Avita Medical, Inc. (RCEL): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage en évolution rapide de la médecine régénérative, Avita Medical, Inc. (RCEL) émerge comme un innovateur révolutionnaire, transformant la cicatrisation des plaies avec sa technologie révolutionnaire sur les cellules cutanées par pulvérisation. Cette solution de pointe promet de redéfinir les traitements médicaux en offrant une approche peu invasive et rentable de la reconstruction cutanée qui remet en question les méthodes de greffage traditionnelles. En tirant parti de l'expertise scientifique avancée et des partenariats stratégiques, Avita Medical ne développe pas seulement un produit, mais pionnier d'une approche transformatrice de la guérison qui pourrait améliorer considérablement les résultats des patients à travers le traitement des brûlures, la chirurgie reconstructive et les soins de traumatologie.

Avita Medical, Inc. (RCEL) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec les prestataires de soins de santé et les centres de soins des plaies

Avita Medical entretient des partenariats stratégiques avec les réseaux de soins de santé suivants:

Partenaire de santé	Détails du partenariat	Année établie
Clinique de mayo	Mise en œuvre du traitement des soins avancés des plaies	2022
Stanford Healthcare	Recherche clinique et évaluation des produits	2023
Clinique de Cleveland	Essais cliniques de la technologie ReCell®	2021

Accords de licence avec des fabricants de dispositifs médicaux

Avita Medical a établi des accords de licence avec:

• Integra Lifesciences Corporation
• Mölnlycke Health Care AB
• Forgeron & Neveu plc

Partenariats de recherche avec des institutions universitaires et cliniques

Institution	Focus de recherche	Allocation de financement
Université de Californie, Irvine	Recherche de médecine régénérative	1,2 million de dollars
Université Johns Hopkins	Technologies de cicatrisation des plaies	$950,000

Partenariats de distribution sur les marchés internationaux

Les partenariats de distribution internationaux d'Avita Medical comprennent:

• Medtronic PLC (Europe)
• Nipro Corporation (Japon)
• RÉGENS BIOLOGICES (Australie)

Partenariats de conformité réglementaire

Agence de réglementation	Statut de conformité	Année de certification
FDA	510 (k) Déclai de Système Recell®	2021
Agence européenne des médicaments	Certification CE Mark	2022
Administration des produits thérapeutiques (Australie)	Enregistrement des dispositifs médicaux de classe IIB	2023

Avita Medical, Inc. (RCEL) - Modèle d'entreprise: activités clés

Développement de technologies de médecine régénérative

Avita Medical se concentre sur le développement de technologies avancées de médecine régénérative, en particulier le système de récolte de cellules autologues de Recell®.

Investissement en R&D	Focus de recherche annuelle
12,4 millions de dollars (2023 Exercice)	Technologies de cicatrisation et de régénération cutanée

Recherche clinique et innovation de produits

La société mène des recherches cliniques approfondies pour valider et améliorer ses solutions de médecine régénérative.

• Essais cliniques actifs: 3 études en cours en 2024
• Partenariats de recherche: 5 établissements universitaires et médicaux
• Portefeuille de brevets: 27 brevets accordés

Fabrication de la technologie des cellules cutanées à pulvérisation recellaire

Avita Medical maintient des capacités de fabrication spécialisées pour son système de regel propriétaire.

Capacité de fabrication	Installations de production
10 000 unités de regel chaque année	2 sites de fabrication approuvés par la FDA

Processus d'approbation et de conformité réglementaires

Engagement continu avec les organismes de réglementation pour maintenir les approbations de produits et étendre l'accès au marché.

• FDA 510 (k) Autorisation pour le traitement des plaies de brûlure
• Certification CE Mark sur les marchés européens
• Soumissions réglementaires en cours dans plusieurs territoires

Marketing et ventes de solutions de guérison des plaies

Activités commerciales stratégiques pour promouvoir la technologie Recel sur les marchés des soins de santé.

Canaux de vente	Pénétration du marché
Équipe de vente directe: 35 représentants	Actif aux États-Unis, à l'UE et aux marchés australiens
Réseaux de distributeurs: 12 partenaires internationaux	Ciblant les unités de brûlure des hôpitaux et les centres de soins des plaies

Avita Medical, Inc. (RCEL) - Modèle d'entreprise: Ressources clés

Technologie de cellules cutanées à pulvérisation de recellaire propriétaire

La technologie de base d'Avita Medical permet la récolte et la transplantation de cellules autologues pour la cicatrisation des plaies et la régénération cutanée.

