Avita Medical, Inc. (RCEL): Modelo de negócios Canvas [Jan-2025 Atualizado]

Na paisagem em rápida evolução da medicina regenerativa, a Avita Medical, Inc. (RCEL) surge como inovadora inovadora, transformando a cicatrização de feridas com sua revolucionária tecnologia de células de pele de spray-on. Essa solução de ponta promete redefinir o tratamento médico, oferecendo uma abordagem minimamente invasiva e econômica da reconstrução da pele que desafia os métodos tradicionais de enxerto. Ao alavancar a experiência científica avançada e as parcerias estratégicas, a Avita Medical não está apenas desenvolvendo um produto, mas pioneiro em uma abordagem transformadora da cura que possa melhorar drasticamente os resultados do paciente durante o tratamento queimaduras, cirurgia reconstrutiva e cuidados com o trauma.

Avita Medical, Inc. (RCEL) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com profissionais de saúde e centros de atendimento a feridas

A Avita Medical mantém parcerias estratégicas com as seguintes redes de saúde:

Parceiro de saúde	Detalhes da parceria	Ano estabelecido
Clínica Mayo	Implementação avançada de tratamento de cuidados com feridas	2022
Stanford Healthcare	Pesquisa clínica e avaliação de produtos	2023
Clínica de Cleveland	Ensaios clínicos de tecnologia da RECLEL®	2021

Acordos de licenciamento com fabricantes de dispositivos médicos

A Avita Medical estabeleceu acordos de licenciamento com:

• Integra Lifesciences Corporation
• Mölnlycke Health Care AB
• Smith & Sobrinho plc

Parcerias de pesquisa com instituições acadêmicas e clínicas

Instituição	Foco na pesquisa	Alocação de financiamento
Universidade da Califórnia, Irvine	Pesquisa de Medicina Regenerativa	US $ 1,2 milhão
Universidade Johns Hopkins	Tecnologias de cicatrização de feridas	$950,000

Parcerias de distribuição em mercados internacionais

As parcerias de distribuição internacional da Avita Medical incluem:

• Medtronic PLC (Europa)
• Nipro Corporation (Japão)
• Regen Biologics (Austrália)

Parcerias de conformidade regulatória

Agência regulatória	Status de conformidade	Ano de certificação
FDA	510 (k) folga para o sistema Recell®	2021
Agência Europeia de Medicamentos	Certificação de marca CE	2022
Administração de bens terapêuticos (Austrália)	Classe IIB Registro de dispositivos médicos	2023

Avita Medical, Inc. (RCEL) - Modelo de negócios: Atividades -chave

Desenvolvimento de tecnologias de medicina regenerativa

A Avita Medical se concentra no desenvolvimento de tecnologias avançadas de medicina regenerativa, especificamente o sistema de colheita de células autólogas do RECLELL®.

Investimento em P&D	Foco anual de pesquisa
US $ 12,4 milhões (2023 ano fiscal)	Tecnologias de cicatrização e regeneração da pele

Pesquisa clínica e inovação de produtos

A empresa realiza extensa pesquisa clínica para validar e melhorar suas soluções de medicina regenerativa.

• Ensaios clínicos ativos: 3 estudos em andamento em 2024
• Parcerias de pesquisa: 5 instituições acadêmicas e médicas
• Portfólio de patentes: 27 patentes concedidas

Fabricação de tecnologia de células de pele de spray-on Spray

A Avita Medical mantém recursos especializados de fabricação para seu sistema de receita proprietário.

Capacidade de fabricação	Instalações de produção
10.000 unidades de receita anualmente	2 locais de fabricação aprovados pela FDA

Processos de aprovação e conformidade regulatórios

O envolvimento contínuo com os órgãos regulatórios para manter as aprovações do produto e expandir o acesso ao mercado.

• FDA 510 (k) depuração para tratamento de feridas queimaduras
• Certificação de marca CE em mercados europeus
• Envios regulatórios em andamento em vários territórios

Marketing e vendas de soluções de cicatrização de feridas

Atividades comerciais estratégicas para promover a tecnologia de receita nos mercados de saúde.

