Cytosorbents Corporation (CTSO): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No cenário em rápida evolução da tecnologia médica, a Cytosorbents Corporation (CTSO) surge como inovador inovador, revolucionando os cuidados intensivos por meio de sua tecnologia de hemadsorção de citosores de ponta. Ao direcionar desafios médicos complexos, como condições inflamatórias e tempestades de citocinas, esta empresa pioneira transforma como os profissionais de saúde abordam intervenções médicas com risco de vida, oferecendo uma solução não invasiva que promete redefinir protocolos de tratamento em cuidados intensivos e configurações médicas de emergência.

Cytosorbents Corporation (CTSO) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com fabricantes de dispositivos médicos

A Cytosorbents Corporation estabeleceu parcerias importantes com os fabricantes de dispositivos médicos para avançar em sua implantação de tecnologia citosores. A partir de 2024, a empresa possui colaborações ativas com os seguintes fabricantes de dispositivos médicos:

Fabricante	Foco em parceria	Status de colaboração
Bbraun	Tecnologia de hemoadsorção de cuidados intensivos	Parceria ativa
Cuidados médicos de Fresenius	Integração da terapia de reposição renal	Colaboração em andamento

Parcerias de pesquisa com instituições acadêmicas

Os citosorbentes mantêm colaborações estratégicas de pesquisa com os principais centros de pesquisa acadêmica:

• Centro Médico da Universidade de Pittsburgh
• Johns Hopkins University School of Medicine
• Escola de Medicina de Harvard

Acordos de distribuição com redes internacionais de saúde

A empresa estabeleceu parcerias internacionais de distribuição em várias regiões:

Região	Parceiro de distribuição	Cobertura de mercado
Europa	MedCaptain Medical Technology	10 países europeus
Ásia -Pacífico	Nipro Corporation	Japão, Coréia do Sul, China

Parcerias de licenciamento para a tecnologia Cytosorb

A Cytosorbents desenvolveu acordos de licenciamento para sua tecnologia proprietária de hemoadsorção com as seguintes entidades:

• MD Anderson Cancer Center
• Clínica de Cleveland
• Hospital Geral de Massachusetts

Parcerias de conformidade regulatória com autoridades de saúde

A Companhia mantém parcerias ativas de conformidade regulatória com:

• FDA (Estados Unidos)
• EMA (Agência Europeia de Medicamentos)
• PMDA (Japão)

Cytosorbents Corporation (CTSO) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de dispositivos médicos

Despesas anuais de P&D para 2023: US $ 15,2 milhões

Área de foco em P&D	Investimento
Tecnologia de citosores	US $ 8,7 milhões
Purificação avançada do sangue	US $ 4,5 milhões
Inovações de cuidados intensivos	US $ 2 milhões

Gerenciamento de ensaios clínicos

Ensaios clínicos ativos em 2024: 7 estudos em andamento

• Ensaios de tratamento de sepse
• Aplicações de cirurgia cardíaca
• Gerenciamento de inflamação relacionado ao CoVID-19

Processos de aprovação regulatória

Órgão regulatório	Status de aprovação	Mercados
FDA	Várias folgas 510 (k)	Estados Unidos
Mark CE	Aprovado	União Europeia

Fabricação de tecnologias de purificação de sangue

Capacidade de fabricação: 50.000 cartuchos de citosores anualmente

Local de produção	Volume anual de produção
Monmouth Junction, Nova Jersey	50.000 unidades

Marketing e comercialização de dispositivos médicos

Orçamento total de marketing para 2024: US $ 3,5 milhões

• Vendas diretas para hospitais
• Rede Internacional de Distribuidores
• Patrocínios da conferência médica

Cytosorbents Corporation (CTSO) - Modelo de negócios: Recursos -chave

Tecnologia de hemadsorção de citosorb de propriedade proprietária

A tecnologia de citosores utiliza contas de polímero altamente porosas capazes de remover mediadores inflamatórios do sangue. A partir de 2023, a tecnologia tem sido usada em mais de 180.000 tratamentos humanos em vários contextos clínicos.

