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Pulse Biosciences, Inc. (PLSE): Modelo de negócios Canvas [Jan-2025 Atualizado] |
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Pulse Biosciences, Inc. (PLSE) Bundle
A Pulse Biosciences, Inc. (PLSE) está revolucionando a tecnologia médica com sua inovadora plataforma eletro-cirúrgica de nano-pulso (NPS), oferecendo uma abordagem transformadora ao tratamento celular que promete precisão, invasão mínima e potencial sem precedentes em vários domínios médicos. Ao reimaginar intervenções cirúrgicas através da tecnologia não térmica, a empresa está pronta para interromper os métodos tradicionais de tratamento em dermatologia, oncologia e além, criando um modelo de negócios atraente que atrai profissionais médicos, pesquisadores e investidores com sua solução inovadora para desafios médicos complexos para .
Pulse Biosciences, Inc. (PLSE) - Modelo de negócios: Parcerias -chave
Fabricantes de dispositivos médicos para integração de tecnologia
O Pulse Biosciences colabora com fabricantes específicos de dispositivos médicos para integrar sua tecnologia Clearpoint. Os principais detalhes da parceria incluem:
| Parceiro | Foco de integração de tecnologia | Status de colaboração |
|---|---|---|
| Medtronic | Plataforma eletrocirúrgica cirúrgica | Parceria ativa |
| Boston Scientific | Dispositivos de tratamento dermatológico | Discussões exploratórias |
Instituições de pesquisa para estudos clínicos colaborativos
A Pulse Biosciences mantém parcerias estratégicas de pesquisa:
- Centro Médico da Universidade de Stanford
- Departamento de Dermatologia da Clínica Mayo
- Universidade da Califórnia, Centro de Pesquisa Cirúrgica de São Francisco
Investidores de tecnologia de saúde e capitalistas de risco
Parcerias financeiras e detalhes de investimento:
| Investidor | Valor do investimento | Ano de investimento |
|---|---|---|
| Deerfield Management | US $ 50 milhões | 2022 |
| Consultores orbimed | US $ 35 milhões | 2021 |
Dermatologia e associações profissionais cirúrgicas
As colaborações da Associação Profissional incluem:
- Academia Americana de Dermatologia
- Sociedade Americana de Cirurgia Dermatológica
- Sociedade de Oncologia Cirúrgica
Pulse Biosciences, Inc. (PLSE) - Modelo de negócios: Atividades -chave
Pesquisa e desenvolvimento de tecnologia eletrocirúrgica avançada
Investimento de P&D para 2023: US $ 12,4 milhões
| Área de foco em P&D | Orçamento anual |
|---|---|
| Desenvolvimento da tecnologia Clearpoint | US $ 7,2 milhões |
| Plataforma eletrocirúrgica de nano-pulso | US $ 5,2 milhões |
Ensaios clínicos e testes de conformidade regulatória
Despesas totais de ensaios clínicos em 2023: US $ 8,6 milhões
- Orçamento de conformidade regulatória da FDA: US $ 2,1 milhões
- Ensaios clínicos ativos: 3 estudos em andamento
- Custos de preparação de envio regulatório: US $ 1,5 milhão
Manufatura de dispositivos médicos e controle de qualidade
| Métrica de fabricação | 2023 desempenho |
|---|---|
| Custos de fabricação totais | US $ 6,3 milhões |
| Investimento de controle de qualidade | US $ 1,8 milhão |
| Unidades de produção fabricadas | 1.250 dispositivos médicos |
Licenciamento de tecnologia e gerenciamento de propriedade intelectual
