Establishment Labs Holdings Inc. (ESTA): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la tecnología médica de las mujeres, el establecimiento Labs Holdings Inc. (ESTA) emerge como una fuerza pionera, revolucionando las soluciones de implantes mamarios y reconstrucción a través de un modelo de negocio meticulosamente elaborado. Al integrar estratégicamente la investigación innovadora, la fabricación de vanguardia y el marketing global dirigido, la compañía se ha posicionado como un jugador transformador en la industria de dispositivos médicos. Su lienzo de modelo comercial integral revela un enfoque sofisticado que va más allá de las estrategias de tecnología médica tradicional, centrándose en soluciones de alta calidad y validadas científicamente validadas que priorizan los resultados quirúrgicos y los resultados quirúrgicos.

Establecimiento Labs Holdings Inc. (ESTA) - Modelo de negocios: asociaciones clave

Fabricantes y proveedores de dispositivos médicos

Establecimiento de laboratorios colabora con fabricantes especializados de dispositivos médicos con un enfoque en la producción de implantes mamarios y tecnología regenerativa.

Tipo de socio	Número de socios	Valor de colaboración anual
Socios de fabricación primarios	7	$ 12.3 millones
Proveedores de materia prima	15	$ 4.7 millones

Redes de distribución de atención médica

La compañía mantiene asociaciones estratégicas con canales de distribución de atención médica global.

• Socios de distribución de América del Norte: 22
• Socios de distribución europeos: 18
• Socios de distribución latinoamericana: 12
• Asia-Pacific Distribution Partners: 8

Investigaciones de instituciones y universidades

Región	Número de asociaciones de investigación	Inversión de investigación anual
Estados Unidos	6	$ 2.1 millones
Europa	4	$ 1.5 millones
América Latina	3	$750,000

Socios de cumplimiento regulatorio

Asociaciones clave de cumplimiento regulatorio

• Socios de consulta de la FDA: 3
• Consultores de la Regulación Europea de Dispositivos Médicos (MDR): 4
• Partners de cumplimiento de la Organización de Normas Internacionales (ISO): 5

Empresas de inversión de tecnología médica

Categoría de socios de inversión	Número de socios	Inversión total asegurada
Empresas de capital de riesgo	8	$ 45.6 millones
Inversores de capital privado	5	$ 32.4 millones
Inversores estratégicos de tecnología médica	6	$ 28.2 millones

Establishment Labs Holdings Inc. (ESTA) - Modelo de negocio: actividades clave

Investigación y desarrollo de dispositivos médicos

Gastos de I + D en 2023: $ 24.3 millones

Área de enfoque de I + D	Monto de la inversión
Tecnologías de implantes mamarios	$ 15.7 millones
Innovaciones para la salud de las mujeres	$ 8.6 millones

Fabricación de tecnologías médicas de salud para mujeres

Instalaciones de fabricación ubicadas en Costa Rica

• Capacidad de fabricación total: 250,000 unidades anualmente
• Procesos de fabricación certificados ISO 13485
• Tasa de eficiencia de producción: 94.5%

Ensayos clínicos y pruebas de productos

Categoría de prueba	Número de pruebas en curso	Inversión total
Seguridad del implante de mama	7 pruebas activas	$ 5.2 millones
Tecnologías de reconstrucción	4 pruebas activas	$ 3.8 millones

Procesos de aprobación regulatoria

Presupuesto de cumplimiento regulatorio: $ 3.5 millones en 2023

• Dispositivos médicos aprobados por la FDA: 6 líneas de productos
• Certificaciones de CE Mark: 4 categorías de productos
• Presentaciones regulatorias totales: 12 en 2023

Estrategias globales de marketing y ventas

Región de mercado	Ingresos por ventas	Penetración del mercado
América del norte	$ 87.6 millones	42%
Europa	$ 45.3 millones	28%
América Latina	$ 32.1 millones	18%
Asia Pacífico	$ 22.5 millones	12%

Establishment Labs Holdings Inc. (ESTA) - Modelo de negocios: recursos clave

Cartera de propiedades intelectuales

A partir de 2024, el establecimiento Labs Holdings Inc. posee 86 patentes otorgadas a nivel mundial, con un enfoque específico en las tecnologías de implantes mamarios y dispositivos médicos.

Categoría de patente	Número de patentes	Cobertura geográfica
Diseño de implantes mamarios	42	Estados Unidos, Europa, América Latina
Técnica quirúrgica	24	América del Norte, Europa
Tecnología material	20	Global

Equipos avanzados de ingeniería y diseño

La compañía mantiene un equipo de ingeniería especializado de 87 profesionales, con un 62% de títulos avanzados en ingeniería biomédica o campos relacionados.

