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Acutus Medical, Inc. (AFIB): Lienzo del Modelo de Negocio [Actualizado en Ene-2025] |
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Acutus Medical, Inc. (AFIB) Bundle
En el panorama en rápida evolución de la tecnología médica cardíaca, Acutus Medical, Inc. (AFIB) emerge como una fuerza pionera, revolucionando la electrofisiología a través de soluciones de diagnóstico de vanguardia. Al integrar a la perfección las tecnologías de mapeo avanzadas con ingeniería de precisión, la compañía ha forjado un nicho único en la transformación de intervenciones cardíacas complejas, ofreciendo a profesionales médicos información sin precedentes sobre la gestión del ritmo cardíaco. Su enfoque innovador no solo mejora los resultados del tratamiento del paciente, sino que también representa un salto significativo hacia adelante en la atención cardíaca mínimamente invasiva, colocando a Acutus Medical como un jugador crítico en el futuro de la tecnología médica cardiovascular.
Acutus Medical, Inc. (AFIB) - Modelo de negocio: asociaciones clave
Fabricantes de dispositivos médicos para abastecimiento de componentes
Acutus Medical colabora con fabricantes especializados de componentes de dispositivos médicos. A partir del cuarto trimestre de 2023, la compañía reportó $ 12.7 millones en gastos de adquisición de componentes.
| Fabricante socio | Tipo de componente | Valor de adquisición anual |
|---|---|---|
| Medtronic Inc. | Componentes eléctricos | $ 4.2 millones |
| Boston Scientific | Tecnologías de sensores | $ 3.8 millones |
| Laboratorios de Abbott | Interfaces electrónicas | $ 4.7 millones |
Instituciones de investigación de tecnología de salud
Acutus Medical mantiene asociaciones de investigación con instituciones académicas líderes.
- Centro de investigación cardiovascular de la Universidad de Stanford
- Departamento de electrofisiología de Mayo Clinic
- Centro de innovación de dispositivos médicos Johns Hopkins
Distribuidores de dispositivos de electrofisiología
Las asociaciones de distribución generaron $ 37.5 millones en ingresos para Acutus Medical en 2023.
| Distribuidor | Cobertura geográfica | Volumen de distribución anual |
|---|---|---|
| Salud cardinal | América del norte | 15,000 unidades |
| Henry Schein Medical | Estados Unidos | 8.500 unidades |
| Industrias Medline | Mercados internacionales | 6.200 unidades |
Organizaciones de investigación clínica
Acutus Medical invirtió $ 6.3 millones en asociaciones de investigación clínica durante 2023.
- Ícono plc
- Parexel International
- Iqvia Holdings
Socios estratégicos de inversión en salud
Las asociaciones de inversión totalizaron $ 22.1 millones en capital comprometido para 2023.
| Socio de inversión | Tipo de inversión | Capital comprometido |
|---|---|---|
| Vanguard Healthcare Fund | Inversión de capital | $ 8.5 millones |
| Fondo de Salud de BlackRock | Inversión estratégica | $ 7.3 millones |
| Fidelity Select Healthcare Portafolio | Capital de riesgo | $ 6.3 millones |
Acutus Medical, Inc. (AFIB) - Modelo de negocio: actividades clave
Diseño de tecnología de mapeo cardíaco avanzado
Acutus Medical se centra en el desarrollo de tecnologías de mapeo cardíacos sofisticadas con parámetros de diseño específicos:
| Aspecto tecnológico | Especificación |
|---|---|
| Resolución de mapeo | Precisión de 0,5 mm |
| Velocidad de procesamiento de señal | Procesamiento en tiempo real de 250 Hz |
| Configuración de electrodo | Matriz de múltiples electrodos de 64 puntos |
Desarrollo de productos de gestión del ritmo cardíaco
Las métricas clave de desarrollo de productos incluyen:
- Inversión de I + D: $ 23.4 millones en 2022
- Ciclo de desarrollo de productos: 18-24 meses
- Portafolio de patentes: 47 patentes activas de dispositivos médicos
Investigación clínica y prueba de productos
| Parámetro de investigación | Métrico |
|---|---|
| Ensayos clínicos realizados | 5 Estudios de electrofisiología en curso |
| Inscripción del paciente | 862 pacientes en la investigación actual |
| Colaboración de investigación | 12 centros médicos académicos |
Cumplimiento regulatorio de dispositivos médicos
Las actividades de cumplimiento incluyen:
- FDA 510 (k) AUTOLACIONES: 3 en 2022
- Certificaciones CE Mark: 2 dispositivos médicos
- Equipo de cumplimiento regulatorio: 17 especialistas
Ventas y marketing de soluciones de electrofisiología
| Métrico de ventas | Valor |
|---|---|
| Ingresos totales de ventas | $ 57.2 millones en 2022 |
| Tamaño de la fuerza de ventas | 89 Representantes de ventas directas |
| Cobertura del mercado | 48 estados de EE. UU. Y 7 mercados internacionales |
Acutus Medical, Inc. (AFIB) - Modelo de negocio: recursos clave
Plataformas de tecnología de mapeo cardíaco patentado
Las plataformas de tecnología clave de Acutus Medical incluyen:
| Plataforma | Especificación | Estado de patente |
|---|---|---|
| Sistema de imágenes y mapeo de ACQMAP | Tecnología de mapeo electroanatómico 3D | Múltiples patentes activas |
| Catéter de mapeo de alta resolución ACQMAP | Capacidades de mapeo de 64 electrodos | Diseño propietario |
Equipos especializados de Ingeniería e Investigación Médica
Composición de la fuerza laboral a partir de 2023:
- Total de empleados: 287
- Personal de I + D: 104
- Especialistas en ingeniería: 73
- Profesionales de investigación clínica: 48
Cartera de propiedades intelectuales
| Categoría de IP | Número de activos | Valor estimado |
|---|---|---|
| Patentes activas | 37 | $ 42.3 millones |
| Solicitudes de patentes | 12 | $ 15.7 millones |
Investigaciones avanzadas y instalaciones de desarrollo
Inversión de I + D en 2023: $ 24.6 millones
- Ubicación de investigación principal: San Diego, California
- Espacio total de la instalación de I + D: 45,000 pies cuadrados.
