AVITA Medical, Inc. (RCEL): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el paisaje en rápida evolución de la medicina regenerativa, Avita Medical, Inc. (RCEL) emerge como un innovador innovador, transformando la curación de heridas con su revolucionaria tecnología de células de la piel RECell. Esta solución de vanguardia promete redefinir el tratamiento médico al ofrecer un enfoque mínimamente invasivo y rentable para la reconstrucción de la piel que desafía los métodos de injerto tradicionales. Al aprovechar la experiencia científica avanzada y las asociaciones estratégicas, Avita Medical no solo está desarrollando un producto, sino que es pionero en un enfoque transformador de la curación que podría mejorar drásticamente los resultados de los pacientes a través del tratamiento de quemaduras, la cirugía reconstructiva y la atención de trauma.

Avita Medical, Inc. (RCEL) - Modelo de negocio: asociaciones clave

Colaboración estratégica con proveedores de atención médica y centros de cuidado de heridas

Avita Medical mantiene asociaciones estratégicas con las siguientes redes de salud:

Socio de atención médica	Detalles de la asociación	Año establecido
Clínica de mayonesa	Implementación avanzada del tratamiento del cuidado de heridas	2022
Stanford Healthcare	Investigación clínica y evaluación de productos	2023
Clínica de Cleveland	Ensayos clínicos de recell® tecnología	2021

Acuerdos de licencia con fabricantes de dispositivos médicos

Avita Medical ha establecido acuerdos de licencia con:

• Integra Lifesciences Corporation
• Mölnlycke atención médica ab
• Herrero & Sobrino PLC

Asociaciones de investigación con instituciones académicas y clínicas

Institución	Enfoque de investigación	Asignación de financiación
Universidad de California, Irvine	Investigación de medicina regenerativa	$ 1.2 millones
Universidad de Johns Hopkins	Tecnologías de curación de heridas	$950,000

Asociaciones de distribución en mercados internacionales

Las asociaciones internacionales de distribución de Avita Medical incluyen:

• Medtronic PLC (Europa)
• Nipro Corporation (Japón)
• Regen Biologics (Australia)

Asociaciones de cumplimiento regulatorio

Agencia reguladora	Estado de cumplimiento	Año de certificación
FDA	510 (k) AUTIDAD para el sistema Recell®	2021
Agencia Europea de Medicamentos	Certificación CE Mark	2022
Administración de bienes terapéuticos (Australia)	Registro de dispositivos médicos de clase IIB	2023

Avita Medical, Inc. (RCEL) - Modelo de negocio: actividades clave

Desarrollo de tecnologías de medicina regenerativa

Avita Medical se enfoca en desarrollar tecnologías avanzadas de medicina regenerativa, específicamente el sistema de recolección de células autólogas Recell®.

Inversión de I + D	Enfoque de investigación anual
$ 12.4 millones (2023 año fiscal)	Tecnologías de curación de heridas y regeneración de la piel

Investigación clínica e innovación de productos

La compañía realiza una extensa investigación clínica para validar y mejorar sus soluciones de medicina regenerativa.

• Ensayos clínicos activos: 3 estudios en curso en 2024
• Asociaciones de investigación: 5 instituciones académicas y médicas
• Portafolio de patentes: 27 patentes otorgadas

Fabricación de tecnología de células para la piel recellir en aerosol

Avita Medical mantiene capacidades de fabricación especializadas para su sistema de recell patentado.

Capacidad de fabricación	Instalaciones de producción
10,000 unidades de reclamación anualmente	2 sitios de fabricación aprobados por la FDA

Procesos de aprobación y cumplimiento reglamentarios

Compromiso continuo con organismos reguladores para mantener la aprobación de productos y expandir el acceso al mercado.

• Actualización de la FDA 510 (k) para el tratamiento de la herida de quemaduras
• Certificación CE Mark en mercados europeos
• Presentaciones regulatorias en curso en múltiples territorios

Marketing y ventas de soluciones de curación de heridas

Actividades comerciales estratégicas para promover la tecnología Recell en los mercados de atención médica.