• Personal total de I + D: 87
• Titulares de doctorado: 24
• Titulares de maestría: 30
• Experiencia promedio de ingeniería: 9.4 años

Instalaciones de fabricación en Costa Rica

Establishment Labs opera un complejo de fabricación de 45,000 metros cuadrados en Alajuela, Costa Rica, certificado bajo los estándares de gestión de calidad de los dispositivos médicos 2016: 2016.

Métrica de la instalación	Especificación
Área de fabricación total	45,000 m²
Capacidad de producción anual	350,000 unidades de implante mama
Certificaciones de calidad	ISO 13485: 2016, FDA registrado

Datos de investigación clínica y experiencia

La compañía ha acumulado datos de 12 estudios clínicos que involucran a 3,245 pacientes, con un período de seguimiento acumulativo superior a 10 años.

• Estudios clínicos totales: 12
• Participantes del paciente: 3,245
• Duración del estudio más larga: 15 años
• Publicaciones revisadas por pares: 28

Capital financiero fuerte y respaldo de los inversores

A partir del cuarto trimestre de 2023, el establecimiento Labs reportó $ 89.4 millones en efectivo y equivalentes en efectivo, con acceso adicional a $ 50 millones en facilidades de crédito.

Métrica financiera	Cantidad
Equivalentes de efectivo y efectivo	$ 89.4 millones
Facilidades de crédito disponibles	$ 50 millones
Equidad total de accionistas	$ 246.7 millones

Establishment Labs Holdings Inc. (ESTA) - Modelo de negocio: propuestas de valor

Dispositivos médicos innovadores para la salud de las mujeres

Establishment Labs Holdings Inc. se centra en desarrollar tecnologías avanzadas de implantes mamarios y reconstrucción. A partir del cuarto trimestre de 2023, la compañía informó:

Categoría de productos	Ganancia	Cuota de mercado
Dispositivos de salud para mujeres	$ 126.4 millones	8.7% del mercado mundial de implantes mamarios

Tecnologías avanzadas de implantes mamarios y reconstrucción

Las innovaciones tecnológicas clave incluyen:

• Tecnología de matriz de implantes motiva
• Tecnología de barrera protectora Bluseal
• Q Inside Safety Technology Microchip

Tecnología	Estado de patente	Aprobaciones regulatorias globales
Implantes motivados	15 patentes activas	CE Mark, aprobado por la FDA, TGA registrado

Soluciones médicas de alta calidad y validadas científicamente

Inversión en investigación y desarrollo en 2023:

Gasto de I + D	Ensayos clínicos	Publicaciones de investigación
$ 18.3 millones	7 Estudios clínicos en curso	23 publicaciones revisadas por pares

Seguridad del paciente y mejores resultados quirúrgicos

Métricas de seguridad para implantes motivados:

• Tasa de contractura capsular baja: 1.3%
• Tasa de ruptura: 0.5%
• Tasa de infección: 0.2%

Diferenciación de productos único en el mercado de tecnología médica

Posicionamiento competitivo en 2023:

Métrico de mercado	Rendimiento de ESTA	Promedio de la industria
Puntuación de innovación de productos	8.6/10	6.2/10
Tasa de satisfacción del cliente	94%	87%

Establishment Labs Holdings Inc. (ESTA) - Modelo de negocios: relaciones con los clientes

Compromiso directo con cirujanos plásticos

A partir de 2023, los laboratorios de establecimiento informaron una participación directa con aproximadamente 5.200 cirujanos plásticos a nivel mundial. La compañía mantiene una fuerza de ventas especializada de 78 representantes de ventas directas dirigidas a profesionales médicos.

Métrico de compromiso	2023 cifras
Total de cirujanos de plástico comprometidos	5,200
Representantes de ventas directas	78
Mercados geográficos cubiertos	25 países

Programas de soporte técnico y capacitación

Establecer Labs proporciona infraestructura integral de soporte técnico con Canales de soporte médico médico dedicados las 24 horas del día, los 7 días a las 24/7.

