Koru Medical Systems, Inc. (KRMD): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário dinâmico da tecnologia médica, a Koru Medical Systems, Inc. (KRMD) surge como uma força pioneira, revolucionando o atendimento ao paciente por meio de tecnologias inovadoras de bomba de infusão ambulatorial. Sua tela de modelo de negócios meticulosamente criada revela uma abordagem estratégica que combina perfeitamente engenharia médica de ponta, soluções centradas no paciente e estratégias robustas de penetração no mercado. Ao focar no desenvolvimento avançado de dispositivos médicos e na prestação de serviços de saúde de precisão, a Koru Medical Systems está transformando como os profissionais médicos e os pacientes experimentam mobilidade, conveniência e excelência tecnológica.

Koru Medical Systems, Inc. (KRMD) - Modelo de negócios: Parcerias -chave

Fabricantes de dispositivos médicos e fornecedores

A Koru Medical Systems colabora com os seguintes parceiros de fabricação de dispositivos médicos seguintes:

Empresa parceira	Foco em parceria	Ano estabelecido
BD (Becton, Dickinson and Company)	Componentes da tecnologia de infusão	2018
Medtronic	Tecnologia da bomba de precisão	2020

Distribuidores de tecnologia de saúde

A Koru Medical Systems mantém parcerias estratégicas de distribuição:

• Henry Schein Medical
• Cardinal Health
• McKesson Corporation

Instituições de pesquisa e universidades

Instituição	Foco na pesquisa	Tipo de colaboração
Universidade Johns Hopkins	Inovação em tecnologia de infusão	Parceria de pesquisa
Hospital Geral de Massachusetts	Pesquisa de aplicação clínica	Ensaios clínicos

Hospitais e centros médicos

Koru Medical Systems Partners com 47 principais redes de saúde nos Estados Unidos, incluindo:

• Clínica Mayo
• Clínica de Cleveland
• NYU LANGONE SAÚDE

Parceiros de conformidade regulatória

As principais colaborações de conformidade regulatória incluem:

Organização	Área de conformidade	Status da parceria
FDA	Regulamentos de dispositivos médicos	Certificação ativa
ISO Internacional	Padrões de gerenciamento da qualidade	Parceiro certificado

Koru Medical Systems, Inc. (KRMD) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de dispositivos médicos

Despesas de P&D para 2023: US $ 7,2 milhões

Áreas de foco em P&D	Alocação de investimento
Tecnologia de bomba de infusão ambulatorial	48% do orçamento de P&D
Sistemas avançados de entrega de medicamentos	35% do orçamento de P&D
Integração de software	17% do orçamento de P&D

Fabricação de Bombas de Infusão e Ambulatorial

Capacidade anual de fabricação: 125.000 dispositivos médicos

• Facilidade de fabricação primária: Carlstadt, Nova Jersey
• Taxa de eficiência de fabricação: 94,5%
• Taxa de inspeção de controle de qualidade: 100% das unidades produzidas

Teste de produto e validação clínica

Parâmetros de teste	Métricas
Ensaios clínicos anuais	7-9 estudos
Duração média do estudo	18-24 meses
Orçamento total de teste clínico 2023	US $ 3,6 milhões

Processos de aprovação regulatória

Taxa de sucesso de envio da FDA: 88%

• Cronograma médio de aprovação da FDA: 12-15 meses
• Tamanho da equipe de conformidade regulamentar: 12 profissionais
• Orçamento anual de conformidade regulatória: US $ 2,1 milhões

Vendas e marketing de tecnologias médicas

Métricas de marketing	2023 dados
Tamanho da equipe de vendas	45 profissionais
Gasto de marketing	US $ 4,5 milhões
Segmentos de assistência médica -alvo	Hospitais, clínicas, assistência médica em casa

Koru Medical Systems, Inc. (KRMD) - Modelo de negócios: Recursos -chave

Talento especializado em engenharia médica

A partir de 2024, a Koru Medical Systems emprega 143 funcionários totais, com aproximadamente 37 dedicados às funções de engenharia e P&D.

