EDAP TMS S.A. (EDAP): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el mundo dinámico de la tecnología médica, EDAP TMS S.A. surge como una fuerza pionera, revolucionando soluciones de ultrasonido terapéutico que redefinen la atención médica de precisión. Al integrar perfectamente la ingeniería de vanguardia con una investigación médica avanzada, esta empresa innovadora transforma la forma en que los urólogos y los especialistas en oncología abordan los tratamientos no invasivos, ofreciendo tecnologías innovadoras que prometen remodelar la atención al paciente y las intervenciones médicas. Su lienzo de modelo comercial integral revela un plan estratégico que posiciona EDAP a la vanguardia de la innovación de dispositivos médicos, ofreciendo soluciones transformadoras que equilibran la sofisticación tecnológica con la efectividad clínica.

EDAP TMS S.A. (EDAP) - Modelo de negocios: asociaciones clave

Fabricantes de dispositivos médicos para la integración de equipos

Pareja	Enfoque de integración	Año establecido
Philips Healthcare	Sistemas de imágenes de ultrasonido	2019
Saludos de Siemens	Compatibilidad del equipo de diagnóstico	2020

Proveedores de atención médica y hospitales

EDAP colabora con 127 instituciones de atención médica a nivel mundial en todos los departamentos de urología y oncología.

Región	Número de asociaciones hospitalarias	Penetración del mercado
Europa	68	53.5%
América del norte	42	33.1%
Asia-Pacífico	17	13.4%

Instituciones de investigación para el desarrollo de la tecnología

• Hospital General de Massachusetts
• Clínica de mayonesa
• Centro Médico de la Universidad de Stanford
• Instituto de Investigación de la Universidad de París

Inversión de colaboración de investigación: $ 3.2 millones anualmente

Cuerpos reguladores

Autoridad reguladora	Estado de aprobación	Año de cumplimiento
FDA (Estados Unidos)	Aprobado	2022
Agencia Europea de Medicamentos	CE Mark certificado	2021
Agencia de productos farmacéuticos y dispositivos médicos japoneses	Registrado	2020

Socios de distribución en mercados de urología y oncología

Socios de distribución total: 46 distribuidores globales

Región de distribución	Número de socios	Cobertura del mercado
Europa	22	47.8%
América del norte	12	26.1%
Asia-Pacífico	8	17.4%
América Latina	4	8.7%

EDAP TMS S.A. (EDAP) - Modelo de negocio: actividades clave

Desarrollo de tecnologías de ultrasonido médico

EDAP TMS S.A. invirtió € 4,8 millones en gastos de investigación y desarrollo en 2022. La compañía se centra en tecnologías de ultrasonido terapéuticas innovadoras, específicamente en:

• Tecnología de ultrasonido enfocado (HIFU) de alta intensidad
• Soluciones de tratamiento de cáncer de próstata
• Innovaciones de dispositivos médicos mínimamente invasivos

Ensayos clínicos e investigación para dispositivos médicos

Categoría de investigación	Número de estudios activos	Inversión estimada
Tratamientos de cáncer de próstata	3 ensayos clínicos en curso	€ 2.3 millones
Investigación de dispositivos urológicos	2 programas de investigación activos	1.7 millones de euros

Fabricación de equipos de ultrasonido terapéutico

EDAP opera instalaciones de fabricación con capacidad de producción anual de:

• 50 Sistemas ABLATHERM HIFU por año
• 75 focal uno dispositivos robóticos hifu anualmente

Procesos de cumplimiento y certificación regulatoria

Certificación regulatoria	Estado	Mercados cubiertos
Aprobación de la FDA	Obtenido para el dispositivo HIFU Focal One	Estados Unidos
Marca	Certificado para múltiples dispositivos médicos	unión Europea

Marketing y ventas de soluciones de tecnología médica

El gasto de marketing de EDAP en 2022 fue de 3,1 millones de euros, dirigido:

• Profesionales de la salud de la urología
• Centros de tratamiento oncológico
• Conferencias médicas internacionales

Región de ventas	Ingresos 2022	Penetración del mercado
América del norte	12.5 millones de euros	35% de las ventas totales
Europa	8,7 millones de euros	25% de las ventas totales
Resto del mundo	€ 13.2 millones	40% de las ventas totales