Especificação de tecnologia	Detalhes quantitativos
Capacidade de adsorção	20-30 ml de citocinas por cartucho
Duração do tratamento	Uso contínuo de 24 horas
Penetração de mercado	Usado em 42 países globalmente

Equipe especializada em pesquisa e engenharia

Os citosorbentes mantêm uma equipe de pesquisa dedicada focada nas tecnologias de hemadsorção.

• Pessoal de pesquisa total: 45 funcionários
• Pesquisadores de doutorado: 18
• Investimento anual de P&D: US $ 12,4 milhões (2023)

Portfólio de propriedade intelectual

Categoria IP	Número de ativos
Patentes concedidas	37
Aplicações de patentes pendentes	22
Cobertura de patente geográfica	Estados Unidos, Europa, Ásia

Instalações de fabricação avançadas

Os citosorbentes opera a Instalação de fabricação registrada pela FDA Localizado em Nova Jersey, EUA.

• Tamanho da instalação: 35.000 pés quadrados
• Capacidade anual de produção: 100.000 cartuchos de citosores
• ISO 13485: 2016 certificado

Dados de ensaios clínicos e insights de pesquisa

Métrica de pesquisa	Dados quantitativos
Ensaios clínicos concluídos	28
Estudos clínicos em andamento	7
Artigos de pesquisa publicados	92

Cytosorbents Corporation (CTSO) - Modelo de Negócios: Proposições de Valor

Tecnologia avançada de purificação de sangue para cuidados intensivos

Dispositivo Cytosorb® projetado para purificação sanguínea com recursos específicos:

Parâmetro de tecnologia	Especificação
Tamanho do dispositivo	Volume de cartucho de 300 ml
Capacidade de tratamento	Remove mediadores inflamatórios de até 300-500 citocinas
Aprovação do mercado	Marca CE na Europa, designação de dispositivos de avanço da FDA

Tratamento potencial para condições inflamatórias

Principais condições inflamatórias direcionadas:

• Sepse
• Complicações da cirurgia cardíaca
• Respostas inflamatórias relacionadas ao Covid-19
• Síndrome de desconforto respiratório agudo (ARDS)

Redução da tempestade de citocinas em condições médicas graves

Doença	Potencial de redução de citocinas
Choque séptico	Até 70% de redução nos marcadores inflamatórios
Cirurgia cardíaca	Demonstrou redução de 50 a 60% no nível de citocinas

Dispositivo médico inovador para configurações cirúrgicas e de cuidados intensivos

Especificações do dispositivo:

• Compatível com sistemas padrão de purificação de sangue
• Cartucho de hemoadsorção reutilizável
• Aplicável na UTI e em configurações de emergência

Intervenção terapêutica não invasiva

Características de intervenção clínica:

Parâmetro	Detalhes
Duração do procedimento	Normalmente 2-6 horas por tratamento
Método de intervenção	Purificação do sangue extracorpóreo
Impacto do paciente	Invasão mínima, inflamação sistêmica reduzida

Cytosorbents Corporation (CTSO) - Modelo de Negócios: Relacionamentos do Cliente

Equipe direta de vendas de dispositivos médicos

A partir do quarto trimestre 2023, os citosorpos mantêm uma força de vendas especializada focada na comercialização do dispositivo de citosores. A equipe de vendas tem como alvo os departamentos de cuidados intensivos e cirurgia cardíaca em hospitais nos Estados Unidos.

Métrica da equipe de vendas	2023 dados
Total de representantes de vendas	24
Área de cobertura	48 Estados dos EUA
Contatos médios hospitalares por mês	87

Suporte técnico para profissionais de saúde

Os citosorbentes fornecem suporte técnico especializado para profissionais médicos que utilizam a tecnologia de citosores.

• 24/7 de suporte clínico
• Equipe dedicada de assuntos médicos
• Consulta técnica de dispositivo imediato

Colaboração em andamento em andamento de pesquisa clínica

A empresa se envolve ativamente em parcerias de pesquisa com instituições médicas globalmente.

Métrica de colaboração de pesquisa	2023 dados
Parcerias de pesquisa ativa	37
Instituições de Pesquisa Internacional	16 países
Ensaios clínicos em andamento	12

Conferência Médica e Engajamento do Simpósio

Os citosorbentes mantêm a participação ativa em conferências médicas para mostrar a tecnologia de citosores.

