
Représentants totaux des ventes directes	37
Couverture géographique	États-Unis
Cycle de vente moyen	4,2 mois

Distributeurs d'équipement médical

KORU Medical Systems s'associe à 12 distributeurs d'équipements médicaux spécialisés à l'échelle nationale.

• Accords de distribution stratégiques avec les réseaux de fournitures médicales régionales
• Partenariats couvrant 48 États
• Taux de commission des distributeurs: 12-15%

Plateformes de commerce électronique en ligne

La société utilise deux canaux de vente en ligne principaux avec 2,3 millions de dollars de revenus numériques en 2023.

Plate-forme en ligne	2023 Revenus numériques
Site Web de l'entreprise	1,4 million de dollars
Plates-formes d'approvisionnement médicales tierces	$900,000

Conférences médicales et salons commerciaux

KORU Medical Systems a participé à 17 conférences médicales en 2023, générant environ 780 000 $ en ventes directes.

• Conférences assistées: 17
• Revenus totaux générés par la conférence: 780 000 $
• Revenu moyen par conférence: 45 882 $

Réseaux de prestataires de soins de santé

La société a établi des relations avec 243 réseaux de prestataires de soins de santé, représentant une clientèle potentielle.

Type de réseau	Nombre de réseaux
Réseaux hospitaliers	127
Cliniques spécialisées	86
Institutions de recherche	30

Koru Medical Systems, Inc. (KRMD) - Modèle d'entreprise: segments de clientèle

Hôpitaux et centres médicaux

Taille du marché pour les clients hospitaliers potentiels: 6 129 hôpitaux aux États-Unis en 2023.

Type d'hôpital	Nombre total	Pénétration potentielle du marché de Koru
Hôpitaux communautaires	4,752	35.6%
Hôpitaux à but non lucratif	2,873	42.1%

Fournisseurs de soins de santé à domicile

Total des agences de soins de santé à domicile aux États-Unis: 12 422 en 2022.

• Agences de santé à domicile certifiées par Medicare: 9 815
• Fournisseurs de santé à domicile privés: 2 607

Centres de soins ambulatoires

Total des établissements de soins ambulatoires aux États-Unis: 41 285 en 2023.

Type d'installation	Nombre d'installations
Centres chirurgicaux	5,687
Centres de soins urgents	11,523

Cliniques médicales spécialisées

Total des cliniques médicales spécialisées aux États-Unis: 28 456 en 2023.

• Cliniques d'oncologie: 3 245
• Cliniques d'hématologie: 1 876
• Centres de perfusion: 4 532

Professionnels de la santé individuels

Nombre total de médecins actifs aux États-Unis: 1 073 616 en 2022.

Groupe de spécialité	Nombre de professionnels
Oncologistes	14,680
Hématologues	6,542
Spécialistes de la perfusion	8,234

Koru Medical Systems, Inc. (KRMD) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, KORU Medical Systems a déclaré des dépenses de R&D de 7,3 millions de dollars, ce qui représente 19,2% des revenus totaux.

Exercice fiscal	Dépenses de R&D	Pourcentage de revenus
2023	7,3 millions de dollars	19.2%
2022	6,8 millions de dollars	18.5%

Coûts de fabrication et de production

Les coûts de fabrication totaux pour 2023 étaient de 12,5 millions de dollars, avec une ventilation comme suit:

• Coûts de matériel direct: 5,2 millions de dollars
• Coûts de main-d'œuvre directs: 3,8 millions de dollars
• Fabrication des frais généraux: 3,5 millions de dollars

Investissements de vente et de marketing

Les dépenses de vente et de marketing pour 2023 ont totalisé 9,6 millions de dollars, ce qui représente 25,3% des revenus totaux.

Catégorie de dépenses	Montant
Personnel de vente	4,2 millions de dollars
Campagnes marketing	3,1 millions de dollars
Salon et événements	1,3 million de dollars
Marketing numérique	1,0 million de dollars

Dépenses de conformité réglementaire

Les coûts de conformité réglementaire pour 2023 s'élevaient à 2,9 millions de dollars, ce qui comprend:

• Conformité de la FDA: 1,5 million de dollars
• Systèmes de gestion de la qualité: 0,8 million de dollars
• Tests cliniques et validation: 0,6 million de dollars

Gestion des frais généraux opérationnels

Les frais généraux opérationnels pour 2023 étaient de 6,2 millions de dollars, distribués sur diverses fonctions administratives:

Catégorie aérienne	Montant
Frais administratifs généraux	2,7 millions de dollars
Infrastructure informatique	1,5 million de dollars
Gestion des installations	1,2 million de dollars
Services professionnels	0,8 million de dollars

Koru Medical Systems, Inc. (KRMD) - Modèle d'entreprise: Strots de revenus

Ventes de produits de dispositif médical

KORU Medical Systems a déclaré un chiffre d'affaires total de 17,6 millions de dollars pour l'exercice 2023, avec des ventes de produits médicaux avec une partie importante.

Catégorie de produits	Revenus annuels	Pourcentage du total des revenus
Système de perfusion de seringue de liberté	12,3 millions de dollars	70%
Pompe à seringue de précision	3,5 millions de dollars	20%
Autres dispositifs médicaux	1,8 million de dollars	10%

Contrats de maintenance des équipements récurrents

Les revenus du contrat de maintenance pour 2023 ont totalisé 1,2 million de dollars, ce qui représente une croissance de 5 à 7% par rapport à l'année précédente.

• Contrat de maintenance annuel Valeur moyenne: 450 $ - 750 $ par appareil
• Contrats de maintenance active totale: 1 650
• Taux de renouvellement des contrats: 85%

Consommables et ventes d'accessoires

Les consommables et les ventes d'accessoires ont généré 2,4 millions de dollars de revenus pour 2023.

Type consommable	Ventes annuelles
Ensembles de seringues jetables	1,6 million de dollars
Kits accessoires	0,8 million de dollars

Frais de service de formation et de soutien

Les services de formation et de soutien ont contribué 0,7 million de dollars aux revenus de l'entreprise en 2023.

• Coût de session de formation moyenne: 250 $ - 500 $
• Revenus de formation en ligne: 0,3 million de dollars
• Revenus de formation sur place: 0,4 million de dollars

Revenus d'expansion du marché international

Les ventes internationales ont atteint 3,5 millions de dollars en 2023, ce qui représente 20% du total des revenus de l'entreprise.

Région géographique	Revenus internationaux	Pourcentage de ventes internationales
Europe	1,8 million de dollars	51%
Asie-Pacifique	1,2 million de dollars	34%
Moyen-Orient et Afrique	0,5 million de dollars	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.