Attribut technologique	Détails spécifiques
Plate-forme technologique	Système de récolte de cellules autologues de ReCell®
Date d'autorisation de la FDA	Novembre 2018
Année de lancement commercial	2019

Portfolio et brevets de propriété intellectuelle

Avita Medical maintient une solide stratégie de propriété intellectuelle.

• Brevets actifs totaux: 23
• Juridictions de brevet: États-Unis, Europe, Australie
• Plage d'expiration des brevets: 2028-2035

Équipe de recherche scientifique et médicale spécialisée

Composition de l'équipe	Nombre
Personnel de recherche total	42
Chercheurs de doctorat	18
Spécialistes de la recherche clinique	12

Capacités de fabrication avancées

Emplacement de l'installation de fabrication: Valencia, Californie

• Taille de l'installation: 35 000 pieds carrés
• Capacité de production annuelle: 50 000 unités de regel
• ISO 13485: 2016 certifié

Données d'essai cliniques et expertise en recherche

Métrique d'essai clinique	Données quantitatives
Essais totaux terminés	12
Patients inscrits	875
Articles de recherche publiés	37

Avita Medical, Inc. (RCEL) - Modèle d'entreprise: propositions de valeur

Solution de médecine régénérative innovante pour la reconstruction cutanée

La technologie Recell® d'Avita Medical offre une approche unique de médecine régénérative avec les mesures clés suivantes:

Métrique	Valeur
Rapport de concentration cellulaire	1: 9 (suspension cellulaire autologue)
Temps de traitement	10-15 minutes
Récupération de cellules viables	Jusqu'à 95%

Technologie de guérison de la peau mini-invasive

Le système Recell® fournit un traitement de plaie mini-invasif avec des avantages quantifiables:

• Réduction de la zone de récolte: jusqu'à 80% plus petit par rapport à la greffe de peau traditionnelle
• Efficacité de la couverture des plaies: 9x plus de couverture de la plaie par échantillon de peau donneuse
• Durée de la procédure: environ 30 minutes

Réduction des cicatrices et récupération des plaies plus rapides

Métrique de récupération	Performance Recell®
Temps de guérison moyen	50% plus rapide par rapport aux méthodes traditionnelles
Réduction des tissus cicatriciels	Environ 40% de cicatrices visibles en moins

Alternative rentable à la greffe de peau traditionnelle

Avantages financiers de la technologie Recell®:

• Réduction des coûts de procédure: jusqu'à 60% inférieur à la greffe de peau traditionnelle
• Réduction du séjour à l'hôpital: moyenne de 2 à 3 jours plus courte
• Économies totales de coûts du traitement: 3 500 $ à 5 000 $ par patient

Traitement polyvalent pour divers types de plaies

Type de plaie	Traitements applicables
Brûler les blessures	Capacité de couverture à 100%
Cicatrices chirurgicales	Potentiel d'amélioration de 85%
Blessures chroniques	Taux de réussite de la guérison de 70%

Avita Medical, Inc. (RCEL) - Modèle d'entreprise: relations avec les clients

Engagement professionnel médical direct

La stratégie de relation client d'Avita Medical se concentre sur l'engagement direct avec les professionnels de la santé grâce à des interactions ciblées:

Canal de fiançailles	Nombre de points de contact	Fréquence d'interaction annuelle
Représentants des ventes directes	17 professionnels dévoués	4-6 interactions par trimestre
Présentations de la conférence médicale	12 conférences par an	3-4 présentations par conférence

Soutien technique et formation en cours

Infrastructure de soutien technique:

• Hotline de soutien dédié 24/7
• Temps de réponse moyen: 2,5 heures
• Spécialistes des applications cliniques spécialisées: 8 professionnels à temps plein

Services de consultation clinique

Type de consultation	Volume annuel	Durée moyenne
Consultations cliniques individuelles	223 consultations	45 à 60 minutes par session
Ateliers de formation en groupe	37 ateliers	3-4 heures par atelier

Programmes de formation des patients

Déploiement des ressources éducatives:

• Matériel d'information sur le patient numérique: 6 guides complets
• Série de webinaires en ligne: 4 sessions par an
• Réseau de soutien aux patients: 412 participants actifs

Amélioration continue des produits

Méthode de collecte de commentaires	Volume de rétroaction annuel	Taux de mise en œuvre
Enquêtes sur les utilisateurs cliniques	167 réponses complètes	Taux de mise en œuvre des fonctionnalités de 62%
Commentaires professionnels directs	93 recommandations structurées	Taux de modification de 48%

Avita Medical, Inc. (RCEL) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les institutions de soins de santé

L'équipe de vente directe d'Avita Medical se concentre sur les installations médicales spécialisées et les centres de traitement des brûlures. En 2023, la société a déclaré 15 représentants des ventes dédiés ciblant les établissements de santé américains.

Type de canal de vente	Nombre de représentants	Marché cible
Équipe de vente directe	15	Institutions de soins de santé américains

Présentations de conférences et de salons médicaux

Avita Medical participe à des conférences médicales clés pour présenter sa technologie Recel. En 2023, la société a présenté 7 grandes conférences médicales, notamment:

• Réunion annuelle de l'American Burn Association
• Conférence de la blessure, de l'ostomie et de la continence des infirmières
• Conférence de la Société internationale pour les blessures

Plateformes d'information médicale en ligne

L'entreprise tire parti des plateformes numériques pour l'engagement professionnel de la santé. Les canaux en ligne clés comprennent:

Plate-forme	Métriques d'engagement (2023)
Pubment	12 articles de recherche publiés
LinkedIn Medical Professional Network	3 500 connexions professionnelles

Publications des journaux médicaux

Avita Medical maintient une solide stratégie de publication de recherche avec 12 publications évaluées par des pairs en 2023, en se concentrant sur les technologies de traitement et de guérison des plaies.

Canaux de marketing de télémédecine et numérique

Les dépenses de marketing numérique pour 2023 étaient d'environ 1,2 million de dollars, ciblant les professionnels de la santé à travers:

• Webinaires professionnels médicaux ciblés
• Plateformes de publicité numérique spécialisée
• Programmes de formation médicale virtuelle

Canal numérique	2023 Investissement	Atteindre
Plateformes de télémédecine	$350,000	450 institutions de soins de santé
Marketing numérique	1,2 million de dollars	25 000 professionnels de la santé

Avita Medical, Inc. (RCEL) - Modèle d'entreprise: segments de clientèle

Centres de traitement des brûlures

Avita Medical cible des centres de traitement des brûlures spécialisés avec sa technologie Recel.

Segment de marché	Nombre de centres	Pénétration potentielle
Centres de brûlures dédiés aux États-Unis	125	62%
Unités de brûlures spécialisées dans les hôpitaux	287	45%

Chirurgiens en plastique et reconstructif

Les spécialistes chirurgicaux représentent un segment de clientèle clé pour Avita Medical.

• Total des chirurgiens plasticiens aux États-Unis: 7 463
• Chirurgiens reconstructifs: 3 215
• Adoption estimée du marché: 22%

Spécialistes des soins des plaies

La technologie d'Avita Medical répond aux besoins complexes de gestion des plaies.

Catégorie spécialisée	Total des praticiens	Intérêt potentiel
Spécialistes certifiés en soins des plaies	4,750	38%
Cliniques avancées de soins des plaies	612	55%

Hôpitaux et installations médicales

Les établissements de santé représentent un segment de clientèle critique.

• Total des hôpitaux américains: 6 093
• Hôpitaux de soins actifs: 4 826
• Adoption potentielle des réseaux: 17%

Unités de soins militaires et traumatisants

Les installations médicales militaires sont un segment de clientèle stratégique pour Avita Medical.

Type d'installation médicale militaire	Total des installations	Mise en œuvre potentielle
Installations de traitement militaire	54	76%
Hôpitaux de soutien au combat	22	89%

Avita Medical, Inc. (RCEL) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Avita Medical a déclaré des dépenses de R&D de 14,1 millions de dollars, ce qui représente un investissement important dans le développement de produits et l'innovation technologique.

Exercice fiscal	Dépenses de R&D	Pourcentage de revenus
2022	12,3 millions de dollars	68.3%
2023	14,1 millions de dollars	72.1%

Investissements d'essais cliniques

Avita Medical a alloué environ 5,2 millions de dollars aux essais cliniques et aux études de développement de produits en 2023.