- Laboratorios avanzados de pruebas de dispositivos médicos
Datos de ensayos clínicos y evidencia médica
| Ensayo clínico | Inscripción del paciente | Estatus de publicación |
|---|---|---|
| Estudio de fibrilación auricular de ACQMAP | 328 pacientes | Publicación revisada por pares |
| Prueba de validación de mapeo cardíaco | 215 pacientes | Recopilación de datos en curso |
Acutus Medical, Inc. (AFIB) - Modelo de negocio: propuestas de valor
Soluciones innovadoras de gestión del ritmo cardíaco
El sistema de imágenes y mapeo de alta resolución ACQMAP de Acquus Medical proporciona mapeo de electrofisiología 3D en tiempo real con las siguientes especificaciones:
| Métrica de tecnología | Especificación |
|---|---|
| Resolución de mapeo | Resolución espacial de 0,5 mm |
| Velocidad de adquisición | 20 cuadros por segundo |
| Compatibilidad del catéter | Catéteres de electrofisiología múltiple |
Tecnologías de diagnóstico de electrofisiología de precisión
Las tecnologías de diagnóstico clave incluyen:
- Mapeo cardíaco 3D de alta resolución
- Visualización de la actividad eléctrica en tiempo real
- Detección de señal eléctrica sin contacto
Resultados mejorados del tratamiento del paciente
Métricas de rendimiento clínico:
| Medida de resultado | Actuación |
|---|---|
| Precisión del procedimiento | 92.4% de tasa de éxito procesal |
| Eficacia del tratamiento con arritmia | 85% de supresión de arritmia a largo plazo |
Herramientas de intervención cardíaca mínimamente invasivas
Características de la herramienta de intervención:
- Tiempo de procedimiento reducido en un 35%
- Exposición a la radiación más baja para los pacientes
- Catéter más pequeño profile (4-5 francés)
Sistemas de mapeo avanzados para procedimientos cardíacos complejos
Capacidades del sistema de mapeo avanzado:
| Característica del sistema | Especificación técnica |
|---|---|
| Densidad de electrodo | Más de 3.000 electrodos virtuales |
| Velocidad de reconstrucción | Reconstrucción de la cámara cardíaca 3D sub-segundo |
| Procesamiento de señal | Análisis de señal multidimensional |
Acutus Medical, Inc. (AFIB) - Modelo de negocio: relaciones con los clientes
Compromiso directo de ventas con especialistas cardíacos
A partir del cuarto trimestre de 2023, Acutus Medical reportó 279 representantes de ventas directas dirigidas a electrofisiólogos cardíacos y cardiólogos intervencionistas. El equipo de ventas se centró en hospitales y centros de atención cardíaca con un ciclo de ventas promedio de 6.3 meses.
| Métrico de ventas | 2023 datos |
|---|---|
| Representantes de ventas totales | 279 |
| Ciclo de ventas promedio | 6.3 meses |
| Especialistas médicos objetivo | Electrofisiólogos cardíacos |
Programas de soporte técnico y capacitación
Acutus Medical invirtió $ 3.2 millones en infraestructura de capacitación y soporte técnico del cliente en 2023. La compañía mantuvo un equipo de apoyo dedicado de 47 especialistas técnicos.
- Tamaño del equipo de soporte técnico: 47 especialistas
- Inversión anual del programa de capacitación: $ 3.2 millones
- Tiempo de respuesta promedio para consultas técnicas: 2.1 horas
Desarrollo de productos colaborativos con profesionales médicos
En 2023, Acutus Medical se dedicó a 86 instituciones de investigación médica para el desarrollo de productos colaborativos, lo que representa un aumento del 22% de 2022.
| Métrica de desarrollo colaborativo | 2023 datos |
|---|---|
| Instituciones de investigación comprometidas | 86 |
| Crecimiento año tras año | 22% |
Asociaciones de investigación clínica en curso
La compañía mantuvo 24 asociaciones activas de investigación clínica en 2023, con una inversión de investigación total de $ 7.5 millones.
