Pulse Biosciences, Inc. (PLSE) Business Model Canvas

Pulse Biosciences, Inc. (PLSE): Modelo de Negocio Canvas [Actualizado en Ene-2025]

US | Healthcare | Medical - Instruments & Supplies | NASDAQ
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Pulse Biosciences, Inc. (PLSE) está revolucionando la tecnología médica con su innovadora plataforma electroquirúrgica (NPS) de nano pulso, que ofrece un enfoque transformador para el tratamiento celular que promete precisión, invasividad mínima y potencial sin precedentes en múltiples dominios de medicina. Al reinventar las intervenciones quirúrgicas a través de la tecnología no térmica, la compañía está preparada para interrumpir los métodos de tratamiento tradicionales en dermatología, oncología y más allá, creando un modelo comercial convincente que atrae a profesionales médicos, investigadores e inversores por igual con su innovadora solución a complejos desafíos médicos. .


Pulse Biosciences, Inc. (PLSE) - Modelo de negocios: asociaciones clave

Fabricantes de dispositivos médicos para la integración de tecnología

Pulse Biosciences colabora con fabricantes específicos de dispositivos médicos para integrar su tecnología ClearPoint. Los detalles clave de la asociación incluyen:

Pareja Enfoque de integración tecnológica Estado de colaboración
Medtrónico Plataforma electroquirúrgica quirúrgica Asociación activa
Boston Scientific Dispositivos de tratamiento dermatológico Discusiones exploratorias

Instituciones de investigación para estudios clínicos colaborativos

Pulse Biosciences mantiene asociaciones de investigación estratégica:

  • Centro Médico de la Universidad de Stanford
  • Departamento de dermatología de Mayo Clinic
  • Universidad de California, Centro de Investigación Quirúrgica de San Francisco

Inversores de tecnología de salud y capitalistas de riesgo

Asociaciones financieras y detalles de inversión:

Inversor Monto de la inversión Año de inversión
Administración de Deerfield $ 50 millones 2022
Orbimed Advisors $ 35 millones 2021

Asociaciones profesionales de dermatología y quirúrgica

Las colaboraciones de la asociación profesional incluyen:

  • Academia Americana de Dermatología
  • Sociedad Americana de Cirugía Dermatológica
  • Sociedad de Oncología Quirúrgica

Pulse Biosciences, Inc. (PLSE) - Modelo de negocio: actividades clave

Investigación y desarrollo de tecnología electroquirúrgica avanzada

Inversión de I + D para 2023: $ 12.4 millones

Área de enfoque de I + D Presupuesto anual
Desarrollo de tecnología de ClarePoint $ 7.2 millones
Plataforma electrosquirúrgica de nano pulso $ 5.2 millones

Ensayos clínicos y pruebas de cumplimiento regulatorio

Gastos totales de ensayos clínicos en 2023: $ 8.6 millones

  • Presupuesto de cumplimiento regulatorio de la FDA: $ 2.1 millones
  • Ensayos clínicos activos: 3 estudios en curso
  • Costos de preparación de presentación regulatoria: $ 1.5 millones

Fabricación de dispositivos médicos y control de calidad

Métrico de fabricación 2023 rendimiento
Costos de fabricación totales $ 6.3 millones
Inversión de control de calidad $ 1.8 millones
Unidades de producción fabricadas 1.250 dispositivos médicos

Licencias de tecnología y gestión de propiedades intelectuales

Portafolio de propiedad intelectual: 47 patentes emitidas

  • Costos anuales de gestión de IP: $ 1.2 millones
  • Gastos de presentación de patentes: $ 650,000
  • Acuerdos de licencia activa: 2 asociaciones tecnológicas

Desarrollo del mercado para la tecnología ClearPoint

Métrico de desarrollo del mercado 2023 inversión
Presupuesto de marketing y ventas $ 4.5 millones
Participación de la conferencia médica 7 eventos internacionales
Programas de capacitación profesional de la salud 12 talleres especializados

Pulse Biosciences, Inc. (PLSE) - Modelo de negocios: recursos clave

Plataforma de tecnología electroúrgica (NPS) patentada

A partir de 2024, Pulse Biosciences tiene 1 plataforma de tecnología primaria Con las siguientes especificaciones:

Atributo tecnológico Detalles específicos
Plataforma tecnológica Tecnología electroúrgica (NPS) de nano pulso
Protección de patentes Múltiples familias de patentes que cubren la tecnología central
Mecanismo único Tratamiento celular a base de campo eléctrico de nano pulso

Cartera de propiedades intelectuales

Pulse Biosciences mantiene una sólida estrategia de propiedad intelectual:

  • Patentes totales otorgadas: 42
  • Aplicaciones de patentes pendientes: 18
  • Cobertura de patentes geográficas: Estados Unidos, Europa, Japón

Talento científico e de ingeniería especializado

Categoría de personal Número
Total de empleados 87
Investigadores a nivel de doctorado 23
Personal de ingeniería 35