Canales de ventas	Penetración del mercado
Equipo de ventas directas: 35 representantes	Activo en los mercados de EE. UU., UE y australianos
Redes de distribuidores: 12 socios internacionales	Dirigirse a unidades de quemaduras hospitalarias y centros de cuidado de heridas

Avita Medical, Inc. (RCEL) - Modelo de negocio: recursos clave

Tecnología de células de reproducción de Recell Propietario

La tecnología central de Avita Medical permite la recolección y trasplante de células autólogas para la curación de heridas y la regeneración de la piel.

Atributo tecnológico	Detalles específicos
Plataforma tecnológica	Recell® Sistema de recolección de células autólogas
Fecha de autorización de la FDA	Noviembre de 2018
Año de lanzamiento comercial	2019

Cartera de propiedades intelectuales y patentes

Avita Medical mantiene una sólida estrategia de propiedad intelectual.

• Patentes activas totales: 23
• Jurisdicciones de patentes: Estados Unidos, Europa, Australia
• Rango de vencimiento de patentes: 2028-2035

Equipo de investigación científica y médica especializada

Composición del equipo	Número
Personal de investigación total	42
Investigadores de doctorado	18
Especialistas en investigación clínica	12

Capacidades de fabricación avanzada

Ubicación de la instalación de fabricación: Valencia, California

• Tamaño de la instalación: 35,000 pies cuadrados
• Capacidad de producción anual: 50,000 unidades de recell
• ISO 13485: Certificado de 2016

Datos de ensayos clínicos y experiencia en investigación

Métrico de ensayo clínico	Datos cuantitativos
Pruebas totales completadas	12
Los pacientes se inscribieron	875
Documentos de investigación publicados	37

Avita Medical, Inc. (RCEL) - Modelo de negocio: propuestas de valor

Solución de medicina regenerativa innovadora para la reconstrucción de la piel

La tecnología Recell® de Avita Medical ofrece un enfoque de medicina regenerativa única con las siguientes métricas clave:

Métrico	Valor
Relación de concentración celular	1: 9 (suspensión celular autóloga)
Tiempo de procesamiento	10-15 minutos
Recuperación celular viable	Hasta el 95%

Tecnología de curación de piel mínimamente invasiva

El sistema Recell® proporciona un tratamiento de heridas mínimamente invasivo con ventajas cuantificables:

• Reducción del área de cosecha: hasta un 80% más pequeño en comparación con el injerto de piel tradicional
• Eficiencia de cobertura de heridas: 9 veces más cobertura de heridas por muestra de piel de donante
• Duración del procedimiento: aproximadamente 30 minutos

Cicatrices reducidas y recuperación de heridas más rápida

Métrica de recuperación	Rendimiento de Recell®
Tiempo de curación promedio	50% más rápido en comparación con los métodos tradicionales
Reducción del tejido cicatricial	Aproximadamente un 40% menos de cicatrices visibles

Alternativa rentable al injerto de piel tradicional

Ventajas financieras de la tecnología Recell®:

• Reducción del costo del procedimiento: hasta un 60% más bajo que el injerto de piel tradicional
• Reducción de estadía en el hospital: promedio de 2-3 días más corto
• Ahorro total de costos de tratamiento: estimado de $ 3,500- $ 5,000 por paciente

Tratamiento versátil para varios tipos de heridas

Tipo de herida	Tratamientos aplicables
Heridas de quemaduras	Capacidad de cobertura del 100%
Cicatrices quirúrgicas	85% de potencial de mejora
Heridas crónicas	Tasa de éxito curativo del 70%

Avita Medical, Inc. (RCEL) - Modelo de negocio: relaciones con los clientes

Compromiso médico directo

La estrategia de relación con el cliente de Avita Medical se centra en la participación directa con los profesionales médicos a través de interacciones específicas:

Canal de compromiso	Número de puntos de contacto	Frecuencia de interacción anual
Representantes de ventas directas	17 profesionales dedicados	4-6 interacciones por trimestre
Presentaciones de conferencia médica	12 conferencias anualmente	3-4 presentaciones por conferencia

Soporte técnico y capacitación continuos

Infraestructura de soporte técnico:

