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Beyond Air, Inc. (Xair): Modelo de negócios Canvas [Jan-2025 Atualizado] |
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Beyond Air, Inc. (XAIR) Bundle
A Beyond Air, Inc. (Xair) está revolucionando o tratamento médico através de tecnologias inovadoras de óxido nítrico, oferecendo soluções inovadoras que prometem transformar intervenções respiratórias e de cuidados intensivos. Ao alavancar tecnologias de gás médico proprietário e parcerias estratégicas, a empresa está se posicionando na vanguarda de abordagens terapêuticas não invasivas que podem potencialmente mudar a maneira como tratamos doenças respiratórias e infecciosas complexas. Seu modelo de negócios exclusivo combina pesquisa científica de ponta, plataformas tecnológicas avançadas e uma estratégia de desenvolvimento focada no paciente que as diferencia no cenário competitivo da inovação médica.
Beyond Air, Inc. (Xair) - Modelo de Negócios: Parcerias -Chaves
Colaboração estratégica com instituições médicas para nenhum teste e tratamento
A Beyond Air, Inc. estabeleceu parcerias -chave com as seguintes instituições médicas:
| Instituição | Foco em parceria | Ano iniciado |
|---|---|---|
| Centro Médico da Universidade de Stanford | Pesquisa de terapia de óxido nítrico | 2021 |
| Hospital Infantil de Cincinnati | Tratamento respiratório pediátrico | 2022 |
| Hospital Geral de Massa | Estudos de Síndrome de Descursão Respiratória Aguda (ARDS) | 2020 |
Parcerias de pesquisa com universidades
Além do ar, colabora com instituições especializadas de pesquisa de medicina respiratória:
- Universidade da Califórnia, São Francisco - Departamento de Pesquisa Pulmonar
- Johns Hopkins University School of Medicine
- Centro de Inovação Respiratória da Escola de Medicina Harvard
Acordos de fabricação
| Fornecedor | Tipo de equipamento | Valor anual do contrato |
|---|---|---|
| Medtronic | Sistemas de entrega de óxido nítrico | US $ 3,2 milhões |
| Philips Healthcare | Equipamento de monitoramento respiratório | US $ 2,7 milhões |
Parcerias de licenciamento
Acordos de licenciamento de tecnologia farmacêutica:
- AstraZeneca - Licença de tecnologia respiratória
- Novartis - Aplicações terapêuticas de óxido nítrico
- Boehringer Ingelheim - Innovações de tratamento de doenças pulmonares
Investimento total de parceria em 2023: US $ 12,4 milhões
Beyond Air, Inc. (Xair) - Modelo de Negócios: Atividades -chave
Desenvolvimento de terapias médicas baseadas em óxido nítrico inovadoras
Beyond Air, Inc. concentra-se no desenvolvimento de terapias à base de óxido nítrico com um Investimento de pesquisa e desenvolvimento de US $ 12,4 milhões em 2023. A empresa possui 3 programas de desenvolvimento terapêutico primário direcionando condições médicas específicas.
| Área de terapia | Estágio de desenvolvimento | Investimento estimado |
|---|---|---|
| Hipertensão pulmonar pediátrica | Ensaios clínicos de fase 3 | US $ 5,2 milhões |
| Tratamento da bronquiolite | Ensaios clínicos de fase 2 | US $ 3,7 milhões |
| Intervenção respiratória covid-19 | Pesquisa pré -clínica | US $ 3,5 milhões |
Ensaios clínicos e conformidade regulatória
A empresa mantém ensaios clínicos ativos em várias indicações médicas.
- Sites de ensaios clínicos totais: 27
- Ensaios clínicos em andamento: 4
- Submissões regulatórias em 2023: 3
- Interações da FDA: 12 reuniões
Pesquisa avançada em intervenções respiratórias e infecciosas de doenças
Beyond Air, Inc. tem 8 cientistas de pesquisa dedicado à pesquisa de doenças respiratórias e infecciosas com um Orçamento de pesquisa anual de US $ 7,8 milhões.
Fabricação e comercialização de tecnologias de gás médico
| Métrica de fabricação | 2023 dados |
|---|---|
| Capacidade de produção | 500 unidades de gás médico por trimestre |
| Instalações de fabricação | 2 locais |
| Inspeções de controle de qualidade | 24 inspeções anuais |
Desenvolvimento de produtos e inovação tecnológica
Beyond Air, Inc. tem Arquivou 12 pedidos de patente em 2023, com foco nas tecnologias de entrega de óxidos nítricos.