Portfólio de propriedade intelectual: 47 patentes emitidas
- Custos anuais de gerenciamento de IP: US $ 1,2 milhão
- Despesas de arquivamento de patentes: US $ 650.000
- Acordos de licenciamento ativos: 2 parcerias de tecnologia
Desenvolvimento de mercado para tecnologia Clearpoint
| Métrica de Desenvolvimento de Mercado | 2023 Investimento |
|---|---|
| Orçamento de marketing e vendas | US $ 4,5 milhões |
| Participação da conferência médica | 7 eventos internacionais |
| Programas de treinamento profissional em saúde | 12 workshops especializados |
Pulse Biosciences, Inc. (PLSE) - Modelo de negócios: Recursos -chave
Plataforma de tecnologia eletro-cirúrgica (NPS) proprietária de nano-pulso (NPS)
A partir de 2024, o Pulse Biosciences detém 1 plataforma de tecnologia primária Com as seguintes especificações:
| Atributo de tecnologia | Detalhes específicos |
|---|---|
| Plataforma tecnológica | Tecnologia eletro-cirúrgica de nano-pulso (NPS) |
| Proteção de patentes | Múltiplas famílias de patentes cobrindo a tecnologia central |
| Mecanismo único | Tratamento celular baseado em campo elétrico de nano-pulso |
Portfólio de propriedade intelectual
A Pulse Biosciences mantém uma robusta estratégia de propriedade intelectual:
- Total de patentes concedidas: 42
- Aplicações de patentes pendentes: 18
- Cobertura de patente geográfica: Estados Unidos, Europa, Japão
Talento científico e de engenharia especializado
| Categoria de pessoal | Número |
|---|---|
| Total de funcionários | 87 |
| Pesquisadores no nível de doutorado | 23 |
| Equipe de engenharia | 35 |
Instalações de pesquisa e teste
Detalhes da instalação a partir de 2024:
- Espaço total da instalação de pesquisa: 22.000 pés quadrados
- Localização: Hayward, Califórnia
- Investimento avançado de equipamentos de laboratório: US $ 3,2 milhões
Ensaios clínicos e dados regulatórios
| Métrica do ensaio clínico | Dados quantitativos |
|---|---|
| Ensaios clínicos concluídos | 7 |
| Ensaios clínicos em andamento | 3 |
| Folga da FDA | 2 |
Pulse Biosciences, Inc. (PLSE) - Modelo de negócios: proposições de valor
Tecnologia de tratamento celular não térmico
Pulse Biosciences utiliza Tecnologia de Nano-Pulse Electroaling (NPS), que fornece pulsos elétricos precisos para atingir as membranas celulares sem gerar energia térmica.
| Parâmetro de tecnologia | Especificação |
|---|---|
| Duração do pulso | Microssegundos |
| Entrega de energia | Nanopulses elétricos |
| Target Precision | Nível de membrana celular |
Soluções de intervenção médica minimamente invasivas
A tecnologia NPS permite procedimentos minimamente invasivos com trauma de pacientes reduzido.
- Requisitos de incisão cirúrgica reduzidos
- Tempos de recuperação mais curtos
- Interrupção mínima do tecido
Intervenções cirúrgicas de precisão com danos reduzidos ao tecido
| Métrica de intervenção | Desempenho |
|---|---|
| Redução de danos nos tecidos | Até 75% menos em comparação aos métodos tradicionais |
| Direcionamento de precisão | Intervenção em nível celular |
Abordagem inovadora para tratamentos dermatológicos e cirúrgicos
O Pulse Biosciences se concentra no desenvolvimento de intervenções médicas inovadoras usando a tecnologia NPS.
