Établissement Labs Holdings Inc. (ESTA): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage dynamique de la technologie médicale des femmes, l'établissement Labs Holdings Inc. (ESTA) apparaît comme une force pionnière, révolutionnant les solutions d'implants mammaires et de reconstruction grâce à un modèle commercial méticuleusement conçu. En intégrant stratégiquement la recherche innovante, la fabrication de pointe et le marketing mondial ciblé, la société s'est positionnée comme un acteur transformateur dans l'industrie des dispositifs médicaux. Leur toile complète du modèle commercial révèle une approche sophistiquée qui va au-delà des stratégies traditionnelles de technologie médicale, en se concentrant sur des solutions de haute qualité et validées scientifiquement qui hiérarchisent la sécurité des patients et les résultats chirurgicaux.

Établissement Labs Holdings Inc. (ESTA) - Modèle commercial: partenariats clés

Fabricants et fournisseurs de dispositifs médicaux

Les laboratoires d'établissement collaborent avec des fabricants de dispositifs médicaux spécialisés en mettant l'accent sur les implants mammaires et la production de technologies régénératives.

Type de partenaire	Nombre de partenaires	Valeur de collaboration annuelle
Partenaires de fabrication primaires	7	12,3 millions de dollars
Fournisseurs de matières premières	15	4,7 millions de dollars

Réseaux de distribution de soins de santé

La société maintient des partenariats stratégiques avec les canaux mondiaux de distribution des soins de santé.

• North American Distribution Partners: 22
• Partenaires de distribution européenne: 18
• Partners de distribution d'Amérique latine: 12
• Asie-Pacifique Partners de distribution: 8

Institutions de recherche et universités

Région	Nombre de partenariats de recherche	Investissement de recherche annuel
États-Unis	6	2,1 millions de dollars
Europe	4	1,5 million de dollars
l'Amérique latine	3	$750,000

Partenaires de conformité réglementaire

Partenariats clés de la conformité réglementaire

• FDA Consultation Partners: 3
• Consultants de la réglementation des dispositifs médicaux européens (MDR): 4
• Organisation internationale des normes (ISO) Partenaires de conformité: 5

Entreprises d'investissement en technologie médicale

Catégorie de partenaire d'investissement	Nombre de partenaires	Investissement total garanti
Sociétés de capital-risque	8	45,6 millions de dollars
Investisseurs en capital-investissement	5	32,4 millions de dollars
Investisseurs de technologie médicale stratégique	6	28,2 millions de dollars

Établissement Labs Holdings Inc. (ESTA) - Modèle d'entreprise: activités clés

Recherche et développement des dispositifs médicaux

Dépenses de R&D en 2023: 24,3 millions de dollars

Zone de focus R&D	Montant d'investissement
Technologies d'implant mammaire	15,7 millions de dollars
Innovations pour la santé des femmes	8,6 millions de dollars

Fabrication de technologies médicales en santé des femmes

Installations de fabrication situées au Costa Rica

• Capacité de fabrication totale: 250 000 unités par an
• Processus de fabrication certifiés ISO 13485
• Taux d'efficacité de la production: 94,5%

Essais cliniques et tests de produits

Catégorie d'essai	Nombre d'essais en cours	Investissement total
Sécurité des implants mammaires	7 essais actifs	5,2 millions de dollars
Technologies de reconstruction	4 essais actifs	3,8 millions de dollars

Processus d'approbation réglementaire

Budget de conformité réglementaire: 3,5 millions de dollars en 2023

• Dispositifs médicaux approuvés par la FDA: 6 gammes de produits
• Certifications CE Mark: 4 catégories de produits
• Total des soumissions réglementaires: 12 en 2023

Stratégies mondiales de marketing et de vente

Région de marché	Revenus de vente	Pénétration du marché
Amérique du Nord	87,6 millions de dollars	42%
Europe	45,3 millions de dollars	28%
l'Amérique latine	32,1 millions de dollars	18%
Asie-Pacifique	22,5 millions de dollars	12%

Établissement Labs Holdings Inc. (ESTA) - Modèle d'entreprise: Ressources clés

Portefeuille de propriété intellectuelle

En 2024, l'établissement Labs Holdings Inc. détient 86 brevets accordés à l'échelle mondiale, avec un accent spécifique sur les technologies de l'implant mammaire et des dispositifs médicaux.

Catégorie de brevet	Nombre de brevets	Couverture géographique
Conception de l'implant mammaire	42	États-Unis, Europe, Amérique latine
Technique chirurgicale	24	Amérique du Nord, Europe
Technologie matérielle	20	Mondial

Équipes de génie avancé et de conception

La société maintient une équipe d'ingénierie spécialisée de 87 professionnels, avec 62% détenant des diplômes avancés en génie biomédical ou en domaines connexes.