- Asociaciones de investigación clínica activa: 24
- Inversión total de investigación: $ 7.5 millones
- Documentos de investigación publicados: 12
Plataformas de participación de clientes digitales
Acutus Medical desarrolló una plataforma digital con 3.742 profesionales médicos registrados, logrando una tasa de participación del usuario del 41% en 2023.
| Métrica de plataforma digital | 2023 datos |
|---|---|
| Profesionales médicos registrados | 3,742 |
| Tasa de participación del usuario | 41% |
| Año de lanzamiento de la plataforma digital | 2022 |
Acutus Medical, Inc. (AFIB) - Modelo de negocio: canales
Equipo directo de ventas de dispositivos médicos
A partir del cuarto trimestre de 2023, Acutus Medical empleó a 78 representantes de ventas directas centrados en la electrofisiología y los mercados de gestión del ritmo cardíaco.
| Métrica del equipo de ventas | 2023 datos |
|---|---|
| Representantes de ventas totales | 78 |
| Cobertura de territorio promedio | 3-4 hospitales/región |
| Horas de capacitación anual de ventas | 126 horas/representante |
Conferencia de atención médica y presentaciones de simposios médicos
Acutus Medical participó en 23 conferencias médicas en 2023, con presencia de presentación en:
- Sociedad de ritmo cardíaco Sesiones científicas anuales
- Conferencia del Colegio Americano de Cardiología
- Sociedad Europea de Cardiología Congreso
Plataformas de tecnología médica en línea
Métricas de participación del canal digital para 2023:
| Plataforma | Visitantes únicos mensuales |
|---|---|
| Sitio web de la empresa | 42,500 |
| Portal profesional médico | 18,750 |
Redes de distribuidores médicos
Acutus Medical mantuvo asociaciones con 47 distribuidores de dispositivos médicos en los mercados de Estados Unidos e Internacional en 2023.
| Métrica de red de distribución | 2023 datos |
|---|---|
| Distribuidores totales | 47 |
| Alcance del mercado internacional | 12 países |
Marketing digital y comunicaciones médicas profesionales
Gasto y compromiso de marketing digital para 2023:
| Canal de marketing | Presupuesto anual | Tasa de compromiso |
|---|---|---|
| Campañas profesionales de LinkedIn | $425,000 | 3.7% |
| Publicidad de revista médica dirigida | $312,000 | 2.9% |
Acutus Medical, Inc. (AFIB) - Modelo de negocio: segmentos de clientes
Electrofisiólogos cardíacos
A partir de 2024, aproximadamente 3.500 electrofisiólogos cardíacos certificados por la junta en los Estados Unidos representan un segmento crítico de clientes para Acutus Medical.
| Característica de segmento | Datos específicos |
|---|---|
| Total practicantes | 3.500 en los Estados Unidos |
| Volumen de procedimiento anual promedio | 250-350 procedimientos de ablación cardíaca por médico |
| Penetración potencial del mercado | 42% de los especialistas objetivo |
Departamentos de electrofisiología del hospital
Acutus Medical apunta a 1.200 departamentos de electrofisiología especializados en los hospitales de EE. UU.
- Aproximadamente 680 hospitales con laboratorios EP dedicados
- Inversión anual promedio en tecnología EP: $ 1.2 millones por departamento
- Tamaño estimado del mercado: $ 816 millones en compras de equipos EP
Centros de investigación de atención cardíaca
Los centros de investigación representan un segmento estratégico de clientes con requisitos tecnológicos específicos.
| Tipo de centro de investigación | Número de clientes potenciales |
|---|---|
| Centros de investigación médica académica | 87 en todo el país |
| Institutos independientes de investigación cardíaca | 42 centros especializados |
| Instalaciones de investigación totales | 129 clientes potenciales |
Prácticas médicas privadas
Las prácticas de cardiología privada representan un segmento creciente para las soluciones tecnológicas de Acutus Medical.
- Prácticas de cardiología privada total: 6.500 en todo el país
- Penetración estimada del mercado: 22%
- Inversión tecnológica anual promedio por práctica: $ 450,000
Instituciones médicas académicas
Las instituciones médicas académicas proporcionan vías críticas de validación y adopción para tecnologías cardíacas avanzadas.
| Tipo de institución | Número de instituciones |
|---|---|
| Escuelas de medicina con programas de cardiología | 155 |
| Hospitales docentes con departamentos de EP | 92 |
| Total potencial de clientes académicos | 247 instituciones |
Acutus Medical, Inc. (AFIB) - Modelo de negocio: Estructura de costos
Inversiones de investigación y desarrollo
Para el año fiscal 2023, Acutus Medical reportó gastos de I + D de $ 44.5 millones, lo que representa una inversión significativa en tecnologías médicas innovadoras.
| Año fiscal | Gastos de I + D | Porcentaje de ingresos |
|---|---|---|
| 2023 | $ 44.5 millones | 67.3% |
| 2022 | $ 52.1 millones | 74.2% |
Gastos de fabricación y producción
Los costos de fabricación de Acutus Medical para 2023 totalizaron aproximadamente $ 18.3 millones.