EDAP TMS S.A. (EDAP) - Modelo de negocio: recursos clave

Plataformas de tecnología de ultrasonido patentadas

EDAP posee 5 plataformas de tecnología de ultrasonido primario, con un enfoque específico en:

• Sistemas de litotripia
• Tecnología de HIFU (ultrasonido enfocado de alta intensidad)
• Dispositivos de ultrasonido de diagnóstico

Plataforma tecnológica	Estado de patente	Despliegue del mercado
Ablatherm hifu	7 patentes activas	Desplegado en 25 países
Focal uno hifu	4 patentes pendientes	Desplegado en 15 países

Talento especializado de ingeniería médica

EDAP emplea a 126 empleados totales a partir del cuarto trimestre de 2023, con:

• 42 ingenieros de I + D
• 24 especialistas en investigación clínica
• 18 expertos avanzados en tecnología médica

Propiedad intelectual y patentes

EDAP tiene:

• 17 patentes globales activas
• 9 solicitudes de patentes pendientes
• Valor estimado de la cartera de patentes: $ 24.3 millones

Instalaciones avanzadas de I + D

Ubicación	Tamaño	Inversión anual de I + D
Lyon, Francia	2.500 metros cuadrados	6.2 millones de euros
Boston, EE. UU.	1.200 metros cuadrados	$ 4.7 millones

Experiencia clínica y técnica en urología y oncología

La experiencia especializada incluye:

• Experiencia de investigación clínica promedio de 15 años
• Colaboración con 42 instituciones de investigación médica líderes
• Publicado 63 estudios clínicos revisados ​​por pares en 2023

EDAP TMS S.A. (EDAP) - Modelo de negocio: propuestas de valor

Soluciones de tratamiento médico no invasivo

EDAP TMS S.A. ofrece tecnología Focal One HIFU (ultrasonido enfocado de alta intensidad) para el tratamiento del cáncer de próstata. A partir de 2023, la tecnología se ha utilizado en más de 50,000 tratamientos para pacientes en todo el mundo.

Tipo de tratamiento	Cobertura del paciente	Tasa de precisión
Cáncer de próstata hifu	Más de 50,000 pacientes	95.2% de precisión del tratamiento dirigido

Tecnologías de ultrasonido terapéutico avanzado

El sistema Ablatherm Hifu de la compañía genera € 24.3 millones en ingresos para tratamientos urológicos en 2022.

• Orientación de precisión de ultrasonido terapéutico
• Capacidades de intervención mínimamente invasivas
• Tecnologías de dispositivos médicos aprobados por la FDA

Dispositivos médicos de precisión para el tratamiento del cáncer

Los dispositivos médicos de EDAP demuestran un 99.1% de eficacia del tratamiento para intervenciones de cáncer de próstata localizadas.

Dispositivo	Especificidad de tratamiento	Penetración del mercado
Focal uno hifu	99.1% de precisión	17 países desplegados

Opciones de diagnóstico y tratamiento mínimamente invasivas

EDAP generó ingresos totales de € 47.2 millones en 2022, con ventas de dispositivos médicos que representan una parte significativa de su modelo de negocio.

Alternativas de tecnología médica rentable

Las tecnologías HIFU de la compañía reducen los costos de tratamiento promedio en aproximadamente un 35% en comparación con las intervenciones quirúrgicas tradicionales.

Comparación de costos	Cirugía tradicional	Tratamiento de hifu
Costo promedio de tratamiento	$35,000	$22,750

EDAP TMS S.A. (EDAP) - Modelo de negocios: relaciones con los clientes

Compromiso del equipo de ventas directo

EDAP TMS S.A. utiliza un equipo de ventas directo especializado centrado en profesionales médicos de urología y oncología. A partir de 2024, la compañía mantiene una fuerza de ventas de 47 representantes dedicados en los mercados clave.

Región de ventas	Número de representantes de ventas
América del norte	18
Europa	22
Asia Pacífico	7

Programas de soporte técnico y capacitación

EDAP proporciona servicios de soporte técnico integrales para sus tecnologías de dispositivos médicos.