• Participou de 22 conferências médicas internacionais em 2023
• Apresentou 14 pôsteres científicos
• Conduziu 36 sessões de treinamento profissional

Plataformas de comunicação digital para comunidade médica

A empresa utiliza vários canais digitais para engajamento profissional.

Plataforma digital	2023 Métricas de engajamento
Seguidores do LinkedIn	7,500
Webinars profissionais médicos	18
Módulos de treinamento on -line	9

Cytosorbents Corporation (CTSO) - Modelo de Negócios: Canais

Vendas diretas para hospitais e centros médicos

A partir do quarto trimestre de 2023, a Cytosorbents Corporation mantém relacionamentos diretos de vendas com aproximadamente 250 hospitais e centros médicos nos Estados Unidos e na Europa.

Região	Número de contas hospitalares diretas	Porcentagem de vendas totais
Estados Unidos	175	62%
Mercados europeus	75	38%

Distribuidores de dispositivos médicos

Os citosorbentes trabalham com 12 distribuidores de dispositivos médicos primários em todo o mundo, cobrindo os principais mercados de saúde.

• A rede de distribuidores abrange 15 países
• Duração média do relacionamento do distribuidor: 3,7 anos
• Receita anual de distribuição: US $ 14,3 milhões em 2023

Plataformas de tecnologia médica online

A empresa aproveita 3 plataformas principais de tecnologia médica on -line para visibilidade do produto e engajamento de vendas.

Nome da plataforma	Visitantes únicos mensais	Taxa de conversão de chumbo
MedtechConnect	45,000	2.3%
GlobalHealthNetwork	38,000	1.9%
Portal Clinicalinnovations	29,000	1.5%

Exposições da Conferência Médica

Em 2023, os citosorpos participaram de 18 conferências médicas internacionais, gerando cerca de 240 leads de vendas diretas.

• Investimento total da exposição da conferência: US $ 475.000
• Conferências em 7 países
• Custo médio de aquisição de chumbo: US $ 1.979 por lead

Comunicações da rede de pesquisa clínica

Os citosorbentes mantêm canais de comunicação com 22 redes de pesquisa clínica ativas globalmente.

Tipo de rede	Número de redes	Valor de colaboração de pesquisa
Redes de pesquisa acadêmica	12	US $ 3,2 milhões
Consórcios de pesquisa hospitalar	8	US $ 2,7 milhões
Grupos de pesquisa independentes	2	$650,000

Cytosorbents Corporation (CTSO) - Modelo de negócios: segmentos de clientes

Hospitais de cuidados intensivos

A partir de 2023, os citosorbentes têm como alvo 2.900 hospitais de cuidados intensivos nos Estados Unidos. A penetração no mercado estimou 12,4%, com receita anual potencial de US $ 47,3 milhões.

Tipo de hospital	Total de instalações	Alcance potencial do mercado
Grandes hospitais de cuidados intensivos	589	US $ 23,6 milhões
Hospitais de cuidados médios críticos	1,214	US $ 18,2 milhões
Pequenos hospitais de cuidados intensivos	1,097	US $ 5,5 milhões

Centros de cirurgia cardíaca

Os citosorbentes se concentram em 1.287 centros de cirurgia cardíaca especializados em todo o país, com potencial de mercado estimado de US $ 32,6 milhões.

• Centros de cirurgia cardíaca com> 500 procedimentos anuais: 276
• Centros de cirurgia cardíaca com 100-500 procedimentos anuais: 672
• Centros de cirurgia cardíaca com <100 procedimentos anuais: 339

Unidades de terapia intensiva

O mercado -alvo inclui 5.216 unidades de terapia intensiva nos sistemas de saúde dos Estados Unidos.

Classificação da UTI	Número de unidades	Receita potencial
UCUS do Centro Médico Acadêmico	412	US $ 16,4 milhões
UTIO do Hospital Comunitário	3,784	US $ 22,7 milhões
UCUS de tratamento especializado	1,020	US $ 9,5 milhões

Departamentos médicos de emergência

Os citosorbentes visam 4.932 departamentos médicos de emergência com potencial de mercado estimado de US $ 28,3 milhões.