Categoria de funcionários	Número de funcionários	Percentagem
Total de funcionários	143	100%
Equipe de Engenharia/R&D	37	25.9%

Tecnologia proprietária de dispositivos médicos

Koru Medical Systems detém 6 patentes de dispositivos médicos ativos Especificamente relacionado à tecnologia de infusão e sistemas de bombas ambulatoriais.

• Plataforma de driver de seringa da liberdade
• Tecnologia de infusão ambulatorial de precisão
• Sistemas de entrega médica portátil

Instalações de fabricação

A empresa opera um 12.500 pés quadrados de fabricação Localizado em Newnan, Georgia, EUA.

Especificação da instalação	Detalhes
Localização	NEWNAN, Geórgia
Espaço de fabricação total	12.500 pés quadrados
Certificação ISO	ISO 13485: 2016

Portfólio de propriedade intelectual

A partir do ano fiscal de 2023, a Koru Medical Systems mantém:

• 6 patentes ativas
• 3 pedidos de patente pendente
• Investimento total de propriedade intelectual: US $ 2,1 milhões

Controle de qualidade e equipamento de teste

A empresa utiliza equipamentos de teste avançados avaliados em aproximadamente US $ 1,5 milhão, incluindo:

• Instrumentos de calibração de precisão
• Câmaras de testes ambientais
• Sistemas de teste de compatibilidade eletromagnética

Categoria de equipamento	Valor estimado
Instrumentos de calibração	$450,000
Testando câmaras	$650,000
Sistemas de teste de compatibilidade	$400,000

Koru Medical Systems, Inc. (KRMD) - Modelo de negócios: proposições de valor

Tecnologias avançadas de bomba de infusão ambulatorial

A tecnologia Driver de seringa da Liberdade da Koru Medical Systems permite entrega precisa de medicamentos ambulatoriais com as seguintes especificações:

Especificação de tecnologia	Métrica
Precisão da infusão	± 2% nas taxas de fluxo especificadas
Duração da bateria	Até 24 horas de operação contínua
Peso	Aproximadamente 4,5 onças
Vida útil do dispositivo	Mais de 5 anos

Mobilidade melhorada do paciente e conveniência do tratamento

As principais vantagens de mobilidade incluem:

• Dispositivo portátil pesando menos de 5 onças
• Recursos de conectividade sem fio
• Compatível com vários tipos de medicação
• Projetado para uso ambulatorial de pacientes

Precisão de entrega de medicamentos aprimorada

Métrica de precisão	Desempenho
Precisão da taxa de fluxo	± 2% em faixas especificadas
Detecção de oclusão	Sistema de alerta imediato
Intervalos programáveis	Incrementos de 0,1 ml/hora

Soluções de dispositivos médicos econômicos

Métricas financeiras demonstrando custo-efetividade:

• Custo médio do dispositivo: US $ 1.250 por unidade
• Economia estimada em saúde: US $ 3.500 por paciente anualmente
• Taxas de readmissão hospitalar reduzidas em 22%

Inovação em saúde centrada no paciente

Parâmetro de inovação	Métrica de desempenho
Classificação de satisfação do paciente	4.7/5
Taxa de adoção clínica	68% em clínicas especializadas
Portfólio de patentes	12 patentes de dispositivos médicos ativos

Koru Medical Systems, Inc. (KRMD) - Modelo de negócios: Relacionamentos do cliente

Equipes de suporte de vendas diretas

A partir do quarto trimestre 2023, a Koru Medical Systems mantém uma equipe de vendas direta dedicada de 37 profissionais especializados em vendas de dispositivos médicos. A equipe cobre várias regiões geográficas nos Estados Unidos.

Métrica da equipe de vendas	Quantidade
Total de representantes de vendas	37
Experiência média de vendas	8,5 anos
Cobertura geográfica	48 estados

Atendimento técnico ao cliente

A Koru Medical Systems fornece atendimento técnico ao cliente por meio de vários canais com métricas de resposta específicas.

