AVITA Medical, Inc. (RCEL) Business

Item 1. BUSINESS

OVERVIEW

AVITA Medical is a leading therapeutic acute wound care company delivering transformative solutions designed to optimize wound healing, accelerate patient recovery, and improve clinical and economic outcomes across the continuum of acute wound management. Our technologies address critical healing needs arising from burns, traumatic injuries and surgical repairs, through a portfolio of proprietary and complementary products that support wound bed preparation, definitive closure, and recovery.

Our current commercial portfolio includes RECELL® (“RECELL”), and two complementary wound care products, PermeaDerm® and Cohealyx™, which together support a comprehensive standard of care for acute wounds.

At the forefront of our portfolio is RECELL, approved by the United States Food & Drug Administration (the “FDA”) for the treatment of thermal burn wounds and full-thickness skin defects. While RECELL is also approved in the United States for restoring pigmentation of stable depigmented vitiligo lesions, we have paused further commercial investment in vitiligo at this time.

In 2024 and 2025, we expanded our product offerings to address additional acute wound care needs. In January 2024, we entered into an exclusive multi-year distribution agreement with Stedical Scientific, Inc. (“Stedical”) to market, sell, and distribute PermeaDerm, a biosynthetic wound matrix in the United States (“U.S.”). In March 2025, we entered into a multi-year agreement to also manufacture PermeaDerm. In July 2024, we entered into an exclusive multi-year development and distribution agreement with Collagen Matrix, LLC d/b/a as Regenity Biosciences (“Regenity”), granting us exclusive rights to market, sell, and distribute Cohealyx, an AVITA-medical branded collagen-based dermal matrix in the U.S., with potential expansion into the European Union (“E.U.”), Australia, and Japan. Cohealyx was commercially launched in the U.S. on April 1, 2025.

CORPORATE HISTORY

AVITA Medical Limited (“AVITA Australia”), the former Australian parent company of AVITA Medical, was founded in December 1992. On October 1, 2019, AVITA Australia began trading its American Depositary Shares on the Nasdaq Capital Market (“Nasdaq”) under the symbol “RCEL”. In 2020, the Company redomiciled to the U.S. (the “Redomiciliation”). Today, our common stock continues to trade on Nasdaq under “RCEL” and our CHESS Depositary Interests (“CDIs”) trade on the Australian Securities Exchange (“ASX”) under the symbol “AVH.”

STRATEGY

RECELL remains the cornerstone of our business; however, beginning in 2024 we evolved AVITA Medical into a multi-product acute wound care platform company. Our strategy is to build a comprehensive portfolio that addresses wound management from initial coverage and wound bed preparation through definitive closure and healing, while leveraging a single commercial infrastructure focused on burn, trauma and surgical centers.

Key elements of our strategy include:

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Increasing market penetration in U.S. burn centers, positioning RECELL as the standard of care in burn management;

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Expanding adoption of RECELL for the treatment of traumatic and surgical wounds throughout the U.S.;

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Commercializing and expanding adoption of Cohealyx as a dermal matrix that supports wound bed preparation and accelerates readiness for grafting;

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Driving adoption of RECELL GO mini in burn and trauma centers treating smaller wounds;

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Advancing post-market clinical studies for Cohealyx and PermeaDerm to generate additional clinical and health economic evidence supporting adoption;

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Expanding internationally through distributor-led commercialization following regulatory approvals, including CE Mark approval for RECELL GO in Europe;

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Driving commercial revenue growth, improving operating leverage, generating positive cash flow, and achieving long-term operating profitability; and

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Pursuing additional business development opportunities complementary to our target acute wound care markets.

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PRODUCT PORTFOLIO

RECELL Technology Platform

RECELL is an autologous cell harvesting technology that enables clinicians to create a suspension of a patient’s own skin cells, called Spray-On Skin™, at the point of care. The technology allows clinicians to treat large wounds using a small donor skin sample, reducing donor site morbidity while maintaining or improving healing outcomes.

How RECELL Works

RECELL enables clinicians to harvest a thin, split-thickness skin sample from the patient and process it into an autologous cellular suspension in approximately 30 minutes. The suspension contains key skin cell populations, including keratinocytes, fibroblasts, and melanocytes, which are critical to regenerative wound healing and pigment restoration.

The technology underlying RECELL was invented in Australia, by the pioneering work of Professor Fiona Wood and fellow scientist Marie Stoner.