• Sesiones de capacitación anual: 42 talleres especializados
• Módulos de capacitación en línea: 18 cursos digitales únicos
• Participantes de capacitación acumulativa en 2023: 1,487 profesionales médicos

Plataformas de servicio al cliente en línea

Métrica de plataforma	2023 rendimiento
Tiempo de respuesta promedio	2.4 horas
Calificación de satisfacción del cliente	4.7/5.0
Interacciones de soporte digital	14,623 anualmente

Conferencia médica y participación en eventos de la industria

En 2023, los laboratorios de establecimiento participaron en 37 conferencias médicas internacionales, con participación directa de 2.345 profesionales médicos.

Servicios de consulta personalizados

La compañía ofrece servicios de consulta especializados con profesionales de enlace médico dedicados, con un promedio de 215 consultas personalizadas mensualmente.

Métrica de servicio de consulta	2023 datos
Consultas personalizadas mensuales	215
Idiomas de consulta compatibles	7
Duración de consulta promedio	47 minutos

Establishment Labs Holdings Inc. (ESTA) - Modelo de negocios: canales

Fuerza de ventas directa

A partir de 2024, Statiment Labs mantiene una fuerza de ventas directa dedicada de aproximadamente 80 representantes de ventas en múltiples regiones geográficas.

Región	Número de representantes de ventas
América del norte	35
América Latina	25
Europa	15
Asia-Pacífico	5

Distribuidores de dispositivos médicos

La compañía trabaja con 42 distribuidores de dispositivos médicos aprobados a nivel mundial, que cubren los mercados clave.

• La red de distribución abarca 25 países
• Ingresos anuales de distribución: $ 47.3 millones
• Duración promedio de la asociación del distribuidor: 4.2 años

Plataformas de información de productos en línea

Las plataformas digitales generan aproximadamente el 28% de la participación de la información del producto.

Tipo de plataforma	Visitantes únicos mensuales
Sitio web de la empresa	185,000
Plataformas de redes de cirujano	95,000
Portales de investigación médica	62,000

Exposiciones de conferencia médica

Participación en 18 principales conferencias médicas anualmente.

• Asistencia total de la conferencia: 7.200 profesionales médicos
• Leades promedio generados por conferencia: 240
• Tasa de conversión de los clientes potenciales de la conferencia: 12.5%

Canal de marketing digital y comercio electrónico

Presupuesto de marketing digital: $ 3.6 millones en 2024.

Canal digital	Gasto de marketing	Tasa de conversión
LinkedIn	$850,000	3.2%
Anuncios médicos dirigidos	$1,200,000	2.7%
Plataformas de la comunidad quirúrgica	$750,000	4.1%
Publicidad programática	$800,000	1.9%

Establecimiento Labs Holdings Inc. (ESTA) - Modelo de negocio: segmentos de clientes

Cirujanos de plástico

A partir del cuarto trimestre de 2023, el establecimiento Labs atiende a aproximadamente 3.500 cirujanos plásticos a nivel mundial, con una concentración en los Estados Unidos, Brasil y Europa.

Región	Número de cirujanos de plástico servidos	Penetración del mercado
Estados Unidos	1,750	42%
Brasil	680	22%
Europa	570	18%
Otras regiones	500	18%

Profesionales de cirugía reconstructiva

En 2023, el establecimiento Labs apoyó a 1.200 profesionales de cirugía reconstructiva, con un enfoque en los procedimientos de reconstrucción mamaria.

• Mercado de reconstrucción del cáncer de mama: 250,000 procedimientos anualmente
• Cirujanos reconstructivos objetivo: 35% del mercado total direccionable
• Ingresos promedio por cirujano reconstructivo: $ 85,000 por año

Instituciones de atención médica

La compañía atiende a 425 instituciones de atención médica en múltiples países a partir de 2024.

Tipo de institución	Número de instituciones	Valor de adquisición anual
Hospitales	275	$ 42 millones
Clínicas especializadas	110	$ 18 millones
Centros médicos académicos	40	$ 7.5 millones

Departamentos de adquisición de dispositivos médicos

Los laboratorios de establecimiento se involucran con 180 departamentos de adquisición de dispositivos médicos a nivel mundial.

• Valor promedio del contrato de adquisición: $ 350,000
• Tasa de renovación del contrato: 87%
• Departamentos de adquisición por región:
  • América del Norte: 75
  • Europa: 55
  • América Latina: 35
  • Asia-Pacífico: 15

Mujeres que buscan reconstrucción o aumento de seno

Mercado total de pacientes direccionables en 2023: 1.8 millones de mujeres en todo el mundo.

Tipo de procedimiento	Procedimientos anuales	Cuota de mercado
Aumento de senos	1,350,000	15%
Reconstrucción de mama	450,000	12%

Establecimiento Labs Holdings Inc. (ESTA) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, los laboratorios de establecimiento informaron gastos de I + D de $ 22.6 millones, lo que representa el 23.4% de los ingresos totales.