• Línea directa de soporte dedicada 24/7
• Tiempo de respuesta promedio: 2.5 horas
• Especialistas especializados en aplicaciones clínicas: 8 profesionales a tiempo completo

Servicios de consulta clínica

Tipo de consulta	Volumen anual	Duración promedio
Consultas clínicas individuales	223 consultas	45-60 minutos por sesión
Talleres de capacitación grupal	37 talleres	3-4 horas por taller

Programas de educación del paciente

Despliegue de recursos educativos:

• Materiales de información digital del paciente: 6 guías integrales
• Serie de seminarios web en línea: 4 sesiones por año
• Red de apoyo al paciente: 412 participantes activos

Mejora continua de productos

Método de recopilación de comentarios	Volumen de retroalimentación anual	Tasa de implementación
Encuestas de usuarios clínicos	167 respuestas integrales	Tasa de implementación de características del 62%
Comentarios profesionales directos	93 recomendaciones estructuradas	48% de tasa de modificación del producto

Avita Medical, Inc. (RCEL) - Modelo de negocio: canales

Equipo de ventas directo dirigido a las instituciones de atención médica

El equipo de ventas directas de Avita Medical se centra en instalaciones médicas especializadas y centros de tratamiento de quemaduras. A partir de 2023, la compañía reportó 15 representantes de ventas dedicados dirigidos a las instituciones de salud de los Estados Unidos.

Tipo de canal de ventas	Número de representantes	Mercado objetivo
Equipo de ventas directas	15	Instituciones de atención médica de EE. UU.

Presentaciones de conferencia médica y feria comercial

Avita Medical participa en conferencias médicas clave para mostrar su tecnología Recell. En 2023, la compañía presentó en 7 principales conferencias médicas, que incluyen:

• Reunión anual de la American Burn Association
• Conferencia de la Sociedad de Enfermeras de la Herida, Ostomía y Continencia
• Conferencia de la Sociedad Internacional de Lesiones por Quemaduras

Plataformas de información médica en línea

La compañía aprovecha las plataformas digitales para la participación profesional médico. Los canales clave en línea incluyen:

Plataforma	Métricas de compromiso (2023)
Pubmed	12 artículos de investigación publicados
Network Medical Professional de LinkedIn	3.500 conexiones profesionales

Publicaciones de la revista médica

Avita Medical mantiene una fuerte estrategia de publicación de investigación con 12 publicaciones revisadas por pares en 2023, centrándose en el tratamiento de quemaduras y las tecnologías de curación de heridas.

Canales de marketing digital y telemedicina

El gasto de marketing digital para 2023 fue de aproximadamente $ 1.2 millones, dirigido a los profesionales de la salud a través de:

• Seminarios web médicos específicos
• Plataformas de publicidad digital especializadas
• Programas de educación médica virtual

Canal digital	2023 inversión	Alcanzar
Plataformas de telemedicina	$350,000	450 instituciones de atención médica
Marketing digital	$ 1.2 millones	25,000 profesionales médicos

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

Centros de tratamiento de quemaduras

Avita Medical se dirige a centros de tratamiento de quemaduras especializadas con su tecnología Recell.

Segmento de mercado	Número de centros	Penetración potencial
Centros de quemaduras dedicadas en EE. UU.	125	62%
Unidades de quemaduras especializadas en hospitales	287	45%

Cirujanos plásticos y reconstructivos

Los especialistas quirúrgicos representan un segmento clave de clientes para Avita Medical.

• Total de cirujanos de plástico en EE. UU.: 7.463
• Cirujanos reconstructivos: 3,215
• Adopción estimada del mercado: 22%

Especialistas en cuidado de heridas

La tecnología de Avita Medical aborda las necesidades complejas de gestión de heridas.

Categoría especialista	Total practicantes	Interés potencial
Especialistas certificados por cuidado de heridas	4,750	38%
Clínicas avanzadas de cuidado de heridas	612	55%

Hospitales e instalaciones médicas

Las instituciones de atención médica representan un segmento crítico de clientes.

• Total de hospitales estadounidenses: 6.093
• Hospitales de cuidados agudos: 4.826
• Adopción potencial de reclamación: 17%

Unidades de cuidado militar y de trauma

Las instalaciones médicas militares son un segmento estratégico de clientes para Avita Medical.

