EDAP TMS S.A. (EDAP): Business Model Canvas [Jan-2025 Mise à jour]

Dans le monde dynamique de la technologie médicale, Edap TMS S.A. émerge comme une force pionnière, révolutionnant des solutions d'échographie thérapeutiques qui redéfinissent les soins de santé de précision. En intégrant de manière transparente l'ingénierie de pointe à des recherches médicales avancées, cette entreprise innovante transforme comment les urologues et les spécialistes de l'oncologie abordent des traitements non invasifs, offrant des technologies révolutionnaires qui promettent de remodeler les soins aux patients et les interventions médicales. Leur toile complète du modèle commercial révèle un plan stratégique qui positionne EDAP à l'avant-garde de l'innovation des dispositifs médicaux, offrant des solutions transformatrices qui équilibrent la sophistication technologique avec l'efficacité clinique.

EDAP TMS S.A. (EDAP) - Modèle d'entreprise: partenariats clés

Fabricants d'appareils médicaux pour l'intégration d'équipement

Partenaire	Focus d'intégration	Année établie
Philips Healthcare	Systèmes d'imagerie à ultrasons	2019
Siemens Healthineers	Compatibilité des équipements de diagnostic	2020

Fournisseurs de soins de santé et hôpitaux

Edap collabore avec 127 institutions de soins de santé dans le monde entier à travers les services d'urologie et d'oncologie.

Région	Nombre de partenariats hospitaliers	Pénétration du marché
Europe	68	53.5%
Amérique du Nord	42	33.1%
Asie-Pacifique	17	13.4%

Institutions de recherche pour le développement de la technologie

• Hôpital général du Massachusetts
• Clinique de mayo
• Centre médical de l'Université de Stanford
• Institut de recherche de l'Université de Paris

Investissement de collaboration de recherche: 3,2 millions de dollars par an

Organismes de réglementation

Autorité réglementaire	Statut d'approbation	Année de conformité
FDA (États-Unis)	Approuvé	2022
Agence européenne des médicaments	CE Mark certifié	2021
Agence japonaise des produits pharmaceutiques et des appareils médicaux	Inscrit	2020

Partenaires de distribution sur les marchés de l'urologie et de l'oncologie

Partners de distribution totaux: 46 distributeurs mondiaux

Région de distribution	Nombre de partenaires	Couverture du marché
Europe	22	47.8%
Amérique du Nord	12	26.1%
Asie-Pacifique	8	17.4%
l'Amérique latine	4	8.7%

EDAP TMS S.A. (EDAP) - Modèle d'entreprise: Activités clés

Développement de technologies d'échographie médicale

EDAP TMS S.A.

• Technologie d'échographie (HIFU) axée sur une intensité à haute intensité (HIFU)
• Solutions de traitement du cancer de la prostate
• Innovations de dispositifs médicaux mini-invasifs

Essais cliniques et recherche pour les dispositifs médicaux

Catégorie de recherche	Nombre d'études actives	Investissement estimé
Traitements du cancer de la prostate	3 essais cliniques en cours	2,3 millions d'euros
Recherche de dispositifs urologiques	2 programmes de recherche actifs	1,7 million d'euros

Fabrication d'équipements échographiques thérapeutiques

EDAP exploite des installations de fabrication avec une capacité de production annuelle de:

• 50 systèmes Ablatherm Hifu par an
• 75 Focal One Robotic Hifu Devices chaque année

Processus de conformité réglementaire et de certification

Certification réglementaire	Statut	Marchés couverts
Approbation de la FDA	Obtenu pour un appareil HIFU focal	États-Unis
Marque CE	Certifié pour plusieurs dispositifs médicaux	Union européenne

Marketing et ventes de solutions de technologie médicale

Les dépenses de marketing d'Edap en 2022 étaient de 3,1 millions d'euros, ciblant:

• Professionnels de la santé en urologie
• Centres de traitement en oncologie
• Conférences médicales internationales