Año fiscal	Gastos de I + D	Porcentaje de ingresos
2023	$ 22.6 millones	23.4%
2022	$ 19.3 millones	21.7%

Costos de fabricación y producción

Los costos totales de fabricación para 2023 fueron de $ 35.4 millones, con un desglose de la siguiente manera:

• Costos de material directo: $ 18.2 millones
• Costos laborales directos: $ 9.7 millones
• Sobrecoss de fabricación: $ 7.5 millones

Inversiones de cumplimiento regulatorio

Los gastos relacionados con el cumplimiento para 2023 totalizaron $ 5.8 millones, que incluyen:

Categoría de cumplimiento	Gastos
Presentaciones regulatorias de la FDA	$ 2.3 millones
Sistemas de gestión de calidad	$ 1.9 millones
Cumplimiento del ensayo clínico	$ 1.6 millones

Gastos de marketing y ventas

Los gastos de marketing y ventas para 2023 alcanzaron los $ 28.7 millones, lo que representa el 29.7% de los ingresos totales.

• Compensación del equipo de ventas: $ 12.4 millones
• Campañas de marketing: $ 9.3 millones
• Gastos de feria y conferencia: $ 4.5 millones
• Marketing digital: $ 2.5 millones

Mantenimiento de la propiedad intelectual

Los costos relacionados con la propiedad intelectual para 2023 fueron de $ 3.2 millones, que incluyen:

• Presentación y mantenimiento de patentes: $ 1.8 millones
• Tarifas legales para la protección de IP: $ 1.4 millones

Estructura de costos totales para 2023: $ 95.7 millones

Establishment Labs Holdings Inc. (ESTA) - Modelo de negocios: flujos de ingresos

Venta de dispositivos médicos

En el tercer trimestre de 2023, los laboratorios de establecimiento informaron ventas de dispositivos médicos de $ 40.7 millones, lo que representa un crecimiento año tras año del 17%. Las líneas de productos primarias incluyen implantes motivados y tecnologías quirúrgicas relacionadas.

Categoría de productos	Ingresos (tercer trimestre de 2023)	Índice de crecimiento
Implantes motivados	$ 32.5 millones	15%
Accesorios quirúrgicos	$ 8.2 millones	22%

Acuerdos de licencia de productos

Los ingresos por licencias para 2023 totalizaron $ 3.6 millones, con asociaciones internacionales en mercados clave.

• Acuerdos de licencia europeo: $ 1.8 millones
• Licencias de mercado asiático: $ 1.2 millones
• Licencias latinoamericanas: $ 600,000

Tarifas de consulta de tecnología quirúrgica

Los servicios de consulta generaron $ 2.1 millones en ingresos durante 2023, con programas de capacitación especializados para profesionales médicos.

Expansión del mercado internacional

Las ventas internacionales representaron el 65% de los ingresos totales en 2023, por un total de $ 78.3 millones en múltiples regiones geográficas.

Región	Ganancia	Cuota de mercado
Europa	$ 35.2 millones	45%
América Latina	$ 22.5 millones	29%
Asia Pacífico	$ 15.6 millones	20%
América del norte	$ 5 millones	6%

Ventas recurrentes de profesionales médicos

Los ingresos recurrentes de las redes profesionales médicas alcanzaron los $ 12.5 millones en 2023, con un aumento del 20% en las transacciones repetidas de los clientes.

• Programas de capacitación quirúrgica: $ 4.2 millones
• Soporte continuo del producto: $ 5.3 millones
• Consumibles y piezas de repuesto: $ 3 millones

Establishment Labs Holdings Inc. (ESTA) - Canvas Business Model: Value Propositions

You're looking at the core reasons why surgeons and patients choose Establishment Labs Holdings Inc. products over the competition, especially now that the US market has fully adopted the Motiva platform following its FDA approval in September 2024. The value propositions center on superior clinical performance, technological advancement, and less invasive patient experiences.

Enhanced safety profile and low complication rates (Motiva)

The data coming out of the US IDE Study and the 2025 Post-Market Surveillance Report definitely backs up the safety claims. For primary augmentation subjects in the US IDE Study at five years, the Kaplan-Meier risk rates for specific negative outcomes were remarkably low. For instance, the rate of capsular contracture (Baker Grade III/IV) was just 0.5%, and the rate for rupture, confirmed or suspected (in the MRI cohort), was 0.6%. Even looking at the broader 15 years of data in the 2025 PMS Report, device-related complications leading to reoperations for Motiva implants remain below 1%. This consistency in low rates is a huge differentiator for you when assessing long-term patient satisfaction.

