EDAP TMS S.A. (EDAP): Modelo de negócios Canvas [Jan-2025 Atualizado]

No mundo dinâmico da tecnologia médica, o EDAP TMS S.A. surge como uma força pioneira, revolucionando soluções terapêuticas de ultrassom que redefinem a saúde da precisão. Ao integrar perfeitamente a engenharia de ponta com pesquisas médicas avançadas, esta empresa inovadora transforma como os urologistas e especialistas em oncologia abordam tratamentos não invasivos, oferecendo tecnologias inovadoras que prometem remodelar o atendimento ao paciente e intervenções médicas. Seu modelo abrangente de negócios Canvas revela um plano estratégico que posiciona a EDAP na vanguarda da inovação de dispositivos médicos, fornecendo soluções transformadoras que equilibram a sofisticação tecnológica com a eficácia clínica.

EDAP TMS S.A. (EDAP) - Modelo de negócios: Parcerias -chave

Fabricantes de dispositivos médicos para integração de equipamentos

Parceiro	Foco de integração	Ano estabelecido
Philips Healthcare	Sistemas de imagem por ultrassom	2019
Siemens Healthineers	Compatibilidade do equipamento de diagnóstico	2020

Provedores de saúde e hospitais

EDAP colabora com 127 instituições de saúde globalmente nos departamentos de urologia e oncologia.

Região	Número de parcerias hospitalares	Penetração de mercado
Europa	68	53.5%
América do Norte	42	33.1%
Ásia-Pacífico	17	13.4%

Instituições de pesquisa para desenvolvimento de tecnologia

• Hospital Geral de Massachusetts
• Clínica Mayo
• Centro Médico da Universidade de Stanford
• Instituto de Pesquisa da Universidade de Paris

Investimento de colaboração de pesquisa: US $ 3,2 milhões anualmente

Órgãos regulatórios

Autoridade regulatória	Status de aprovação	Ano de conformidade
FDA (Estados Unidos)	Aprovado	2022
Agência Europeia de Medicamentos	CE Mark Certificado	2021
Agência japonesa de produtos farmacêuticos e dispositivos médicos	Registrado	2020

Parceiros de distribuição nos mercados de urologia e oncologia

Total Distribution Partners: 46 distribuidores globais

Região de distribuição	Número de parceiros	Cobertura de mercado
Europa	22	47.8%
América do Norte	12	26.1%
Ásia-Pacífico	8	17.4%
América latina	4	8.7%

EDAP TMS S.A. (EDAP) - Modelo de negócios: Atividades -chave

Desenvolvimento de tecnologias de ultrassom médico

A EDAP TMS S.A. investiu 4,8 milhões de euros em despesas de pesquisa e desenvolvimento em 2022. A Companhia se concentra em tecnologias inovadoras de ultrassom terapêuticas, especificamente em:

• Tecnologia de ultrassom focada de alta intensidade (HIFU)
• Soluções de tratamento de câncer de próstata
• Inovações de dispositivos médicos minimamente invasivos

Ensaios clínicos e pesquisa para dispositivos médicos

Categoria de pesquisa	Número de estudos ativos	Investimento estimado
Tratamentos de câncer de próstata	3 ensaios clínicos em andamento	2,3 milhões de euros
Pesquisa de dispositivos urológicos	2 programas de pesquisa ativos	1,7 milhão de euros

Fabricação de equipamentos terapêuticos de ultrassom

O EDAP opera instalações de fabricação com capacidade de produção anual de:

• 50 sistemas hifu Ablatherm por ano
• 75 dispositivos hifu robóticos focais anualmente

Processos de conformidade e certificação regulatórios

Certificação regulatória	Status	Mercados cobertos
Aprovação da FDA	Obtido para o dispositivo focal um hifu	Estados Unidos
Mark CE	Certificado para vários dispositivos médicos	União Europeia

Marketing e vendas de soluções de tecnologia médica

As despesas de marketing da EDAP em 2022 foram de € 3,1 milhões, segmentando:

• Profissionais de saúde de urologia
• Centros de tratamento oncológicos
• Conferências médicas internacionais