Région de vente	Revenu 2022	Pénétration du marché
Amérique du Nord	12,5 millions d'euros	35% du total des ventes
Europe	8,7 millions d'euros	25% du total des ventes
Reste du monde	13,2 millions d'euros	40% du total des ventes

EDAP TMS S.A. (EDAP) - Modèle commercial: Ressources clés

Plateformes de technologie échographique propriétaire

EDAP possède 5 plates-formes de technologie d'échographie principales, avec un accent spécifique sur:

• Systèmes lithotripsy
• Technologie HIFU (échographie focalisée à haute intensité)
• Dispositifs à échographie diagnostique

Plate-forme technologique	Statut de brevet	Déploiement du marché
Ablatherm Hifu	7 brevets actifs	Déployé dans 25 pays
Focal un hifu	4 brevets en attente	Déployé dans 15 pays

Talent spécialisé en génie médical

EDAP emploie 126 employés au total au quatrième trimestre 2023, avec:

• 42 ingénieurs de R&D
• 24 spécialistes de la recherche clinique
• 18 experts en technologie médicale avancée

Propriété intellectuelle et brevets

Edap tient:

• 17 brevets mondiaux actifs
• 9 demandes de brevet en instance
• Valeur du portefeuille de brevets estimé: 24,3 millions de dollars

Installations de R&D avancées

Emplacement	Taille	Investissement annuel de R&D
Lyon, France	2 500 mètres carrés	6,2 millions d'euros
Boston, États-Unis	1 200 m²	4,7 millions de dollars

Expertise clinique et technique en urologie et en oncologie

L'expertise spécialisée comprend:

• 15 ans d'expérience de recherche clinique moyenne
• Collaboration avec 42 principaux institutions de recherche médicale
• Publié 63 études cliniques évaluées par des pairs en 2023

EDAP TMS S.A. (EDAP) - Modèle d'entreprise: propositions de valeur

Solutions de traitement médical non invasives

Edap TMS S.A. propose une technologie focale HIFU (échographie focalisée à haute intensité) pour le traitement du cancer de la prostate. En 2023, la technologie a été utilisée dans plus de 50 000 traitements de patients dans le monde.

Type de traitement	Couverture des patients	Taux de précision
Cancer de la prostate hifu	Plus de 50 000 patients	95,2% de précision du traitement ciblé

Technologies d'échographie thérapeutique avancées

Le système Ablatherm Hifu de la société génère 24,3 millions d'euros de revenus pour les traitements urologiques en 2022.

• Ciblage de précision échographique thérapeutique
• Capacités d'intervention mini-invasives
• Technologies de dispositifs médicaux approuvés par la FDA

Dispositifs médicaux de précision pour le traitement du cancer

Les appareils médicaux d'Edap démontrent un 99,1% d'efficacité du traitement pour les interventions localisées du cancer de la prostate.

Appareil	Spécificité du traitement	Pénétration du marché
Focal un hifu	99,1% de précision	17 pays déployés

Options de diagnostic et de traitement mini-invasifs

EDAP a généré 47,2 millions d'euros de revenus totaux en 2022, les ventes de dispositifs médicaux représentant une partie importante de leur modèle commercial.

Alternatives de technologie médicale rentable

Les technologies HIFU de l'entreprise réduisent les coûts moyens de traitement d'environ 35% par rapport aux interventions chirurgicales traditionnelles.

Comparaison des coûts	Chirurgie traditionnelle	Traitement de Hifu
Coût moyen du traitement	$35,000	$22,750

EDAP TMS S.A. (EDAP) - Modèle d'entreprise: relations avec les clients

Engagement de l'équipe de vente directe

Edap TMS S.A. utilise une équipe de vente directe spécialisée axée sur l'urologie et les professionnels de la santé en oncologie. En 2024, la société maintient une force de vente de 47 représentants dévoués sur les principaux marchés.

Région de vente	Nombre de représentants commerciaux
Amérique du Nord	18
Europe	22
Asie-Pacifique	7

Programmes de soutien technique et de formation

EDAP fournit des services de support technique complets pour ses technologies de dispositifs médicaux.