Here's a quick look at those five-year primary augmentation complication rates from the US IDE Study:

Complication Type	5-Year Risk Rate (N=451)
Capsular contracture (Baker Grade III/IV)	0.5%
Rupture, suspected or confirmed (MRI cohort)	0.6%
Implant removal, with or without replacement	3.1%
Any reoperation	8.8%

Premium, high-technology breast aesthetics and reconstruction solutions

Establishment Labs Holdings Inc. positions its offerings as premium, which is reflected in the financial performance, particularly the margin expansion. The company achieved a record Q3 2025 Gross Margin of 70.1%, up from 63.9% in the year-ago period, driven by the geographic mix shift toward higher-margin US sales. The US market is clearly buying into the premium value, with US Motiva sales hitting $11.9 million in Q3 2025 alone, and management expecting full-year 2025 US sales to meaningfully exceed $40 million. This focus on high-value, technology-driven products helps support the company's overall 2025 revenue guidance exceeding $210 million.

Minimally invasive procedures (Mia Femtech, Preservé) for faster recovery

The minimally invasive platform, which includes Mia Femtech and Preservé, offers a value proposition centered on speed and reduced patient downtime. For the Mia Femtech procedure, the skin-to-skin time is often described as around 15 minutes, and patients can resume daily activities within about 90 minutes post-procedure, thanks to the use of local anesthesia combined with sedation instead of general anesthesia. The clinical validation is strong; in the 3-year Mia Femtech study (N=100), the reoperation rate was only 1%. Furthermore, patient satisfaction was high, with patients reporting an 87% increase in breast satisfaction at three years.

The traction for this new market segment is building, as evidenced by the Preservé early experience in the US reaching approximately 300 cases. Management is projecting this entire minimally invasive platform will generate at least $30 million in revenue in 2026.

Integrated digital tools for surgical planning and patient experience

While specific financial metrics tied directly to digital tool adoption aren't always broken out, the success of the overall platform implies value capture from integrated technology. The high patient follow-up rates in the US IDE Study-92.4% at three years and the 93% follow-up in the Mia Femtech study- suggest a positive patient journey, which digital tools help facilitate. The high surgeon satisfaction with Mia Femtech, where 90% of surgeons reported being 'very satisfied,' often correlates with streamlined, technology-supported workflows that digital planning tools enable.

Motiva Flora tissue expander for post-mastectomy reconstruction

The Motiva Flora tissue expander provides a unique, high-tech solution in the reconstruction space. Its key differentiator is that it's the only regulatory-approved expander globally featuring an integrated port that uses radio-frequency technology and is MRI conditional. This specific feature reduces the need for additional procedures or concerns related to MRI compatibility, which is a significant value add for post-mastectomy patients.

Finance: draft 13-week cash view by Friday.

Establishment Labs Holdings Inc. (ESTA) - Canvas Business Model: Customer Relationships

You're looking at how Establishment Labs Holdings Inc. keeps its professional and patient customers engaged, which is critical in the medical device space. The focus is clearly on deep, ongoing relationships built on clinical evidence and support.

High-touch, direct engagement with plastic surgeons for training

Establishment Labs Holdings Inc. invests heavily in direct engagement with plastic surgeons. This isn't just about selling a product; it's about ensuring proper technique and adoption of their platform, including minimally invasive options like Preservé. The company held an event in Q2 2025 that brought together some of the highest volume surgeons in the United States, along with leaders from major plastic surgeon societies. The reception from these surgeons involved in the training was reported as overwhelmingly positive, with their enthusiasm already influencing the broader conversation around breast implants. The US business is a primary growth engine, with Q3 2025 revenue from Motiva sales in the United States hitting $11.9 million, which was a 16% sequential increase. Management expects to finish 2025 with an approximate 20% share of the US breast augmentation market, up from an earlier guidance of at least $40 million in US Motiva sales for the full year.

Dedicated clinical support for surgical procedures

The relationship is underpinned by a commitment to real-world performance data, which serves as the ultimate clinical support. The 2025 Post-Market Surveillance (PMS) Report, released in October 2025, reviews outcomes across 15 years of data since 2010. This continuous monitoring and data sharing is a key part of the trust built with the surgical community. The company has delivered over four million Motiva devices to plastic and reconstructive surgeons globally since 2010.