Device Evolution

We continue to refine and expand the RECELL technology to meet a range of clinical and workflow needs; including automating key steps in some RECELL procedures, and adopting the technology to efficiently treat a range of different wound sizes:

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RECELL Autologous Cell Harvesting Device (“RECELL 1920”): A single-use, stand-alone, battery operated device capable of treating wounds up to 1,920 cm2.

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RECELL Autologous Cell Harvesting Device with Ease-of-Use (“RECELL Ease-of-Use” or “RECELL EOU”): An enhanced, single-use device designed to improve workflow efficiency while maintaining treatment capacity up to 1,920 cm².

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RECELL GO® Autologous Cell Harvesting Device (“RECELL GO”): A next-generation system consisting of a reusable, AC-powered RECELL Processing Device (“RPD”) and a single-use preparation kit (“RPK”). A single RPK can treat wounds up to 1,920 cm2. RECELL GO standardizes the preparation of Spray-On Skin Cells, significantly reducing the training burden on medical staff, improving workflow efficiency in the operating room, and precisely regulating the incubation times of the RECELL Enzyme™ to optimize cell yield and promote cell viability.

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RECELL GO mini Autologous Cell Harvesting Device (“RECELL GO mini”): A line extension of RECELL GO designed to treat smaller wounds up to 480 cm2. RECELL GO mini uses the same RPD with an RPK optimized for smaller skin samples. FDA approval was received on December 23, 2024, and commercial rollout began at the end of the first quarter of 2025.

We expect the RECELL GO platform to serve as a growth driver, further advancing our strategy to expand our impact on wound healing and patient care.

Key U.S. FDA Regulatory Approvals

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Market Opportunity

Burn Injuries

In the U.S., approximately 40,000 people have burn injuries severe enough to require hospital admission annually, with an inpatient mortality rate of 2.7%. Second- and third-degree burns often require autologous split-thickness skin grafts (“STSGs”) to achieve definitive closure of the burn wound. However, donor-site creation in a STSG, or autograft, procedure is associated with significant pain, risk of infection, scarring, delayed healing, and increased healthcare costs. In patients with extensive burns, the availability of healthy donor skin may be limited, requiring staged procedures and temporary coverage with allograft (cadaver skin) or xenograft (typically pig skin), which can prolong hospitalization and increase overall cost of care. As such, treatment with STSGs is expensive, costing around $579,000 and resulting in an average hospital stay of 59.4 days for a patient with a 40% TBSA burn injury to recover and return to normal daily activities.

The clinical benefits of achieving rapid and durable wound closure are well recognized and include increased survival, decreased pain duration, reduced infection risk, improved functional and aesthetic outcomes, and potentially shorter hospital stays. RECELL was designed to address the limitations of traditional grafting by enabling treatment of wound areas using a substantially smaller donor skin sample, while preserving or improving healing outcomes.

In pivotal clinical trials, RECELL significantly reduced donor-skin requirements by up to 97.5% for second-degree burns and 32% for third-degree burns when used with meshed autografts, compared to standard of care autografting, without compromising healing. Additionally, a clinical trial for second-degree burns revealed a statistically significant reduction in patient-reported pain, increased patient satisfaction, and improved scar outcomes.

Retrospective studies further demonstrated that fewer autografting procedures are required for definitive closure of full-thickness burns when RECELL is used compared to conventional autografting alone. In pediatric cases (N = 284), treatment with RECELL resulted in a 56% reduction in the mean number of autograft procedures required compared to National Burn Registry (“NBR”) data. Additionally, in adult patients with greater than 50% TBSA (N=318), RECELL resulted in a 60% reduction in the mean number of autograft procedures versus NBR data.

In addition to these clinical benefits, RECELL has demonstrated meaningful health-economic advantages across a range of burn severities. Health-economic analyses have shown that RECELL use is associated with reductions in overall cost of care driven by fewer operative procedures, reduced donor-site morbidity, and the potential for shorter hospital stays. These cost savings have been observed across both deep partial-thickness and full-thickness burns and are net of the cost of the RECELL device.

Budget impact modeling developed by the Company further indicates that, in a representative burn center treating approximately 200 patients annually, adoption of RECELL could reduce total annual treatment costs by approximately 17% compared to conventional autografting alone. Real-world evidence published by IQVIA and supported by the Biomedical Advanced Research and Development Authority (“BARDA”) demonstrates that these economic benefits are observed across a broad range of burn sizes and patient demographics.