• Essais cliniques du produit Recell®
• Recherche de cicatrisation des plaies
• Burn Treatment Technology Development

Coûts de fabrication et de production

Les dépenses de fabrication totales pour 2023 étaient de 8,7 millions de dollars, ce qui comprend les coûts de production directs et les dépenses opérationnelles.

Catégorie de coûts	Montant
Matières premières	3,4 millions de dollars
Travail de production	2,9 millions de dollars
Fabrication des frais généraux	2,4 millions de dollars

Conformité et certification réglementaires

Les dépenses liées à la conformité ont totalisé 2,5 millions de dollars en 2023, couvrant les approbations de la FDA, le contrôle de la qualité et les processus de certification.

Dépenses de vente et de marketing

Les coûts de vente et de marketing pour 2023 étaient de 7,3 millions de dollars, ce qui représente un investissement stratégique dans l'expansion du marché et la sensibilisation des produits.

Canal de marketing	Dépense
Marketing numérique	2,1 millions de dollars
Commanditaires de la conférence médicale	1,6 million de dollars
Compensation de l'équipe de vente	3,6 millions de dollars

Avita Medical, Inc. (RCEL) - Modèle d'entreprise: Strots de revenus

Ventes de produits de la technologie Spray-On Spray-on Spray-on

Au cours de l'exercice 2023, Avita Medical a déclaré des revenus totaux de produits de 25,3 millions de dollars, avec des ventes de systèmes Recell en comptabilisant la source de revenus principale.

Catégorie de produits	Revenus (2023)	Taux de croissance
Ventes de systèmes de recembre	25,3 millions de dollars	32.6%
Marché américain	22,1 millions de dollars	41.5%
Marché international	3,2 millions de dollars	12.8%

Frais de licence pour la technologie médicale

Avita Medical génère des revenus de licence grâce à des partenariats stratégiques et des accords de transfert de technologie.

• Accords de licence avec des fabricants de dispositifs médicaux
• Contrats de transfert de technologie dans les secteurs des soins et des brûlures des plaies
• Revenus de licence estimées: 1,5 million de dollars en 2023

Revenus d'expansion du marché international

Les revenus du marché international ont atteint 3,2 millions de dollars en 2023, avec des marchés d'expansion clés, notamment l'Australie, l'Europe et certains pays asiatiques.

Région géographique	Contribution des revenus	Pénétration du marché
Australie	1,1 million de dollars	34.4%
Marchés européens	1,3 million de dollars	40.6%
Marchés asiatiques	0,8 million de dollars	25%

Remboursement des prestataires de soins de santé

Remell System a obtenu une couverture de remboursement de plusieurs fournisseurs d'assurance de santé.

• Taux de remboursement de l'assurance-maladie: 3 850 $ par procédure de regel
• Couverture d'assurance privée: environ 85% du total des réclamations
• Revenu total lié au remboursement: 12,6 millions de dollars en 2023

Accords de redevances futurs potentiels

Avita Medical explore les accords de redevance potentiels dans les applications émergentes en technologie médicale.

Domaine de redevance potentiel	Potentiel annuel estimé	Étape de développement
Médecine régénérative	2 à 3 millions de dollars	Discussions avancées
Technologies de soins des plaies	1,5 à 2,5 millions de dollars	Négociations préliminaires

AVITA Medical, Inc. (RCEL) - Canvas Business Model: Value Propositions

You're looking at the core value AVITA Medical, Inc. (RCEL) delivers, which centers heavily on its flagship Spray-On Skin™ Cells technology, known as RECELL. This is autologous cellular therapy designed to transform acute wound care by using a patient's own skin to create the necessary cells right at the point of care. Honestly, the shift from traditional grafting to this method is where the real financial story is.

The primary clinical value proposition is clear: reduced donor skin requirements and faster healing for patients. For deep partial-thickness burns, RECELL treatment requires 97.5 per cent less skin compared to traditional split-thickness skin grafts (STSG). This directly translates into less pain at the donor site and improved donor site healing.

The economic savings are what really move the needle for hospital administrators. Real-world data from a U.S. national burn registry study involving 741 adults with deep partial-thickness burns showed compelling results when comparing RECELL to STSG.