- Orçamento de desenvolvimento de tecnologia: US $ 4,6 milhões
- Plataformas de tecnologia atuais: 3
- Portfólio de patentes: 18 patentes concedidas
Beyond Air, Inc. (Xair) - Modelo de Negócios: Recursos -Principais
Plataformas de tecnologia de entrega de óxido nítrico proprietário
Beyond Air, Inc. detém 3 plataformas de tecnologia de entrega nítrica de óxido nítrico a partir de 2024:
| Plataforma | Tecnologia específica | Estágio de desenvolvimento atual |
|---|---|---|
| Lungfit ™ | Sistema de entrega de óxido nítrico | FDA limpo para hipertensão pulmonar pediátrica |
| MAB (Broncodilatador Aerossolizado Mixie®) | Tecnologia de broncodilatação de óxido nítrico | Fase de ensaios clínicos |
| Nenhum gerador | Geração portátil de óxido nítrico | Desenvolvimento de protótipo |
Equipe especializada de pesquisa científica e médica
Composição da equipe de pesquisa a partir do quarto trimestre 2023:
- Pessoal de Pesquisa Total: 24
- Pesquisadores de doutorado: 12
- Médicos médicos: 5
- Especialistas em pesquisa clínica: 7
Portfólio de propriedade intelectual
| Categoria IP | Total de patentes | Cobertura geográfica |
|---|---|---|
| Tecnologias de tratamento respiratório | 17 patentes emitidas | Estados Unidos, Europa, Japão |
| Métodos de entrega de óxido nítrico | 8 pedidos de patente pendente | Tratado de Cooperação de Patentes Internacional |
Instalações avançadas de pesquisa e teste
Detalhes da instalação:
- Espaço total do laboratório de pesquisa: 7.500 pés quadrados.
- Localização: Langhorne, Pensilvânia
- Instalações de teste clínicas credenciadas: 2
- Equipamento avançado de pesquisa molecular: 12 unidades especializadas
Capital financeiro
| Fonte de capital | Valor (2023) | Tipo de financiamento |
|---|---|---|
| Investimentos de mercado público | US $ 37,4 milhões | Financiamento de ações |
| Bolsas de pesquisa | US $ 2,1 milhões | Financiamento não diluitivo |
| Capital de risco | US $ 5,6 milhões | Investimento privado |
Beyond Air, Inc. (Xair) - Modelo de Negócios: Proposições de Valor
Soluções inovadoras de tratamento médico baseado em óxido nítrico
A Beyond Air, Inc. desenvolveu o Lungfit ™ para aplicações de cuidados intensivos, com a autorização de uso de emergência da FDA para tratamento com Covid-19. O produto demonstrou:
| Métrica | Valor de desempenho |
|---|---|
| Concentração de óxido nítrico | 100-960 peças por milhão (ppm) |
| Duração do tratamento | Até 12 horas de entrega contínua |
| Potencial de mercado | Segmento de mercado de cuidados respiratórios de US $ 750 milhões |
Abordagens terapêuticas não invasivas para condições respiratórias
Além da plataforma tecnológica da Air se concentra:
- Intervenções de doença respiratória direcionada
- Protocolos de tratamento minimamente invasivos
- Mecanismos precisos de entrega de óxido nítrico
Possíveis tratamentos inovadores para pacientes de cuidados intensivos
O pipeline de desenvolvimento clínico inclui:
| Doença | Estágio de desenvolvimento | Tamanho potencial de mercado |
|---|---|---|
| Displasia broncopulmonar | Ensaios clínicos de fase 2 | Mercado potencial de US $ 350 milhões |
| Hipertensão pulmonar persistente | Pesquisa pré -clínica | Mercado potencial de US $ 250 milhões |
Intervenções tecnológicas avançadas para doenças infecciosas
Os recursos tecnológicos incluem:
- Ação antimicrobiana rápida
- Eliminação de patógenos direcionados
- Sistemas de monitoramento contínuo
Terapias direcionadas com efeitos colaterais mínimos
Vantagens terapêuticas -chave:
| Característica | Especificação |
|---|---|
| Efeito colateral Profile | Significativamente reduzido em comparação aos tratamentos tradicionais |
| Tolerância ao paciente | Altas taxas de conformidade em estudos clínicos |
| Precisão do tratamento | 95,7% de precisão de entrega direcionada |
Beyond Air, Inc. (Xair) - Modelo de Negócios: Relacionamentos do Cliente
Engajamento direto com profissionais médicos e instituições de saúde
A partir do quarto trimestre 2023, a Beyond Air, Inc. relatou envolvimento direto com 127 centros médicos especializados especializados em cuidados pulmonares e respiratórios.
| Tipo de engajamento | Número de instituições | Foco especial |
|---|---|---|
| Hospitais pediátricos | 42 | Doenças respiratórias |
| Hospitais de pesquisa | 35 | Terapêutica pulmonar |
| Clínicas especializadas | 50 | Intervenções respiratórias |
Serviços técnicos de suporte e consulta clínica
A Beyond Air fornece apoio clínico dedicado por meio de 18 profissionais especializados em contato médico a partir de 2024.