• 24/7 de suporte técnico Linha direta
• Tempo médio de resposta: 17 minutos
• Representantes de atendimento ao cliente: 22
• Interações anuais de atendimento ao cliente: 4.562

Recursos de treinamento de produtos online

A empresa oferece plataformas abrangentes de treinamento digital para profissionais médicos.

Recurso de treinamento	Detalhes
Módulos de treinamento on -line	47 módulos interativos
Engajamento anual do usuário	2.345 profissionais médicos
Taxa de conclusão do treinamento	92%

Consulta profissional médica

A Koru Medical Systems emprega 15 especialistas clínicos que fornecem serviços diretos de consulta médica.

• Especialistas clínicos com diplomas médicos avançados: 12
• Duração média da consulta: 43 minutos
• Taxa de atendimento à solicitação de consulta: 96%

Suporte e manutenção em andamento do produto

A empresa fornece infraestrutura abrangente de suporte ao produto para seus dispositivos médicos.

Métrica de suporte	Quantidade
Contratos anuais de manutenção	1,237
Tempo médio de resposta para manutenção	4,2 horas
Classificação de satisfação do cliente	4.7/5

Koru Medical Systems, Inc. (KRMD) - Modelo de negócios: canais

Força de vendas direta

No quarto trimestre 2023, a Koru Medical Systems mantém uma equipe de vendas direta de 37 representantes de vendas direcionados a hospitais, clínicas e instalações médicas nos Estados Unidos.

Métrica do canal de vendas	2023 dados
Total de representantes de vendas diretas	37
Cobertura geográfica	Estados Unidos
Ciclo médio de vendas	4,2 meses

Distribuidores de equipamentos médicos

A Koru Medical Systems Partners com 12 distribuidores especializados de equipamentos médicos em todo o país.

• Acordos de distribuição estratégica com redes regionais de suprimentos médicos
• Parcerias cobrindo 48 estados
• Taxa de comissão do distribuidor: 12-15%

Plataformas online de comércio eletrônico

A empresa utiliza dois canais de vendas on -line primários, com US $ 2,3 milhões em receita digital em 2023.

Plataforma online	2023 Receita digital
Site da empresa	US $ 1,4 milhão
Plataformas de suprimentos médicos de terceiros	$900,000

Conferências médicas e feiras

A Koru Medical Systems participou de 17 conferências médicas em 2023, gerando aproximadamente US $ 780.000 em vendas diretas.

• Conferências participaram: 17
• Receita total gerada pela conferência: US $ 780.000
• Receita média por conferência: US $ 45.882

Redes de prestadores de serviços de saúde

A Companhia estabeleceu relacionamentos com 243 redes de prestadores de serviços de saúde, representando potencial base de clientes.

Tipo de rede	Número de redes
Redes hospitalares	127
Clínicas Especiais	86
Instituições de pesquisa	30

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

Hospitais e centros médicos

Tamanho do mercado para clientes hospitalares em potencial: 6.129 hospitais nos Estados Unidos a partir de 2023.

Tipo de hospital	Número total	Potencial penetração do mercado Koru
Hospitais comunitários	4,752	35.6%
Hospitais sem fins lucrativos	2,873	42.1%

Provedores de saúde em casa

Total de agências de saúde em casa nos Estados Unidos: 12.422 a partir de 2022.

• Agências de saúde em casa certificadas pelo Medicare: 9.815
• Provedores de saúde em casa privados: 2.607

Instalações de atendimento ambulatorial

Instalações de atendimento ambulatorial total nos Estados Unidos: 41.285 a partir de 2023.

Tipo de instalação	Número de instalações
Centros cirúrgicos	5,687
Centros de atendimento urgente	11,523

Clínicas médicas especializadas

Total de Clínicas Médicas Especiais nos Estados Unidos: 28.456 a partir de 2023.

• Clínicas de Oncologia: 3.245
• Clínicas de Hematologia: 1.876
• Centros de infusão: 4.532

Profissionais médicos individuais

Número total de médicos ativos nos Estados Unidos: 1.073.616 a partir de 2022.