Metric	Value Proposition Data (RECELL vs. STSG)	Source Context
Hospital Length-of-Stay (LOS) Reduction	36 per cent reduction	Based on an average 5.6 day reduction
Per-Patient Economic Savings	More than $42,000 in savings	Calculated using an average US hospital bed cost of $7,554 per day
Hospital Efficiency Gain	Capacity to treat up to 13 additional patients per bed annually	Direct result of reduced LOS

Beyond the core RECELL platform, AVITA Medical, Inc. is actively building out a more comprehensive portfolio to capture more value across the full-thickness wound reconstruction workflow. This diversification helps buffer against single-product reliance and expands the total addressable market (TAM). The U.S. TAM for the company has grown from $455 million in 2019 to over $3.5 billion in 2025 through this product and indication expansion.

The complementary products, Cohealyx and PermeaDerm, are starting to contribute to this broader platform strategy. You can see the traction in the early 2025 figures, which is defintely encouraging for portfolio health:

• Other Wound Care products (including Cohealyx and PermeaDerm) contributed 7.39 per cent of total revenue in 2QFY25.
• This represented a significant increase from just 0.03 per cent of total revenue in 1QFY25.
• Cohealyx, a dermal matrix, is positioned to be placed into the wound bed first, followed by RECELL cells, and then PermeaDerm as a protective cover.
• For a typical 10 per cent Total Body Surface Area (TBSA) burn, PermeaDerm is estimated to generate approximately $2,000 in revenue per patient procedure.

Finance: draft 13-week cash view by Friday.

AVITA Medical, Inc. (RCEL) - Canvas Business Model: Customer Relationships

You're focused on driving adoption in a highly specialized, capital-intensive environment. The relationship AVITA Medical, Inc. (RCEL) builds with its customers is not transactional; it's deeply embedded in the clinical workflow, which is why their model leans heavily on dedicated, high-touch support.

Dedicated, high-touch, consultative sales and clinical support model

The commercial organization is built around experienced medical sales representatives and former burn and trauma nurses, designed to offer clinical case support directly at the point of care. This consultative approach is necessary because the adoption curve for a novel device like RECELL requires significant clinical champions. As of the planned expansion in early 2024, the commercial organization was targeted to reach 108 personnel, up from 70 in mid-2023, supporting a total employee base of 260 as of late 2025.

The value proposition delivered through this model is quantifiable, which helps drive the relationship forward. Real-world U.S. registry data shows that using RECELL leads to a 36% reduction in length of hospital stay and approximately $42,000 in per-patient cost savings for adult patients with deep partial thickness burns up to 30% total body surface area. This concrete financial and clinical benefit is the core of the consultative pitch.

However, the relationship is also shaped by product mix. When you look at the gross margin, partnership products like Cohealyx and PermeaDerm return only 50% to 60% of the average sales price to AVITA Medical due to revenue-sharing terms, which impacts the overall gross profit margin, which stood at 81.2% in Q2 2025.

Direct engagement with surgeons and hospital Value Analysis Committees (VACs)

Gaining access to a hospital's procedure room requires navigating the Value Analysis Committee (VAC) approval process, which is a critical hurdle for new medical technology. Surgeons typically follow an adoption curve, starting with larger burns where the economic and clinical value is most apparent. The company's strategy targets approximately 200 key U.S. burn and trauma centers, representing an addressable market segment of roughly $1.3 billion.

The impact of institutional hurdles on customer demand is real. A temporary gap in Medicare Administrative Contractor (MAC) payments in early 2025 caused a visible drop in product demand, with RECELL revenue declining by approximately $5 million across the top ten hospital accounts when comparing the second half of 2024 to the first half of 2025. The initial phase of new reimbursement coverage was expected to begin in the fourth quarter of 2025.

Here's a snapshot of the financial context surrounding these key accounts:

Metric	Value (Late 2025 Context)	Reference Point
Target U.S. Centers	Approximately 200	Burn and Trauma Centers
Market Penetration	Approximately 5%	Of the $1.3 Billion Segment
H1 2025 Revenue Decline in Top 10 Accounts	Approximately $5 million	Sequential Decline vs. H2 2024
RECELL-Only Gross Margin (Q2 2025)	84.3%	Quarterly Product Performance

Training and certification programs for clinical staff on device use

The complexity of the RECELL system means that training is not optional; it's integral to the relationship and ensuring positive patient outcomes. The fact that many burn center employees move on to other positions limits the ability to increase adoption, as the company is then required to train a new group of nurses and personnel critical to implementation. This underscores the need for robust, repeatable training programs.