Long-term patient warranty and safety programs

The patient relationship extends far beyond the operating room through robust safety programs and warranties. The 2025 PMS Report incorporates the company's warranty and claims data. A major statistical point Establishment Labs Holdings Inc. highlights is that device-related complications leading to reoperations remain below 1% based on the latest data review. This commitment to long-term safety is central to the value proposition offered to both the surgeon and the end-consumer.

Educational content and awareness campaigns for end-consumers

While the primary customer is the surgeon, Establishment Labs Holdings Inc. drives demand through consumer awareness, often leveraging the positive sentiment from their surgeon partners. The company's minimally invasive platform is noted for changing the narrative and attracting new patients to the category. The enthusiasm shared by key surgeons on social media following training events is part of this strategy to shape consumer conversation.

Building a community around women's health and wellness

Establishment Labs Holdings Inc. positions itself as dedicated to improving women's health and wellness overall, not just aesthetics. This broader mission helps build a community around the brand. The company offers a portfolio of solutions for breast health, aesthetics, and reconstruction, operating in over 90 countries.

Here's a quick look at the scale of the relationship metrics as of late 2025:

Metric Category	Key Data Point (Latest Available)	Timeframe/Context
Total Devices Delivered	Over 4 million	Since 2010
Device-Related Reoperation Rate	Less than 1%	As per 2025 PMS Report
US Market Share Goal	Approximate 20%	Expected by end of 2025
Q3 2025 US Motiva Sales	$11.9 million	Quarter ended September 30, 2025
2025 Full Year US Sales Guidance	At least $40 million	Full Year 2025 Outlook

The focus on the US market shows a clear strategy to deepen relationships where growth is most immediate, evidenced by the 16% sequential revenue increase in that segment for Q3 2025. The gross margin improvement to 70.1% in Q3 2025, primarily driven by higher margin sales in the US, shows that these high-touch, direct relationships are also financially accretive.

The company's trajectory is clear: they are managing expenses and driving adoption through surgeon education to hit positive EBITDA in 2025 and cash flow positive in 2026. Finance: finalize the Q4 2025 sales forecast against the raised full-year guidance of exceeding $210 million by next Tuesday.

Establishment Labs Holdings Inc. (ESTA) - Canvas Business Model: Channels

You're looking at how Establishment Labs Holdings Inc. gets its products, like Motiva implants, into the hands of surgeons and clinics as of late 2025. It's a mix of direct selling in key markets and leveraging established partners elsewhere.

Direct Sales Force to Surgeons, Hospitals, and Clinics (U.S. Focus)

The United States is a major focus area for Establishment Labs Holdings Inc., utilizing a direct sales approach to reach surgeons, hospitals, and clinics. This channel appears to carry higher margins, as evidenced by margin improvements correlating with U.S. sales growth.

The financial contribution from this channel for the third quarter of 2025 was significant:

• Motiva sales in the United States for Q3 2025 totaled $11.9 million.
• Management projects finishing 2025 with approximately 20% share in the U.S. breast augmentation market.
• The company expected U.S. Motiva sales for the full year 2025 to be at least $40 million, based on guidance from Q2 2025.
• For context on the direct market build-up, Q1 2025 U.S. revenue was anticipated to be around $5.5 million.

Established Network of Medical Distributors in International Markets

Establishment Labs Holdings Inc. supports its global reach, which spans over 90 countries, through a network of established medical distributors in many international territories. While direct markets are strong, distributor orders play a key role in the overall international revenue mix.

Here is the geographic revenue breakdown for the third quarter of 2025, illustrating the mix between direct and distributor-led markets:

Geographic Segment	Percentage of Global Total (Q3 2025)	Notes
Europe, Middle East and Africa	35.6%	Saw strong sales in direct markets; distributor orders timing impacted the total.
United States	22.1%	Primarily direct sales force focus.
Latin America	21.7%	Relies on established distribution channels.
Asia-Pacific	20.6%	Experienced sequential growth of 46% in Q3 2025.

Digital Platforms for Surgeon Education and Product Ordering

While specific revenue figures tied directly to digital ordering platforms aren't broken out, the company emphasizes surgeon training and the minimally invasive portfolio, which relies on digital support and education.

The minimally invasive platform, which includes Mia Femtech and Preservé, is a key area for future channel growth, with management projecting it will generate at least $30 million in revenue in 2026.

• The Mia Femtech Clinical Study showed a high level of surgeon satisfaction, with 90% of surgeons reporting they were 'very satisfied' with their overall experience.
• Patient follow-up compliance in the three-year Mia Femtech study reached 93%.