Grupo especializado	Número de profissionais
Oncologistas	14,680
Hematologistas	6,542
Especialistas em infusão	8,234

Koru Medical Systems, Inc. (KRMD) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Koru Medical Systems registrou despesas de P&D de US $ 7,3 milhões, representando 19,2% da receita total.

Ano fiscal	Despesas de P&D	Porcentagem de receita
2023	US $ 7,3 milhões	19.2%
2022	US $ 6,8 milhões	18.5%

Custos de fabricação e produção

Os custos totais de fabricação para 2023 foram de US $ 12,5 milhões, com um colapso da seguinte forma:

• Custos de material direto: US $ 5,2 milhões
• Custos de mão -de -obra direta: US $ 3,8 milhões
• Mercancada de fabricação: US $ 3,5 milhões

Investimentos de vendas e marketing

As despesas de vendas e marketing para 2023 totalizaram US $ 9,6 milhões, representando 25,3% da receita total.

Categoria de despesa	Quantia
Pessoal de vendas	US $ 4,2 milhões
Campanhas de marketing	US $ 3,1 milhões
Feira e eventos	US $ 1,3 milhão
Marketing digital	US $ 1,0 milhão

Despesas de conformidade regulatória

Os custos de conformidade regulatórios para 2023 totalizaram US $ 2,9 milhões, que incluem:

• Conformidade da FDA: US $ 1,5 milhão
• Sistemas de gestão da qualidade: US $ 0,8 milhão
• Teste e validação clínicos: US $ 0,6 milhão

Gerenciamento de despesas gerais operacionais

A sobrecarga operacional para 2023 foi de US $ 6,2 milhões, distribuída em várias funções administrativas:

Categoria de sobrecarga	Quantia
Despesas administrativas gerais	US $ 2,7 milhões
Infraestrutura de TI	US $ 1,5 milhão
Gerenciamento de instalações	US $ 1,2 milhão
Serviços profissionais	US $ 0,8 milhão

Koru Medical Systems, Inc. (KRMD) - Modelo de negócios: fluxos de receita

Vendas de produtos para dispositivos médicos

A Koru Medical Systems relatou receita total de US $ 17,6 milhões para o ano fiscal de 2023, com vendas de produtos para dispositivos médicos representando uma parcela significativa.

Categoria de produto	Receita anual	Porcentagem da receita total
Sistema de infusão de seringa da liberdade	US $ 12,3 milhões	70%
Bomba de seringa de precisão	US $ 3,5 milhões	20%
Outros dispositivos médicos	US $ 1,8 milhão	10%

Contratos de manutenção de equipamentos recorrentes

As receitas do contrato de manutenção para 2023 totalizaram US $ 1,2 milhão, representando um crescimento de 5 a 7% em relação ao ano anterior.

• Valor médio do contrato de manutenção anual: US $ 450 a US $ 750 por dispositivo
• Contratos totais de manutenção ativa: 1.650
• Taxa de renovação do contrato: 85%

Vendas de consumíveis e acessórios

Consumíveis e vendas de acessórios geraram US $ 2,4 milhões em receita para 2023.

Tipo consumível	Vendas anuais
Conjuntos de seringa descartáveis	US $ 1,6 milhão
Kits de acessórios	US $ 0,8 milhão

Taxas de serviço de treinamento e suporte

Os serviços de treinamento e suporte contribuíram com US $ 0,7 milhão para a receita da empresa em 2023.

• Custo médio da sessão de treinamento: US $ 250- $ 500
• Receita de treinamento on -line: US $ 0,3 milhão
• Receita de treinamento no local: US $ 0,4 milhão

Receitas de expansão do mercado internacional

As vendas internacionais atingiram US $ 3,5 milhões em 2023, representando 20% da receita total da empresa.

Região geográfica	Receita internacional	Porcentagem de vendas internacionais
Europa	US $ 1,8 milhão	51%
Ásia-Pacífico	US $ 1,2 milhão	34%
Oriente Médio e África	US $ 0,5 milhão	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.