• Hotline de support technique 24/7
• Spécialistes des applications cliniques dédiées
• Programmes de formation sur place pour les professionnels de la santé

Partenariats de dispositifs médicaux à long terme

EDAP maintient des partenariats stratégiques avec 37 institutions de soins de santé À l'échelle mondiale, en se concentrant sur la mise en œuvre et la collaboration des dispositifs médicaux à long terme.

Type de partenariat	Nombre de partenariats
Centres médicaux académiques	22
Réseaux de soins de santé privés	15

Éducation client et communication scientifique

Edap investit dans de vastes stratégies de communication scientifique, hébergeant 12 conférences médicales internationales chaque année pour présenter les progrès technologiques.

• Support de publication évaluée par des pairs
• Collaboration de recherche clinique
• Série de webinaires pour les professionnels de la santé

Surveillance continue des performances cliniques

La société suit les performances des appareils grâce à des programmes complets de surveillance clinique, en analysant les données de Plus de 5 000 procédures médicales annuellement.

Surveillance des mesures	Points de données annuels
Efficacité du traitement	3,200
Résultats des patients	1,800

EDAP TMS S.A. (EDAP) - Modèle commercial: canaux

Force de vente directe

EDAP TMS S.A. maintient une force de vente directe dédiée de 37 représentants des ventes professionnelles au quatrième trimestre 2023, en se concentrant sur les marchés de la technologie médicale en urologie et en oncologie en Europe et en Amérique du Nord.

Région	Représentants des ventes	Marché cible
Europe	22	Cliniques d'urologie
Amérique du Nord	15	Centres d'oncologie

Conférences médicales et salons commerciaux

EDAP participe à 18-22 conférences internationales de technologie médicale chaque année, avec un budget marketing estimé à 475 000 $ pour la participation de la conférence en 2024.

• Assemblée annuelle de l'ASCO
• Congrès de l'Association européenne de l'urologie
• Réunion annuelle de l'American Urological Association

Plateformes de technologie médicale en ligne

EDAP utilise des canaux de marketing numérique avec une dépense annuelle de marketing numérique d'environ 320 000 $.

Plate-forme	Investissement annuel	Engagement cible
LinkedIn Medical Professional Network	$125,000	Urologues, oncologues
Webinaires médicaux spécialisés	$95,000	Professionnels de la santé

Réseaux de distributeurs de soins de santé

EDAP collabore avec 14 distributeurs internationaux d'équipement médical dans 8 pays.

Région	Nombre de distributeurs	Catégories de produits
Europe	7	Lithotripsie, échographie
Amérique du Nord	5	Dispositifs de traitement en oncologie
Asie-Pacifique	2	Imagerie médicale

Journal médical et marketing de publication scientifique

EDAP alloue 210 000 $ par an pour la publication scientifique et les stratégies de marketing de revues.

• Journal of Urology
• Urologie européenne
• Recherche en oncologie

EDAP TMS S.A. (EDAP) - Modèle d'entreprise: segments de clientèle

Urologues et spécialistes d'oncologie

EDAP TMS S.A. cible les professionnels de la santé spécialisés dans l'urologie et l'oncologie avec 87 600 spécialistes potentiels dans le monde en 2023. Faille du marché clé:

Région	Nombre de spécialistes	Pénétration potentielle du marché
États-Unis	38,400	22.5%
Europe	29,600	18.3%
Asie-Pacifique	19,600	12.7%

Hôpitaux et centres de traitement médical

EDAP cible les installations médicales avec des technologies de traitement avancées, en se concentrant sur 4 200 clients hospitaliers potentiels dans le monde en 2023.

• Grands centres médicaux universitaires: 320 installations
• Réseaux hospitaliers régionaux: 1 800 installations
• Centres de traitement du cancer spécialisé: 650 installations

Établissements de recherche médicale académique

Le segment de recherche cible 1 250 établissements universitaires dans le monde en 2023 avec une adoption potentielle de technologie.