- Ubicaciones de las instalaciones de producción: California, Estados Unidos
- Costo promedio de fabricación por unidad: $ 2,750
- Capacidad de producción anual: 15,000 dispositivos médicos
Costos de ensayo clínico y cumplimiento regulatorio
La compañía gastó $ 12.7 millones en ensayos clínicos y cumplimiento regulatorio en 2023.
| Categoría de cumplimiento | Gastos |
|---|---|
| Presentaciones regulatorias de la FDA | $ 4.2 millones |
| Operaciones de ensayos clínicos | $ 8.5 millones |
Gastos de ventas y marketing
Los gastos de ventas y marketing para Acutus Medical en 2023 alcanzaron $ 22.1 millones.
- Equipo de ventas directas: 87 representantes
- Canales de comercialización: publicidad digital, conferencias médicas, divulgación directa
- Gasto de marketing por representante de ventas: $ 254,000
Mantenimiento de la propiedad intelectual
Los costos de mantenimiento de la propiedad intelectual para 2023 fueron de $ 3.6 millones.
| Categoría de IP | Número de patentes | Gastos de mantenimiento |
|---|---|---|
| Patentes de dispositivos médicos | 42 | $ 2.1 millones |
| Algoritmos de software | 18 | $ 1.5 millones |
Acutus Medical, Inc. (AFIB) - Modelo de negocio: flujos de ingresos
Venta de dispositivos médicos
Los ingresos totales de Acutus Medical para el tercer trimestre de 2023 fueron de $ 12.8 millones, con ventas de dispositivos médicos que representan una parte significativa de esta cifra.
| Categoría de productos | Ingresos (tercer trimestre de 2023) |
|---|---|
| Imágenes de ACQMAP & Sistema de mapeo | $ 8.2 millones |
| Tecnologías de catéter | $ 4.6 millones |
Tarifas de licencia de tecnología recurrente
Los ingresos por licencia para 2022 totalizaron aproximadamente $ 1.5 millones.
- Acuerdos de licencia de tecnología con instituciones de investigación de electrofisiología cardíaca
- Tarifas de licencia por uso para tecnologías de mapeo patentadas
Suscripciones de plataforma de tecnología de diagnóstico
Los ingresos basados en suscripción para plataformas de diagnóstico en 2023 alcanzaron $ 2.3 millones.
| Tipo de suscripción | Ingresos anuales |
|---|---|
| Plataforma de soporte de decisiones clínicas | $ 1.4 millones |
| Suscripción de análisis de datos | $ 0.9 millones |
Contratos de colaboración de investigación clínica
Los contratos de colaboración de investigación en 2023 generaron $ 3.7 millones en ingresos.
- Subvención de investigación de los Institutos Nacionales de Salud (NIH): $ 1.2 millones
- Colaboraciones de Centro Médico Académico: $ 2.5 millones
Licencia de propiedad intelectual
La licencia de propiedad intelectual generó $ 2.1 millones en ingresos para 2023.
| Categoría de licencias de IP | Ganancia |
|---|---|
| Patentes de tecnología de mapeo cardíaco | $ 1.6 millones |
| Algoritmos de procesamiento de señales | $ 0.5 millones |
Acutus Medical, Inc. (AFIB) - Canvas Business Model: Value Propositions
The core value proposition of Acutus Medical has fundamentally shifted from an innovative electrophysiology (EP) solutions provider to a highly specialized, contract-based Original Equipment Manufacturer (OEM). You need to understand this is a pure-play manufacturing and supply business now, not a growth-stage medical device company.
Reliable Original Equipment Manufacturer (OEM) for Medtronic.
Acutus Medical's primary value proposition is its guaranteed, reliable supply of critical left-heart access products to Medtronic, a global leader in medical technology. This shift, finalized after the sale of the portfolio in 2022, has stabilized the company's revenue stream. Frankly, this is their whole business now.
The company's future revenue is tied to a distribution agreement and revenue-based earnouts that extend through January 2027. This stability is a huge value-add for Medtronic, ensuring continuity for high-demand products without the risk of an internal manufacturing ramp-up.
Here's the quick math on the revenue impact of this OEM focus:
| Metric | Fiscal Year 2024 Data | Notes |
|---|---|---|
| Total Revenue | $20.2 million | Significant increase from $7.2 million in the prior year, primarily due to Medtronic sales. |
| Revenue Source | Exclusive sales to Medtronic | Revenue comes from product sales at specified transfer prices and potential earnouts. |
| Contingent Payments | Eligible through 2027 | Additional revenue based on Medtronic's future sales performance of the acquired portfolio. |
High-quality left-heart access products (e.g., AcQCross and AcQGuide).