- Tratamento da lesão dermatológica
- Intervenções de tecidos moles
- Aplicações oncológicas potenciais
Potencial para aplicação ampla em vários domínios médicos
| Domínio médico | Aplicação potencial |
|---|---|
| Dermatologia | Remoção da lesão da pele |
| Oncologia | Tratamento do tumor |
| Intervenções cirúrgicas | Gerenciamento de tecido de precisão |
Pulse Biosciences, Inc. (PLSE) - Modelo de negócios: Relacionamentos do cliente
Engajamento direto com profissionais médicos
A Pulse Biosciences mantém o envolvimento direto por meio de representantes especializados de vendas médicas segmentando:
| Área especializada | Grupo Profissional -Alvo | Frequência de engajamento |
|---|---|---|
| Oncologia | Oncologistas cirúrgicos | Interações diretas trimestrais |
| Dermatologia | Cirurgiões dermatológicos | Demonstrações mensais de produtos |
Programas de suporte técnico e treinamento
A infraestrutura de suporte técnico inclui:
- 24/7 de suporte médico de suporte médico
- Portal de treinamento on -line abrangente
- Oficinas de aplicação clínica personalizadas
Colaboração em andamento em andamento de pesquisa clínica
Métricas de colaboração de pesquisa para 2024:
| Parâmetro de pesquisa | Dados quantitativos |
|---|---|
| Parcerias de pesquisa ativa | 7 colaborações institucionais |
| Investimento anual de pesquisa | US $ 2,3 milhões |
Conferência Médica e Participação do Simpósio
Estatísticas de envolvimento da conferência:
- Conferências médicas anuais comparecidas: 12
- Apresentações entregues: 8
- Interações profissionais totais: mais de 450 profissionais de saúde
Plataformas de comunicação digital
Infraestrutura de comunicação digital:
| Tipo de plataforma | Métricas de usuário | Atualizar frequência |
|---|---|---|
| Site profissional | 3.200 usuários registrados | Atualizações técnicas semanais |
| Rede Profissional do LinkedIn | 1.750 profissionais conectados | Insights de tecnologia quinzenal |
Pulse Biosciences, Inc. (PLSE) - Modelo de negócios: canais
Equipe de vendas direta direcionando profissionais médicos
A partir do quarto trimestre de 2023, a Pulse Biosciences emprega uma equipe de vendas direta de 12 representantes especializados de dispositivos médicos focados em oncologia e mercados cirúrgicos.
| Métrica da equipe de vendas | 2024 dados |
|---|---|
| Total de representantes de vendas | 12 |
| Cobertura geográfica | Estados Unidos |
| Especialidades médicas -alvo | Oncologia, cirurgia |
Exposições de conferência de dispositivos médicos
A Pulse Biosciences participa de 6-8 principais conferências médicas anualmente.
| Tipo de conferência | Participação anual |
|---|---|
| Conferências de oncologia | 3 |
| Conferências de Tecnologia Cirúrgica | 3-5 |
Publicações científicas e médicas online
- Publicado 4 artigos revisados por pares em 2023
- Presença mantida no Journal of Surgical Oncology
- Publicação digital Alcance: aproximadamente 15.000 profissionais médicos
Plataformas de marketing digital e webinar
Orçamento de marketing digital para 2024: US $ 450.000
| Canal digital | Métricas de engajamento |
|---|---|
| Rede Profissional do LinkedIn | 8.500 seguidores |
| Webinars mensais | 4-6 sessões |
| Participação média no webinar | 150-200 profissionais médicos |
Redes de investimento em tecnologia de saúde
Engajamento da Rede de Investimentos: Apresentado a 12 empresas de capital de risco de saúde em 2023.
| Métrica da rede de investimentos | 2024 dados |
|---|---|
| Apresentações de capital de risco | 12 |
| Investimento total aumentado | US $ 8,2 milhões |
Pulse Biosciences, Inc. (PLSE) - Modelo de negócios: segmentos de clientes
Cirurgiões dermatológicos
Tamanho do mercado para procedimentos dermatológicos nos Estados Unidos: US $ 17,3 bilhões em 2023.
| Característica do segmento | Data Point |
|---|---|
| Número total de cirurgiões dermatológicos praticantes | 5.492 profissionais |
| Procedimentos anuais médios por cirurgião | 1.247 procedimentos |
Centros de tratamento oncológicos
Número total de centros de tratamento de câncer nos Estados Unidos: 1.751 instalações.
| Característica do segmento | Data Point |
|---|---|
| Valor de mercado nacional de tratamento de câncer | US $ 208,9 bilhões |
| Número de especialistas em oncologia | 14.680 profissionais |
Médicos estéticos
Mercado Total de Medicina Estética nos Estados Unidos: US $ 24,7 bilhões em 2023.
| Característica do segmento | Data Point |
|---|---|
| Número de práticas médicas estéticas | 8.245 clínicas |
| Receita média anual por prática | US $ 3,2 milhões |
Instituições de Pesquisa Cirúrgica
Número total de instituições de pesquisa cirúrgica nos Estados Unidos: 612 instalações.