• Personnel total de R&D: 87
• THEPORTS DES PHD: 24
• Titulaires de maîtrise: 30
• Expérience d'ingénierie moyenne: 9,4 ans

Installations de fabrication au Costa Rica

Les laboratoires d'établissement exploitent un complexe de fabrication de 45 000 mètres carrés à Alajuela, Costa Rica, certifié sous les normes de gestion de la qualité des dispositifs médicaux ISO 13485: 2016.

Métrique de l'installation	Spécification
Zone de fabrication totale	45 000 m²
Capacité de production annuelle	350 000 unités d'implants mammaires
Certifications de qualité	ISO 13485: 2016, FDA enregistré

Données de recherche clinique et expertise

La société a accumulé des données de 12 études cliniques impliquant 3 245 patients, une période de suivi cumulative dépassant 10 ans.

• Études cliniques totales: 12
• Participants des patients: 3 245
• Durée de l'étude la plus longue: 15 ans
• Publications évaluées par des pairs: 28

Souvent capital financier et soutien des investisseurs

Au quatrième trimestre 2023, l'établissement Labs a déclaré 89,4 millions de dollars en espèces et en espèces, avec un accès supplémentaire à 50 millions de dollars de facilités de crédit.

Métrique financière	Montant
Equivalents en espèces et en espèces	89,4 millions de dollars
Facilités de crédit disponibles	50 millions de dollars
Total des capitaux propres des actionnaires	246,7 millions de dollars

Établissement Labs Holdings Inc. (ESTA) - Modèle d'entreprise: propositions de valeur

Dispositifs médicaux innovants pour la santé des femmes

Eatebment Labs Holdings Inc. se concentre sur le développement des technologies avancées d'implants et de reconstructions mammaires. Au quatrième trimestre 2023, la société a rapporté:

Catégorie de produits	Revenu	Part de marché
Dispositifs de santé des femmes	126,4 millions de dollars	8,7% du marché mondial des implants mammaires

Technologies avancées des implants mammaires et de la reconstruction

Les principales innovations technologiques comprennent:

• Technologie de matrice de l'implant motiva
• Technologie de barrière protectrice de Buséal
• Q Inside Safety Technology Microchip

Technologie	Statut de brevet	Approbations réglementaires mondiales
Implants motiva	15 brevets actifs	CE Mark, FDA approuvé, TGA enregistré

Solutions médicales de haute qualité et scientifiquement validées

Investissement de recherche et développement en 2023:

Dépenses de R&D	Essais cliniques	Publications de recherche
18,3 millions de dollars	7 études cliniques en cours	23 publications évaluées par des pairs

Sécurité des patients et amélioration des résultats chirurgicaux

Métriques de sécurité pour les implants motiva:

• Taux de contracture capsulaire faible: 1,3%
• Taux de rupture: 0,5%
• Taux d'infection: 0,2%

Différenciation unique des produits sur le marché des technologies médicales

Positionnement concurrentiel en 2023:

Métrique du marché	ESTA Performance	Moyenne de l'industrie
Score d'innovation des produits	8.6/10	6.2/10
Taux de satisfaction client	94%	87%

Établissement Labs Holdings Inc. (ESTA) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les chirurgiens plasticiens

En 2023, les laboratoires d'établissement ont signalé un engagement direct avec environ 5 200 chirurgiens plasticiens dans le monde. La société maintient une force de vente spécialisée de 78 représentants des ventes directes ciblant les professionnels de la santé.

Métrique de l'engagement	2023 chiffres
Total des chirurgiens plasticiens engagés	5,200
Représentants des ventes directes	78
Marchés géographiques couverts	25 pays

Programmes de soutien technique et de formation

Eatebment Labs fournit une infrastructure de soutien technique complète avec Canaux de soutien professionnel médical 24/7 24/7.

• Sessions de formation annuelles: 42 ateliers spécialisés
• Modules de formation en ligne: 18 cours numériques uniques
• Participants de la formation cumulative en 2023: 1 487 professionnels de la santé

Plateformes de service client en ligne

Métrique de la plate-forme	Performance de 2023
Temps de réponse moyen	2,4 heures
Évaluation de satisfaction du client	4.7/5.0
Interactions de support numérique	14 623 annuel

Conférence médicale et participation à l'événement de l'industrie

En 2023, les laboratoires d'établissement ont participé à 37 conférences médicales internationales, avec un engagement direct de 2 345 professionnels de la santé.