Instalaciones de investigación y prueba

Detalles de la instalación a partir de 2024:

  • Espacio total de la instalación de investigación: 22,000 pies cuadrados
  • Ubicación: Hayward, California
  • Inversión avanzada de equipos de laboratorio: $ 3.2 millones

Ensayo clínico y datos regulatorios

Métrico de ensayo clínico Datos cuantitativos
Ensayos clínicos completados 7
Ensayos clínicos en curso 3
Espacios de la FDA 2

Pulse Biosciences, Inc. (PLSE) - Modelo de negocio: propuestas de valor

Tecnología de tratamiento celular no térmico

Pulse Biosciences utiliza Tecnología de electro-señalización de nano pulso (NPS), que ofrece pulsos eléctricos precisos a las membranas celulares objetivo sin generar energía térmica.

Parámetro tecnológico Especificación
Duración del pulso Microsegundos
Entrega de energía Nanopulsos eléctricos
Precisión objetivo Nivel de membrana celular

Soluciones de intervención médica mínimamente invasivas

La tecnología NPS permite procedimientos mínimamente invasivos con un trauma de pacientes reducido.

  • Requisitos de incisión quirúrgica reducida
  • Tiempos de recuperación más cortos
  • Interrupción mínima del tejido

Intervenciones quirúrgicas de precisión con daño tisular reducido

Métrico de intervención Actuación
Reducción del daño tisular Hasta un 75% menos en comparación con los métodos tradicionales
Orientación de precisión Intervención a nivel celular

Enfoque innovador para los tratamientos dermatológicos y quirúrgicos

Pulse Biosciences se centra en desarrollar intervenciones médicas innovador utilizando tecnología NPS.

  • Tratamiento de lesión dermatológica
  • Intervenciones de tejidos blandos
  • Aplicaciones oncológicas potenciales

Potencial para una amplia aplicación en múltiples dominios médicos

Dominio médico Aplicación potencial
Dermatología Extracción de la lesión de la piel
Oncología Tratamiento tumoral
Intervenciones quirúrgicas Manejo de tejidos de precisión

Pulse Biosciences, Inc. (PLSE) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

Pulse Biosciences mantiene la participación directa a través de representantes especializados de ventas médicas dirigidas:

Área especializada Grupo profesional objetivo Frecuencia de compromiso
Oncología Oncólogos quirúrgicos Interacciones directas trimestrales
Dermatología Cirujanos dermatológicos Demostraciones mensuales de productos

Programas de soporte técnico y capacitación

La infraestructura de soporte técnico incluye:

  • Línea directa de soporte de dispositivos médicos dedicados 24/7
  • Portal integral de capacitación en línea
  • Talleres de aplicación clínica personalizada

Colaboración en investigación clínica en curso

Investigación de métricas de colaboración para 2024:

Parámetro de investigación Datos cuantitativos
Asociaciones de investigación activa 7 colaboraciones institucionales
Inversión de investigación anual $ 2.3 millones

Conferencia médica y participación del simposio

Estadísticas de compromiso de la conferencia:

  • Conferencias médicas anuales a la que asistieron: 12
  • Presentaciones entregadas: 8
  • Interacciones profesionales totales: más de 450 profesionales de la salud

Plataformas de comunicación digital

Infraestructura de comunicación digital:

Tipo de plataforma Métricas de usuario Actualización de frecuencia
Sitio web profesional 3.200 usuarios registrados Actualizaciones técnicas semanales
Red profesional de LinkedIn 1.750 profesionales conectados Insights de tecnología quincenal

Pulse Biosciences, Inc. (PLSE) - Modelo de negocios: canales

Equipo de ventas directo dirigido a profesionales médicos

A partir del cuarto trimestre de 2023, Pulse Biosciences emplea un equipo de ventas directo de 12 representantes especializados de dispositivos médicos centrados en oncología y mercados quirúrgicos.

Métrica del equipo de ventas 2024 datos
Representantes de ventas totales 12
Cobertura geográfica Estados Unidos
Especialidades médicas objetivo Oncología, cirugía

Exposiciones de la conferencia de dispositivos médicos

Pulse Biosciences participa en 6-8 conferencias médicas principales anualmente.

Tipo de conferencia Participación anual
Conferencias oncológicas 3
Conferencias de tecnología quirúrgica 3-5

Publicaciones científicas y médicas en línea

  • Publicado 4 artículos revisados ​​por pares en 2023
  • Mantenida presencia en Journal of Surgical Oncology
  • Alcance de publicación digital: aproximadamente 15,000 profesionales médicos

Plataformas de marketing digital y seminarios web

Presupuesto de marketing digital para 2024: $ 450,000

Canal digital Métricas de compromiso
Red profesional de LinkedIn 8.500 seguidores
Seminarios web mensuales 4-6 sesiones
Asistencia promedio de seminarios web 150-200 profesionales médicos

Redes de inversión de tecnología de salud

Compromiso de la red de inversión: presentado a 12 empresas de capital de riesgo de atención médica en 2023.