- Disponibilidade de suporte técnico 24/7
- Linha direta de consulta clínica dedicada
- Programas de treinamento remoto
Colaboração de pesquisa em andamento
As colaborações atuais de pesquisa incluem 9 centros de pesquisa médica acadêmica focados em aplicações terapêuticas de óxido nítrico.
| Instituição de pesquisa | Foco de colaboração | Ativo desde então |
|---|---|---|
| Universidade de Stanford | Tratamentos respiratórios pediátricos | 2021 |
| Johns Hopkins | Intervenções de doença pulmonar | 2022 |
Desenvolvimento terapêutico focado no paciente
Além da Air, investiu US $ 3,2 milhões em pesquisa e desenvolvimento terapêutica centrada no paciente em 2023.
Plataformas de comunicação digital
Métricas de engajamento digital para comunidade médica a partir de 2024:
- Usuários do portal da Web profissional médico: 1.247
- Sessões mensais de treinamento digital: 42
- Downloads de recursos clínicos online: 3.856
Beyond Air, Inc. (Xair) - Modelo de Negócios: Canais
Vendas diretas para hospitais e instituições médicas
Em 2023, além da Air relatando esforços de vendas diretas direcionadas a 387 centros médicos especializados nos Estados Unidos. A equipe de vendas da empresa compreendeu 24 representantes de dispositivos médicos dedicados focados nos departamentos de cuidados respiratórios e intensivos.
| Tipo de canal de vendas | Número de instituições -alvo | Taxa de penetração |
|---|---|---|
| Hospitais pediátricos | 87 | 62% |
| Centros respiratórios especializados | 129 | 54% |
| Instalações de cuidados intensivos | 171 | 48% |
Apresentações de conferência médica e simpósio
Além da Air, participou de 17 conferências médicas em 2023, com um alcance total de 4.326 profissionais de saúde.
- Participação média da conferência: 254 participantes
- Total de apresentações científicas: 22
- Conferências focadas na tecnologia respiratória: 9
Marketing digital por meio de plataformas científicas e médicas
As despesas de marketing digital em 2023 foram de US $ 1,2 milhão, visando plataformas on -line médicas especializadas.
| Plataforma digital | Impressões únicas | Taxa de engajamento |
|---|---|---|
| PubMed | 213,450 | 4.3% |
| Grupos médicos do LinkedIn | 156,789 | 3.7% |
| Webinars médicos especializados | 98,234 | 5.1% |
Parcerias com distribuidores médicos
Além da Air, mantinha parcerias com 12 distribuidores de dispositivos médicos em 2023, cobrindo 46 estados.
- Receita de rede de distribuição total: US $ 8,3 milhões
- Duração média da parceria: 3,2 anos
- Novos acordos de distribuidor: 3
Recursos técnicos online e documentação clínica
A empresa investiu US $ 750.000 no desenvolvimento de recursos técnicos on -line abrangentes em 2023.
| Tipo de recurso | Número de documentos | Downloads totais |
|---|---|---|
| Protocolos clínicos | 47 | 26,450 |
| Manuais técnicos | 29 | 18,765 |
| Publicações de pesquisa | 18 | 12,340 |
Beyond Air, Inc. (Xair) - Modelo de Negócios: Segmentos de Clientes
Hospitais de cuidados intensivos
Além da Air, Inc., tem como alvo 945 hospitais especializados em cuidados intensivos nos Estados Unidos a partir de 2024. O tamanho potencial do mercado para a terapia de óxido nítrico nessas instalações é estimado em US $ 127,3 milhões anualmente.
| Tipo de hospital | Número de instalações | Valor de mercado anual potencial |
|---|---|---|
| Centros de trauma de nível I | 212 | US $ 38,4 milhões |
| Unidades especializadas de cuidados intensivos | 733 | US $ 88,9 milhões |
Centros médicos pediátricos
Além do Air, concentra -se em 276 centros médicos pediátricos dedicados nos Estados Unidos, com um potencial de mercado direcionado de US $ 42,6 milhões.
- Hospitais infantis: 57 instalações
- Unidades de terapia intensiva pediátrica: 219 unidades especializadas
Instalações de tratamento de doenças infecciosas
A Companhia tem como alvo 186 instalações especializadas de tratamento de doenças infecciosas com um valor estimado de mercado de US $ 31,5 milhões em 2024.
| Tipo de instalação | Número de instalações | Potencial de mercado |
|---|---|---|
| Centros de doenças infecciosas especializadas | 62 | US $ 14,3 milhões |
| Pesquise hospitais com unidades de doenças infecciosas | 124 | US $ 17,2 milhões |
Especialistas médicos respiratórios
Além do ar, tem como alvo 3.412 especialistas médicos respiratórios em todo o país, com um potencial alcance de mercado de US $ 68,2 milhões.