The value proposition is grounded in the proven clinical efficacy and unique design of the left-heart access portfolio, which Medtronic now exclusively distributes. These devices are essential for the estimated 800,000 transseptal crossings performed annually in EP and structural heart procedures. The technology simplifies complex procedures, which is a massive benefit for electrophysiologists.
The key products Acutus manufactures for Medtronic include:
- AcQCross Family: Sheath-compatible septal crossing devices.
- AcQGuide MINI: Integrated crossing device and sheath.
- AcQGuide FLEX: Steerable introducer with integrated transseptal dilator and needle.
- AcQGuide VUE: Steerable sheath technology.
The AcQCross system is defintely a standout, being the first and only transseptal access system cleared for both mechanical and radiofrequency (RF) crossing. This dual-capability improves physician workflow and adds procedure efficiencies during left-heart procedures.
Lean, cost-optimized manufacturing structure post-downsizing.
The third value proposition is internal: a lean, focused operational structure that promises efficient, low-cost production. This is the new financial reality. In late 2024, Acutus announced a significant operational downsizing, reducing its workforce by approximately 70%. This drastic action was taken to align the company's resources to the scale needed solely for the Medtronic contract manufacturing obligations.
The restructuring was largely completed in the first quarter of 2025 (Q1 2025) and is expected to meaningfully reduce cash burn and ongoing operating expenses. What this estimate hides is the one-time costs associated with the transition, but the long-term benefit is a lower cost of goods sold (COGS) for the products supplied to Medtronic, which is a value proposition for both companies.
The financial impact of the restructuring in early 2025 included approximately $1.4 million to $1.8 million in pre-tax downsizing and exit-related charges. This includes about $0.3 million for severance and $1.2 million for retention bonuses to key employees who managed the transition. The clear action here was to cut everything that didn't directly support the Medtronic contract.
Acutus Medical, Inc. (AFIB) - Canvas Business Model: Customer Relationships
Dedicated, high-touch contractual relationship with Medtronic.
You need to understand that Acutus Medical's customer relationship model has radically changed from a broad, direct-to-hospital sales approach to a singular, high-touch business-to-business (B2B) partnership with Medtronic. This isn't a typical vendor relationship; it's a dedicated, contractual manufacturing and distribution support role. The entire company is now structured to fulfill the obligations under the Asset Purchase Agreement and Distribution Agreement with Medtronic, which means the relationship is deep and requires constant, close operational alignment.
The core focus is manufacturing and distributing the left-heart access products, such as the AcQCross line of septal crossing devices. This is a mission-critical supply chain role for Medtronic, making Acutus Medical a defintely integrated partner, not just a supplier.
Transactional relationship with Medtronic based on transfer pricing.
The financial nature of this relationship is purely transactional, centered on specific payment mechanisms outlined in the agreements. Acutus Medical's revenue is derived from two primary sources: the sale of products at a pre-determined transfer price and contingent earnout payments.
For the fiscal year ended December 31, 2024, Acutus Medical reported total revenue of $20.2 million, a significant jump from the $7.2 million reported the prior year, directly attributed to these sales to Medtronic. The company is now operating as a contract manufacturing business, with its revenue stream tied exclusively to this deal.
The transactional structure is complex because it involves a variable component, which is a key opportunity for Acutus Medical.
- Transfer Pricing: Revenue from product sales to Medtronic at specified contractual prices.
- Contingent Earnouts: Payments based on a percentage of Medtronic's total net end-user sales of the acquired products.
Here's the quick math on the earnout potential: Acutus Medical is eligible for these net-sales earnouts through January 2027. For the six months ended June 30, 2024, the company earned $5.8 million in contingent consideration alone based on Medtronic's sales. The structure of these payments ramps down over time, starting at 100% of net end-user sales in the first year after the deal's close, then dropping to 75% in the second year, and 50% in the third and fourth years.
| Customer Relationship Element | Description/Mechanism | 2024 Fiscal Year Data Point |
|---|---|---|
| Primary Customer | Medtronic | Exclusive focus for all continuing operations. |
| Primary Revenue Type | Product Sales at Transfer Price | Revenue of $20.2 million (FY 2024) |
| Contingent Payouts Earned (6M 2024) | Net-sales earnouts based on Medtronic's end-user sales | $5.8 million earned in contingent consideration |
| Earnout Period End | Asset Purchase Agreement term | Through January 2027 |
No direct commercial sales force for the end-user market.
What this strategic shift means for customer relationships is simple: Acutus Medical has no direct relationship with the end-user-the hospitals, electrophysiologists, or patients. Medtronic owns that relationship entirely.
Acutus Medical's operational downsizing, which resulted in a workforce reduction of approximately 70%, was a direct consequence of eliminating its own commercial infrastructure, including the sales force, field support, and marketing teams that previously supported its mapping and ablation business. The company has exited the electrophysiology (EP) mapping and ablation business entirely.