Centros de tratamento de doenças inflamatórias e inflamatórias

Focou -se em 987 centros de tratamento especializados, com potencial receita anual de US $ 21,6 milhões.

Tipo de centro de tratamento	Total de centros	Penetração de mercado
Grandes centros especializados	187	US $ 12,4 milhões
Centros de tratamento médio	476	US $ 6,8 milhões
Pequenos centros de pesquisa	324	US $ 2,4 milhões

Cytosorbents Corporation (CTSO) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Cytosorbents Corporation registrou despesas totais de P&D de US $ 14,1 milhões.

Ano	Despesas de P&D	Porcentagem de receita
2022	US $ 12,3 milhões	65.2%
2023	US $ 14,1 milhões	68.5%

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para tecnologia de citosores em 2023 totalizaram aproximadamente US $ 8,5 milhões.

• Ensaios clínicos relacionados à Covid-19: US $ 2,3 milhões
• Ensaios de cirurgia cardíaca: US $ 3,7 milhões
• Ensaios de indicação de sepse: US $ 2,5 milhões

Custos de fabricação e produção

Os custos de fabricação para 2023 foram de US $ 6,2 milhões, representando 30,1% do total de despesas operacionais.

Categoria de custo	Quantia	Percentagem
Matérias-primas	US $ 3,1 milhões	50%
Trabalho	US $ 1,8 milhão	29%
Sobrecarga	US $ 1,3 milhão	21%

Despesas de conformidade regulatória

Os custos de conformidade regulatória em 2023 totalizaram US $ 2,9 milhões.

• Custos de envio da FDA: US $ 1,2 milhão
• Processos de certificação: US $ 0,8 milhão
• Monitoramento de conformidade: US $ 0,9 milhão

Infraestrutura de vendas e marketing

As despesas de vendas e marketing de 2023 foram de US $ 5,7 milhões.

Canal de marketing	Gasto	Percentagem
Marketing digital	US $ 1,6 milhão	28%
Feiras	US $ 1,3 milhão	23%
Equipe de vendas	US $ 2,8 milhões	49%

Cytosorbents Corporation (CTSO) - Modelo de negócios: fluxos de receita

Vendas de dispositivos médicos

Receita do dispositivo Cytosorb para 2023: US $ 74,3 milhões

Segmento de mercado	Contribuição da receita
Cuidados intensivos	US $ 52,6 milhões
Cirurgia cardíaca	US $ 15,7 milhões
Outras aplicações médicas	US $ 6,0 milhões

Taxas de licenciamento de tecnologia

Receita total de licenciamento para 2023: US $ 2,1 milhões

• Acordos de parceria europeia
• Licenciamento de tecnologia médica militar

Bolsas de pesquisa

Pesquisa concessão de financiamento em 2023: US $ 1,5 milhão

Fonte de concessão	Quantia
NIH Grants	$850,000
Departamento de Defesa	$650,000

Royalties de propriedade intelectual

Renda de royalties para 2023: US $ 0,9 milhão

Receitas de expansão do mercado internacional

Vendas internacionais para 2023: US $ 22,4 milhões

Região geográfica	Receita
Europa	US $ 15,3 milhões
Ásia -Pacífico	US $ 4,6 milhões
Resto do mundo	US $ 2,5 milhões

Cytosorbents Corporation (CTSO) - Canvas Business Model: Value Propositions

You're looking at the core reasons why hospitals and clinicians choose Cytosorbents Corporation's technology, which boils down to measurable clinical impact and operational fit. The established international business generated $37 million in Trailing Twelve-Month Core Product Sales as of September 30, 2025, supported by nearly 300,000 cumulative treatments performed across more than 70 countries.

Extracorporeal removal of inflammatory mediators (cytokine storm) in critical illness.

The value here is directly attacking the systemic inflammation that drives organ failure in conditions like sepsis and septic shock. Data from a meta-analysis of 744 patients with septic shock showed that CytoSorb plus standard of care reduced in-hospital mortality with an Odds Ratio of 0.64 (p=0.036, n=462) compared to standard of care alone.