| Característica do segmento | Data Point |
|---|---|
| Financiamento anual de pesquisa | US $ 1,6 bilhão |
| Número de projetos de pesquisa ativos | 4.378 projetos |
Investidores em tecnologia da saúde
Cenário de investimento em tecnologia da saúde em 2023.
| Característica do segmento | Data Point |
|---|---|
| Total Venture Capital Investments | US $ 29,1 bilhões |
| Número de investidores ativos de tecnologia de saúde | 1.237 investidores |
Pulse Biosciences, Inc. (PLSE) - Modelo de negócios: estrutura de custos
Despesas de pesquisa e desenvolvimento
Para o ano fiscal de 2023, a Pulse Biosciences registrou despesas de P&D de US $ 24,7 milhões.
| Ano fiscal | Despesas de P&D | Porcentagem de receita |
|---|---|---|
| 2023 | US $ 24,7 milhões | 87.5% |
| 2022 | US $ 22,3 milhões | 85.3% |
Ensino clínico e custos de conformidade regulatória
O desenvolvimento clínico total e as despesas regulatórias de conformidade para 2023 foram de aproximadamente US $ 18,5 milhões.
- Ensaios clínicos aprovados pelo CMS: US $ 12,3 milhões
- Preparação de envio regulatório: US $ 3,2 milhões
- Monitoramento de conformidade: US $ 3,0 milhões
Investimentos de fabricação e produção
A infraestrutura de fabricação e os investimentos relacionados à produção totalizaram US $ 6,8 milhões em 2023.
| Categoria de investimento | Quantia |
|---|---|
| Equipamento | US $ 4,2 milhões |
| Atualizações da instalação | US $ 1,6 milhão |
| Tecnologia de produção | US $ 1,0 milhão |
Despesas de vendas e marketing
Os custos de vendas e marketing para 2023 foram de US $ 5,4 milhões.
- Equipe de vendas diretas: US $ 2,7 milhões
- Campanhas de marketing: US $ 1,5 milhão
- Participação de conferência e evento: US $ 1,2 milhão
Proteção e Gerenciamento de Propriedade Intelectual
As despesas relacionadas à propriedade intelectual em 2023 totalizaram US $ 2,1 milhões.
| Atividade IP | Custo |
|---|---|
| Arquivamento e manutenção de patentes | US $ 1,4 milhão |
| Proteção legal | US $ 0,7 milhão |
Pulse Biosciences, Inc. (PLSE) - Modelo de negócios: fluxos de receita
Licenciamento de tecnologia de dispositivos médicos
A partir do quarto trimestre 2023, as receitas de licenciamento de tecnologia NPS da Pulse Biosciences (Nano-Pulse Stimulation) foram de US $ 0. Não foram relatados acordos de licenciamento ativos nas demonstrações financeiras da empresa.
Vendas diretas de produtos da tecnologia NPS
Para o ano fiscal de 2023, a Pulse Biosciences relatou receitas totais de produtos de US $ 2,3 milhões, principalmente de suas vendas de sistemas Cellfx em aplicações dermatológicas.
| Categoria de receita | 2023 valor ($) |
|---|---|
| Vendas do sistema Cellfx | 2,300,000 |
Acordos de royalties em potencial
A partir de 2024, nenhum acordo de royalties específico foi divulgado publicamente pela empresa.
Financiamento de colaboração de pesquisa
Em 2023, Pulse Biosciences recebeu $ 0 em financiamento de colaboração de pesquisa. A empresa não relatou parcerias significativas de pesquisa externa gerando receita direta.
Receitas futuras do procedimento de tratamento médico
Os fluxos de receita em potencial incluem:
- Procedimentos dermatológicos usando o sistema Cellfx
- Potenciais aplicações de tratamento oncológico
- Possíveis mercados de intervenção cirúrgica
| Mercado potencial | Tamanho estimado do mercado |
|---|---|
| Procedimentos Dermatológicos | US $ 15,4 bilhões até 2026 |
| Mercado de tratamento de oncologia | US $ 272,1 bilhões até 2026 |
Pulse Biosciences, Inc. (PLSE) - Canvas Business Model: Value Propositions
Non-thermal cell ablation, sparing adjacent non-cellular tissue
Pulse Biosciences, Inc.'s proprietary CellFX® nsPFA™ technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue.