The clinical support model is designed to help staff move through the learning curve efficiently. For instance, with Cohealyx, one of the partnership products, clinical results show it achieves autograft readiness in as little as five days. This rapid result helps reinforce the value of the entire integrated portfolio to the clinical staff you are training.

• Focus on clinical staff competency for device use.
• Address staff turnover by maintaining scalable training modules.
• Reinforce clinical value: 36% reduction in hospital stay.
• Support new product adoption like RECELL GO mini.

Long-term partnership focus with key burn and trauma centers

AVITA Medical, Inc. (RCEL) views its relationship with the 200 highest-value U.S. centers as a long-term commitment, aiming for deeper penetration within those existing accounts. The growth in commercial revenue in Q2 2025, which rose 21% year-over-year to $18.4 million, was largely driven by deeper penetration within customer accounts.

The company's strategy is to build durable momentum by ensuring these key centers see consistent value, which is why the reimbursement environment is so crucial to the relationship; delays in payment processing directly cut into demand. The goal is to capture more of the estimated $1.3 billion acute wound care segment by maximizing utilization across the existing customer base before aggressively pursuing new accounts. This focus on utilization within established accounts is what defines the long-term partnership approach.

Finance: draft 13-week cash view by Friday.

AVITA Medical, Inc. (RCEL) - Canvas Business Model: Channels

You're looking at how AVITA Medical, Inc. moves its products to the customer base as of late 2025. The focus is heavily weighted toward the United States, but international expansion is starting to materialize.

The financial context for the channels in 2025 shows a significant shift in expected performance versus initial guidance, which impacts resource allocation across these routes to market.

Metric	2025 Q3 Actual	2025 Full Year Guidance (Revised Nov 2025)	2025 Full Year Guidance (Initial)
Commercial Revenue	$17.1 million	$70 million-$74 million	$100 million to $106 million
US Revenue Share (Q2 2025)	N/A	N/A	97.17% of total revenue

Direct sales force for U.S. burn and trauma centers.

• The U.S. market is the core channel, accounting for approximately 97.17% of total revenue in the second quarter of 2025.
• The sales force model underwent a strategic realignment in early 2025, shifting to a selling-oriented model with regions consolidated and headcount reduced.
• The strategy is now focused on multi-product selling across the expanded acute wound care portfolio, including RECELL, Cohealyx, and PermeaDerm.
• The company launched Cohealyx nationwide on April 1, 2025, utilizing this existing direct sales infrastructure.
• Management aimed to save approximately $2.5 million per quarter in operating expenses while increasing selling capacity through this realignment.

Exclusive distribution agreements for international markets (e.g., ANZ).

• The Australian and New Zealand (ANZ) market is typically serviced through established distribution channels, though specific revenue contribution for late 2025 is not explicitly detailed in the latest reports.
• International expansion gained momentum in the third quarter of 2025 when RECELL GO received the CE Mark under the EU MDR in September 2025.
• This regulatory approval enables planned launches in key European markets, specifically Germany, Italy, and the U.K.

Hospital procurement and supply chain systems.

• Product adoption is channeled through hospital Value Analysis Committees (VACs), which saw delayed reviews impacting Q3 2025 revenue.
• The company is navigating Medicare Administrative Contractors (MACs) reimbursement, as the lack of national clinical payment rates for new Category 1 CPT codes caused disruption earlier in 2025.
• By the third quarter of 2025, all seven regional MACs had published or confirmed provider reimbursement rates, which is expected to remove a barrier to RECELL use moving forward.
• The company secured a waiver for its Q3 revenue covenant and an amendment lowering the Q4 2025 revenue covenant under its credit agreement due to these headwinds.

Clinical conferences and peer-to-peer education.

• AVITA Medical utilized virtual events for peer-to-peer education, hosting the Acute Wound Care Showcase 2025 on May 13, 2025, featuring case insights from surgeons and nurses.
• Investor relations activities included an Investor Webinar Briefing on August 13, 2025, and another scheduled for November 12, 2025.
• The company also presented at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 8, 2025.

Finance: Review Q4 2025 operating expense run-rate against the Q3 2025 actual of $23 million.