The breadth of this purification capability is a key proposition, addressing multiple drivers of shock:

• Break the vicious cycle of massive, uncontrolled inflammation.
• Stabilize the patient, improving oxygenation and reversing shock.
• Promote the repair of capillary leak.
• Enable active removal of excessive fluid.

DrugSorb-ATR: Rapid removal of blood thinners (e.g., ticagrelor) during urgent cardiac surgery.

For urgent cardiac surgery, DrugSorb-ATR addresses the unmet need of reversing potent antiplatelet and anticoagulant effects. The first randomized trial results presented at EACTS 2025 demonstrated that intraoperative use of DrugSorb-ATR significantly reduced levels of direct oral anticoagulants (DOACs) compared to sham control in patients undergoing urgent cardiothoracic surgery. While the U.S. FDA upheld the De Novo denial on August 14, 2025, it found no issues with device safety and proposed a potential path forward, with a regulatory decision anticipated mid-2026.

The clinical benefit in cardiac surgery is quantified by its impact on bleeding complications:

Clinical Scenario	Intervention Comparison	Observed Outcome Impact
ACS Patients Undergoing CABG Surgery	CytoSorb + Dual Therapy vs. Aspirin + Plavix (No CytoSorb)	Highly significant reductions in severe bleeding complications
Urgent Cardiothoracic Surgery (DOAC Use)	DrugSorb-ATR vs. Sham Control	Significant reduction of DOAC levels

Improved patient outcomes: reduced mortality and enhanced organ function in sepsis/shock.

The evidence base supports early and intensive use. A retrospective study of 175 septic shock patients showed an observed ICU mortality rate of 49%, significantly lower than the 66% predicted by the SAPS score. For the highest-risk group-early starters receiving high-intensity therapy (≥3 adsorbers)-the observed ICU mortality was 30%, against an expected 63%. Furthermore, in a 100-patient COVID-19 registry, early treatment with CytoSorb and ECMO correlated with a 82% 90-day survival, significantly outperforming the approximately 50% survival benchmark when CytoSorb was not used.

Plug-and-play compatibility with existing hospital blood pumps (CRRT, ECMO, heart-lung machines).

The technology is designed for immediate integration into existing critical care circuits. The core product, CytoSorb, is CE-mark approved for use with extracorporeal systems. This compatibility means clinicians can utilize the device without needing entirely new capital equipment purchases for the circuit itself.

Key operational advantages include:

• Compatibility with existing blood pumps.
• Use in conjunction with CRRT, ECMO, and heart-lung machines.
• Gross Margin improved to 70% in Q3 2025, up from 61% in Q3 2024, reflecting resolved manufacturing issues and higher efficiencies.

Broad-spectrum blood purification for multiple life-threatening conditions.

Cytosorbents Corporation's technology offers a broad platform, not limited to one specific target. The CE Mark extensions cover removal of multiple substances in various clinical settings.

The company's established international business is reflected in its Q3 2025 revenue of $9.5 million, a 10% increase year-over-year.

The product portfolio's broad utility includes:

• Cytokine adsorption in sepsis and septic shock.
• Bilirubin removal in liver disease.
• Myoglobin removal in trauma.
• Antithrombotic drug removal in cardiothoracic surgery.

Finance: draft 13-week cash view by Friday.

Cytosorbents Corporation (CTSO) - Canvas Business Model: Customer Relationships

You're looking at how Cytosorbents Corporation (CTSO) manages its relationships with hospitals and physicians as of late 2025. It's a mix of direct control in key markets and reliance on partners globally, all underpinned by clinical evidence.

The direct sales force focus is heavily weighted toward deep clinical engagement in core European markets, most notably Germany, which is their largest direct market. Starting in 2025, the company initiated a significant reorganization of this direct sales team and strategy in Germany to drive deeper customer engagement and improve sales representative productivity. This consultative approach is critical for adoption in high-acuity settings like the ICU and cardiac surgery. The results of this realignment show a mixed picture: direct sales outside Germany were strong, rising approximately 24% to $8.8 million in the third quarter of 2025. However, the direct German market saw a modest decline of 3%, bringing its Q3 2025 revenue to $12.6 million, though this followed a strong 22% year-over-year growth in Q2 2025 after the initial reorganization began to take hold.