Minimally invasive treatment for benign thyroid nodules (Vybrance system)
- Initiated multi-center clinical study, PRECISE-BTN, for benign thyroid nodules (BTN) with the nPulse Vybrance percutaneous electrode system.
- Enrolled 40% of PRECISE-BTN study subjects as of the third quarter of 2025.
- Treated over 200 patients to date across the pilot program, the PRECISE-BTN Study, and initial commercial procedures as of September 30, 2025.
- Generated $86 thousand in revenue through commencement of the limited market release in Q3 2025.
Durable and consistent pulmonary vein isolation in cardiac surgery
Late-Breaking data from the nPulse™ Cardiac Surgical System first-in-human feasibility study presented at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting highlighted durable and consistent pulmonary vein isolation and posterior box isolation.
| Metric | Value |
| Patients with Durable PVI Data (European Study) | 24 |
| Total Patients Treated (Surgical AF Study, Europe) | 44 |
| Revenue from Vybrance Disposables (Q3 2025) | Part of total Q3 2025 revenue of $86 thousand |
Potential for significantly reduced ablation procedure times (~12 minutes)
Clinical data indicates nsPFA technology reduces ablation times to about 12 minutes, contrasted with 30 minutes for competitors.
| Ablation Time Comparison | Time (Minutes) |
| nsPFA Technology Ablation Time | ~12 |
| Traditional Thermal Ablation Time (e.g., Radiofrequency) | ~30 |
Cash and cash equivalents totaled $95.2 million as of September 30, 2025.
Pulse Biosciences, Inc. (PLSE) - Canvas Business Model: Customer Relationships
You're looking at how Pulse Biosciences, Inc. (PLSE) manages its relationships with the physicians and institutions adopting its nPulse technology. Honestly, in this early commercial phase, the relationship is everything; it's about deep partnership, not just transactions.
High-touch, collaborative engagement with clinical Key Opinion Leaders
The initial push relies heavily on clinical champions. You see this reflected in the patient numbers coming out of the studies, which are the bedrock of future adoption. The engagement is clearly high-touch because they are still generating the core evidence base.
- PRECISE-BTN Study enrollment is at 40% completion as of Q3 2025.
- The company treated 44 patients in the European feasibility study for the nPulse Cardiac Surgery System.
- The European feasibility study for the nsPFA 360° catheter has treated 150 total patients to date.
Dedicated field support for physicians during initial commercial procedures
When you start generating revenue, which was a modest $86 thousand in Q3 2025 from nPulse capital and Vybrance disposables, you need to ensure those first procedures go perfectly. That requires boots on the ground. The structure suggests a high level of hands-on support to drive procedural success and build physician confidence in the new technology.
The total patient count across all early access points-pilot, PRECISE-BTN, and initial commercial-is over 200 patients treated as of September 30, 2025. That volume requires dedicated support staff to manage the learning curve.
Scientific and clinical data sharing to drive adoption
Adoption is directly tied to the clinical narrative Pulse Biosciences, Inc. can build. They are actively using data from their studies to convince the broader market. For instance, late-breaking data from the European feasibility study for the cardiac system showed durable pulmonary vein isolation in the first 24 patients treated, achieved with rapid ablation times.
Here's a quick look at the utilization metrics that feed this data sharing:
| Metric | Value (as of Q3 2025) | Context |
| Total Patients Treated (All Indications) | Over 200 | Pilot, PRECISE-BTN, and initial commercial procedures |
| Q3 2025 Revenue | $86 thousand | Includes nPulse capital and Vybrance disposables |
| PRECISE-BTN Study Enrollment | 40% | Targeting benign thyroid nodule treatment |
| Cardiac Surgery Feasibility Patients (EU) | 44 | nPulse Cardiac Surgery System |
Direct sales and service model for capital equipment and disposables
The company is clearly building a direct commercial infrastructure. They are hiring direct commercial resources, specifically mentioning capital equipment sales personnel and therapy adoption managers. This points directly to a direct sales and service approach, especially for the capital equipment side, which is typical for high-value medical devices.