Canais de vendas	Penetração de mercado
Equipe de vendas diretas: 35 representantes	Ativo em EUA, UE e mercados australianos
Redes de distribuidores: 12 parceiros internacionais	Direcionando unidades de queimadura hospitalar e centros de atendimento a feridas

Avita Medical, Inc. (RCEL) - Modelo de negócios: Recursos -chave

Tecnologia de células da pele com spray-on de receita proprietária

A tecnologia principal da Avita Medical permite a colheita e o transplante de células autólogas para a cicatrização de feridas e a regeneração da pele.

Atributo de tecnologia	Detalhes específicos
Plataforma de tecnologia	Sistema de colheita de células autólogas do RECLEL®
Data de liberação da FDA	Novembro de 2018
Ano de lançamento comercial	2019

Portfólio de propriedades intelectuais e patentes

A Avita Medical mantém uma robusta estratégia de propriedade intelectual.

• Total de patentes ativas: 23
• Jurisdições de patentes: Estados Unidos, Europa, Austrália
• Faixa de expiração de patentes: 2028-2035

Equipe especializada de pesquisa científica e médica

Composição da equipe	Número
Pessoal de pesquisa total	42
Pesquisadores de doutorado	18
Especialistas em pesquisa clínica	12

Recursos de fabricação avançados

Localização da instalação de fabricação: Valencia, Califórnia

• Tamanho da instalação: 35.000 pés quadrados
• Capacidade anual de produção: 50.000 unidades de receita
• ISO 13485: 2016 certificado

Dados de ensaios clínicos e experiência em pesquisa

Métrica do ensaio clínico	Dados quantitativos
TOTAL CONCLUSO CONCLUSO	12
Pacientes inscritos	875
Artigos de pesquisa publicados	37

Avita Medical, Inc. (RCEL) - Modelo de negócios: proposições de valor

Solução de medicina regenerativa inovadora para reconstrução da pele

A tecnologia Recell® da Avita Medical oferece uma abordagem de medicina regenerativa única com as seguintes métricas -chave:

Métrica	Valor
Taxa de concentração celular	1: 9 (suspensão autóloga de células)
Tempo de processamento	10-15 minutos
Recuperação viável de células	Até 95%

Tecnologia de cura de pele minimamente invasiva

O sistema Recell® fornece tratamento de feridas minimamente invasivo com vantagens quantificáveis:

• Redução da área da colheita: até 80% menor em comparação com o enxerto de pele tradicional
• Eficiência de cobertura da ferida: 9x mais cobertura de ferida por amostra de pele de doador
• Duração do procedimento: aproximadamente 30 minutos

Cicatrização reduzida e recuperação de feridas mais rápida

Métrica de recuperação	Desempenho do RECLEL®
Tempo médio de cicatrização	50% mais rápido em comparação aos métodos tradicionais
Redução do tecido cicatricial	Aproximadamente 40% menos cicatrizes visíveis

Alternativa econômica ao enxerto de pele tradicional

Vantagens financeiras da tecnologia Recell®:

• Redução de custo do procedimento: até 60% menor que o enxerto de pele tradicional
• Redução de internação hospitalar: média 2-3 dias mais curta
• Economia total de custos de tratamento: estimado US $ 3.500 a US $ 5.000 por paciente

Tratamento versátil para vários tipos de feridas

Tipo de ferida	Tratamentos aplicáveis
Ferimentos queimados	Capacidade de cobertura de 100%
Cicatrizes cirúrgicas	85% de potencial de melhoria
Feridas crônicas	70% de taxa de sucesso de cura

Avita Medical, Inc. (Rcel) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento profissional médico direto

A estratégia de relacionamento com o cliente da Avita Medical se concentra no envolvimento direto com os profissionais médicos por meio de interações direcionadas:

Canal de engajamento	Número de pontos de contato	Frequência de interação anual
Representantes de vendas diretas	17 profissionais dedicados	4-6 interações por trimestre
Apresentações da conferência médica	12 Conferências anualmente	3-4 apresentações por conferência

Suporte técnico e treinamento em andamento

Infraestrutura de suporte técnico:

• 24/7 de suporte de suporte dedicado
• Tempo médio de resposta: 2,5 horas
• Especialistas especializados de aplicação clínica: 8 profissionais em tempo integral

Serviços de consulta clínica

Tipo de consulta	Volume anual	Duração média
Consultas clínicas individuais	223 consultas	45-60 minutos por sessão
Oficinas de treinamento em grupo	37 workshops	3-4 horas por workshop

Programas de educação do paciente

Implantação de recursos educacionais:

• Materiais de informação do paciente digital: 6 guias abrangentes
• Série de on -line online: 4 sessões por ano
• Rede de suporte ao paciente: 412 participantes ativos

Melhoria contínua do produto

Método de coleta de feedback	Volume de feedback anual	Taxa de implementação
Pesquisas de usuários clínicos	167 Respostas abrangentes	62% de taxa de implementação de recursos
Feedback profissional direto	93 recomendações estruturadas	Taxa de modificação de produto de 48%

Avita Medical, Inc. (Rcel) - Modelo de Negócios: Canais

Equipe direta da equipe de vendas direcionando instituições de saúde

A equipe de vendas diretas da Avita Medical se concentra em instalações médicas especializadas e centros de tratamento de queimaduras. A partir de 2023, a Companhia relatou 15 representantes de vendas dedicados direcionando as instituições de saúde dos EUA.

Tipo de canal de vendas	Número de representantes	Mercado -alvo
Equipe de vendas diretas	15	Instituições de Saúde dos EUA

Apresentações da Conferência Médica e da Feira

A Avita Medical participa de conferências médicas importantes para mostrar sua tecnologia de receita. Em 2023, a empresa apresentou em 7 principais conferências médicas, incluindo:

• Reunião Anual da American Burn Association
• Conferência da Sociedade de Ferida, Ostomia e Continence
• Conferência Internacional da Sociedade para Lesões de Burn

Plataformas de informações médicas online

A empresa utiliza plataformas digitais para engajamento profissional médico. Os principais canais online incluem:

Plataforma	Métricas de engajamento (2023)
PubMed	12 Artigos de pesquisa publicados
Rede de Profissional Médico do LinkedIn	3.500 conexões profissionais

Publicações de revistas médicas

A Avita Medical mantém uma forte estratégia de publicação de pesquisa com 12 publicações revisadas por pares em 2023, focando no tratamento de queimaduras e tecnologias de cicatrização de feridas.

Canais de telemedicina e marketing digital

As despesas de marketing digital para 2023 foram de aproximadamente US $ 1,2 milhão, direcionando os profissionais de saúde por meio de:

• Webinars profissionais médicos direcionados
• Plataformas de publicidade digital especializadas
• Programas de educação médica virtual

Canal digital	2023 Investimento	Alcançar
Plataformas de telemedicina	$350,000	450 instituições de saúde
Marketing digital	US $ 1,2 milhão	25.000 profissionais médicos

Avita Medical, Inc. (RCEL) - Modelo de negócios: segmentos de clientes

Centros de tratamento de queimadura

Avita Medical Targets Specialized Burn Treatment Centers com sua tecnologia de receita.

Segmento de mercado	Número de centros	Potencial penetração
Centros de queimadura dedicados nos EUA	125	62%
Unidades de queimadura especializadas em hospitais	287	45%

Cirurgiões plásticos e reconstrutivos

Especialistas cirúrgicos representam um segmento importante do cliente para a Avita Medical.

• Cirurgiões plásticos totais nos EUA: 7.463
• Cirurgiões reconstrutivos: 3.215
• Adoção estimada do mercado: 22%

Especialistas em atendimento a feridas

A tecnologia da Avita Medical atende às necessidades complexas de gerenciamento de feridas.

Categoria especializada	Total de praticantes	Interesse potencial
Especialistas certificados por cuidados de feridas	4,750	38%
Clínicas avançadas de atendimento a feridas	612	55%

Hospitais e instalações médicas

As instituições de saúde representam um segmento crítico de clientes.

• Hospitais do Total dos EUA: 6.093
• Hospitais de cuidados agudos: 4.826
• Potencial Adoção de Correios: 17%

Unidades de cuidados militares e de trauma

As instalações médicas militares são um segmento estratégico de clientes da Avita Medical.