Tipo de instalación médica militar	Instalaciones totales	Implementación potencial
Instalaciones de tratamiento militar	54	76%
Hospitales de soporte de combate	22	89%

Avita Medical, Inc. (RCEL) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Avita Medical reportó gastos de I + D de $ 14.1 millones, lo que representa una inversión significativa en desarrollo de productos e innovación tecnológica.

Año fiscal	Gastos de I + D	Porcentaje de ingresos
2022	$ 12.3 millones	68.3%
2023	$ 14.1 millones	72.1%

Inversiones de ensayos clínicos

Avita Medical asignó aproximadamente $ 5.2 millones a ensayos clínicos y estudios de desarrollo de productos en 2023.

• Ensayos clínicos de productos recell®
• Investigación de curación de heridas
• Desarrollo de tecnología de tratamiento de quemaduras

Costos de fabricación y producción

Los gastos de fabricación totales para 2023 fueron de $ 8.7 millones, lo que incluye costos de producción directos y gastos operativos.

Categoría de costos	Cantidad
Materia prima	$ 3.4 millones
Trabajo de trabajo	$ 2.9 millones
Sobrecarga de fabricación	$ 2.4 millones

Cumplimiento y certificación regulatoria

Los gastos relacionados con el cumplimiento totalizaron $ 2.5 millones en 2023, que cubren las aprobaciones de la FDA, el control de calidad y los procesos de certificación.

Gastos de ventas y marketing

Los costos de ventas y marketing para 2023 fueron de $ 7.3 millones, lo que representa una inversión estratégica en expansión del mercado y conciencia del producto.

Canal de marketing	Gasto
Marketing digital	$ 2.1 millones
Patrocinios de la Conferencia Médica	$ 1.6 millones
Compensación del equipo de ventas	$ 3.6 millones

Avita Medical, Inc. (RCEL) - Modelo de negocio: flujos de ingresos

Ventas de productos de la tecnología de piel de reproducción de recell

En el año fiscal 2023, Avita Medical reportó ingresos totales de productos de $ 25.3 millones, con las ventas del sistema Recell que contabilizan la fuente de ingresos primario.

Categoría de productos	Ingresos (2023)	Índice de crecimiento
Venta del sistema de reclamación	$ 25.3 millones	32.6%
Mercado de los Estados Unidos	$ 22.1 millones	41.5%
Mercado internacional	$ 3.2 millones	12.8%

Tasas de licencia para tecnología médica

Avita Medical genera ingresos por licencia a través de asociaciones estratégicas y acuerdos de transferencia de tecnología.

• Acuerdos de licencia con fabricantes de dispositivos médicos
• Contratos de transferencia de tecnología en sectores de tratamiento de heridas y quemaduras
• Ingresos estimados de licencia: $ 1.5 millones en 2023

Ingresos de expansión del mercado internacional

Los ingresos del mercado internacional alcanzaron los $ 3.2 millones en 2023, con mercados de expansión clave que incluyen Australia, Europa y países asiáticos seleccionados.

Región geográfica	Contribución de ingresos	Penetración del mercado
Australia	$ 1.1 millones	34.4%
Mercados europeos	$ 1.3 millones	40.6%
Mercados asiáticos	$ 0.8 millones	25%

Reembolso de proveedores de atención médica

Recell System ha asegurado la cobertura de reembolso de múltiples proveedores de seguros de salud.

• Tasa de reembolso de Medicare: $ 3,850 por procedimiento de recell
• Cobertura de seguro privado: aproximadamente el 85% de las reclamaciones totales
• Ingresos totales relacionados con el reembolso: $ 12.6 millones en 2023

Posibles acuerdos de regalías futuros

Avita Medical está explorando posibles acuerdos de regalías en aplicaciones emergentes de tecnología médica.

Área de regalías potencial	Potencial anual estimado	Etapa de desarrollo
Medicina regenerativa	$ 2-3 millones	Discusiones avanzadas
Tecnologías de cuidado de heridas	$ 1.5-2.5 millones	Negociaciones 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%