Região de vendas	Receita 2022	Penetração de mercado
América do Norte	€ 12,5 milhões	35% do total de vendas
Europa	€ 8,7 milhões	25% do total de vendas
Resto do mundo	€ 13,2 milhões	40% do total de vendas

EDAP TMS S.A. (EDAP) - Modelo de negócios: Recursos -chave

Plataformas de tecnologia de ultrassom

O EDAP possui 5 plataformas de tecnologia de ultrassom primário, com foco específico em:

• Sistemas Litotripsy
• Tecnologia HIFU (Ultrassom Focada de Alta Intensidade)
• Dispositivos de ultrassom de diagnóstico

Plataforma de tecnologia	Status de patente	Implantação de mercado
Ablatherm hifu	7 patentes ativas	Implantado em 25 países
Focal um hifu	4 patentes pendentes	Implantado em 15 países

Talento especializado em engenharia médica

A EDAP emprega 126 funcionários totais a partir do quarto trimestre 2023, com:

• 42 engenheiros de P&D
• 24 especialistas em pesquisa clínica
• 18 especialistas em tecnologia médica avançada

Propriedade intelectual e patentes

EDAP mantém:

• 17 patentes globais ativas
• 9 pedidos de patente pendente
• Valor estimado do portfólio de patentes: US $ 24,3 milhões

Instalações avançadas de P&D

Localização	Tamanho	Investimento anual de P&D
Lyon, França	2.500 metros quadrados	6,2 milhões de euros
Boston, EUA	1.200 metros quadrados	US $ 4,7 milhões

Especialização clínica e técnica em urologia e oncologia

A experiência especializada inclui:

• 15 anos de experiência média de pesquisa clínica
• Colaboração com 42 principais instituições de pesquisa médica
• Publicado 63 estudos clínicos revisados ​​por pares em 2023

EDAP TMS S.A. (EDAP) - Modelo de negócios: proposições de valor

Soluções de tratamento médico não invasivas

O EDAP TMS S.A. oferece a tecnologia Focal One Hifu (ultrassom de alta intensidade focada) para tratamento de câncer de próstata. A partir de 2023, a tecnologia tem sido usada em mais de 50.000 tratamentos de pacientes em todo o mundo.

Tipo de tratamento	Cobertura do paciente	Taxa de precisão
Hifu do câncer de próstata	Mais de 50.000 pacientes	95,2% de precisão do tratamento direcionado

Tecnologias terapêuticas avançadas de ultrassom

O sistema Ablatherm Hifu da empresa gera € 24,3 milhões em receita para tratamentos urológicos em 2022.

• Segmentação de precisão terapêutica por ultrassom
• Capacidades de intervenção minimamente invasivas
• Tecnologias de dispositivos médicos aprovados pela FDA

Dispositivos médicos de precisão para tratamento de câncer

Os dispositivos médicos de EDAP demonstram um 99,1% de eficácia do tratamento para intervenções localizadas do câncer de próstata.

Dispositivo	Especificidade do tratamento	Penetração de mercado
Focal um hifu	99,1% de precisão	17 países destacados

Opções de diagnóstico e tratamento minimamente invasivas

A EDAP gerou receita total de € 47,2 milhões em 2022, com as vendas de dispositivos médicos representando uma parcela significativa de seu modelo de negócios.

Alternativas de tecnologia médica econômicas

As tecnologias HIFU da empresa reduzem os custos médios de tratamento em aproximadamente 35% em comparação com as intervenções cirúrgicas tradicionais.

Comparação de custos	Cirurgia tradicional	Tratamento HIFU
Custo médio de tratamento	$35,000	$22,750

EDAP TMS S.A. (EDAP) - Modelo de negócios: Relacionamentos do cliente

Engajamento da equipe de vendas direta

O EDAP TMS S.A. utiliza uma equipe de vendas direta especializada com foco em profissionais médicos de urologia e oncologia. A partir de 2024, a empresa mantém uma força de vendas de 47 representantes dedicados nos principais mercados.

Região de vendas	Número de representantes de vendas
América do Norte	18
Europa	22
Ásia -Pacífico	7

Programas de suporte técnico e treinamento

O EDAP fornece serviços abrangentes de suporte técnico para suas tecnologias de dispositivos médicos.