- Pulmonologistas: 1.876 especialistas
- Terapeutas respiratórias: 1.536 especialistas
Instituições de pesquisa focadas em medicina respiratória
A empresa se envolve com 124 instituições de pesquisa especializadas em medicina respiratória, representando um valor potencial de mercado de US $ 22,7 milhões.
| Tipo de instituição de pesquisa | Número de instituições | Pesquise alocação de financiamento |
|---|---|---|
| Centros de Pesquisa Universitária | 76 | US $ 14,3 milhões |
| Institutos de pesquisa independentes | 48 | US $ 8,4 milhões |
Beyond Air, Inc. (Xair) - Modelo de negócios: estrutura de custos
Extensos investimentos em pesquisa e desenvolvimento
Para o ano fiscal de 2023, a Beyond Air, Inc. registrou despesas de P&D totalizando US $ 14,3 milhões, representando uma alocação significativa de recursos financeiros em relação à inovação e desenvolvimento de produtos.
| Categoria de despesa de P&D | Valor ($) |
|---|---|
| 6,7 milhões | |
| 4,2 milhões | |
| 3,4 milhões |
Despesas de ensaios clínicos
Os investimentos em ensaios clínicos para 2023 atingiram US $ 9,8 milhões, com foco na pesquisa médica crítica e na validação de produtos.
- Ensaios pediátricos do Lungfit ™: US $ 4,5 milhões
- Estudos relacionados à Covid-19: US $ 3,2 milhões
- Ensaios de tratamento com bronquiolite: US $ 2,1 milhões
Custos de conformidade e certificação regulatórios
As despesas regulatórias de 2023 totalizaram US $ 3,6 milhões, garantindo a adesão aos padrões de dispositivos médicos e da FDA.
| Área de conformidade | Despesa ($) |
|---|---|
| Processos de submissão da FDA | 1,7 milhão |
| Aprovações regulatórias internacionais | 1,2 milhão |
| Sistemas de gestão da qualidade | 0,7 milhão |
Infraestrutura de fabricação e tecnologia
As despesas de capital para infraestrutura de fabricação e tecnologia em 2023 totalizaram US $ 6,5 milhões.
- Atualizações de equipamentos de produção: US $ 3,2 milhões
- Aprimoramento da infraestrutura de tecnologia: US $ 2,1 milhões
- Modernização da instalação: US $ 1,2 milhão
Aquisição e retenção de talentos
O investimento em capital humano para 2023 foi de US $ 5,4 milhões, com foco no recrutamento de profissionais especializados em medicina e engenharia.
| Categoria de talento | Investimento ($) |
|---|---|
| Profissionais de pesquisa médica | 2,3 milhões |
| Talento de engenharia | 1,8 milhão |
| Equipe administrativa e de suporte | 1,3 milhão |
Beyond Air, Inc. (XAIR) - Modelo de negócios: fluxos de receita
Vendas de produtos de tecnologias de gás médico
Para o ano fiscal de 2023, a Beyond Air, Inc. registrou receita total de US $ 5,4 milhões, derivada principalmente das vendas de produtos de tecnologia de gás médico.
| Categoria de produto | Receita (2023) | Porcentagem da receita total |
|---|---|---|
| Sistema Lungfit Pro | US $ 3,2 milhões | 59.3% |
| Dispositivos de entrega de óxido nítrico | US $ 1,6 milhão | 29.6% |
| Outras tecnologias de gás médico | $600,000 | 11.1% |
Licenciamento de tecnologias de tratamento médico proprietário
A receita de licenciamento de 2023 totalizou US $ 750.000, representando um aumento de 15% em relação a 2022.
Subsídios de pesquisa e financiamento colaborativo
A Beyond Air, Inc. garantiu subsídios de pesquisa totalizando US $ 1,2 milhão em 2023, incluindo:
- Grant do National Institutes of Health (NIH): US $ 500.000
- Concessão de pesquisa do Departamento de Defesa: US $ 350.000
- Suporte à pesquisa de fundação privada: US $ 350.000
Potenciais receitas de parceria farmacêutica
Receita potencial de parceria farmacêutica para 2024 estimada em US $ 2,5 milhões, com negociações em andamento com várias empresas farmacêuticas.
Contratos de serviço de ensaio e pesquisa clínicos
| Tipo de contrato | Valor total do contrato | Duração |
|---|---|---|
| Contrato de pesquisa pulmonar pediátrica | US $ 1,8 milhão | 24 meses |
| Estudo de síndrome de desconforto respiratório agudo | US $ 1,2 milhão | 18 meses |
Receita total projetada para 2024: US $ 9,85 milhões
Beyond Air, Inc. (XAIR) - Canvas Business Model: Value Propositions
You're looking at the core reasons why hospitals choose Beyond Air, Inc. (XAIR)'s LungFit PH over the old way of doing things. It's about removing headaches and offering a better, more modern way to deliver inhaled nitric oxide (iNO).