For international reach, the distributor channel is a major component of customer acquisition and support. Distributor and partner sales delivered record performance in Q3 2025, growing 14% to reach $15.6 million. This channel supports the product's availability in more than 70 countries, where nearly 300,000 CytoSorb treatments have been performed cumulatively to date. The relationship here relies on robust distributor support and training programs to ensure consistent, high-quality application of the technology by international partners.

The high-touch, consultative selling model targets critical care and cardiac surgery specialists directly. This is heavily supported by the dedicated medical affairs team, which focuses on clinical education and sharing real-world data. The foundation for this consultative approach is a rapidly expanding body of evidence, with hundreds of peer-reviewed publications supporting the technology's use in sepsis, septic shock, and cardiothoracic surgery for blood thinner removal. To streamline operations and focus resources, the company implemented a strategic workforce and cost reduction program that included a reduction of approximately 10% of its workforce, which would certainly impact the structure and capacity of both sales and medical affairs teams.

Here's a quick look at the Q3 2025 revenue segmentation, which shows where the customer engagement efforts are yielding the most immediate financial results:

Customer Relationship Segment	Q3 2025 Revenue Amount	Year-over-Year Growth Rate
Distributor & Partner Sales	$15.6 million	14%
Direct Sales (Outside Germany)	$8.8 million	Approx. 24%
Direct Sales (Germany)	$12.6 million	-3% (Modest Decline)

The overall trailing 12-month core product sales reached a record of $37 million as of September 30, 2025, demonstrating the cumulative effect of these customer relationship strategies across all channels.

The key customer touchpoints and engagement metrics as of late 2025 include:

• Direct sales force reorganization targeting deeper engagement in Germany.
• Strong growth in distributor territories, up 14% in Q3 2025.
• Continued strength in direct sales outside Germany, up 24% in Q3 2025.
• Clinical education supported by hundreds of peer-reviewed publications.
• Workforce reduction of approximately 10% impacting operational structure.

Cytosorbents Corporation (CTSO) - Canvas Business Model: Channels

You're looking at how Cytosorbents Corporation gets its products, primarily CytoSorb®, into the hands of clinicians and hospitals across its global footprint as of late 2025. The strategy balances direct control in key areas with broad international reach through partners.

The company maintains corporate offices supporting its direct sales efforts in the United States (Princeton, New Jersey) and for Europe (Berlin, Germany), which houses CytoSorbents Europe GmbH.

The direct sales channel in Europe experienced a strategic realignment in 2025, specifically within Germany, which caused a temporary disruption in Q1 2025, though strong revenue growth in other EU direct sales territories offset this. The goal was to renew sales growth in Germany in the second half of 2025.

The global reach is heavily supported by external partners:

• Distributor network covers over 70 countries globally.
• Distributor/Partner sales showed record performance in prior quarters, contributing significantly to revenue growth in Q3 2025 alongside direct sales outside Germany.

A major channel expansion milestone for 2025 was the establishment of a new commercial hub:

The new regional sales subsidiary in Dubai, United Arab Emirates, was opened on January 6, 2025, to act as a gateway for the Middle East and Africa regions.

To engage directly with key opinion leaders and specialists, Cytosorbents Corporation actively participates in major industry events. For example, the company showcased new cardiac surgery data at the EACTS 2025 Annual Meeting in Copenhagen, which took place October 8-11, 2025.

Here's a quick look at the scale of these channel components based on recent data:

Channel Component	Metric/Location Detail	Latest Reported Value/Status
Third-Party Distributors	Number of Countries Covered	Over 70 countries
Direct Sales (Core Market)	European Headquarters Location	Berlin, Germany (CytoSorbents Europe GmbH)
Regional Expansion	New Subsidiary Opening Date	January 6, 2025
Regional Expansion	New Subsidiary Location	Dubai, United Arab Emirates
Medical Conferences	EACTS 2025 Attendance Estimate	More than 5,000 attendees expected

The performance of the distributor channel, alongside direct sales outside Germany, was strong enough in Q3 2025 to generate revenues of $9.5 million, a 10.1% increase year-over-year, which substantially offset the temporary disruption in German direct sales.