Tipo de instalação médica militar	Total de instalações	Implementação potencial
Instalações de tratamento militar	54	76%
Hospitais de suporte de combate	22	89%

Avita Medical, Inc. (RCEL) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Avita Medical reportou despesas de P&D de US $ 14,1 milhões, representando um investimento significativo no desenvolvimento de produtos e inovação tecnológica.

Ano fiscal	Despesas de P&D	Porcentagem de receita
2022	US $ 12,3 milhões	68.3%
2023	US $ 14,1 milhões	72.1%

Investimentos de ensaios clínicos

A Avita Medical alocou aproximadamente US $ 5,2 milhões a ensaios clínicos e estudos de desenvolvimento de produtos em 2023.

• Ensaios clínicos de produtos RECLEL®
• Pesquisa de cura de feridas
• Desenvolvimento de tecnologia de tratamento queimado

Custos de fabricação e produção

As despesas totais de fabricação para 2023 foram de US $ 8,7 milhões, o que inclui custos diretos de produção e despesas operacionais.

Categoria de custo	Quantia
Matérias-primas	US $ 3,4 milhões
Trabalho de produção	US $ 2,9 milhões
Manufatura de sobrecarga	US $ 2,4 milhões

Conformidade e certificação regulatória

As despesas relacionadas à conformidade totalizaram US $ 2,5 milhões em 2023, cobrindo as aprovações da FDA, controle de qualidade e processos de certificação.

Despesas de vendas e marketing

Os custos de vendas e marketing para 2023 foram de US $ 7,3 milhões, representando um investimento estratégico na expansão do mercado e na conscientização do produto.

Canal de marketing	Gasto
Marketing digital	US $ 2,1 milhões
Patrocínios da conferência médica	US $ 1,6 milhão
Compensação da equipe de vendas	US $ 3,6 milhões

Avita Medical, Inc. (RCEL) - Modelo de negócios: fluxos de receita

Vendas de produtos da tecnologia de pele de spray-on de receita

No ano fiscal de 2023, a Avita Medical relatou receitas totais de produtos de US $ 25,3 milhões, com as vendas do sistema de receita representando a fonte de receita primária.

Categoria de produto	Receita (2023)	Taxa de crescimento
Vendas de sistema de receita	US $ 25,3 milhões	32.6%
Mercado dos Estados Unidos	US $ 22,1 milhões	41.5%
Mercado internacional	US $ 3,2 milhões	12.8%

Taxas de licenciamento para tecnologia médica

A Avita Medical gera receita de licenciamento por meio de parcerias estratégicas e acordos de transferência de tecnologia.

• Acordos de licenciamento com fabricantes de dispositivos médicos
• Contratos de transferência de tecnologia em setores de tratamento de feridas e queimaduras
• Receita estimada de licenciamento: US $ 1,5 milhão em 2023

Receitas de expansão do mercado internacional

As receitas do mercado internacional atingiram US $ 3,2 milhões em 2023, com os principais mercados de expansão, incluindo Austrália, Europa e países asiáticos selecionados.

Região geográfica	Contribuição da receita	Penetração de mercado
Austrália	US $ 1,1 milhão	34.4%
Mercados europeus	US $ 1,3 milhão	40.6%
Mercados asiáticos	US $ 0,8 milhão	25%

Reembolso de prestadores de serviços de saúde

O sistema de receita garantiu a cobertura de reembolso de vários provedores de seguros de saúde.

• Taxa de reembolso do Medicare: US $ 3.850 por procedimento de recepção
• Cobertura de seguro privado: aproximadamente 85% do total de reivindicações
• Receita total relacionada ao reembolso: US $ 12,6 milhões em 2023

Potenciais acordos futuros de royalties

A Avita Medical está explorando possíveis acordos de royalties em aplicações emergentes de tecnologia médica.

Área de royalties potencial	Potencial anual estimado	Estágio de desenvolvimento
Medicina Regenerativa	US $ 2-3 milhões	Discussões avançadas
Tecnologias de cuidados com feridas	US $ 1,5-2,5 milhão	Negociações preliminares

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%