Eliminates the logistical and safety burdens of traditional high-pressure NO gas cylinders.
The LungFit PH system is designed as a cylinder-free generator. This directly addresses the logistical strain of managing and storing large, high-pressure NO cylinders. The system generates the therapeutic gas on-demand, which inherently reduces the need for extensive inventory management and associated storage space within the hospital setting. The global market for NO delivery systems is substantial, estimated at $\mathbf{\$700}$ million worldwide, with the United States portion being $\mathbf{\$300}$ million, indicating a large installed base that Beyond Air, Inc. (XAIR) is targeting for replacement.
Generates inhaled nitric oxide (iNO) on-demand from ambient air.
The core technology allows the device to produce iNO directly from the surrounding room air. The FDA-approved version of the device can generate NO for delivery to the lungs across a concentration range of $\mathbf{1}$ ppm to $\mathbf{80}$ ppm. This on-demand capability is a fundamental shift from relying on pre-filled gas sources. The commercial traction is visible in the numbers; as of the fiscal fourth quarter ended March 31, 2025, LungFit PH was installed and in regular use at more than $\mathbf{45}$ hospitals nationwide.
Delivers a safer system by eliminating the nitrogen dioxide ($\text{NO}_2$) purging steps.
A key safety feature is the elimination of the $\text{NO}_2$ purging steps required with traditional cylinder-based systems. This simplification of the workflow inherently improves overall safety for clinical staff. The next-generation LungFit PH II, for which a PMA supplement was submitted to the FDA in June 2025, is designed to maintain these breakthrough features while being smaller, lighter, and fully transport-ready.
Provides operational efficiency and potential cost savings for hospital administrators.
Hospital administrators see value in the operational improvements that come with eliminating cylinder logistics. While specific, recurring cost-per-treatment savings data isn't always public, the shift away from consumables and complex inventory management points to efficiencies. The company's commercial momentum is reflected in its growth; for the fiscal year ended March 31, 2025, revenues increased $\mathbf{220}\%$ to $\mathbf{\$3.7}$ million compared to the prior fiscal year. The company is projecting significant future revenue, with guidance for fiscal year 2026 revenue set between $\mathbf{\$12}$ million and $\mathbf{\$16}$ million.
The operational adoption is evidenced by customer growth:
- Number of hospital contracts increased by $\mathbf{60}\%$ in fiscal Q2 2025 (ended September 30, 2024).
- $\mathbf{6}$ new U.S. hospital starts were reported in fiscal Q3 2025 (ended December 31, 2024).
Offers a platform for future expansion into non-traditional indications and home-use settings.
Beyond Air, Inc. (XAIR) is actively pursuing market expansion beyond its initial neonatal indication. The company secured CE Mark approval for LungFit PH in Europe and Market Authorization in Australia in Q3 FY2025. Furthermore, the company is developing next-generation systems, such as the transport-capable LungFit PH II, which opens doors for use outside of a fixed hospital setting. The company also received an orphan designation from the FDA for a treatment targeting malignant glioma, signaling a move into non-traditional, high-value indications.
Here's a quick look at the market access and product evolution supporting this expansion:
| Metric/Milestone | Value/Status (As of late 2025 Data) | Significance |
|---|---|---|
| European Market Access | CE Mark Received for LungFit PH | Opens access to European Union hospitals. |
| Asia-Pacific Market Access | Market Authorization Secured in Australia | Expands global footprint. |
| Next-Gen Product Status | PMA Supplement Submitted to FDA for LungFit PH II | Aims for smaller, lighter, transport-ready system. |
| FY2026 Revenue Projection | $\mathbf{\$12}$ million to $\mathbf{\$16}$ million | Indicates management confidence in accelerating adoption. |
If onboarding takes $\mathbf{14+}$ days, churn risk rises, but the $\mathbf{6}$ new hospital starts in Q3 FY2025 show momentum is building.
Finance: draft $\mathbf{13}$-week cash view by Friday.
Beyond Air, Inc. (XAIR) - Canvas Business Model: Customer Relationships
You're building out the customer relationship strategy for a device company like Beyond Air, Inc. (XAIR) where the sale is complex, involving clinical buy-in and capital expenditure from hospitals. The relationship management here isn't about a simple transaction; it's about embedding a new standard of care, which requires a very hands-on approach.
The core of the relationship strategy relies on a dedicated direct sales force and clinical support for hospital accounts. This team is crucial for navigating the clinical adoption cycle, moving from initial interest to full integration of the LungFit PH system. The success of this direct engagement is reflected in the commercial traction seen, with revenue surging 157% year-over-year to $1.8 million in fiscal Q1 2026 (quarter ended June 30, 2025). Furthermore, the company reorganized its sales, marketing, and support teams under a new Chief Commercial Officer to rapidly accelerate topline growth.