• Línea directa de soporte técnico 24/7
• Especialistas de aplicación clínica dedicada
• Programas de capacitación en el sitio para profesionales médicos

Asociaciones de dispositivos médicos a largo plazo

Edap mantiene asociaciones estratégicas con 37 instituciones de atención médica A nivel mundial, centrándose en la implementación y colaboración del dispositivo médico a largo plazo.

Tipo de asociación	Número de asociaciones
Centros médicos académicos	22
Redes de atención médica privadas	15

Educación al cliente y comunicación científica

EDAP invierte en extensas estrategias de comunicación científica, alojamiento 12 conferencias médicas internacionales anualmente para mostrar avances tecnológicos.

• Soporte de publicación revisada por pares
• Colaboración de investigación clínica
• Serie de seminarios web para profesionales médicos

Monitoreo de rendimiento clínico continuo

La compañía rastrea el rendimiento del dispositivo a través de programas integrales de monitoreo clínico, analizando datos de Más de 5,000 procedimientos médicos anualmente.

Monitoreo de métricas	Puntos de datos anuales
Eficacia del tratamiento	3,200
Resultados del paciente	1,800

EDAP TMS S.A. (EDAP) - Modelo de negocios: canales

Fuerza de ventas directa

EDAP TMS S.A. mantiene una fuerza de ventas directa dedicada de 37 representantes de ventas profesionales a partir del cuarto trimestre de 2023, centrándose en los mercados de tecnología médica de urología y oncología en Europa y América del Norte.

Región	Representantes de ventas	Mercado objetivo
Europa	22	Clínicas de urología
América del norte	15	Centros de oncología

Conferencias médicas y ferias comerciales

EDAP participa en 18-22 conferencias internacionales de tecnología médica anualmente, con un presupuesto de marketing estimado de $ 475,000 para la participación de la conferencia en 2024.

• Reunión anual de ASCO
• Congreso de la Asociación Europea de Urología
• Reunión anual de la Asociación Americana de Urología

Plataformas de tecnología médica en línea

EDAP utiliza canales de marketing digital con un gasto anual de marketing digital de aproximadamente $ 320,000.

Plataforma	Inversión anual	Compromiso objetivo
Network Medical Professional de LinkedIn	$125,000	Urólogos, oncólogos
Seminarios médicos especializados	$95,000	Profesionales de la salud

Redes de distribuidores de atención médica

EDAP colabora con 14 distribuidores internacionales de equipos médicos en 8 países.

Región	Número de distribuidores	Categorías de productos
Europa	7	Litotricia, ultrasonido
América del norte	5	Dispositivos de tratamiento oncológico
Asia-Pacífico	2	Imagen médica

Revista médica y marketing de publicación científica

EDAP asigna $ 210,000 anuales para publicaciones científicas y estrategias de marketing de revistas.

• Revista de Urología
• Urología europea
• Investigación oncológica

EDAP TMS S.A. (EDAP) - Modelo de negocio: segmentos de clientes

Urólogos y especialistas en oncología

EDAP TMS S.A. se dirige a profesionales médicos especializados en urología y oncología con 87,600 especialistas potenciales a nivel mundial en 2023. Desglose del mercado clave:

Región	Número de especialistas	Penetración potencial del mercado
Estados Unidos	38,400	22.5%
Europa	29,600	18.3%
Asia-Pacífico	19,600	12.7%

Hospitales y centros de tratamiento médico

EDAP se dirige a las instalaciones médicas con tecnologías de tratamiento avanzadas, centrándose en 4.200 clientes potenciales de hospitales en todo el mundo en 2023.

• Grandes centros médicos académicos: 320 instalaciones
• Redes regionales de hospitales: 1.800 instalaciones
• Centros de tratamiento de cáncer especializados: 650 instalaciones

Instituciones de investigación médica académica

El segmento de investigación se dirige a 1.250 instituciones académicas a nivel mundial en 2023 con una posible adopción de tecnología.

Tipo de institución	Número de instituciones	Enfoque de investigación
Universidades médicas	540	Investigación urológica
Centros de investigación del cáncer	410	Tecnologías oncológicas
Laboratorios de investigación especializados	300	Innovación de dispositivos médicos

Prácticas médicas privadas

EDAP se dirige a 62,500 prácticas médicas privadas especializadas en urología y oncología en 2023.