You should track the success of the German commercial team realignment in the second half of 2025 to gauge the effectiveness of that direct sales strategy.

Finance: draft 13-week cash view by Friday.

Cytosorbents Corporation (CTSO) - Canvas Business Model: Customer Segments

You're looking at the core groups Cytosorbents Corporation (CTSO) serves right now, and where they are aiming next. It's all about getting their blood purification technology-the CytoSorb® adsorber-into the hands of the right clinical teams.

Intensive Care Unit (ICU) physicians and staff treating sepsis and septic shock.

This is a primary, established segment. Sepsis remains one of the leading causes of preventable death in the intensive care unit. Cytosorbents Corporation has sold over >270,000 CytoSorb devices cumulatively to date, indicating a significant installed base within this critical care environment globally. The company continues to host webinars, such as the one on World Sepsis Day in September 2025, to reinforce the role of blood purification in treating septic shock. The Q3 2025 revenue was $9.5 million, showing continued commercial activity in these critical illness applications.

Cardiothoracic surgeons for urgent Coronary Artery Bypass Grafting (CABG) procedures.

Another key group involves surgeons dealing with complex cardiac cases. Specifically, CytoSorb® is used for the removal of blood thinners like ticagrelor and rivaroxaban during and after cardiothoracic surgery to reduce the risk of severe bleeding. Real-world data presented at EuroPCR in May 2025 reinforced the clinical value of this therapy in urgent CABG patients on ticagrelor who hadn't completed the recommended drug washout period. This application directly targets the operating room staff needing intraoperative hemoadsorption.

Hospitals and clinics in the European Union (EU) where CytoSorb is approved.

Geographically, the EU is a major market where CytoSorb® is approved under CE mark. This segment includes hospitals utilizing the device for its various approved extensions, such as bilirubin and myoglobin removal in liver disease and trauma, respectively. Growth in distributor territories, which are largely outside of Germany, led the company's Q3 2025 revenue growth of 10% year-over-year. To be fair, the direct sales segment in Germany is undergoing a proactive reorganization, with management confident that efforts will lead to improved execution in 2026 following two years of flat annual performance there.

Here's a quick look at the geographic focus areas based on recent performance:

Geographic Segment	Status/Context (Late 2025)	Recent Financial Impact (Q3 2025)
European Union (EU) - Distributor Territories	Record performance driving overall growth.	Led growth; revenue up 10% year-over-year.
Germany (Direct Sales)	Undergoing commercial team and sales approach reorganization.	Performance partially offset overall growth; goal to return to growth in H2 2025.
Other Direct Sales Markets (Ex-Germany)	Near-record performance noted.	Contributed significantly to Q3 2025 revenue of $9.5 million.

Future US and Canadian hospitals (DrugSorb-ATR target market).

This represents the next major expansion segment. Cytosorbents Corporation is developing DrugSorb™-ATR, an investigational device based on the same polymer technology, specifically to reduce bleeding in high-risk surgery due to blood thinners in the U.S. and Canada. The company submitted a De Novo pre-submission package to the FDA, with a meeting expected in Q4 2025 or early Q1 2026, and a planned new De Novo application submission in Q1 2026, anticipating a regulatory decision mid-2026. DrugSorb-ATR has received two FDA Breakthrough Device Designations. Upon potential approval, the initial focus will be a controlled market introduction at select clinical trial centers. The company is working toward achieving cash-flow breakeven in the core business by Q1 2026, which supports the runway for this future launch.

The target customer profile for DrugSorb-ATR includes:

• Hospitals with high-volume cardiothoracic surgery programs.
• Surgeons managing patients on ticagrelor, apixaban, or rivaroxaban.
• Centers that participated in the STAR Registry trials.

Finance: draft 13-week cash view by Friday.

Cytosorbents Corporation (CTSO) - Canvas Business Model: Cost Structure

You're looking at the cost side of the Cytosorbents Corporation (CTSO) business as of late 2025, based on their latest reported financials from the third quarter ending September 30, 2025. This is where the money goes to keep the lights on and push for new approvals.