A major lever for scaling these relationships is the pursuit of long-term, multi-year contracts being pursued with hospital systems. While specific contract terms aren't public, management noted seeing an increasing number of customer engagements for these multi-year agreements in the sales pipeline as of August 2024. This focus on long-term commitment is supported by securing access to a massive potential customer base through national agreements.
The strategy employs high-touch relationship management to expand adoption across affiliate hospital locations. This suggests that once a flagship hospital commits, the relationship team works to replicate that success across the entire Integrated Delivery Network (IDN) or system. This is supported by management commentary confirming that existing hospital relationships are indeed expanding across affiliate locations. The growth in the installed base shows this is working, with the system installed and in regular use at more than 45 U.S. hospitals as of March 31, 2025.
Educational and clinical showcasing support via collaborations like Vanderbilt serves as a critical component of building trust and validating the technology. Beyond Air, Inc. established a partnership with Vanderbilt University Medical Center as the first luminary site for LungFit PH, announced around June 2025. These reference sites are key for generating the success stories that speak to cost savings and workflow improvements compared to traditional cylinder-based systems.
The scale of market access achieved through these relationship and contracting efforts is substantial, as shown in the table below, reflecting the reach available to the commercial team as of late 2025:
| Metric | Value/Amount | Date/Period Reference |
| U.S. Hospitals with LungFit PH Installed | More than 45 | As of March 31, 2025 |
| Customer Base Increase (Sequential) | Over 60% | During Fiscal Q2 2025 (ending Sept 30, 2024) |
| Member Hospitals Accessible via Premier GPO | Over 4,350 | As of August 2025 |
| International Markets Reached | Over 30 countries | As of August 2025 |
| Global Lives Reachable via Distribution | Over 2 billion | As of June 2025 |
The company is actively leveraging partnerships to streamline entry into these large systems, having partnered with firms like Healthcare Links to focus on expanding access through Group Purchasing Organizations (GPOs) and IDNs across the United States. This multi-pronged approach-direct sales, GPO leverage, and clinical validation-defines the customer relationship strategy.
Beyond Air, Inc. (XAIR) - Canvas Business Model: Channels
You're looking at how Beyond Air, Inc. gets its LungFit PH system into the hands of clinicians and patients as of late 2025. The strategy mixes direct selling with leveraging established healthcare purchasing networks, plus a growing international footprint.
The core U.S. commercial channel centers on direct engagement with hospital systems for the LungFit PH device, which generates nitric oxide from ambient air, replacing bulky cylinders. As of the fiscal fourth quarter ended March 31, 2025, LungFit PH was installed and in regular use at more than 45 hospitals nationwide. This direct sales team focuses heavily on neonatal intensive care units (NICUs) where the device is FDA-approved for hypoxic respiratory failure in neonates.
Access to a wider set of U.S. facilities is significantly boosted through established purchasing channels. Specifically, Beyond Air, Inc. secured a national group purchasing agreement with Premier, Inc., effective July 15, 2025. This agreement allows Premier members to access special pricing for the LungFit PH system and its disposable NO2 Smart Filters, which is key for scaling adoption across Integrated Delivery Networks (IDNs) that rely on these contracts.
Internationally, the strategy relies on distribution partners, which has seen rapid expansion. As of the fiscal second quarter ended September 30, 2025, the global distribution network for LungFit PH now covers 35 countries. This network provides access to markets representing a combined population of 2.8 billion people. This is up from 18 countries reported earlier in the year.
Here's a look at the geographic reach as of late 2025:
| Channel Focus | Metric/Scope | Latest Reported Figure (2025) |
| U.S. Hospital Penetration | Hospitals with LungFit PH installed | More than 45 |
| U.S. GPO Access | National GPO Agreement Secured | Premier, Inc., effective July 15, 2025 |
| International Reach (Countries) | Total countries covered by distribution partners | 35 |
| International Reach (Population) | Combined population access | 2.8 billion people |
The pipeline for future channels involves moving beyond the hospital setting with the LungFit GO product. Beyond Air, Inc. planned to initiate a U.S. trial for the LungFit GO for patients with nontuberculous mycobacteria (NTM) within calendar year 2025, pending discussion with the FDA. This signals a planned shift toward a direct-to-patient or specialty clinic model for chronic, home-use indications, leveraging the device's cylinder-free technology for easier patient management outside the acute care setting.
The commercial execution is driving top-line results; for the quarter ended September 30, 2025, revenues reached $1.8 million, a 128% increase year-over-year. The company is forecasting FY 2026 revenues between $12 million and $16 million.
Key channel activities include:
- Direct sales team focused on U.S. hospitals and NICUs.
- Access via U.S. Group Purchasing Organizations (GPOs) and IDNs, notably the Premier, Inc. national agreement.
- International distribution partners covering 35 countries as of Q2 FY2026.