• Practicantes en solitario: 24,000
• Prácticas de grupo pequeño: 31,500
• Clínicas de especialidades múltiples: 7,000

Sistemas de salud en todo el mundo

La estrategia de penetración del mercado global del mercado de la salud cubre a 78 países con una posible adopción de tecnología.

Región geográfica	Países atendidos	Valor de mercado potencial
América del norte	2	$ 42.3 millones
unión Europea	27	$ 35.6 millones
Asia-Pacífico	18	$ 28.9 millones
Resto del mundo	31	$ 22.4 millones

EDAP TMS S.A. (EDAP) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, EDAP TMS S.A. informó gastos de investigación y desarrollo de $ 8.3 millones, lo que representa aproximadamente el 19.5% de los ingresos totales.

Año fiscal	Gastos de I + D ($)	Porcentaje de ingresos
2023	8,300,000	19.5%
2022	7,650,000	18.2%

Costos de fabricación y producción

Los costos de fabricación para el segmento de dispositivos médicos de EDAP en 2023 fueron de $ 12.5 millones, con un desglose de la siguiente manera:

• Costos de materia prima: $ 5.2 millones
• Trabajo directo: $ 3.8 millones
• Sobrecoss de fabricación: $ 3.5 millones

Inversiones de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 totalizaron $ 2.1 millones, lo que incluye:

Categoría de cumplimiento	Gasto ($)
Certificación de la FDA	850,000
Mantenimiento de la marca CE	650,000
Control de calidad	600,000

Gastos de ventas y marketing

Los gastos de ventas y marketing para 2023 fueron de $ 6.7 millones, lo que representa el 15.8% de los ingresos totales.

Adquisición de personal y talento técnico

Los costos de personal para 2023 ascendieron a $ 15.2 millones, con el siguiente desglose:

• Salarios del personal técnico: $ 9.6 millones
• Personal administrativo: $ 3.8 millones
• Reclutamiento y capacitación: $ 1.8 millones

Estructura de costos totales para 2023: $ 44.8 millones

EDAP TMS S.A. (EDAP) - Modelo de negocios: flujos de ingresos

Ventas de equipos de dispositivos médicos

En 2022, EDAP TMS S.A. informó ventas de equipos de dispositivos médicos de $ 53.4 millones, específicamente de su dispositivo HIFU Focal One para el tratamiento del cáncer de próstata.

Producto	Ingresos 2022	Volumen de ventas
Dispositivo focal de HIFU	$ 53.4 millones	47 unidades
Sistema ABLATHERM HIFU	$ 12.6 millones	22 unidades

Contratos de servicio y mantenimiento recurrentes

Los ingresos por contratos de servicio para 2022 totalizaron $ 8.2 millones, lo que representa el 12% de los ingresos totales de la compañía.

• Valor promedio de contrato de servicio anual: $ 185,000
• Tasa de renovación del contrato: 87%
• Duración del contrato de mantenimiento: 3-5 años

Acuerdos de licencia de tecnología

En 2022, la licencia de tecnología generó $ 3.7 millones en ingresos de las asociaciones internacionales de tecnología médica.

Socio de licencia	Ingreso de la licencia	Región geográfica
Tecnologías médicas asiáticas	$ 1.9 millones	Asia Pacífico
Innovaciones médicas europeas	$ 1.8 millones	unión Europea

Ensayo clínico e financiación de la investigación

La financiación de la investigación en 2022 ascendió a $ 2.5 millones de varias instituciones de investigación académica y médica.

Ingresos de expansión del mercado internacional

Las ventas internacionales representaron el 45% de los ingresos totales en 2022, por un total de $ 30.6 millones.

Región	Ganancia	Cuota de mercado
Europa	$ 18.2 millones	26%
Asia Pacífico	$ 12.4 millones	19%

EDAP TMS S.A. (EDAP) - Canvas Business Model: Value Propositions

You're looking at the core reasons why urologists and patients choose EDAP TMS S.A.'s (EDAP) Focal One platform over established procedures. The value proposition centers on clinical efficacy without the functional trade-offs of traditional surgery. It's about getting the job done effectively while preserving quality of life.