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In 2025, real-world evidence derived from the American Burn Association’s national burn registry further supported the clinical and operational benefits of RECELL in adult patients with deep partial-thickness burns. In a matched analysis, RECELL treatment for such patients was associated with an average 36% reduction in hospital length of stay compared to traditional split-thickness skin grafting. These findings reinforce prior clinical and retrospective studies demonstrating that RECELL use is associated with shorter hospitalizations and improved patient throughput in high-acuity burn care settings.

Further supporting the durability and generalizability of these outcomes, a global systematic synthesis of peer-reviewed clinical evidence evaluating RECELL was presented in September 2025. This review encompassed clinical studies across diverse wound etiologies, depths, patient populations, and care settings and demonstrated consistent trends toward reduced donor-site burden, faster healing, and decreased hospital length of stay and healthcare utilization compared to traditional grafting approaches. Collectively, this body of evidence supports RECELL as an evidence-based approach to wound healing with broad clinical applicability.

Adoption decisions in burn centers are typically evaluated through hospital value analysis committees (“VACs”), which assess both clinical outcomes and total cost of care. We have observed that surgeons often adopt RECELL first in larger and more complex burns, where the clinical and economic benefits are most pronounced, and subsequently expand use to smaller or less severe wounds as familiarity with the technology increases.

In the U.S., RECELL is reimbursed through established inpatient and outpatient reimbursement mechanisms. In the inpatient setting, hospitals receive payment under the Medicare Severity Diagnosis-Related Group (“MS-DRG”) system, which classifies hospital stays by diagnosis and procedures performed. For physicians, as well as in outpatient and ambulatory surgical center (“ASC”) settings, Current Procedural Terminology ("CPT") codes are used to describe procedures and support billing. On January 1, 2025, new Category I CPT codes (15011–15018) became effective to describe Skin Cell Suspension Autograft (“SCSA”) procedures performed using RECELL, replacing prior coding constructs and enabling standardized billing for healthcare providers. The Company continues to collaborate with both Medicare and commercial payers to expand coverage and ensure appropriate reimbursement for RECELL and its associated procedures, aiming to enhance patient access and support broader adoption in clinical practice.

The U.S. burn treatment market is highly concentrated, with approximately 140 specialized burn centers treating the majority of severe burn patients. Historically, our commercial focus has been centered on these burn centers, which continue to represent a core component of our customer base. With the expansion of RECELL indications to include full-thickness skin defects, we have broadened our commercial focus to additional trauma and surgical settings that treat complex acute wounds and often share clinical, operational, and economic characteristics with burn centers. Many burn centers are designated trauma centers, and adoption in these settings is supported by overlapping surgeon populations, similar care pathways, and comparable hospital value analysis and purchasing processes.

Full-Thickness Skin Defects

Full-thickness wounds arise from traumatic injuries, surgical wounds, and oncologic excisions and resections that extend through the dermal layer into deeper tissues. These acute wounds are frequently associated with significant tissue loss, contamination, and complex zones of injury, and they present many of the same challenges encountered in severe burns, including limited donor skin availability, risk of delayed healing, and the need for staged reconstruction.

RECELL is approved for the treatment of full-thickness skin defects, enabling clinicians to reduce donor skin harvesting while achieving wound closure outcomes comparable to conventional autografting. The clinical studies that supported FDA approval demonstrated statistically significant donor skin sparing with non-inferior healing outcomes relative to standard of care. In the U.S., we estimate that approximately 272,000 procedures annually may be eligible for treatment with RECELL across traumatic injuries, surgical wounds, and cancer-related resections. This indication materially expands our addressable market and allows us to leverage our existing commercial infrastructure and clinical relationships. Approximately half of U.S. burn centers are also designated trauma centers, and many trauma and surgical centers follow similar adoption and value analysis processes. As a result, the expansion into full-thickness skin defects represents a natural extension of our burn-focused business rather than the creation of a distinct new market.

From a reimbursement perspective, the same DRG code that is currently being used to treat inpatient burns is now being applied for the treatment of full-thickness skin defects.

Effective October 1, 2025, the Centers for Medicare & Medicaid Services ("CMS") approved a New Technology Add-On Payment ("NTAP") for RECELL when used in combination with meshed autograft for certain inpatient non-thermal full-thickness skin defects. NTAP provides incremental reimbursement above the applicable MS-DRG payment for a limited period, intended to support hospital adoption of innovative technologies like ours that demonstrate substantial clinical improvement.