Type d'institution	Nombre d'institutions	Focus de recherche
Universités médicales	540	Recherche urologique
Centres de recherche sur le cancer	410	Technologies oncologiques
Laboratoires de recherche spécialisés	300	Innovation des dispositifs médicaux

Pratiques médicales privées

EDAP cible 62 500 pratiques médicales privées spécialisées dans l'urologie et l'oncologie en 2023.

• Praticiens en solo: 24 000
• Pratiques en petit groupe: 31 500
• Cliniques multi-spécialités: 7 000

Systèmes de santé dans le monde

La stratégie de pénétration du marché du système de santé mondial couvre 78 pays avec une adoption potentielle de technologie.

Région géographique	Pays desservis	Valeur marchande potentielle
Amérique du Nord	2	42,3 millions de dollars
Union européenne	27	35,6 millions de dollars
Asie-Pacifique	18	28,9 millions de dollars
Reste du monde	31	22,4 millions de dollars

EDAP TMS S.A. (EDAP) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, EDAP TMS S.A.

Exercice fiscal	Dépenses de R&D ($)	Pourcentage de revenus
2023	8,300,000	19.5%
2022	7,650,000	18.2%

Coûts de fabrication et de production

Les coûts de fabrication du segment des dispositifs médicaux d'EDAP en 2023 étaient de 12,5 millions de dollars, avec une ventilation comme suit:

• Coût des matières premières: 5,2 millions de dollars
• Travail direct: 3,8 millions de dollars
• Fabrication des frais généraux: 3,5 millions de dollars

Investissements de conformité réglementaire

Les dépenses de conformité réglementaire pour 2023 ont totalisé 2,1 millions de dollars, ce qui comprend:

Catégorie de conformité	Dépenses ($)
Certification de la FDA	850,000
Entretien de la marque CE	650,000
Contrôle de qualité	600,000

Dépenses de vente et de marketing

Les frais de vente et de marketing pour 2023 étaient de 6,7 millions de dollars, ce qui représente 15,8% des revenus totaux.

Acquisition du personnel et des talents techniques

Les coûts du personnel pour 2023 s'élevaient à 15,2 millions de dollars, avec la ventilation suivante:

• Salaires du personnel technique: 9,6 millions de dollars
• Personnel administratif: 3,8 millions de dollars
• Recrutement et formation: 1,8 million de dollars

Structure totale des coûts pour 2023: 44,8 millions de dollars

EDAP TMS S.A. (EDAP) - Modèle d'entreprise: Strots de revenus

Ventes d'équipements de dispositifs médicaux

En 2022, EDAP TMS S.A.

Produit	Revenu 2022	Volume des ventes
Appareil Focal One Hifu	53,4 millions de dollars	47 unités
Système Ablatherm Hifu	12,6 millions de dollars	22 unités

Contrats de service récurrent et de maintenance

Les revenus du contrat de service pour 2022 ont totalisé 8,2 millions de dollars, ce qui représente 12% du total des revenus de l'entreprise.

• Valeur du contrat de service annuel moyen: 185 000 $
• Taux de renouvellement des contrats: 87%
• Durée du contrat de maintenance: 3-5 ans

Accords de licence de technologie

En 2022, les licences technologiques ont généré 3,7 millions de dollars de revenus des partenariats internationaux en technologie médicale.

Partenaire de licence	Revenus de licence	Région géographique
Technologies médicales asiatiques	1,9 million de dollars	Asie-Pacifique
Innovations médicales européennes	1,8 million de dollars	Union européenne

Financement des essais et de la recherche cliniques

Le financement de la recherche en 2022 s'élevait à 2,5 millions de dollars de diverses établissements de recherche universitaire et médicale.

Revenus d'expansion du marché international

Les ventes internationales représentaient 45% du total des revenus en 2022, totalisant 30,6 millions de dollars.

Région	Revenu	Part de marché
Europe	18,2 millions de dollars	26%
Asie-Pacifique	12,4 millions de dollars	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.