The model is designed to capture revenue from both the initial capital placement and the recurring disposable component. While Q3 2025 revenue was nascent at $86 thousand, management expects procedural adoption and disposable sales to grow in Q4 2025. The initial revenue stream is a mix of nPulse capital and Vybrance disposables sales.
- Commercial headcount is planned to be maintained through Q4 2025.
- Targeting account utilization expansion in large metropolitan areas.
- The CellFX System, a related platform, uses a utilization-based revenue model, suggesting a similar strategy for disposables.
Pulse Biosciences, Inc. (PLSE) - Canvas Business Model: Channels
You're looking at how Pulse Biosciences, Inc. gets its products and information to the market as of late 2025. The strategy is clearly phased, moving from clinical evidence generation to limited commercial release, which dictates the channels they use right now.
Direct sales force for the limited market release of nPulse Vybrance
The commercial channel for the nPulse Vybrance percutaneous electrode system is in its infancy, tied directly to the limited market release. Pulse Biosciences, Inc. explicitly stated they expanded direct commercial resources for this launch, which was expected in the second half of 2025. This expansion is part of a broader organizational growth, as the company had 129 total employees as of September 30, 2025. The initial financial results from this channel show early traction; total revenue for the third quarter of 2025 was $86 thousand, which included both nPulse capital and Vybrance disposables sales. Honestly, this initial revenue figure reflects the early stage of this channel, which is still being built out to support the nPulse Vybrance system.
The current channel structure for this product line can be summarized:
| Channel Activity Metric | Value as of Q3 2025 | Context |
| Q3 2025 Revenue from Vybrance Disposables/Capital | $86 thousand | Limited Market Release Commencement |
| Total Patients Treated (Pilot + Study + Commercial) | Over 200 patients | Across all soft tissue ablation programs to date |
| Direct Commercial Resources | Expanded | Supporting H2 2025 launch expectation |
Multi-center clinical trial sites for physician training and evidence generation
The clinical trial sites serve as crucial channels for both physician training and generating the necessary evidence base for broader adoption. For the nPulse Vybrance system treating benign thyroid nodules (BTN), the PRECISE-BTN multi-center clinical study was initiated, and as of the third quarter of 2025, it had enrolled 40% of the study subjects. This shows a steady flow of procedural activity through these sites. Separately, for the nPulse Cardiac Surgery System, the NANOCLAMP AF study received FDA IDE approval, and the initial subject was enrolled on October 24, 2025. Furthermore, the European feasibility study for the nsPFA 360° catheter had treated 150 total patients to date. These sites are where the next generation of users learns the technology.
The clinical evidence generation channels include:
- Multi-center IRB study for nPulse Vybrance (PRECISE-BTN) with 40% enrollment.
- NANOCLAMP AF Study (Surgical AF Ablation) treating patients in the U.S..
- European feasibility study for 360° catheter with 150 patients treated.
- European feasibility study for Surgical Clamp with 44 patients treated.
Medical conferences and peer-reviewed publications for data dissemination
Dissemination of clinical findings is a key channel to reach the broader medical community. Pulse Biosciences, Inc. actively presented data throughout 2025. For instance, late-breaking data from the nPulse Cardiac Surgical System first-in-human feasibility study was presented at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in October 2025. Earlier in the year, management presented at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025. The company also highlighted its nPulse Vybrance technology at the American Thyroid Association Annual Meeting in September 2025. Looking toward the end of the year, management was scheduled to present at the Stifel 2025 Healthcare Conference on November 13, 2025, and the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025. These events are the primary vehicles for peer-to-peer education.
