AVITA Medical Profile
AVITA Medical, Inc. operates as a regenerative medicine company. The company is transforming the standard of care in wound care management and skin restoration with innovative devices. At the forefront of its portfolio is the company's patented and proprietary RECELL System (RECELL System or RECELL), approved by the United States Food & Drug Administration (FDA) for the treatment of thermal burn wounds and full-thickness skin defects, and for repigmentation of stable depigmented vitiligo lesions. RECELL harnesses the regenerative properties of a patient's own skin to create an autologous skin cell suspension, Spray-On Skin Cells, delivering a transformative solution at the point of care. This breakthrough technology serves as the catalyst for a new treatment paradigm enabling improved clinical outcomes.
Strategy
The company focuses on becoming the leading provider of regenerative medicine addressing unmet medical needs in burn injuries, full-thickness skin defects, and in skin repigmentation, such as vitiligo. The key elements of the company's strategy are to become the standard of care in the U.S. burns industry by increasing RECELL penetration and adoption in burn centers; expand into the U.S. trauma centers to increase utilization of RECELL for the treatment of full-thickness skin defects; launch RECELL GO following FDA approval to increase market adoption and expand its customer base; expand its global presence within the European Union and Australia through the exclusive use of third-party distributors; continue to build upon commercial activities in Japan through its partnership with COSMOTEC Company, Ltd (COSMOTEC) with its current Pharmaceuticals and Medical Devices Act (PMDA) approval for RECELL with an indication in burns; continue to pursue business development opportunities that are complementary to its core RECELL System indications and/or its targeted markets, such as the agreement with Stedical Scientific, Inc.; and establish commercial payor coverage for the RECELL System in the U.S. for the treatment of vitiligo lesions; initial phase of coverage expected during the fourth quarter of 2025.
Product Portfolio
RECELL Platform
RECELL is a single use, stand-alone, battery operated, autologous cell harvesting device containing enzymatic and buffer solutions, sterile surgical instruments, and actuators. RECELL is FDA approved for the treatment of thermal burn wounds and full-thickness skin defects, and for repigmentation of stable depigmented vitiligo lesions. The platform technology of the RECELL System enables a thin split-thickness skin sample from the patient to be processed and prepared, producing an autologous cellular suspension called Spray-On Skin Cells. These Spray-On Skin Cells are prepared at the point of care in as little as 30 minutes, providing a new way to treat thermal burn wounds and full-thickness skin defects.
The regenerative skin cell suspension includes the patient's own skin cells, including keratinocytes, fibroblasts, and melanocytes, all of which play critical roles in skin regeneration. The application of these cells stimulates healing and repigmentation throughout the wound bed. The patented and proprietary platform technology underlying the Spray-On Skin Cell suspension originated in Australia, based on the seminal work of Professor Fiona Wood and fellow scientist Marie Stoner. In September 2018, the FDA approved RECELL as a Class 3 device through a premarket approval (PMA) for the treatment of second and third-degree acute thermal burn injuries in patients 18 years and older. Following receipt of its original PMA, the company commenced commercialization of the RECELL System in January 2019 in the United States.
In June 2021, the FDA approved expanded use of RECELL in combination of meshed autografting for acute full-thickness thermal wounds in both pediatric and adult patients, and for full-thickness thermal burns greater than 50% total body surface area (TBSA). As a result of having achieved an expanded indication for use in pediatric burns, the Biomedical Advanced Research and Development Authority (BARDA) funded U.S. Pediatric Burns trial has been closed to new enrollment.
In February 2022, the FDA approved a PMA supplement for the RECELL Autologous Cell Harvesting Device, an enhanced ease-of-use device aimed at providing clinicians a more efficient user experience and streamlined workflow.
On June 7, 2023, the FDA approved a PMA supplement for full-thickness skin defects based on results from the company's pivotal trial for soft tissue repair and reconstruction. Following this approval, it commenced a commercial launch on June 8, 2023.
On June 16, 2023, the FDA approved a PMA application for the repigmentation of stable depigmented vitiligo lesions. Following FDA approval, the company established a three-step framework to secure reimbursement. The first step is a post-market study called, TONE. TONE will evaluate repigmentation using the RECELL device and will also seek to measure the improvement in the quality-of life following treatment of stable vitiligo with RECELL. The company expects to submit the study for publication by the end of 2024.The second step is to capture the longitudinal healthcare costs for a vitiligo patient through a health economics, which is also expected to be submitted for publication by the end of 2024. Following publication of both studies, it is expected that conversations with commercial payors will begin during the second quarter of 2025. Subsequently, the company anticipates commercial coverage will be rolled out on a regional basis, considering state and geographic factors. The initial phase of coverage is likely to begin in the fourth quarter of 2025, with appropriately sized commercial support as coverage is established.
Additionally, on June 29, 2023, the company submitted a PMA supplement to the FDA for RECELL GO. RECELL GO maintains the FDA Breakthrough Device designation from predecessor devices. On September 29, 2023, the company received notice from the FDA that additional information regarding the PMA supplement is required for the continuation of a substantive review for RECELL GO. This request, which is not unique to the Breakthrough Device Program, placed the application file on hold while the company addresses the FDA's questions. A category of questions posed by the FDA requires additional in-house testing, which is substantially completed. Consequently, the company expects to submit a response to the FDA no later than February 28, 2024. Upon the submission to the FDA, the application will reenter the 180-day cycle, with 90 days remaining in the review period. This timing would imply FDA approval on May 30, 2024, with a product launch on May 31, 2024.