For localized prostate cancer, the evidence supports the minimally invasive approach. The Focal Ablation Versus Radical Prostatectomy (FARP) study demonstrated that ultrasound energy-based focal ablation is non-inferior to Robotic Prostatectomy in terms of treatment failure at the final 36-month follow-up. This is Level 1 evidence that directly challenges the surgical standard.

The functional superiority is a major draw. While radical prostatectomy often leads to functional decline, the data from comparative studies, like the HIFI study, showed a salvage-treatment-free survival rate of 97.5% for the HIFU arm compared to 90.3% for the radical prostatectomy arm at intermediate follow-up. To be fair, even in general prostatectomy comparisons, men often report worse urinary incontinence scores and a modestly higher rate of erections insufficient for intercourse at 5 years post-surgery.

Here's a quick look at how the clinical claims stack up against surgery, based on published data:

Metric/Study	Focal Ablation/HIFU Arm	Radical Prostatectomy Arm	Key Finding
FARP Study Treatment Failure (36-mo)	Non-inferior to RP	Reference Standard	Non-inferiority achieved.
HIFI Study Salvage-Free Survival (Intermediate)	97.5%	90.3%	Significantly higher rate for HIFU.
Post-Prostatectomy Incontinence Score (5-yr)	Better than RP	Worse than other options	RP associated with worse score by median difference of 10-12 points.
Post-Prostatectomy Potency (RARP vs ORP)	Significantly more effective (RR 1.201)	Reference for comparison	Robot-Assisted RP showed better potency than Open RP.

For urologists, the value is in the precision and the growing adoption of the technology itself. The platform is robotic and image-guided, offering precise focal therapy. This is translating directly into commercial momentum, which is a strong indicator of physician confidence. For the nine months ending September 30, 2025, total revenue in the core HIFU business grew by 42% year-over-year, reaching €21.3 million (US $23.9 million). Furthermore, Focal One system placements saw a massive increase of 167% year-over-year in the third quarter of 2025.

The technology's value extends beyond prostate cancer, opening up new, high-value markets. EDAP TMS S.A. secured a significant regulatory win for its platform in women's health. Specifically, the Focal One platform received Breakthrough Device designation from the US Food and Drug Administration (FDA) for the treatment of deep infiltrating endometriosis (DIE). This designation signals high potential for a less invasive treatment option in a debilitating condition.

The overall financial performance in Q3 2025 underscores the focus on this core value:

• Total worldwide revenue for Q3 2025 was €13.9 million (US $16.1 million).
• Gross profit margin on net sales improved to 43% in Q3 2025, up from 39% in Q3 2024.
• The company secured a €36 million credit facility with the European Investment Bank to accelerate this HIFU expansion.

The platform is clearly gaining traction with clinicians who want to offer an effective, non-invasive option for early-stage prostate cancer, and that's what drives the business.

EDAP TMS S.A. (EDAP) - Canvas Business Model: Customer Relationships

You're looking at how EDAP TMS S.A. (EDAP) builds and maintains its connections with the urologists and hospitals that use the Focal One® system. This relationship is high-touch, especially given the capital equipment nature of the primary product.

The direct sales and clinical support teams are central to securing and expanding the installed base. For instance, the company saw a 167% year-over-year growth in Focal One System placements in the third quarter of 2025 alone. This growth suggests a very active sales engagement. Furthermore, the relationship deepens through repeat business; hospital networks like Hackensack Meridian Health, Baptist Health, and New York Presbyterian Health purchased a second Focal One system to expand their focal therapy programs across multiple locations. As of September 30, 2025, the U.S. installed base stood at 76 Focal One systems. The commercial structure supports this, with leadership like the VP of Sales for EMEAI overseeing commercial operations.

For installed capital equipment, the relationship shifts into a service and utilization model, which is critical for recurring revenue. While the exact percentage of revenue from long-term service contracts isn't broken out, the core HIFU business, which includes system sales and disposables/procedures, is clearly the focus. HIFU revenue for the third quarter of 2025 hit $7.7 million, up from $4.9 million in the same period of 2024. Also, U.S. Focal One HIFU Procedures showed a 15% year-over-year growth in Q3 2025, indicating continued utilization post-sale. This utilization drives the consumable revenue stream that service agreements often support.