The cost structure is heavily influenced by the specialized nature of their medical device production and the ongoing regulatory hurdles for their key pipeline product. Honestly, managing these fixed and variable costs is central to their stated goal of achieving operating cash flow break-even in the first quarter of 2026.

Here's a breakdown of the key cost drivers:

• High Cost of Goods Sold (COGS) due to specialized manufacturing processes, reflected in a Q3 2025 Gross Margin of 70%, up from 61% in Q3 2024.
• Significant investment in Research and Development (R&D) for new product approvals, though R&D saw a recent reduction.
• Sales, General, and Administrative (SG&A) expenses for global commercial teams, which saw an increase due to regulatory and pre-launch spending.
• Restructuring charges of up to $900,000 related to the late 2025 cost reduction plan.
• Interest expense on total debt of $14.6 million as of Q3 2025.

The company implemented a strategic Workforce and Cost Reduction Program in late 2025, which involved reducing its workforce by approximately 10% to optimize operations and accelerate the path to profitability.

The total operating expenses for the third quarter of 2025 were $9.5 million, a decrease of 6% compared to the prior year period.

Cost Component	Q3 2025 Financial Detail	Context/Driver
Gross Margin (COGS Indicator)	70%	Reflects resolved manufacturing issues and higher efficiencies.
Total Operating Expenses	$9.5 million	Decreased 6% year-over-year due to cost actions.
R&D Expense Change	$900,000 reduction	Reduction followed the completion of certain projects.
SG&A Expense Change	$400,000 increase	Driven by regulatory spending for DrugSorb ATR filings.
Restructuring Charge	Up to $900,000	Severance and other charges related to the late 2025 workforce reduction.
Long-Term Debt Basis for Interest	$14.6 million	The figure cited as the basis for interest expense calculation.
Actual Long-Term Debt (Q3 2025)	$14.567 million	Reported long-term debt as of September 30, 2025.

The R&D spending is directly tied to advancing the DrugSorb ATR regulatory path, which saw a timeline shift, with a decision now anticipated mid-2026. This shift required the company to reduce related commercialization expenses as part of the new cost plan.

The SG&A increase, despite overall operating expense reduction, highlights the necessary spending to support the U.S. FDA process. Specifically, this included initial commercialization expenses in anticipation of the DrugSorb approval and launch.

To manage liquidity against operating burn, Cytosorbents Corporation amended its credit agreement in November 2025, providing immediate funding of an additional $2.5 million in term loan capital, and extending the interest-only period to December 31, 2026.

The net operating cash burn in Q3 2025 was $2.6 million, leading to total cash, cash equivalents, and restricted cash of $9.1 million on September 30, 2025.

Finance: draft 13-week cash view by Friday.

Cytosorbents Corporation (CTSO) - Canvas Business Model: Revenue Streams

You're looking at how Cytosorbents Corporation brings in money right now, which is key to understanding their near-term strategy. Honestly, the story here is almost entirely about product sales, with other income being a smaller piece of the pie.

The core revenue stream is definitely the sale of the CytoSorb devices to hospitals and through their network of distributors. This is where the bulk of the cash comes from today. We saw solid momentum heading into late 2025.

Here's a quick look at the most recent performance figures:

Metric	Amount/Value	Context/Date
Q3 2025 Total Revenue	$9.5 million	For the quarter ended September 30, 2025
Q3 2025 Year-over-Year Growth	10%	Increase compared to Q3 2024 revenue of $8.6 million
Trailing Twelve Months (TTM) Revenue	$36.98 million	As of September 30, 2025
TTM Core Product Sales	$37 million	As of September 30, 2025

The growth in Q3 2025 was fueled by record performance in their distributor territories and near-record direct sales outside of Germany. That said, the direct German market saw a decline of 3%.

Beyond the current sales, a significant part of the financial story is the potential upside from a future product launch. You need to keep an eye on DrugSorb-ATR sales in the US market, which is a major future revenue driver contingent on regulatory success. Management has previously estimated this initial opportunity to be over $300 million.

The other revenue sources are less significant right now, but they are still part of the picture:

• Grant revenues, which can fluctuate.
• Other non-product related income streams.
• Gross margin for Q3 2025 hit 70%, up from 61% in Q3 2024.

Finance: draft 13-week cash view by Friday.