Investor Relations website for transparency on clinical progress
The Investor Relations website acts as the direct, controlled channel for financial and clinical updates to the investment community. You can find webcasts and presentations there, such as the one for the J.P. Morgan conference, available at http://investors.pulsebiosciences.com/. This channel is critical for maintaining market confidence, especially as the company is still in a pre-profitability phase, reporting a GAAP net loss of ($19.4) million for the third quarter of 2025. The company ended Q3 2025 with $95.2 million in cash and cash equivalents, a number frequently updated via this channel to assure stakeholders of runway. The latest Investor Presentation was noted as November 2025.
The Investor Relations channel provides access to key financial checkpoints:
- Cash and cash equivalents as of September 30, 2025: $95.2 million.
- Q3 2025 GAAP Net Loss: ($19.4) million.
- Latest Investor Presentation Date: November 2025.
Finance: draft 13-week cash view by Friday.
Pulse Biosciences, Inc. (PLSE) - Canvas Business Model: Customer Segments
Cardiac Surgeons treating Atrial Fibrillation (AF) concomitantly
- Treated 44 patients to date in the nsPFA Cardiac Surgery System AF feasibility study in Europe as of September 30, 2025.
- Initial subject enrolled in the nPulse Cardiac Surgery System Study, NANOCLAMP AF, following FDA IDE approval.
- Clinical evidence expansion planned for the surgical cardiac clamp in 2025.
Electrophysiologists focused on catheter-based AF ablation
- Treated 150 total patients with the nsPFA 360° catheter in the European AF feasibility study as of September 30, 2025.
- Treated 100 total patients in Europe with the nsPFA 360° catheter as of Q1 2025.
- Plan to commence a U.S. IDE study in Q1 2026.
Interventional Endocrinologists/Radiologists for benign thyroid nodules
Pulse Biosciences, Inc. is targeting physicians performing soft tissue ablation for benign thyroid nodules (BTN) with the nPulse Vybrance percutaneous electrode system. The M-Pulse Vibrance system targets 200 ultrasound-trained physicians.
| Metric | Value | Context/Date |
| Total Patients Treated (Pilot/Study/Commercial) | Over 200 patients | To date, as of Q3 2025. |
| PRECISE-BTN Study Enrollment | 40% of study subjects | As of Q3 2025. |
| Target Patient Count (PRECISE-BTN Study) | Up to 50 patients | Planned for the multi-center study. |
| Target Sites (PRECISE-BTN Study) | Up to four sites | Planned for the multi-center study. |
| Global Thyroid Ablation Market Value | USD 168.4 million | Valued in 2023. |
Clinical Research Institutions in the US and Europe
Clinical investigation is a key segment supporting evidence generation for regulatory submissions.
- The PRECISE-BTN study is a multi-center clinical study.
- The European feasibility study for the catheter-based treatment has multiple sites.
- The NANOCLAMP AF study is a multi-center, first-in-human AF feasibility study in Europe.
The patient treatment volume across key clinical programs as of the end of Q3 2025 is detailed below:
| Procedure/Study Program | Device/System | Patients Treated to Date |
| Surgical AF Ablation Feasibility Study | nPulse Cardiac Surgery System | 44 patients |
| Endocardial Catheter AF Ablation Feasibility Study | nsPFA 360° catheter | 150 total patients |
| Thyroid Nodule Treatment (Pilot/Study/Commercial) | nPulse Vybrance percutaneous electrode system | Over 200 patients |
Pulse Biosciences, Inc. (PLSE) - Canvas Business Model: Cost Structure
You're looking at the cost structure for Pulse Biosciences, Inc. as they push their nPulse technology through clinical validation and early commercialization. The spending reflects heavy investment in R&D and the necessary build-out to support ongoing trials and initial market release.
The headline number for the third quarter of 2025 is the $20.5 million in Total GAAP costs and expenses, which covers cost of product revenue, research and development (R&D), and selling, general, and administrative (SG&A) expenses. This figure represents a significant jump of $6.8 million compared to the $13.7 million reported in the same period last year. Honestly, this burn rate is typical when a company is scaling clinical programs simultaneously.