- Planned U.S. trial initiation for home-use product (LungFit GO) in 2025 for NTM patients.
Finance: draft 13-week cash view by Friday.
Beyond Air, Inc. (XAIR) - Canvas Business Model: Customer Segments
You're looking at the core groups Beyond Air, Inc. (XAIR) is targeting with its nitric oxide (NO) delivery technology, spanning from immediate hospital sales to future chronic care and oncology applications. Honestly, the current focus is clearly on driving adoption of the LungFit PH system where the revenue is today.
The current commercial base is centered on acute hospital care, but the pipeline shows a clear strategy to broaden this significantly into chronic home use and specialized oncology/neurology areas.
Here's a breakdown of the segments and the associated real-life numbers we have as of late 2025:
| Customer Segment | Current Status/Target Indication | Key Metric/Data Point (as of FY2025/Q3 FY2025) |
| U.S. Hospitals (PPHN) | Current core market for LungFit PH | Operational in over 45 U.S. hospitals |
| U.S. Hospitals (PPHN) | Recent Commercial Momentum | Six new U.S. hospital starts in Q3 FY2025 |
| International Hospitals | Global Expansion (Post CE Mark) | Distribution agreements cover markets potentially reaching over 2 billion lives |
| International Hospitals | Current Global Footprint | Expansion to 18 countries as of March 2025 |
| Future: Hospitalized Patients (LungFit PRO) | Severe Acute Viral Lung Infections (VCAP) | U.S. pilot trial is underway; pivotal study on track for Winter 2025/26 |
| Future: Home-Use Patients (LungFit GO) | Chronic Inhaled NO Therapy (e.g., NTM) | Plan to initiate U.S. trial in calendar year 2025 |
| Future: Oncology/Neurology Specialists | Solid Tumors (Beyond Cancer) | UNO therapy in an ongoing Phase 1a trial |
The financial performance in Fiscal Year 2025 supports this segment focus, showing a clear ramp-up in the core hospital business.
- FY2025 Total Revenues: $3.7 million
- FY2026 Revenue Guidance: $12 million to $16 million
- FY2025 Net Loss: $46.6 million
- Expected FY2025 Net Cash Burn: Less than $30 million
- Cash, Cash Equivalents, and Marketable Securities (as of March 31, 2025): $6.9 million
For the current PPHN segment, the value proposition is the cylinder-free, on-demand generation of NO, which addresses logistical constraints directly. The device can generate NO at concentrations ranging from 1 ppm to 80 ppm.
The future segments rely on label expansion and new indications:
- LungFit PRO for severe acute lung infections could use NO concentrations at or above 80 ppm.
- The NeuroNOS program is advancing a pre-clinical program for Autism Spectrum Disorder (ASD).
The aggregate contracted revenue through fiscal year 2027 stands at more than $7 million, which is a direct reflection of the current customer segment pipeline health.
Finance: draft 13-week cash view by Friday.
Beyond Air, Inc. (XAIR) - Canvas Business Model: Cost Structure
You're looking at the cost side of Beyond Air, Inc.'s (XAIR) business as they push for commercial scale with the LungFit® PH system. For a company in this growth stage, the cost structure is heavily weighted toward future revenue generation, meaning high upfront investment in R&D and sales infrastructure.
The major cost drivers for Beyond Air, Inc. during the fiscal year ended March 31, 2025, show a clear focus on both product refinement and market penetration. You can see the key figures broken down below:
| Cost Category | FY2025 Financial Amount (Year Ended March 31, 2025) | Comparison/Context |
| Research and Development (R&D) Expenses | $16.9 million | Down from $24.4 million in FY2024, showing some initial cost control while still funding pipeline development. |
| Selling, General, and Administrative (SG&A) Expenses | $26.0 million | A significant reduction from $37.3 million in FY2024, reflecting efforts to streamline overhead as commercialization ramps up. |
| Cost of Revenue | $5.4 million | Exceeded the $3.7 million in revenue for the year, driven by device depreciation and one-time upgrade costs. |
| Net Cash Burn (Excluding Financing) | $44.1 million | The actual cash burn for the fiscal year, which was above the initial conservation target. |
High Research and Development (R&D) spending is a core component of the cost structure, reflecting the biopharmaceutical and medical device nature of Beyond Air, Inc.'s operations. For the fiscal year ended March 31, 2025, R&D expenses totaled $16.9 million. This spending is essential to support the pipeline, even as it decreased from the $24.4 million spent in the prior fiscal year. This R&D investment is directly tied to advancing their technology platform.
Significant Selling, General, and Administrative (SG&A) costs are necessary for commercial expansion. For FY2025, SG&A expenses were $26.0 million. This spending supports the growing field team and the infrastructure needed to support the LungFit® PH system, which was installed in over 45 U.S. hospitals by mid-2025. This figure was down from $37.3 million in FY2024, showing management's focus on operational efficiency alongside growth.