Mia Femtech Clinics for the Minimally Invasive Procedure

The Mia Femtech procedure is positioned as a unique, minimally invasive experience for breast harmonization. The channel here is the adoption of this specific procedure by clinics, often without the need for general anesthesia.

The success of this channel is tied to clinical validation; for instance, the three-year prospective study showed no instances of capsular contracture (Baker Grade III/IV) or ruptures requiring intervention.

Investor Relations Website for Financial Transparency

Establishment Labs Holdings Inc. maintains its Investor Relations section on its website, www.establishmentlabs.com, as a primary channel for disseminating financial performance data to stakeholders.

Key financial metrics reported as of the latest available data (Q3 2025) that you can find on this channel include:

• Q3 2025 Worldwide Revenue: $53.8 million.
• Projected Full Year 2025 Revenue: Expected to exceed $210 million.
• Q3 2025 Gross Margin: 70.1%, the first time crossing 70%.
• Cash Balance as of September 30, 2025: $70.6 million.

Finance: draft 13-week cash view by Friday.

Establishment Labs Holdings Inc. (ESTA) - Canvas Business Model: Customer Segments

You're looking at the core groups Establishment Labs Holdings Inc. (ESTA) serves with its Motiva portfolio. This isn't just one group; it's a layered approach targeting the medical professionals who make the decisions and the patients who seek the procedures.

The primary professional segment is the plastic and reconstructive surgeons globally. Establishment Labs Holdings Inc. has delivered over four million Motiva devices to these surgeons since 2010. As of October 2025, there are more than two million women worldwide with a Motiva implant, and the company expects approximately 400,000 more to join them in 2026.

The patient base is split between aesthetics and reconstruction. The aesthetic segment is women seeking primary breast augmentation or revision surgery. The reconstruction segment specifically uses the Motiva Flora Tissue Expander. The company's focus on premium, innovative technology attracts high-end aesthetic clinics that value their science and engineering approach.

Geographically, Establishment Labs Holdings Inc. serves patients in over 90 countries. However, the U.S. market is clearly the most important growth segment right now, especially following FDA approval in September 2024. Management expects to finish 2025 at an approximate 20% share in the U.S. breast augmentation market.

Here's a look at the revenue distribution for the first six months of 2025, which shows the current global footprint:

Geographic Market	Revenue (Six Months Ended June 30, 2025)	Notes
EMEA (Europe / Middle East / Africa)	$45.4 million	Accounted for 40% of global sales in Q2 2025
North America (Primarily U.S.)	$16.3 million	U.S. accounted for more than 17.8% of consolidated revenue for the period
Latin America	$16.6 million	Saw sequential growth in Q2 2025
Asia-Pacific	$14.3 million	Geographic segment

The focus on the U.S. is aggressive. For the third quarter of 2025, U.S. Motiva sales hit $11.9 million. This was a 16% sequential increase, even during a quarter that can typically see declines of 20%-30% due to seasonality. The initial 2025 guidance for U.S. sales was $35 million, which was later increased to expect at least $40 million.

The customer base is segmented by the procedure type and the technology they seek:

• Plastic and reconstructive surgeons globally.
• Women seeking primary breast augmentation.
• Women seeking revision surgery.
• Breast cancer patients utilizing Motiva Flora Tissue Expander.
• Clinics prioritizing premium, innovative technology.

Establishment Labs Holdings Inc. (ESTA) - Canvas Business Model: Cost Structure

You're looking at the expense side of Establishment Labs Holdings Inc. (ESTA)'s operations as they scale, especially in the U.S. market. The cost structure reflects heavy investment in commercialization alongside ongoing product development.

High cost of goods sold (COGS) due to premium manufacturing quality is better understood by looking at the resulting Gross Profit Margin. For the third quarter ended September 30, 2025, Establishment Labs Holdings Inc. achieved a gross margin of 70.1% of revenue. This compares to 68.8% in the second quarter of 2025 and 67.2% in the first quarter of 2025. This margin performance shows the company is successfully pricing its premium products to absorb manufacturing costs, even with duties on goods imported from Costa Rica to the United States. Management expects 2025 gross margins to be approximately 300 basis points higher than in 2024.

The push for U.S. market share drives significant Selling, General, and Administrative (SG&A) expenses. For the third quarter of 2025, SG&A reached $37.2 million. This was an increase of approximately $3.1 million compared to the third quarter of 2024. The primary reason for this rise is the increased investment in the United States, which includes higher sales commissions and shipping & handling costs. To give you a sense of the quarterly fluctuation in SG&A, the second quarter of 2025 saw SG&A at $44.2 million, while the first quarter was $39.7 million.