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Vitiligo

RECELL is approved for the repigmentation of stable depigmented vitiligo lesions. Vitiligo is a chronic autoimmune condition characterized by the loss of melanocytes, resulting in depigmented skin patches that can affect patients’ quality of life. Following FDA approval, we conducted post-market clinical and health economic studies to evaluate RECELL use in vitiligo, and these studies were published in 2025. Despite regulatory approval and demonstrated clinical benefit, reimbursement for vitiligo procedures remains limited and uncertain. As a result, we have paused further commercial investment in vitiligo at this time.

Cohealyx

Cohealyx is an AVITA-Medical branded collagen-based dermal matrix developed and commercialized pursuant to a multi-year exclusive development and distribution agreement with Regenity. Designed to support wound bed preparation, Cohealyx features an advanced bovine collagen-based design engineered to facilitate tissue integration and revascularization resulting in reduced treatment timelines and improved patient outcomes in full-thickness wounds.

Preclinical studies in porcine models demonstrated that Cohealyx generated robust tissue capable of consistently supporting a split-thickness skin graft in a two-stage procedure earlier than leading dermal matrices in the study. While animal model results do not necessarily translate to clinical results, this expedited timeline is anticipated to lead to quicker wound closure and streamlined clinician workflows, improving patient outcomes, and resulting in potential reduction in both treatment costs and hospital stays.

The FDA granted 510(k) clearance for Cohealyx on December 19, 2024, and we initiated commercial launch of Cohealyx in the United States on April 1, 2025.

In 2025, the first peer-reviewed clinical publication evaluating Cohealyx was published, reporting early clinical experience in complex full-thickness wounds. The case series provided initial clinical evidence supporting accelerated wound bed vascularization and readiness for autografting, consistent with prior preclinical findings. While limited in scope, these results support the intended role of Cohealyx as part of a two-stage wound management approach leading to definitive closure. To further develop clinical data, we are conducting a post-market clinical study of 40 patients to demonstrate Cohealyx’s performance in real-world settings, focusing on time-to-graft reduction in the treatment of full-thickness wounds and burns.

PermeaDerm

PermeaDerm is a biosynthetic wound matrix that we manufacture, and exclusively market and distribute in the U.S., under multi-year agreements with Stedical. It is FDA-cleared for the treatment of a variety of wound types and sizes until healing is achieved. PermeaDerm has three key attributes: (i) transparency, allowing clinicians to monitor wounds without frequent dressing changes; (ii) variable porosity, allowing clinicians to customize moisture management; and (iii) flexibility and adherency, allowing applications across a wide variety of wound presentations, including articulating joints. This trio of features supports use across acute care hospitals, burn centers, and surgical settings.

Within our portfolio, PermeaDerm complements RECELL by providing wound coverage before and after definitive closure, supporting wound management throughout the healing process. In addition, we are conducting a post-market clinical study, with approximately 40 patients enrolled, to evaluate the health economic impact of PermeaDerm compared to human cadaveric allograft.

INTERNATIONAL STRATEGY

Outside the U.S., RECELL has received regulatory approvals or registrations in multiple markets, including Australia, Europe, and Japan. In September 2025, RECELL GO received Conformité Européene (“CE”) mark approval, enabling commercialization in the European Union and other CE mark-recognizing markets. Our international commercialization strategy relies on third-party distributions rather than direct sales.

RESEARCH & DEVELOPMENT

Our research and development activities are focused on advancing our innovative products and building a comprehensive portfolio of solutions, as well as developing clinical applications to advance the management of wound care. Additionally, we continue to conduct clinical studies to provide further efficacy and health economic evidence.

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SALES AND MARKETING

Our commercial organization is focused on clinical case support, staff training, and building awareness to further expand interest in the clinical and economic benefits of our acute wound care products. It is not uncommon in the treatment of wounds to have rotating staff and it is our commitment for all those working with our products to be comfortable with our technologies both during the procedure as well as during aftercare.

Our commercial organization is composed of highly experienced medical sales representatives as well as former burn and trauma nurses. This organization covers both burns and full-thickness skin defects.

HUMAN CAPITAL

As of December 31, 2025, we employed approximately 226 full-time and part-time employees, the majority of whom are based in the U.S. A significant number of our management and professional employees have prior experience with leading medical device, biotech, or pharmaceutical companies. None of our employees are covered by collective bargaining agreements.