Investor relations is a distinct, yet crucial, relationship channel. EDAP TMS S.A. actively engages with the financial community through presentations at major healthcare conferences. You can see this activity right up to late 2025:

• Participation at the UBS Global Healthcare Conference on November 10, 2025.
• Presentation at the Jefferies Global Healthcare Conference in London on November 18, 2025.
• Scheduled presentation at the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025.

The CEO, Ryan Rhodes, and CFO, Ken Mobeck, were scheduled to host one-on-one investor meetings at these events.

For patient-focused education, the strategy relies on demonstrating clinical superiority to drive urologist adoption, which in turn generates patient demand. The CEO noted that demand is driven as more urologists want to offer patients an effective, non-invasive option. The company also engaged in broader outreach, such as airing a national TV segment on the Lifetime Network as part of Health Uncensored with Dr. Drew.

Here's a quick look at the key customer-facing performance indicators from the latest reported quarter, Q3 2025, compared to the prior year:

Metric	Q3 2025 Value	Year-over-Year Change
Total Worldwide Revenue	€13.9 million (US $16.1 million)	6% increase
HIFU Revenue	$7.7 million	49% increase
Focal One System Placements	N/A	167% growth
U.S. Focal One HIFU Procedures	N/A	15% growth
U.S. Installed Base (as of 9/30/2025)	76 systems	N/A

The shift in business mix towards HIFU, which saw its revenue rise to $7.7 million in Q3 2025 from $4.9 million a year prior, shows where the customer relationship focus is yielding the highest financial return. Finance: review the Q4 2025 pipeline conversion rate by end of January 2026.

EDAP TMS S.A. (EDAP) - Canvas Business Model: Channels

You're looking at how EDAP TMS S.A. gets its Focal One system and services to urologists and healthcare systems as of late 2025. The core channel strategy heavily leans on direct sales in the U.S. market, which is where a lot of the procedure volume growth is happening.

The direct sales force pushes the placement of the Focal One Robotic HIFU System. You can see the system sales cadence through the first three quarters of 2025:

Quarter 2025	Focal One Systems Sold/Placed	Context/Metric
Q1 2025	6 (Reported sales)	Reported as a record number of nine placements for the quarter.
Q2 2025	Net total of 12 placed	Driven by demand in U.S. and international markets.
Q3 2025	6 sold	System placements increased 167% year over year for the quarter.

The U.S. market is showing traction in utilization, too. For the third quarter of 2025, Focal One procedures in the U.S. grew 15% year-over-year, which drove a 9% year-over-year growth in worldwide disposables revenue for that quarter.

For international access and to manage legacy business, EDAP TMS S.A. uses international distribution partners, though the strategic focus is clearly shifting away from this segment. The non-core business, which includes Distribution and ESWL (Extracorporeal ShockWave Lithotripsy), saw revenue decline by 16% in Q3 2025 compared to Q3 2024. The full-year 2025 guidance projects the combined non-core business revenue to decline within the range of 25% to 30% year-over-year.

Clinical publications and industry recognition serve as a critical channel to build credibility and reach urologists directly. Key evidence points supporting the channel include:

• Final results of the FARP randomized controlled trial presented at the American Urology Association (AUA) Annual Meeting in 2025.
• Publication from the large multicenter prospective comparative HIFI study supporting momentum as of Q2 2025.
• The Focal One HIFU platform received the 2025 Industry Award for Innovations in Endourological Instrumentation from the Endourological Society.

Stakeholder communication relies on standard corporate channels, keeping investors informed about progress and strategy. EDAP TMS S.A. management participated in several key investor events in late 2025, which is how they communicate their strategy, including the recent FDA 510(k) clearance for the latest Focal One evolution on November 20, 2025. You can track these communications through their investor relations schedule, such as:

• Participation in the UBS Global Healthcare Conference on November 10, 2025.
• Presentation at the Jefferies London Healthcare Conference on November 18, 2025.
• The Q3 2025 Earnings Conference Call on November 6, 2025, at 8:30 a.m. EST.

The corporate website, focalone.com, is the hub for press releases and investor presentation downloads, such as the one made available on November 18, 2025.