AVITA Medical, Inc. (RCEL) - Canvas Business Model: Customer Segments

You're looking at the core customer base for AVITA Medical, Inc. (RCEL) as of late 2025. The strategy is clearly focused on high-value acute care settings, but the portfolio expansion means the net is cast wider now.

U.S. Burn and Trauma Centers (the primary target market)

The commercial strategy is tightly focused on the most significant revenue generators in acute wound care. AVITA Medical, Inc. is concentrating its efforts on approximately 200 key U.S. burn and trauma centers. These centers represent an addressable market segment estimated at roughly $1.3 billion in the acute wound care space. To be fair, the company currently serves only about 5% of this specific segment, showing the runway for growth within this core group. The broader U.S. market opportunity, following the introduction of RECELL GO mini and Cohealyx, has expanded to more than $3.5 billion.

Here's a quick look at the market focus:

Metric	Value	Context
Key U.S. Target Centers	200	Primary focus for acute wound care portfolio utilization.
Target Acute Wound Care Market Size (US)	$1.3 billion	Estimated value of the highest-value burn and trauma center segment.
Current Penetration in Target Segment	5%	Indicates the current share of the $1.3 billion segment served.
Total Expanded U.S. Addressable Market	$3.5 billion+	Market size including trauma centers and smaller wounds post-new product launches.

Surgeons specializing in plastic surgery, trauma, and wound care

The customer segment here is defined by the institutions and the procedures they perform, which directly translates to the specialists using the technology. The clinical evidence base, including a national retrospective analysis of over 6,000 patients treated with RECELL, is built to influence these providers. The focus on integrating the multi-product platform-RECELL, Cohealyx, and PermeaDerm-is designed to fit smoothly into existing workflows for these specialists.

Patients with acute thermal burns, trauma wounds, and vitiligo

The patient population drives the clinical need, and AVITA Medical, Inc. has treated over 30,000 patients globally with its portfolio to date. The primary focus remains on acute needs, evidenced by the 6,000+ patient retrospective analysis on RECELL in burn care. For vitiligo, however, the commercialization efforts were paused due to reimbursement uncertainty, and management guided to no revenue dependence from this indication in the near term.

Key patient-related statistics include:

• Total patients treated globally (across portfolio): Over 30,000.
• RECELL real-world patients analyzed: Over 6,000.
• Vitiligo revenue contribution: Zero near-term expectation.
• Cohealyx pre-clinical data suggests closure as early as 7 days in full-thickness wounds.

International hospitals and clinics in approved markets (EU, ANZ)

Geographic diversification is a clear goal, supported by regulatory milestones. The RECELL GO system secured CE Mark approval under the EU Medical Device Regulation. This approval paves the way for European launch starting with specific countries.

The initial international rollout targets include:

• Germany
• Italy
• United Kingdom

The company has also closed distribution agreements across 16 European and Asian countries, indicating a broader international footprint beyond the initial EU launch sites.

Finance: draft updated customer segment mapping to new Q3 2025 revenue run-rate by next Tuesday.

AVITA Medical, Inc. (RCEL) - Canvas Business Model: Cost Structure

You're looking at the cost side of AVITA Medical, Inc.'s operations as of late 2025, and honestly, it's a story of high-margin product sales battling significant fixed and variable overhead. The cost structure is heavily influenced by the nature of their medical device business and the ongoing commercial build-out.

The cost of goods sold (COGS) for the device itself is a factor, but the pricing power is evident in the resulting gross margin. For the third quarter ended September 30, 2025, AVITA Medical reported a strong gross profit margin of 81.3%. To be fair, this was a slight dip from 83.7% in Q3 2024, driven by a product mix shift that included higher contributions from lower-margin products like Cohelix and PermeaDerm, alongside inventory adjustments. Still, the core RECELL franchise margin remained robust at 83.6% for the quarter.

Operating expenses are where the bulk of the cash burn happens, though management has been aggressively tackling this. Total operating expenses for Q3 2025 were $23.0 million, a significant year-over-year reduction of $7.2 million, or 24%. This reduction reflects ongoing cost-cutting initiatives, including an annualized reduction of approximately $10 million stemming from the commercial field transformation initiated in Q2.