We embrace differences, diversity and varying perspectives amongst our employee base and are proud to be an equal opportunity employer. We do not discriminate based on race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, military or veteran status, sexual orientation or any other protected characteristic established by federal, state, or local laws. A diverse workforce as well as an inclusive culture and work environment are fundamentally important and strategic to us, starting at the leadership level and extending to all levels of the Company. As of December 31, 2025, the Directors of the Company were 33% female, our senior executive team was 40% female, and our total employee base was 52.5% female.

INTELLECTUAL PROPERTY

Intellectual property, including patents, trade secrets, trademarks and copyrights, is critical to our business. Our commercial success depends in part on our ability to obtain and maintain proprietary intellectual property protection for our current products as well as for future product candidates and novel discoveries, product development technologies, and know-how. Our commercial success also depends in part on our ability to operate without infringing the proprietary rights of others and to prevent others from infringing our proprietary rights.

We protect our intellectual property, core technologies, and other know-how through a combination of patents, trademarks, trade secrets, and IP protection clauses in our agreements. Additionally, we rely on our research and development program, clinical trials, know-how and marketing programs to advance our products and product candidates, and to expand our intellectual property rights.

As of December 31, 2025, we had 6 issued U.S. utility patents, which are expected to expire between 2034 and 2043; 1 issued U.S. design patent, which is expected to expire in 2038, 7 pending U.S. utility patent applications, and 5 pending U.S. design patent applications. Additionally, as of December 31, 2025, we had 3 granted patents in Australia, 1 granted patent in Brazil, 1 granted patent in Canada, 1 granted patent in China, 1 granted patent in Hong Kong, 2 granted patents in Japan, 2 granted patents in Europe, each validated in Germany, Spain, France, Great Britain, and Italy, and 3 German utility models, which are expected to expire between 2033 and 2041; 4 certified registered designs in Australia, 2 design patents in China, 16 registered community designs in Europe, 2 design registrations in Japan, 16 registered designs in the United Kingdom, which are expected to expire between 2034 and 2050; and 5 pending patent applications in Australia, 1 pending patent application in Canada, 4 pending patent applications in China, 7 pending patent applications in Europe, 2 pending patent applications in Hong Kong, 4 pending patent applications in Japan, 1 pending patent application in New Zealand, 6 registered designs in Australia, 1 pending design patent in China, 5 pending design registrations in Japan, and 6 pending registered designs in New Zealand. The foregoing estimated expiration dates for the issued and granted patents do not account for potentially available patent term extensions and assume payment of appropriate maintenance, renewal, annuity and other governmental fees. Calculation of the expiration of issued or granted patents is complex, varies by country and is based upon many factors. Accordingly, the foregoing expiration dates are estimates.

Our owned U.S. and foreign patents and patent applications generally relate to devices for preparing regenerative epidermal suspensions for skin regeneration and wound healing, methods for harvesting and preparing cells for transplant or treatment of a tissue site, including automated preparations, methods of treating a tissue site with a regenerative epidermal suspension, methods of preparing a regenerative suspension with exogenous agents to promote wound healing, methods of evaluating the therapeutic potential of regenerative epidermal suspension, and methods of preparing a cell-free and allogeneic regenerative epidermal suspension supernatant.

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Additionally, as of December 31, 2025, we owned 147 registered trademarks, common or state law trademarks, and 17 pending trademark applications, including “AVITA Medical,” the AVITA Medical logo, “RECELL,” “RECELL GO”, the RECELL GO logo, “RECELL GO mini”, “Spray-On Skin,” the RECELL logo, “Cohealyx,” the Cohealyx logo, and others in the U.S. and international markets.

FACILITIES

AVITA Medical leases approximately 17,500 square feet of administrative and office space in Valencia, California that is currently leased through October 31, 2026. We operate an FDA-registered production plant in Ventura, California, in a 27,840 square foot facility that is currently leased through September 30, 2030. We also lease a 3,360 square foot storage facility adjacent to our existing production plant in Ventura under a lease agreement that expires on September 30, 2030. We also have an administrative office lease in Irvine, California of approximately 10,700 square feet that is currently leased through the end of July 2028. We also lease a limited amount of incubator space in Irvine, California for scientific research and product development activities.