EDAP TMS S.A. (EDAP) - Canvas Business Model: Customer Segments

You're looking at the specific groups EDAP TMS S.A. (EDAP) serves with its Focal One Robotic HIFU technology as of late 2025. This isn't about the whole market; it's about who is actually buying the machines and who is getting the treatment.

Urologists and urological surgeons seeking focal therapy options

This segment represents the core professional users who are adopting the Focal One platform for prostate cancer management. The demand is driven by clinical evidence and the desire to offer less invasive options.

• Urologists are showing increased adoption, evidenced by a 167% year-over-year growth in Focal One System Placements in the third quarter of 2025.
• U.S. Focal One HIFU Procedures showed a 15% year-over-year growth in the third quarter of 2025.
• HIFU revenue, a direct proxy for utilization by these professionals, reached $7.7 million in the third quarter of 2025.

Hospitals and specialized cancer centers purchasing capital equipment

These are the institutions that make the capital expenditure to acquire the Focal One systems. Their purchasing decisions are influenced by technology adoption, procedure volume growth, and now, reimbursement certainty.

Here's a look at the installed base and major center adoption as of late 2025:

Metric	Value/Status	Date/Period
Focal One Systems Installed Base (U.S.)	76 systems	As of September 30, 2025
Focal One System Placements Growth (YoY)	167% increase	Q3 2025
Cleveland Clinic Facilities with Focal One	4 worldwide locations	As of Q2 2025
Hospitals Purchasing Second System	Hackensack Meridian Health, Baptist Health	As of Q2 2025

It's clear that established networks are committing to the platform by adding units; Hackensack Meridian Health and Baptist Health both purchased a second Focal One system to expand their focal therapy programs across multiple sites. The global prostate cancer treatment device market itself was estimated at $2.5 billion in 2025.

Prostate cancer patients seeking non-invasive, function-sparing treatment

This segment is the ultimate beneficiary, seeking alternatives to surgery or radiation. Their demand is directly influenced by physician recommendation and insurance coverage.

• The treatment is positioned as an effective, non-invasive option for localized prostate cancer and salvage treatment following radiotherapy.
• The company is also building clinical evidence for use in Benign Prostatic Hyperplasia (BPH) and deep infiltrating rectal endometriosis.

Healthcare systems and national health services (e.g., French reimbursement)

This group is critical as it determines patient access and the financial viability of the procedure for providers. The French market saw a major shift.

The French Ministry of Health awarded reimbursement for the Focal One Robotic HIFU procedure, effective September 1, 2025. This covers use as a primary treatment for localized prostate cancer or as a salvage option following radiotherapy. Securing this reimbursement in France, one of Europe's largest healthcare markets, is expected to help accelerate reimbursement in additional European countries. For the nine months ended September 30, 2025, EDAP TMS S.A. reported total worldwide revenue of €13.9 million (US $16.1 million).

Finance: draft 13-week cash view by Friday.

EDAP TMS S.A. (EDAP) - Canvas Business Model: Cost Structure

You're looking at the core expenses driving EDAP TMS S.A.'s operations as they push the Focal One Robotic HIFU platform. The cost structure is heavily influenced by the high-value, complex nature of their medical technology, which requires significant investment in development and commercialization.

High Cost of Sales and Margin Performance

The cost of goods sold (Cost of Sales) remains a significant factor, though the shift in product mix is helping. For the nine months ended September 30, 2025, EDAP TMS S.A. reported a gross profit margin of 42.5% on net sales. This is an improvement from the 39.9% margin seen in the same nine-month period of 2024. The gross profit for the nine months ended September 30, 2025, totaled €18.5 million (US $20.7 million). This margin improvement is largely attributed to the favorable product-mix shift toward the higher-margin HIFU revenue stream.

Operating Expenses Context

The prompt mentioned specific figures for Research & Development (R&D) and Selling, General & Administrative (SG&A) expenses for Q3 2025. However, the latest public filings only provide the consolidated Operating Expenses figure. These total operating costs reflect the ongoing investment in both R&D and the commercial push for the Focal One system. For the third quarter of 2025, total operating expenses were €10.9 million (US $12.7 million). Over the longer nine-month period ending September 30, 2025, total operating expenses reached €35.2 million (US $39.4 million).