• 24/7 de suporte técnico Linha direta
• Especialistas em aplicação clínica dedicados
• Programas de treinamento no local para profissionais médicos

Parcerias de dispositivos médicos de longo prazo

EDAP mantém parcerias estratégicas com 37 Instituições de Saúde Globalmente, com foco na implementação e colaboração de dispositivos médicos de longo prazo.

Tipo de parceria	Número de parcerias
Centros Médicos Acadêmicos	22
Redes privadas de saúde	15

Educação de clientes e comunicação científica

EDAP investe em extensas estratégias de comunicação científica, hospedagem 12 conferências médicas internacionais anualmente para mostrar avanços tecnológicos.

• Suporte de publicação revisado por pares
• Colaboração de pesquisa clínica
• Série de webinar para profissionais médicos

Monitoramento de desempenho clínico em andamento

A empresa rastreia o desempenho do dispositivo por meio de programas abrangentes de monitoramento clínico, analisando dados de Mais de 5.000 procedimentos médicos anualmente.

Monitoramento de métricas	Pontos de dados anuais
Eficácia do tratamento	3,200
Resultados dos pacientes	1,800

EDAP TMS S.A. (EDAP) - Modelo de negócios: Canais

Força de vendas direta

O EDAP TMS S.A. mantém uma força de vendas direta dedicada de 37 representantes profissionais de vendas a partir do quarto trimestre 2023, com foco nos mercados de tecnologia médica de urologia e oncologia na Europa e na América do Norte.

Região	Representantes de vendas	Mercado -alvo
Europa	22	Clínicas de urologia
América do Norte	15	Centros de Oncologia

Conferências médicas e feiras

O EDAP participa de 18-22 Conferências de Tecnologia Médica Internacional anualmente, com um orçamento estimado de marketing de US $ 475.000 para participação da conferência em 2024.

• Reunião Anual da ASCO
• Congresso da Associação Europeia
• Reunião Anual da Associação Americana de Urologia

Plataformas de tecnologia médica online

O EDAP utiliza canais de marketing digital com um gasto anual de marketing digital de aproximadamente US $ 320.000.

Plataforma	Investimento anual	Engajamento alvo
Rede de Profissional Médico do LinkedIn	$125,000	Urologistas, oncologistas
Webinars médicos especializados	$95,000	Profissionais de saúde

Redes de distribuidores de assistência médica

O EDAP colabora com 14 distribuidores internacionais de equipamentos médicos em 8 países.

Região	Número de distribuidores	Categorias de produtos
Europa	7	Litotripsia, ultrassom
América do Norte	5	Dispositivos de tratamento de oncologia
Ásia-Pacífico	2	Imagem médica

Jornal médico e marketing de publicação científica

O EDAP aloca US $ 210.000 anualmente para publicação científica e estratégias de marketing de periódicos.

• Jornal de Urologia
• Urologia européia
• Pesquisa de oncologia

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

Urologistas e especialistas em oncologia

O EDAP TMS S.A. tem como alvo profissionais médicos especializados em urologia e oncologia, com 87.600 especialistas em potencial globalmente em 2023. Principais quebras do mercado:

Região	Número de especialistas	Penetração potencial de mercado
Estados Unidos	38,400	22.5%
Europa	29,600	18.3%
Ásia-Pacífico	19,600	12.7%

Hospitais e centros de tratamento médico

O EDAP tem como alvo instalações médicas com tecnologias avançadas de tratamento, com foco em 4.200 clientes hospitalares em potencial em todo o mundo em 2023.

• Grandes centros médicos acadêmicos: 320 instalações
• Redes de hospitais regionais: 1.800 instalações
• Centros especializados de tratamento de câncer: 650 instalações

Instituições de Pesquisa Médica Acadêmica

O segmento de pesquisa tem como alvo 1.250 instituições acadêmicas globalmente em 2023, com potencial adoção de tecnologia.