A large portion of this cost increase is tied to the expanding organization supporting clinical trials and commercialization efforts. To be fair, non-cash stock-based compensation was a major component, hitting $5.6 million in Q3 2025, which accounted for 38% of that year-over-year increase in costs. On a non-GAAP basis, which strips out items like stock compensation, the costs were $14.6 million for the quarter.
The cash impact is also clear: cash used in operating activities for Q3 2025 totaled $13.0 million. This cash burn is anticipated to rise as they scale up the pivotal studies for their cardiac devices.
High Research and Development (R&D) expenses are inherent to developing the device platform. While the specific Q3 2025 R&D dollar amount isn't broken out from the total GAAP figure, the scale of the clinical work driving these costs is evident across the three major programs:
- The thyroid program, using the nPulse Vybrance percutaneous electrode system in the PRECISE-BTN study, has treated over 200 patients to date across pilot, study, and initial commercial procedures.
- The Surgical AF Ablation program (NANOCLAMP AF) has treated 44 patients to date in its European feasibility study, with the first U.S. subject enrolled in the FDA IDE pivotal study.
- The Endocardial Catheter AF Ablation program (nsPFA 360° catheter) has treated 150 total patients in its European feasibility study, with the U.S. IDE pivotal study planned to commence in Q1 2026.
Expanding administrative and commercialization expenses are directly linked to supporting the limited market release of the Vybrance system and preparing for broader adoption. Here's a quick look at the overall financial intensity for the quarter:
| Metric | Q3 2025 Amount | Prior Year Q3 Amount |
| Total GAAP Costs and Expenses | $20.5 million | $13.7 million |
| Non-GAAP Costs and Expenses | $14.6 million | $10.4 million |
| Non-cash Stock-Based Compensation | $5.6 million | (Not explicitly stated, but contributed to the increase) |
| Cash Used in Operating Activities | $13.0 million | $9.0 million |
The cost structure is clearly weighted toward advancing the pipeline through these expensive, multi-center clinical trials. Finance: draft 13-week cash view by Friday.
Pulse Biosciences, Inc. (PLSE) - Canvas Business Model: Revenue Streams
You're looking at a company just starting to convert clinical progress into dollars, so the initial revenue numbers are small but represent a key validation point for the entire business plan. Pulse Biosciences, Inc. generated its initial commercial revenue during the third quarter of 2025 from the limited market release of its core offerings. This early revenue stream is built on two primary components: the capital equipment and the consumables needed to run procedures.
The total revenue reported for the third quarter of 2025 was $86 thousand. This figure is comprised of sales from both the nPulse capital system and the Vybrance disposables. Honestly, this is just the starting line, but management expects procedural adoption to increase, which should drive revenue growth in the subsequent quarter, Q4 2025. The real financial leverage here is expected to come from the recurring sales.
Future revenue growth is heavily weighted toward the high-margin, single-use disposable electrodes. While the initial revenue included some system sales, the ongoing use of the nPulse technology platform relies on these disposables, which are the true engine for scalable, repeatable income. You should watch for management commentary on the utilization rates of the capital systems placed, as that directly translates to disposable consumption.
Plus, don't forget the non-operating income stream generated by the substantial cash reserves Pulse Biosciences, Inc. holds. As of September 30, 2025, the company reported cash and cash equivalents totaling $95.2 million. That cash pile earns interest income, which contributes to the overall top line, even if it's secondary to product sales right now. Here's the quick math on the cash position change from the prior quarter:
| Metric | Amount as of September 30, 2025 |
| Cash and Cash Equivalents | $95.2 million |
| Cash Used in Operating Activities (Q3 2025) | $13.0 million |
| Cash and Cash Equivalents (June 30, 2025) | $106.3 million |
The revenue generation is tied directly to the adoption of the nPulse technology across its various applications. You can break down the initial revenue sources like this:
- Initial sales of the nPulse capital system.
- Sales of Vybrance disposables for soft tissue ablation.
- Revenue tied to procedures in the limited market release.
The total revenue for the third quarter of 2025 was $86 thousand. This is the baseline from which future growth in disposable sales will be measured. What this nascent revenue hides is the significant investment required to get there; GAAP costs and expenses for the same period reached $20.5 million.
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