MANUFACTURING, SUPPLY AND PRODUCTION

We produce RECELL and PermeaDerm in our Ventura facility under current Good Manufacturing Practices (“cGMP”) and per ISO 13485, which also meets the regulatory requirements of other jurisdictions in which we sell RECELL. We maintain a state of regulatory compliance and inspection readiness at all times, and any future material changes to our production processes will be submitted for approval to the FDA and regulatory authorities in other jurisdictions as required.

Within the Ventura facility we perform the final manufacturing, assembly, packaging, and warehousing of RECELL and PermeaDerm. In August of 2025, we received approval from the FDA to conduct quality testing in house for U.S. products, and in October 2025 we received the same approval from our notified body for E.U. products. Bringing quality testing in house reduces our reliance on third-party test laboratories..

AVITA Medical sources multiple components, sub-assemblies, and materials from third-party suppliers, who are required to meet our cGMP quality specifications and associated regulatory requirements. To ensure continuity of supply, we maintain multiple sources of supply for key components, subassemblies and materials, and the majority of critical raw materials and services have multiple qualified suppliers. While a small number of materials remain single-sourced, we are actively working to qualify and validate additional suppliers for these materials as we continue to evaluate methods of removing risk from our supply chain. Additionally, in the second half of 2024, we implemented lean manufacturing methods to increase efficiencies in the production of RECELL. We believe that our current manufacturing capacity at the Ventura facility is sufficient to meet the expected commercial demand for burns, full-thickness skin injuries, and other indications under development, for the foreseeable future.

AVITA Medical ships its products directly from our Ventura facility to customers and distributors. From time-to-time we may also store small quantities of products at satellite distribution sites within the U.S. to better support access to our U.S. customers.

BARDA CONTRACT

BARDA, under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services (“HHS”) has supported our company since 2015. A contract with BARDA provided funding for the development of the RECELL. The BARDA contract also supported the Company’s clinical trial in soft-tissue reconstruction, which led to the full-thickness skin defect indication. In addition to the clinical support provided by BARDA, we managed an inventory system of RECELL devices for BARDA to bolster emergency preparedness and support the logistics of emergency deployment of RECELL for use in mass casualty or other emergency situations. Between 2015 and December 31, 2025, we have received an aggregate total of $40.7 million in payments under the contract with BARDA.

As of December 31, 2023, we no longer have a contractual obligation to manage an inventory system for BARDA. However, from that date through September 28, 2025, we had an agreement to provide access to RECELL inventory in the event of a national emergency. Under that agreement, BARDA would pay for any devices requisitioned from this inventory along with a nominal annual maintenance fee to ensure first right of access. We anticipate BARDA will renew that agreement, but has been delayed due to the recent shutdown of the federal government.

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COMPETITION

We currently believe that there is no direct competition for RECELL. Additionally, our innovative technology is supported by our expanding intellectual property portfolio and we believe that regulatory approval processes around the world will continue to provide additional and significant barriers to entry against meaningful competition. Despite these meaningful competitive advantages, the medical device, biotechnology, and pharmaceutical industries are highly competitive and subject to rapid advancements in technology, as well as changes in practice. In the future, we may face competition from various sources, including medical device, pharmaceutical, and wound care companies, academic and medical institutions, governmental agencies, medical practitioners, and public and private research institutions, among others. Consequently, any product that we successfully develop and/or commercialize will compete with both existing therapies and any new therapies that may emerge in the future.

In both the burn and non-burn wound markets, our indirect competitor is primarily split-thickness autografts. While RECELL complements autografts for the treatment of various wound injuries, split-thickness autografts represent the traditional surgical procedure and the current standard of care. However, based on our clinical trials and commercial experience, we believe that RECELL offers sustainable competitive, clinical, and economic advantages over the traditional surgical procedure. We also believe that our current portfolio products (Cohealyx and PermeaDerm)l enhance these advantages.