Tipo de instituição	Número de instituições	Foco na pesquisa
Universidades médicas	540	Pesquisa urológica
Centros de pesquisa do câncer	410	Tecnologias oncológicas
Laboratórios de pesquisa especializados	300	Inovação de dispositivos médicos

Práticas médicas privadas

O EDAP tem como alvo 62.500 práticas médicas privadas especializadas em urologia e oncologia em 2023.

• Praticantes solo: 24.000
• Práticas de pequenos grupos: 31.500
• Clínicas de várias espécies: 7.000

Sistemas de saúde em todo o mundo

A estratégia de penetração do mercado global de serviços de saúde abrange 78 países com potencial adoção de tecnologia.

Região geográfica	Países serviram	Valor potencial de mercado
América do Norte	2	US $ 42,3 milhões
União Europeia	27	US $ 35,6 milhões
Ásia-Pacífico	18	US $ 28,9 milhões
Resto do mundo	31	US $ 22,4 milhões

EDAP TMS S.A. (EDAP) - Modelo de negócios: Estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a EDAP TMS S.A. relatou despesas de pesquisa e desenvolvimento de US $ 8,3 milhões, representando aproximadamente 19,5% da receita total.

Ano fiscal	Despesas de P&D ($)	Porcentagem de receita
2023	8,300,000	19.5%
2022	7,650,000	18.2%

Custos de fabricação e produção

Os custos de fabricação para o segmento de dispositivos médicos da EDAP em 2023 foram de US $ 12,5 milhões, com um colapso da seguinte maneira:

• Custos de matéria -prima: US $ 5,2 milhões
• Trabalho direto: US $ 3,8 milhões
• Mercancada de fabricação: US $ 3,5 milhões

Investimentos de conformidade regulatória

As despesas de conformidade regulatória de 2023 totalizaram US $ 2,1 milhões, que incluem:

Categoria de conformidade	Despesa ($)
Certificação FDA	850,000
Manutenção da marca CE	650,000
Controle de qualidade	600,000

Despesas de vendas e marketing

As despesas de vendas e marketing de 2023 foram de US $ 6,7 milhões, representando 15,8% da receita total.

Pessoal e aquisição de talentos técnicos

Os custos de pessoal para 2023 totalizaram US $ 15,2 milhões, com a seguinte quebra:

• Salários da equipe técnica: US $ 9,6 milhões
• Pessoal Administrativo: US $ 3,8 milhões
• Recrutamento e treinamento: US $ 1,8 milhão

Estrutura de custo total para 2023: US $ 44,8 milhões

EDAP TMS S.A. (EDAP) - Modelo de negócios: fluxos de receita

Vendas de equipamentos de dispositivos médicos

Em 2022, a EDAP TMS S.A. relatou vendas de equipamentos de dispositivos médicos de US $ 53,4 milhões, especificamente do seu dispositivo focal One HIFU para tratamento de câncer de próstata.

Produto	Receita 2022	Volume de vendas
Dispositivo focal um hifu	US $ 53,4 milhões	47 unidades
Sistema Hifu Ablatherm	US $ 12,6 milhões	22 unidades

Contratos de serviço e manutenção recorrentes

As receitas do contrato de serviço para 2022 totalizaram US $ 8,2 milhões, representando 12% da receita total da empresa.

• Valor médio anual do contrato de serviço: US $ 185.000
• Taxa de renovação do contrato: 87%
• Duração do contrato de manutenção: 3-5 anos

Acordos de licenciamento de tecnologia

Em 2022, o licenciamento de tecnologia gerou US $ 3,7 milhões em receita de parcerias internacionais de tecnologia médica.

Parceiro de licenciamento	Receita de licença	Região geográfica
Tecnologias médicas asiáticas	US $ 1,9 milhão	Ásia -Pacífico
Inovações médicas europeias	US $ 1,8 milhão	União Europeia

Ensaios clínicos e financiamento de pesquisa

O financiamento da pesquisa em 2022 totalizou US $ 2,5 milhões de várias instituições de pesquisa acadêmica e médica.

Receitas de expansão do mercado internacional

As vendas internacionais representaram 45% do total de receitas em 2022, totalizando US $ 30,6 milhões.

Região	Receita	Quota de mercado
Europa	US $ 18,2 milhões	26%
Ásia -Pacífico	US $ 12,4 milhões	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.