You can break down those operating expenses into the key functional areas:

• Sales, General, and Administrative (SG&A) costs are tied directly to the direct sales force and administrative overhead.
• Research and Development (R&D) spending supports new indications and product enhancements.

Here's the quick math on the expense reduction by function for Q3 2025 compared to Q3 2024:

Expense Category	Q3 2025 Reduction Amount	Primary Driver
Sales and Marketing Expenses	$3.1 million decline	Lower salaries, benefits, stock-based compensation, and commissions
General and Administrative Expenses	$2.4 million decrease	Lower personnel and stock-based compensation costs
Research and Development Expenses	$1.7 million decline	Lower personnel cost and capitalization of costs for in-house developed software

Debt servicing and related costs fall under Other Expense, net, which is a key area to watch given the OrbiMed credit agreement. Other expense, net was $2.8 million in Q3 2025, a notable increase from $1.1 million in the prior-year period. This jump was primarily driven by non-cash charges of $2.2 million related to issuing 400,000 shares of common stock to OrbiMed for a fifth amendment executed in August, plus $0.9 million from the change in fair value of the debt. Furthermore, AVITA Medical agreed to a sixth amendment in November 2025, adding $500,000 to the principal balance as consideration for waiving the Q3 revenue covenant. Interest on the outstanding Loan Facility accrues at a rate per annum equal to the greater of the SOFR rate or 4.00% plus 8.00%.

The company is definitely managing the cost base aggressively, but the covenant compliance risk remains a factor in their financing costs. Finance: draft 13-week cash view by Friday.

AVITA Medical, Inc. (RCEL) - Canvas Business Model: Revenue Streams

You're looking at how AVITA Medical, Inc. brings in money across its growing portfolio, which has definitely shifted from being a single-product company to a multi-product platform. The revenue streams are centered on the sale of their core technology and newer complementary products, primarily within the U.S. acute wound care setting.

The primary revenue driver remains the Sales of the RECELL System (device and consumables) for burn and trauma. This system, which creates Spray-on Skin from a small skin sample, is expected to be the dominant source of revenue for the foreseeable future. The unit economics for this core business are strong; for instance, the gross margin for only RECELL products was reported at 86.4% in the first quarter of 2025.

The company has provided updated expectations for its top-line performance for the current fiscal year. AVITA Medical, Inc. has set its full-year 2025 commercial revenue guidance of $70 million to $74 million. This guidance was revised downwards from earlier expectations of $76 million to $81 million, and further down from an initial projection of $100 million to $106 million, due to slower reimbursement recovery and conservative utilization assumptions. As of September 30, 2025, the trailing twelve-month revenue stood at $72.4M.

Revenue diversification comes from the Sales of complementary products, PermeaDerm and Cohealyx. These products are integrated into the treatment workflow alongside RECELL. The overall gross margin percentage declines as revenue from these newer products increases because of partner profit-sharing arrangements.

Here's a look at the structure and potential value capture from these complementary products:

• RECELL GO is the expected long-term revenue driver.
• PermeaDerm, a biosynthetic wound matrix, is estimated to generate approximately $2,000 in revenue per patient procedure (for a 10% TBSA burn/wound).
• Cohealyx, a collagen-based dermal matrix, could generate an estimated $20,000 in revenue per patient procedure for the same 10% TBSA wound, though it is not used in every case.
• AVITA Medical retains a 60% revenue share for PermeaDerm and a 50% share for Cohealyx.

The company's multi-product platform now targets a U.S. market opportunity expanded to more than $3.5 billion, up from $455 million previously, with AVITA Medical currently serving about 5% of this segment as of late 2025.

The final component of the revenue stream involves International product sales through distribution agreements. The focus for growth has clearly shifted to the U.S. market, as international expansion has seen minimal traction. For context, in the second half of 2024, Europe generated only $1,000 in revenue.

You can see the recent quarterly revenue performance that informs the current guidance:

Period Ended	Commercial Revenue (USD)	Year-over-Year Growth
March 31, 2025 (Q1 2025)	$18.5 million	67%
June 30, 2025 (Q2 2025)	$18.4 million	21%
September 30, 2025 (Q3 2025)	$17.1 million	-13%

The gross margin comparison between the core product and the blended portfolio highlights the revenue mix impact:

Metric	Q3 2025 Gross Margin	RECELL Franchise Margin (Q3 2025)
Gross Margin Percentage	81.3%	83.6%