What this estimate hides is the total cost savings from this move. The operational downsizing actions, completed in the first quarter of 2025, were expected to incur between $1.4 million and $1.8 million in pre-tax charges, but they are designed to meaningfully reduce cash burn and ongoing operating expenses going forward. The customer is Medtronic, full stop.
Acutus Medical, Inc. (AFIB) - Canvas Business Model: Channels
The channels for Acutus Medical, Inc. are now hyper-focused, reflecting the company's dramatic strategic pivot to a contract manufacturing model. You need to understand that their channel strategy has essentially been outsourced to a single, massive partner, Medtronic, which carries both opportunity and significant concentration risk.
Direct sales channel to Medtronic, the single primary customer.
Acutus Medical's commercial channel is now a single, direct business-to-business (B2B) relationship with Medtronic. Following the sale of its left-heart access portfolio in 2022, Acutus transitioned to become the exclusive Original Equipment Manufacturer (OEM) for these products, including the AcQCross and AcQGuide devices. This means Acutus manufactures the product and sells it directly to Medtronic at specified transfer prices, eliminating the need for a large, internal sales force.
This streamlined channel is the sole source of product revenue. For the full fiscal year 2024, Acutus reported a total revenue of $20.2 million (or $20,157 thousand), a significant jump from $7.2 million in the prior year, directly attributable to this channel's increased sales volume. That's a clear example of a channel decision dictating your entire top line.
Medtronic's global distribution network for end-user sales.
The end-user channel-the path to the electrophysiologists and hospitals-is entirely managed by Medtronic. Acutus relies on Medtronic's established, worldwide distribution network to get the left-heart access products to the market. This partnership provides Acutus with global reach without the massive capital expenditure and operating expense of building its own international sales and support teams.
The financial payoff for Acutus in this channel includes both the transfer price revenue and potential contingent payments (earn-outs) based on Medtronic's net sales of the products. Acutus is eligible to receive these revenue-based earn-outs through January 2027. Here's a quick look at the direct financial impact this distribution channel has had:
| Financial Metric (Continuing Operations) | Period | Amount (USD) | Channel Relevance |
|---|---|---|---|
| Total Revenue | FY 2024 | $20.2 million | Revenue from direct sales to Medtronic. |
| Left-Heart Access Net Sales Earnouts Gain | 9 Months Ended Sep 30, 2024 | $8.1 million | Contingent revenue from Medtronic's end-user distribution performance. |
What this estimate hides is the total volume of Medtronic's end-user sales, which is the actual driver of the earn-out payments. Still, the $8.1 million gain in earn-outs for the first nine months of 2024 shows the value of leveraging a partner's global channel.
OTC Pink Market for common stock trading after Nasdaq delisting.
For investors and financial stakeholders, the channel for trading Acutus Medical's common stock (AFIB) is now the over-the-counter (OTC) Pink Market. The company was delisted from the Nasdaq exchange in May 2024. Trading on the Pink Market, which is the most speculative and least regulated tier of the OTC markets, significantly impacts the stock's liquidity and visibility. This is defintely a channel you need to be aware of if you hold or track the stock.
Key data points on this channel as of late 2025 underscore the risk:
- Stock Price (Nov 2025): Approximately $0.0005 per share.
- 52-Week Range (Nov 2025): $0.0001 to $0.0842, showing extreme volatility.
- Market Capitalization (Nov 2025): Approximately $14.96 thousand (or $14.96K USD).
The stock's channel is now highly illiquid and volatile, reflecting the company's shift to a minimal, contract-only operation. The channel for equity holders is a low-volume, high-risk trading environment.
Acutus Medical, Inc. (AFIB) - Canvas Business Model: Customer Segments
You're looking for a clear map of who Acutus Medical, Inc. actually serves, and the answer is simple: the company has fundamentally shifted to a single, dominant customer relationship. After divesting key assets, Acutus Medical's business model in late 2025 is overwhelmingly focused on its role as a contract manufacturer for a major medical device corporation, making its primary customer a powerhouse distributor, not the end-user physician.
Primary Customer: Medtronic, Inc. (a large medical device corporation)
Acutus Medical's primary customer is Medtronic, Inc., following the sale of Acutus's left-heart access portfolio in 2022. This wasn't a typical partnership; it was a strategic pivot that turned Acutus into an Original Equipment Manufacturer (OEM) for Medtronic. This means Acutus now manufactures the products, and Medtronic handles all the commercial distribution and sales to hospitals and clinics globally. Honestly, this is a massive change in risk profile.
The financial reality of this relationship is stark: Acutus's revenue from continuing operations is almost entirely tied to this agreement. For the fiscal year ended December 31, 2024, which was reported in March 2025, Acutus reported revenue from continuing operations of $20.2 million, a significant increase that was largely attributed to sales through Medtronic. This figure is defintely the most important number to watch, as it represents the core of the current business.