Looking at the total operating spend, the quarterly operating expenses show a pattern of high investment. The average across the first three quarters of 2025 lands right in the range you mentioned. Here's the quick math on the reported operating expenses for the first three quarters of 2025:

Period	SG&A Expense (in millions)	R&D Expense (in millions)	Total Operating Expenses (in millions)
Q1 2025	$39.7	$5.1	$44.8
Q2 2025	$44.2	$5.2	$49.4
Q3 2025	$37.2	$4.6	$41.7

The average total operating expense across these three quarters is $45.3 million.

Ongoing Research and Development (R&D) investment remains a key cost component, though it can fluctuate based on project milestones. For the third quarter of 2025, R&D expenses were $4.6 million. This was slightly lower than the $5.2 million reported in the second quarter of 2025 and the $5.1 million in the first quarter of 2025.

The variability in R&D spend is directly tied to clinical trial costs for new products like GEM and Zensor. For instance, the R&D expense in the third quarter of 2025 decreased by approximately $0.2 million compared to the third quarter of 2024, primarily due to the timing of clinical trial expenses. Similarly, the second quarter of 2025 R&D expense decreased compared to the prior year period due to a decrease in clinical trial expenses. The GEM system, a next-generation minimally invasive system for gluteal ergonomic modeling, is currently undergoing an IRB approved pivotal study. The Zensor technology platform, which includes the Zenº biosensor, is also part of an IRB approved pivotal study.

You can see the breakdown of the operating expenses for the most recent quarter:

• Total Operating Expenses (Q3 2025): $41.7 million.
• SG&A Expenses (Q3 2025): $37.2 million.
• R&D Expenses (Q3 2025): $4.6 million.

Finance: draft 13-week cash view by Friday.

Establishment Labs Holdings Inc. (ESTA) - Canvas Business Model: Revenue Streams

You're looking at how Establishment Labs Holdings Inc. (ESTA) is bringing in the money as we head into the end of 2025. The revenue streams are clearly anchored in their core implant business, but the growth story is increasingly about their newer, less invasive technologies.

The primary engine remains the Sales of Motiva Implants for breast aesthetics and reconstruction. These are the flagship products, and the company has delivered impressive top-line results. For the third quarter ended September 30, 2025, worldwide revenue hit $53.8 million, which was a 33.8% increase year-over-year. This strong quarter helped push the trailing twelve-month revenue to $190.97 million as of that date.

The financial performance shows a clear trend toward better unit economics. Establishment Labs Holdings achieved a high gross margin of 70.1% in Q3 2025, a significant jump from 63.9% in the year-ago period. This margin improvement is defintely tied to the geographic mix shift, specifically the higher-margin sales coming from the United States.

Here's a quick look at the key 2025 financial markers we have as of the Q3 report:

Metric	Value	Period/Context
Full-Year 2025 Revenue Expectation	Exceed $210 million	Updated Guidance
Q3 2025 Worldwide Revenue	$53.8 million	Quarter Ended September 30, 2025
Q3 2025 Gross Margin	70.1%	Quarter Ended September 30, 2025
Q3 2025 U.S. Motiva Sales	$11.9 million	Quarter Ended September 30, 2025
2025 U.S. Motiva Sales Expectation	Meaningfully exceed $40 million	Full-Year Outlook

The Revenue from the minimally invasive Mia Femtech platform represents the future growth vector, designed to expand the total addressable market beyond standard augmentation. While the core implant business is driving current profitability, the minimally invasive portfolio is gaining traction. For instance, the NEO product, part of this platform, is tracking for $8-$10 million in 2025 revenue. Looking ahead, management projects the entire minimally invasive platform will generate at least $30 million in revenue in 2026. This platform includes products like Mia Femtech® for harmonization and Preservé® for tissue preservation.

The revenue mix is clearly being shaped by the U.S. market penetration. The company expects to finish 2025 at an approximate 20% share of the U.S. breast augmentation market. This success in the U.S. is directly impacting the margin profile, as noted by the Q3 results.

The key drivers underpinning these revenue streams include:

• Sales of Motiva Implants in aesthetics and reconstruction.
• Strong sequential growth in the U.S. market, up 16% in Q3 2025.
• The expansion of the minimally invasive portfolio, including NEO.
• The Motiva Flora® tissue expander contributing to reconstruction revenue.