It's clear that managing these operating costs relative to revenue growth is key, as the company posted an operating loss of €4.9 million (US $5.7 million) for Q3 2025.

Here's a look at the key financial metrics that define the cost absorption:

Metric	Period	Amount (EUR)	Amount (USD)
Gross Profit Margin	9M 2025	N/A	42.5%
Gross Profit	9M 2025	€18.5 million	$20.7 million
Total Operating Expenses	Q3 2025	€10.9 million	$12.7 million
Total Operating Expenses	9M 2025	€35.2 million	$39.4 million
Operating Loss	Q3 2025	€4.9 million	$5.7 million
Net Loss	9M 2025	€17.7 million	$19.8 million

Manufacturing and Inventory Costs

The nature of the Focal One Robotic HIFU system dictates high upfront manufacturing and inventory costs. These costs are tied to precision engineering, specialized components, and the relatively low volume of high-value capital equipment sales. The company saw eight Focal One system placements in Q3 2025 (six capital sales and two operating leases), which means inventory management for these large assets is a critical cost consideration.

Clinical Trials and Regulatory Costs

Sustaining market access and expanding indications-like the move into BPH and endometriosis-requires continuous investment in clinical validation. While specific trial costs aren't itemized in the top-line reports, the ongoing regulatory environment is a structural cost. For instance, EDAP TMS S.A. announced receiving FDA 510(k) Clearance for the latest evolution of Focal One in November 2025, a process that inherently involves substantial internal and external costs related to testing, documentation, and submission fees.

The company is also managing costs related to tariffs, reporting a year-to-date impact of approximately €300,000 from a forecasted 15% tariff on goods transferred between France and the US.

Key cost drivers you should monitor include:

• Absorption of fixed costs through HIFU revenue growth.
• Investment supporting 167% year-over-year growth in Focal One system placements.
• Costs associated with expanding U.S. insurance provider coverage.
• Tariff impact on cross-border transfers.

Finance: draft 13-week cash view by Friday.

EDAP TMS S.A. (EDAP) - Canvas Business Model: Revenue Streams

You're looking at how EDAP TMS S.A. (EDAP) is bringing in cash as we head into the end of 2025. It's a mix of big equipment sales and recurring procedure revenue, plus some legacy stuff that's fading out. Honestly, the story here is the shift toward the high-intensity focused ultrasound (HIFU) platform.

Capital equipment sales, specifically for the Focal One system, are a key part of the top line. For the third quarter of 2025, the company reported selling 6 systems. That's the upfront cash infusion from placing the hardware.

The real growth engine, though, is tied to using that equipment. Revenue generated from HIFU procedures-think disposables and service contracts-showed serious momentum. In Q3 2025, this segment was up a strong 49% year-over-year. That recurring revenue stream is what analysts really watch.

We still have to account for the older business lines. Legacy revenue, which comes from the non-core ESWL (Extracorporeal Shock Wave Lithotripsy) and distribution businesses, is definitely shrinking. The expectation for the full year 2025 is a decline in this area of between 25% and 30%. It's a planned contraction, so it's not a surprise.

Here's the quick math on the overall expectation for the year. Total worldwide revenue guidance for EDAP TMS S.A. (EDAP) for 2025 is set between $58 million and $62 million. What this estimate hides is the exact mix between the capital sales and the procedure-related income, but the trend is clear.

To lay out the components driving that guidance, you can look at it this way:

• Focal One System Sales (Capital Equipment)
• HIFU Procedure-Related Revenue (Disposables/Service)
• Legacy Revenue (ESWL/Distribution)

For a clearer snapshot of the key metrics driving the revenue streams as of late 2025, check out this breakdown:

Revenue Component	Metric/Status	Value/Rate
Focal One System Sales	Units Sold in Q3 2025	6 systems
HIFU Procedure Revenue	Year-over-Year Growth in Q3 2025	Up 49%
Legacy Revenue	Projected Decline for Full Year 2025	25-30%
Total Worldwide Revenue	Full Year 2025 Guidance Range	$58 million to $62 million

The focus is definitely on driving the utilization of the installed base, which fuels that high-margin procedure revenue. If onboarding new centers takes longer than expected, that recurring revenue ramp-up could be slower, defintely something to watch.

Finance: draft 13-week cash view by Friday.