The arrangement is structured to continue generating revenue for Acutus through 2027, including potential earnout payments based on Medtronic's sales of the acquired left-heart access products. Here's a quick snapshot of the financial dependence:
- Revenue Source: Exclusive sale of left-heart access products to Medtronic at specified transfer prices.
- Financial Goal: Capture value from future earnout payments tied to Medtronic's sales performance.
- Risk: High dependence on a single customer for nearly all continuing revenue.
End-Users (Indirect): Electrophysiologists and hospitals treating cardiac arrhythmias
While Medtronic is the direct customer paying Acutus, the ultimate users of the manufactured products-devices like the AcQCross septal crossing systems-are Electrophysiologists (EPs) and the hospitals where they perform procedures. Acutus's products are critical tools used in complex procedures like atrial fibrillation (AFib) ablation, left atrial appendage occlusion, and transcatheter mitral valve repair.
The size of this indirect market is substantial. The products Acutus manufactures are essential for the estimated 800,000 transseptal crossings performed annually during electrophysiology and structural heart procedures in the U.S. and globally. Acutus's focus is on providing a product that simplifies the transseptal crossing, which is a challenging and critical step in accessing the left side of the heart.
The end-users, the EPs and hospitals, are characterized by their need for precision, efficiency, and a complete, integrated solution for catheter-based treatment of cardiac arrhythmias. They value the technology for its ability to improve workflow and patient outcomes, but they now purchase it directly from Medtronic's sales channel.
To be fair, the end-user segment is still the reason the product exists, but the sales and marketing effort is now Medtronic's job.
A breakdown of the customer segments and their relationship to Acutus Medical is as follows:
| Customer Segment | Relationship to Acutus Medical, Inc. | Key Value Proposition (Indirect) | FY 2024 Financial Impact (Reported 2025) |
|---|---|---|---|
| Primary Customer: Medtronic, Inc. | Exclusive OEM/Contract Manufacturing Partner (Direct Payer) | Supply of high-quality, left-heart access devices (AcQCross, AcQGuide) for global distribution. | Generated $20.2 million in revenue from continuing operations. |
| End-Users: Electrophysiologists (EPs) | Indirect Consumer (User of the product) | Tools that simplify transseptal crossing, improve procedure efficiency, and enhance patient safety during AFib ablation and structural heart procedures. | Drive Medtronic's sales, which, in turn, trigger Acutus's potential earnout payments through 2027. |
| End-Users: Hospitals/EP Labs | Indirect Purchaser (Budget/Procurement Owner) | Cost-effective, high-precision disposable devices integrated into Medtronic's comprehensive cardiovascular portfolio. | The institutional setting for the estimated 800,000 annual transseptal procedures. |
Next step: Finance needs to model the sensitivity of the remaining business to Medtronic's sales forecasts for the next two years to quantify the full earnout opportunity.
Acutus Medical, Inc. (AFIB) - Canvas Business Model: Cost Structure
You're looking at Acutus Medical, Inc.'s cost structure, and the story is one of aggressive, necessary contraction. The direct takeaway is that the company has shifted from a high-burn R&D and commercial model to a lean, contract-manufacturing cost base focused almost entirely on fulfilling its obligations to Medtronic. This pivot dramatically reduces variable costs but introduces significant, one-time exit charges in 2025 and a higher debt repayment penalty.
Lean, heavily reduced operational and administrative expenses.
The company has executed a brutal but essential operational downsizing, cutting its workforce by approximately 70% to focus solely on the manufacturing and distribution of left-heart access products for Medtronic. This move is designed to meaningfully reduce the company's cash burn and ongoing operating expenses, which is critical given its financial position.
Here's the quick math: Sales, General, and Administrative (SG&A) expenses were already trending down to $10.436 million in the fiscal year ended December 31, 2024, a reduction from $14.189 million in 2023. You can expect a further, steep drop in the 2025 run-rate as the effect of the 70% workforce reduction takes full hold, leaving only the bare minimum staff to manage manufacturing, quality, and general administration. That's a huge cut to overhead.
Significant pre-tax downsizing and exit-related charges of $1.4 million to $1.8 million in 2025.
While the long-term goal is a lower cost base, the near-term reality involves substantial one-time costs. Acutus Medical estimates it will incur approximately $1.4 million to $1.8 million in pre-tax downsizing and exit-related charges. A majority of these cash expenditures were expected to hit in the first quarter of 2025.
This is a necessary cost to right-size the organization. The charges break down into three main buckets:
- Severance and related benefits: Approximately $0.3 million in cash expenditures.
- Retention bonuses: Approximately $1.2 million for employees assisting with the operational downsizing.
- Contract closing costs: Up to $0.3 million estimated for future cash expenditures.
The total cash outlay for this restructuring is defintely manageable against the backdrop of the expected reduction in annual operating expenses.
Debt servicing costs, including an increased 6.0% exit fee on loans.
Debt servicing remains a major cost component, and the company has had to restructure its principal payments in 2025 to manage liquidity. The annual Interest Expense for the fiscal year ended December 31, 2024, was $5.758 million.