GOVERNMENT REGULATIONS

The production and marketing of our current products, as well as any additional product candidates developed in future ongoing research and development activities, are subject to regulation by numerous governmental authorities including the FDA in the U.S. and similar agencies in other countries throughout the world. Pursuant to its authority under the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), the FDA has jurisdiction over medical devices in the U.S. The FDA regulates the design, development, manufacturing, and distribution of medical devices to ensure that medical products distributed domestically are safe and effective for their intended uses. The FD&C Act classifies medical devices into one of three categories based on the risks associated with the device and the level of control necessary to provide reasonable assurance of safety and effectiveness. Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices deemed not substantially equivalent to a previously 510(k)-cleared device, are categorized as Class III. These devices typically require submission and approval of a PMA. RECELL is categorized as a Class III medical device, and in September 2018 the FDA granted our PMA for use in the treatment of acute thermal burns in patients 18 years and older. In June 2021, the FDA approved a supplement to our PMA to expand the use of RECELL in pediatric patients with full-thickness burns. In June 2023, the FDA approved both a supplement to our PMA to expand the use of RECELL for full-thickness skin defects and an original PMA to expand the use of RECELL for the repigmentation of stable depigmented vitiligo lesions. On May 29, 2024, the FDA approved our PMA supplement for RECELL GO, our next generation autologous cell harvesting device, to treat thermal burn wounds and full-thickness skin defects. On December 23, 2024, the FDA approved RECELL GO mini. Cohealyx and PermeaDerm have both received 510(k) clearance from the FDA.

To support additional PMAs or PMA supplements in the U.S. or applications for approval in other regions, the completion of additional clinical and non-clinical studies and supporting development activities will likely be required. Clinical trials can take many years to complete and require the expenditure of substantial resources. The length of time varies substantially according to the type, complexity, novelty, and intended use of the product candidate. We cannot make any assurances that once clinical trials are completed by us or a collaborative partner, we will be able to submit as scheduled a marketing approval request to the applicable governmental regulatory authority, or that such request and application will be reviewed and cleared by such governmental authority in a timely manner, or at all. Although we intend to make use of fast-track and abbreviated regulatory approval programs when possible and commercially appropriate, we cannot be certain that we will be able to obtain the clearances and approvals necessary for clinical testing or for manufacturing and marketing our product candidates. Delays in obtaining regulatory approvals could adversely affect the development and commercialization of our product candidates and could adversely impact our business, financial condition, and results of operations. During the course of clinical trials and non-clinical studies, product candidates may exhibit unforeseen and unacceptable safety considerations. If any unacceptable side effects were to occur, we may, or regulatory authorities may require us to, interrupt, limit, delay or abort the development of our potential products.

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Any products manufactured or distributed by us pursuant to regulatory approvals are subject to continuing regulation by the FDA and similar agencies in other countries, including maintaining records supporting manufacturing and distribution under cGMP, periodic reporting, advertising, promotion, compliance with any post-approval requirements imposed as a conditional of approval, recordkeeping and reporting requirements, including adverse events experiences. After approval, material changes to the approved product, such as adding new indications or other labeling claims, or changes to the manufacturing process, are subject to prior approval by the FDA and other regulatory agencies. Medical device manufacturers and their subcontractors are required to register their establishments with the FDA, certain state agencies and international agencies. Subcontractors are subject to periodic announced and unannounced inspections by the FDA and other agencies for compliance with cGMP. We have established processes for the categorization of vendor criticality and the associated activities for qualification and monitoring of vendors. These activities include, but are not limited to, requiring certification of supplier in conformance to relevant cGMP requirements and other FDA and international agency regulatory requirements, approved supplier lists, and Company-conducted audits. In addition, all goods and services purchased from suppliers by us must be purchased from only those suppliers on the approved supplier list. Furthermore, the Company itself will continue to comply with all relevant FDA requirements and regulations and any applicable international agency regulatory requirements in its continued manufacturing and promotion of its FDA approved commercial products.

In addition to FDA approval in the U.S., RECELL has received various approvals and registrations in international markets. RECELL (including RECELL GO) has received CE-mark approval in Europe; RECELL, excluding RECELL GO, has received PMDA approval for burns in Japan and is TGA-registered in Australia.

HEALTHCARE LAWS AND REGULATIONS

AVITA Medical is a manufacturer of medical devices, and therefore we are subject to regulations by the FDA and various federal and state healthcare laws and regulations. These regulations govern our advertising and promotional practices, our interactions with healthcare providers (“HCPs”), and our reporting of any payments made to HCPs. AVITA Medical is committed to the highest standards of business conduct in accordance with the AdvaMed Code of Ethics on Interactions with Health Care Professionals (the “AdvaMed Code”). We are members of AdvaMed and have been AdvaMed-certified since December 2025, reflecting our commitment to ethical, transparent, and compliant interactions with healthcare providers.