Services de consultation personnalisés

La société propose des services de consultation spécialisés avec des professionnels de la liaison médicale dédiés, avec une moyenne de 215 consultations personnalisées mensuellement.

Métrique du service de consultation	2023 données
Consultations personnalisées mensuelles	215
Langages de consultation soutenus	7
Durée de consultation moyenne	47 minutes

Établissement Labs Holdings Inc. (ESTA) - Modèle d'entreprise: canaux

Force de vente directe

En 2024, les laboratoires d'établissement maintiennent une force de vente directe dédiée d'environ 80 représentants commerciaux dans plusieurs régions géographiques.

Région	Nombre de représentants commerciaux
Amérique du Nord	35
l'Amérique latine	25
Europe	15
Asie-Pacifique	5

Distributeurs de dispositifs médicaux

La société travaille avec 42 distributeurs de dispositifs médicaux approuvés dans le monde, couvrant les marchés clés.

• Le réseau de distribution s'étend sur 25 pays
• Revenus de distribution annuels: 47,3 millions de dollars
• Durée du partenariat moyen des distributeurs: 4,2 ans

Plateformes d'informations sur les produits en ligne

Les plates-formes numériques génèrent environ 28% de l'engagement des informations sur les produits.

Type de plate-forme	Visiteurs uniques mensuels
Site Web de l'entreprise	185,000
Plateformes de réseautage des chirurgiens	95,000
Portails de recherche médicale	62,000

Expositions de la conférence médicale

Participation à 18 conférences médicales majeures chaque année.

• Total de conférence As fréquenté: 7 200 professionnels de la santé
• Leads moyens générés par conférence: 240
• Taux de conversion à partir des chefs de conférence: 12,5%

Canaux de marketing numérique et de commerce électronique

Budget du marketing numérique: 3,6 millions de dollars en 2024.

Canal numérique	Dépenses marketing	Taux de conversion
Liendin	$850,000	3.2%
Annonces médicales ciblées	$1,200,000	2.7%
Plateformes communautaires chirurgicales	$750,000	4.1%
Publicité programmatique	$800,000	1.9%

Établissement Labs Holdings Inc. (ESTA) - Modèle d'entreprise: segments de clientèle

Chirurgiens plasticiens

Depuis le quatrième trimestre 2023, les laboratoires d'établissement desservent environ 3 500 chirurgiens plasticiens dans le monde, avec une concentration aux États-Unis, au Brésil et en Europe.

Région	Nombre de chirurgiens plasticiens servis	Pénétration du marché
États-Unis	1,750	42%
Brésil	680	22%
Europe	570	18%
Autres régions	500	18%

Professionnels de la chirurgie reconstructive

En 2023, les laboratoires d'établissement ont soutenu 1 200 professionnels de la chirurgie reconstructive, en mettant l'accent sur les procédures de reconstruction mammaire.

• Marché de la reconstruction du cancer du sein: 250 000 procédures par an
• Chirurgiens reconstructifs cibles: 35% du marché total adressable
• Revenu moyen par chirurgien reconstructif: 85 000 $ par an

Institutions de soins de santé

L'entreprise dessert 425 établissements de santé dans plusieurs pays à partir de 2024.

Type d'institution	Nombre d'institutions	Valeur d'achat annuelle
Hôpitaux	275	42 millions de dollars
Cliniques spécialisées	110	18 millions de dollars
Centres médicaux académiques	40	7,5 millions de dollars

Services d'approvisionnement des dispositifs médicaux

Les laboratoires d'établissement s'engagent avec 180 services d'approvisionnement de dispositifs médicaux dans le monde.

• Valeur du contrat d'approvisionnement moyen: 350 000 $
• Taux de renouvellement des contrats: 87%
• Départements d'approvisionnement par région:
  • Amérique du Nord: 75
  • Europe: 55
  • Amérique latine: 35
  • Asie-Pacifique: 15

Femmes à la recherche de reconstruction ou d'augmentation mammaire

Marché total des patients adressables en 2023: 1,8 million de femmes dans le monde.

Type de procédure	Procédures annuelles	Part de marché
Augmentation mammaire	1,350,000	15%
Reconstruction mammaire	450,000	12%

Établissement Labs Holdings Inc. (ESTA) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, l'establishment Labs a déclaré des dépenses de R&D de 22,6 millions de dollars, ce qui représente 23,4% des revenus totaux.