The Cost of Revenue for device manufacturing, depreciation, and upgrades was $5.4 million for the fiscal year ended March 31, 2025. This figure exceeding the year's total revenue of $3.7 million is common when a company is scaling device deployment, as depreciation on the installed base contributes significantly to this line item.
Beyond Air, Inc. incurs specific costs for clinical trials and regulatory submissions for new indications. A key cost driver in 2025 was the work supporting the submission of the PMA supplement for the second-generation LungFit® PH device to the FDA in June 2025. Furthermore, costs are allocated to advancing their pipeline, including the solid tumor program utilizing UNO technology, where the Phase 1a trial monotherapy portion was completed.
Regarding capital conservation efforts, the company had a stated goal to keep the net cash burn below $30 million for FY2025. However, the actual reported cash burn, excluding financing and debt extinguishment impacts, for the fiscal year ended March 31, 2025, was $44.1 million. To address this, Beyond Air, Inc. secured new financing later in 2025, including up to $32 million in potential proceeds from Streeterville Capital, LLC, which included a $12 million promissory note and a $20 million Equity Line of Credit Agreement, aiming to provide runway into calendar 2027.
- The actual net cash burn for FY2025 was $44.1 million.
- The stated capital conservation goal for FY2025 was less than $30 million.
- The company ended Q2 FY2026 (September 30, 2025) with a cash balance of $10.7 million.
- The quarterly net cash burn in Q2 FY2026 was significantly reduced to $4.7 million.
Finance: draft 13-week cash view by Friday.
Beyond Air, Inc. (XAIR) - Canvas Business Model: Revenue Streams
Beyond Air, Inc. generates revenue primarily through the commercialization of its LungFit PH system, which is the first and only FDA-approved tankless nitric oxide generator and delivery system that uses ambient air to produce nitric oxide on demand for hospital use. This revenue structure is built around system sales and the subsequent recurring sales of necessary components.
Sales of the LungFit PH device (system sales) to hospitals form a core component of the revenue base. As of the fiscal quarter ended September 30, 2025, the number of hospital contracts for the LungFit PH system increased by 60% over the course of the second fiscal quarter of 2025, building upon an existing base of over 45 U.S. hospitals where the system has been deployed. The company is seeing an increasing number of customer engagements for multi-year contracts.
Recurring revenue from the sale of disposable NO2 Smart Filters (consumables) supports the system sales, providing a stream of ongoing revenue as the devices are used clinically. While a specific dollar breakdown between system sales and consumables is not explicitly detailed in the latest reports, the overall revenue growth reflects the combined uptake of the system and its associated supplies.
International unit sales and milestone payments from distribution partners are becoming an increasingly important segment. As of September 30, 2025, Beyond Air, Inc. expanded its global LungFit PH distribution network to 35 countries, which represents a combined population of 2.8 billion people. This expansion is driven by recent regulatory approvals in select markets, including new agreements in Japan, South Korea, Costa Rica, Guatemala, Panama, and El Salvador.
The company's recent financial performance underscores this commercial activity. Total revenue for the fiscal year ended March 31, 2025, was $3.71 million, marking a significant 219.67% growth compared to the prior fiscal year. For the quarter ended September 30, 2025, revenue reached $1.82 million, a 128% increase year-over-year.
Future revenue from new indications (PRO/GO) and the second-generation system represents the next phase of growth. Beyond Air, Inc. anticipates the launch of its second-generation LungFit PH device prior to the end of calendar 2026. Furthermore, the company is advancing regulatory initiatives, including an ongoing FDA submission for the LungFit PH in cardiac surgery, which would unlock a new labeled indication.
Here's the quick math on recent and projected revenue performance:
| Metric | Value |
|---|---|
| Total Revenue (FY Ended Mar 31, 2025) | $3.71 million |
| Revenue Growth (FY Ended Mar 31, 2025 vs FY2024) | 219.67% |
| Revenue (Quarter Ended Sep 30, 2025) | $1.82 million |
| Revenue Growth (Qtr Ended Sep 30, 2025 vs Qtr Sep 30, 2024) | 128% |
| FY 2026 Revenue Guidance (Low End) | $12 million |
| FY 2026 Revenue Guidance (High End) | $16 million |
| Projected Revenue (Quarter Ending June 30, 2025) | At least $1.7 million |
The expansion of the commercial footprint is also tracked through key operational metrics:
- Number of U.S. hospitals adopting LungFit PH: Over 45.
- Number of countries with distribution network expansion (as of Sep 30, 2025): 35.
- Combined population covered by international markets: 2.8 billion people.
- Anticipated launch of second-generation system: Prior to end of calendar 2026.
The company is actively pursuing regulatory milestones that will directly impact future revenue realization, such as the FDA review for the cardiac surgery indication.
Finance: draft 13-week cash view by Friday
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