Interactions with Healthcare Providers

Providing any benefits or advantages to HCPs in order to induce or encourage the use or referral of AVITA products is strictly prohibited by both U.S. and international laws and regulations. Restrictions under applicable federal and state healthcare laws and regulations include but are not limited to the following:

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The federal healthcare Anti-Kickback Statute (“AKS”). AKS prohibits any person from soliciting, offering, receiving, or providing any remuneration in cash or in kind, whether directly or indirectly, to induce or reward the referral, purchase, lease, order, or recommendation of any item or service for which payment may be made in whole or in part under a federal healthcare program such as Medicare and Medicaid.

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The federal False Claims Act (“FCA”). FCA may be enforced by either the U.S. Department of Justice or private whistleblowers should they choose to bring civil (qui tam) actions on behalf of the federal government. The FCA imposes civil penalties, as well as liability for treble damages and for attorneys’ fees and costs, on individuals or entities who knowingly present, or cause to be presented, claims for payment that are false or fraudulent to the federal government. FCA also imposes similar penalties on those who make a false statement material to a fraudulent claim, or who improperly avoid, decrease, or conceal an obligation to pay money to the federal government.

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State and foreign laws and regulations may apply to sales or marketing arrangements and claims involving healthcare devices or services reimbursed by non-governmental third-party payors.

Additionally, certain state laws require medical device companies to comply with voluntary guidelines in our interactions with healthcare providers promulgated by global trade associations and relevant compliance guidance issued by the HHS, Office of Inspector General. Such guidelines prohibit medical device manufacturers from offering or providing certain types of payments or gifts to health care providers; and/or require the disclosure of gifts or payments to healthcare providers. We maintain a robust compliance program designed to meet applicable federal and state laws and to align with recognized industry standards, including the AdvaMed Code and relevant HHS Office of Inspector General guidance.

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Interactions with Foreign Officials and Entities

The U.S. Foreign Corrupt Practices Act (“FCPA”) prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party, or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the U.S. to comply with accounting provisions requiring companies to maintain books and records that accurately and fairly reflect all transactions of companies, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. We are also subject to similar regulations under the Australian bribery laws and other anti-corruption laws that apply in countries where we do business.

Federal and State Reporting

Pursuant to the federal National Physician Payment Transparence Program (Open Payments) Act, AVITA Medical is required to annually report certain payments or transfers of value to HCPs annually to CMS. In addition to adhering to these federal reporting requirements, we are required to make similar annual reports to relevant state agencies.

Privacy

Various federal, state, and foreign laws govern the privacy and security of consumer and patient information. We comply with all such applicable laws.

ENVIRONMENTAL, HEALTH AND SAFETY MATTERS

We are subject to extensive environmental, health and safety laws and regulations in a number of jurisdictions, primarily in California and the U.S., governing, among other things: the use, storage, registration, handling, emission and disposal of chemicals, waste materials and sewage; chemicals, air, water and ground contamination; and air emissions and the cleanup of contaminated sites, including any contamination that could result from spills due to our failure to properly dispose of production waste materials. Our operations at our Ventura manufacturing facility produce a small amount of waste materials that are considered minimally hazardous, and we use a third-party waste disposal company to remove any waste generated during operations from the facility. Our activities require permits from various governmental authorities including local municipal authorities. Local and state authorities may conduct periodic inspections in order to review and ensure our compliance with the various regulations. We are not presently aware of any material violations or deficiencies relating to these requirements. These laws, regulations and permits could potentially impose additional costs related to compliance or remediation.

AVAILABLE INFORMATION

The Company files annual, quarterly and current reports, proxy statements and other documents with the Securities and Exchange Commission (“SEC”) under the Securities Exchange Act of 1934 (the “Exchange Act”). The SEC maintains a website that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. The public can obtain any documents that we file with the SEC at www.sec.gov. In addition, copies of announcements made by the Company to ASX are available on the ASX website (www.asx.com.au) and also, under the heading “Investors: Press Releases” at the following link on our website https://ir.avitamedical.com/press-releases/news-releases. Our filings with the SEC, including without limitation, our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, are available free of charge on our website under the heading “Investors: Financials _SEC Filings” at the following link on our website (https://ir.avitamedical.com/financials/sec-filings), as soon as reasonably practicable after we file or furnish them electronically with the SEC. We maintain a website at www.avitamedical.com. Information contained on our website is not part of or incorporated into this Annual Report.