Exercice fiscal	Dépenses de R&D	Pourcentage de revenus
2023	22,6 millions de dollars	23.4%
2022	19,3 millions de dollars	21.7%

Coûts de fabrication et de production

Les coûts de fabrication totaux pour 2023 étaient de 35,4 millions de dollars, avec une ventilation comme suit:

• Coûts de matériel direct: 18,2 millions de dollars
• Coûts de main-d'œuvre directs: 9,7 millions de dollars
• Fabrication des frais généraux: 7,5 millions de dollars

Investissements de conformité réglementaire

Les dépenses liées à la conformité pour 2023 ont totalisé 5,8 millions de dollars, notamment:

Catégorie de conformité	Dépenses
Soumissions réglementaires de la FDA	2,3 millions de dollars
Systèmes de gestion de la qualité	1,9 million de dollars
Conformité des essais cliniques	1,6 million de dollars

Dépenses de marketing et de vente

Les frais de marketing et de vente pour 2023 ont atteint 28,7 millions de dollars, ce qui représente 29,7% des revenus totaux.

• Compensation de l'équipe de vente: 12,4 millions de dollars
• Campagnes marketing: 9,3 millions de dollars
• Dépenses de salon et de conférence: 4,5 millions de dollars
• Marketing numérique: 2,5 millions de dollars

Maintenance de la propriété intellectuelle

Les coûts liés à la propriété intellectuelle pour 2023 étaient de 3,2 millions de dollars, notamment:

• Dépôt et entretien des brevets: 1,8 million de dollars
• Frais juridiques pour la protection IP: 1,4 million de dollars

Structure totale des coûts pour 2023: 95,7 millions de dollars

Établissement Labs Holdings Inc. (ESTA) - Modèle d'entreprise: Strots de revenus

Ventes de dispositifs médicaux

Au troisième trimestre 2023, l'établissement des laboratoires a déclaré des ventes de dispositifs médicaux de 40,7 millions de dollars, ce qui représente une croissance de 17% en glissement annuel. Les principales gammes de produits comprennent les implants motiva et les technologies chirurgicales connexes.

Catégorie de produits	Revenus (T1 2023)	Taux de croissance
Implants motiva	32,5 millions de dollars	15%
Accessoires chirurgicaux	8,2 millions de dollars	22%

Accords de licence de produit

Les revenus de licence pour 2023 ont totalisé 3,6 millions de dollars, avec des partenariats internationaux sur les marchés clés.

• Accords de licence européens: 1,8 million de dollars
• Licence du marché asiatique: 1,2 million de dollars
• Licence latino-américaine: 600 000 $

Frais de consultation en technologie chirurgicale

Les services de consultation ont généré 2,1 millions de dollars de revenus en 2023, avec des programmes de formation spécialisés pour les professionnels de la santé.

Expansion du marché international

Les ventes internationales ont représenté 65% des revenus totaux en 2023, totalisant 78,3 millions de dollars dans plusieurs régions géographiques.

Région	Revenu	Part de marché
Europe	35,2 millions de dollars	45%
l'Amérique latine	22,5 millions de dollars	29%
Asie-Pacifique	15,6 millions de dollars	20%
Amérique du Nord	5 millions de dollars	6%

Ventes récurrentes de professionnels de la santé

Les revenus récurrents des réseaux de professionnels de la santé ont atteint 12,5 millions de dollars en 2023, avec une augmentation de 20% des transactions clients répétées.

• Programmes de formation chirurgicale: 4,2 millions de dollars
• Support produit en cours: 5,3 millions de dollars
• Consommables et pièces de remplacement: 3 millions de dollars

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

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

Enhanced safety profile and low complication rates (Motiva)

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

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

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

Premium, high-technology breast aesthetics and reconstruction solutions

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

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

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

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

Integrated digital tools for surgical planning and patient experience

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

Motiva Flora tissue expander for post-mastectomy reconstruction

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

Finance: draft 13-week cash view by Friday.

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

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

High-touch, direct engagement with plastic surgeons for training

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

Dedicated clinical support for surgical procedures

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

Long-term patient warranty and safety programs

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

Educational content and awareness campaigns for end-consumers

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

Building a community around women's health and wellness

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

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

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

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

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

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

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

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

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

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

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

Established Network of Medical Distributors in International Markets

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

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

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

Digital Platforms for Surgeon Education and Product Ordering

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

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

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

Mia Femtech Clinics for the Minimally Invasive Procedure

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

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

Investor Relations Website for Financial Transparency

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

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

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

Finance: draft 13-week cash view by Friday.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Finance: draft 13-week cash view by Friday.

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

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

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

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

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

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

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

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

The key drivers underpinning these revenue streams include:

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