Métrica de red de inversión 2024 datos
Presentaciones de capital de riesgo 12
Inversión total recaudada $ 8.2 millones

Pulse Biosciences, Inc. (PLSE) - Modelo de negocios: segmentos de clientes

Cirujanos dermatológicos

Tamaño del mercado para procedimientos dermatológicos en los Estados Unidos: $ 17.3 mil millones en 2023.

Característica de segmento Punto de datos
Número total de cirujanos dermatológicos en ejercicio 5.492 profesionales
Procedimientos anuales promedio por cirujano 1,247 procedimientos

Centros de tratamiento oncológico

Número total de centros de tratamiento del cáncer en los Estados Unidos: 1.751 instalaciones.

Característica de segmento Punto de datos
Valor de mercado nacional del tratamiento del cáncer $ 208.9 mil millones
Número de especialistas en oncología 14,680 profesionales

Practicantes médicos estéticos

Mercado total de medicina estética en los Estados Unidos: $ 24.7 mil millones en 2023.

Característica de segmento Punto de datos
Número de prácticas médicas estéticas 8,245 clínicas
Ingresos anuales promedio por práctica $ 3.2 millones

Instituciones de investigación quirúrgica

Número total de instituciones de investigación quirúrgica en los Estados Unidos: 612 instalaciones.

Característica de segmento Punto de datos
Financiación anual de investigación $ 1.6 mil millones
Número de proyectos de investigación activos 4.378 proyectos

Inversores de tecnología de salud

Tecnología de la atención médica panorama de inversión en 2023.

Característica de segmento Punto de datos
Inversiones totales de capital de riesgo $ 29.1 mil millones
Número de inversores activos de tecnología de salud 1.237 inversores

Pulse Biosciences, Inc. (PLSE) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Pulse Biosciences reportó gastos de I + D de $ 24.7 millones.

Año fiscal Gastos de I + D Porcentaje de ingresos
2023 $ 24.7 millones 87.5%
2022 $ 22.3 millones 85.3%

Costos de ensayo clínico y cumplimiento regulatorio

El desarrollo clínico total y los gastos de cumplimiento regulatorio para 2023 fueron de aproximadamente $ 18.5 millones.

  • Ensayos clínicos aprobados por CMS: $ 12.3 millones
  • Preparación de presentación regulatoria: $ 3.2 millones
  • Monitoreo de cumplimiento: $ 3.0 millones

Inversiones de fabricación y producción

La infraestructura de fabricación y las inversiones relacionadas con la producción totalizaron $ 6.8 millones en 2023.

Categoría de inversión Cantidad
Equipo $ 4.2 millones
Actualizaciones de la instalación $ 1.6 millones
Tecnología de producción $ 1.0 millones

Gastos de ventas y marketing

Los costos de ventas y marketing para 2023 fueron de $ 5.4 millones.

  • Equipo de ventas directas: $ 2.7 millones
  • Campañas de marketing: $ 1.5 millones
  • Conferencia y participación de eventos: $ 1.2 millones

Protección y gestión de la propiedad intelectual

Los gastos relacionados con la propiedad intelectual en 2023 ascendieron a $ 2.1 millones.

Actividad de IP Costo
Potente y mantenimiento $ 1.4 millones
Protección legal $ 0.7 millones

Pulse Biosciences, Inc. (PLSE) - Modelo de negocios: flujos de ingresos

Licencias de tecnología de dispositivos médicos

A partir del cuarto trimestre de 2023, los ingresos por tecnología NPS de Pulse Biosciences (estimulación de nano pulso) fueron de $ 0. No se informaron acuerdos de licencia activos en los estados financieros de la Compañía.

Ventas directas de productos de tecnología NPS

Para el año fiscal 2023, Pulse Biosciences informó ingresos por productos totales de $ 2.3 millones, principalmente de las ventas de su sistema CELLFX en aplicaciones dermatológicas.

Categoría de ingresos Cantidad de 2023 ($)
Ventas del sistema CELLFX 2,300,000

Posibles acuerdos de regalías

A partir de 2024, la Compañía no ha revelado públicamente los acuerdos de regalías específicos.

Financiación de la colaboración de investigación

En 2023, Pulse Biosciences recibió $ 0 en fondos de colaboración de investigación. La compañía no ha informado importantes asociaciones de investigación externa que generen ingresos directos.

Ingresos futuros del procedimiento de tratamiento médico

Las medidas de ingresos potenciales incluyen:

  • Procedimientos dermatológicos utilizando el sistema CELLFX
  • Aplicaciones potenciales de tratamiento de oncología
  • Mercados potenciales de intervención quirúrgica
Mercado potencial Tamaño estimado del mercado
Procedimientos dermatológicos $ 15.4 mil millones para 2026
Mercado de tratamiento oncológico $ 272.1 mil millones para 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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