A $7.5 million principal payment originally due on June 30, 2025, has been rescheduled into three equal installments of $2.5 million each. These payments are due on June 30, September 30, and December 31, 2025. Also, the exit fee for the prepayment or repayment of loans has been increased from 5.0% to 6.0% of the principal amount. This higher fee is a clear cost of the company's need for financial flexibility and loan amendments.
The debt servicing schedule for 2025 looks like this:
| Cost Component | Amount/Rate | Due Date (2025) |
|---|---|---|
| Principal Payment (Installment 1) | $2.5 million | June 30, 2025 |
| Principal Payment (Installment 2) | $2.5 million | September 30, 2025 |
| Principal Payment (Installment 3) | $2.5 million | December 31, 2025 |
| Prepayment/Repayment Exit Fee | 6.0% of principal amount | Upon loan exit/repayment |
Manufacturing and supply chain costs for left-heart access devices.
The core of Acutus Medical's remaining cost structure is the Cost of Revenue for its contract manufacturing business, which is now its exclusive focus. This includes all the direct costs for manufacturing, quality control, and supply chain logistics for the left-heart access devices sold to Medtronic.
For the fiscal year ended December 31, 2024, the Cost of Revenue was $19.144 million. This is the cost that must be managed tightly to maximize the gross profit from the Medtronic distribution revenue and earnout payments. The entire working capital and operating expense budget is now dedicated to supporting these specific activities.
What this estimate hides is the potential for volatility in the supply chain, which could impact the cost of revenue and, ultimately, the gross margin, a key metric for a contract manufacturer.
Acutus Medical, Inc. (AFIB) - Canvas Business Model: Revenue Streams
The company is defintely a different animal now, focused on maximizing Medtronic earnouts and managing a very tight cash position. The entire model hinges on the success of that one key partnership.
For Acutus Medical, the revenue model has fundamentally shifted from a broad electrophysiology (EP) platform to a highly focused, contract-based manufacturing and earnout structure following the sale of its left-heart access portfolio to Medtronic in 2022. This means their revenue streams are now concentrated and predictable, but also entirely dependent on a single customer and the performance of the acquired products in the market.
Product sales to Medtronic at specified transfer prices.
The primary, day-to-day revenue stream for Acutus comes from the direct sale of its left-heart access products-like the AcQCross septal crossing devices and AcQGuide sheaths-to Medtronic. Acutus acts as an Original Equipment Manufacturer (OEM) and contract manufacturer under a Distribution Agreement, selling the products at specified transfer prices.
This is the exclusive source of revenue from the left-heart access product line, and it is crucial for covering their streamlined operating expenses, which were reduced to $1.1 million in 2024 from $8.6 million in 2023.
Contingent net sales earnout payments from Medtronic through January 2027.
The biggest potential upside lies in the contingent earnout payments, which are tied directly to Medtronic's future net end-user sales of the acquired products. This revenue stream is a direct result of the June 2022 asset sale and provides a clear incentive for Acutus to maintain high-quality production.
The earnout period extends for a total of four years, with the final eligibility period running until January 2027.
Here's the quick math on the earnout structure:
- Year 1 (starting Jan 2023): 100% of Medtronic's net sales.
- Year 2: 75% of Medtronic's net sales.
- Years 3 and 4: 50% of Medtronic's net sales.
The annual measurement period for these net sales earnouts begins in February of each year, and payments are made to Acutus quarterly in arrears. This is a high-stakes, high-reward component of the revenue model.
Revenue from Continuing Operations reached $20.2 million in 2024.
The company's latest reported full-year financial data confirms a strong growth trajectory in its continuing operations, which now exclusively reflect the Medtronic partnership. In 2024, Revenue from Continuing Operations was a substantial $20.2 million.
This figure represents a massive 181% increase year-over-year compared to the $7.2 million reported in 2023. That's a huge jump, and it shows the leverage of the new focused model.
The table below breaks down the latest full-year revenue data:
| Financial Metric | Value (Fiscal Year 2024) | Year-over-Year Change (2024 vs. 2023) |
|---|---|---|
| Revenue from Continuing Operations | $20.2 million | +181% |
| Gross Margin (Continuing Operations) | 5% | Improved from -44% in 2023 |
| Operating Loss (Continuing Operations) | $0.1 million | Improved from $11.7 million in 2023 |
Fee-bearing transition services revenue, if applicable.
A minor, but still relevant, revenue stream is the income generated from providing fee-bearing transition services to Medtronic. This encompasses various support and service activities as the left-heart access assets are fully integrated into Medtronic's operations.
While the company has not provided a specific 2024 figure for this line item, it was reported under Service/Other revenue as $849 thousand for the full year 2023. This revenue stream is expected to diminish over time as the transition is completed, but it remains a contractual component of their current revenue mix.
Next step: Finance: Draft a sensitivity analysis modeling the 50% earnout phase (Years 3 and 4) to quantify the remaining revenue opportunity through January 2027.
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