International Strategy
In international markets, the RECELL System has received various approvals and registrations to promote skin healing in a wide range of applications, including, burns, full-thickness skin defects, and vitiligo. These endorsements include TGA registration in Australia, CE mark approval in Europe, and PMDA approval in Japan under the Pharmaceuticals and Medical Devices Act for burns. The company's global commercialization strategy focuses on Australia, the European Union, and Japan.
In February 2019, the company entered into a partnership with COSMOTEC, an M3 Group company, to market and distribute the RECELL System in Japan. Following the approval of reimbursement pricing by the Japanese Ministry of Health, Labor, and Welfare, COSMOTEC began the commercial launch of RECELL in September 2022.
As part of its strategic growth plans, the company plans to expand its global presence within the European Union and Australia through the exclusive use of third-party distributors. In November 2023, the company entered into its first European distribution partnership with PolyMedics Innovations GmbH. PolyMedics Innovations will lead its expansion into Germany, Austria, and Switzerland.
The company plans to actively identify new distribution partners in its focused markets over the next 6 to 12 months.
Sales and Marketing
The company's commercial organization focuses on clinical case support, staff training, and building awareness to further expand interest in the clinical and economic benefits of RECELL. The company sells RECELL in the U.S. through its direct commercial organization of 70 individuals, which consists of 10 managers, 40 regenerative tissue specialists, and 20 clinical training specialists. The company's commercial organization is composed of highly experienced medical sales representatives, as well as former burn and trauma nurses. This organization covers both thermal and non-thermal wound accounts. The company plans to further expand its commercial organization to 108 in the first half of 2024.
Intellectual Property
As of December 31, 2023, AVITA Medical's patent portfolio included 22 patent grants and 31 pending patent applications worldwide, with patent coverage either secured or in progress in the U.S., China, Japan, Australia, Brazil, Canada, France, Germany, Hong Kong, Italy, Spain, the United Kingdom, and at the European Patent Office (EPO).
AVITA Medical's patent portfolio covers the original RECELL product, all-in-one RECELL, RECELL GO, methods of using the RECELL System, methods of evaluating the therapeutic potential of Regenerative Epidermal Suspension (RES), a cell-free and allogeneic RES supernate, and methods of preparing a cell suspension with exogenous agents to promote wound healing.
In 2019, AVITA Medical filed a Patent Term Extension (PTE) application with the U.S. Patent and Trademark for U.S. Patent No. 9,029,140, which covers the RECELL System, as a result of patent term lost to the FDA regulatory process. The PTE application was approved, and the patent term of U.S. Patent No. 9,029,140, has been extended to April 9, 2024. AVITA Medical's other patents have expected expiration dates ranging from 2032 to 2033, while AVITA Medical's pending patent applications, if granted, would have expiration dates ranging from 2032 to 2042.
Additionally, AVITA Medical owns and defends a global trademark portfolio comprising 142 registered trademarks, common or state law trademarks, and pending trademark applications, including AVITA Medical, the AVITA Medical logo, RECELL, Spray-On Skin, the RECELL System logo, RES, and others in the U.S. and international markets.
BARDA CONTRACT
The company has a contract with BARDA, under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services. The contract provided funding for the development of the RECELL System. The company entered into the contract on September 29, 2015, with the original contract period ending on December 31, 2023. The company has executed a contract modification with BARDA to extend the period of performance to September 28, 2025.
Research and Development
The company's research and development expenses included $20.8 million in 2023.
Government Regulations
The RECELL System is categorized as a Class III medical device, and in September 2018 the FDA granted the company's 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 the company's PMA to expand the use of RECELL in pediatric patients with full-thickness burns. In June 2023, the FDA approved a supplement to its 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.
The company is a manufacturer of a medical device and therefore it is subject to regulations by the FDA and various federal and state healthcare laws and regulations. The company is subject to similar regulations under the Australian bribery laws and other anti-corruption laws that apply in countries where it does business. Pursuant to the federal Physician Payment Sunshine Act, the company is required to report annually to the Centers for Medicare and Medicaid Services within the U.S. Department of Health and Human Services. The company must comply with the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), which imposes criminal and civil liability for, among other conduct, making false statements relating to healthcare matters and executing a scheme to defraud any healthcare benefit program.
Pursuant to the federal National Physician Payment Transparence Program (Open Payments) Act, AVITA Medical is required to report annually to the Centers for Medicare and Medicaid Services within the U.S. Department of Health and Human Services. Additionally, in adhering to federal reporting requirements, all relevant state marketing reporting regulations, any payments, and transfers of value to physicians and teaching hospitals, as well as other categories of disclosures must be reported annually. In addition to FDA approval in the U.S., the RECELL System has received various approvals and registrations in international markets. The RECELL System is TGA-registered in Australia, received CE-mark approval in Europe, and received Japan's Pharmaceuticals and Medical Devices Act (PMDA) approval for burns in Japan.
The company is a manufacturer of a medical device and therefore it is subject to regulations by the FDA and various federal and state healthcare laws and regulations. These regulations govern the company's advertising and promotional practices, its interactions with healthcare providers (HCPs), and its 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.
History
The company was incorporated in 2000. It was formerly known as AVITA Therapeutics, Inc. and changed its name to AVITA Medical, Inc. in 2020.
