Avita Medical

Avita Medical is an Australian regenerative medicine company focused on technologies that support the repair and regeneration of damaged skin. Its principal platform is ReCell, an autologous cell-harvesting and spray-on skin device designed to enable clinicians to prepare a patient’s own skin cells at the point of care and apply them to burn wounds and other skin defects. The approach is intended to reduce the amount of healthy donor skin required for grafting while avoiding the need to culture tissue in an external laboratory. The company’s origins trace to Clinical Cell Culture, which was listed on the Australian Securities Exchange under the symbol C3. In June 2008, the business reorganized under the Avita Medical name as it concentrated its corporate identity around regenerative medicine. Its early portfolio was broader than its current focus and included respiratory products such as Breath-a-Tech and Funhaler. Avita divested that respiratory business in 2015 in order to prioritize its regenerative medicine activities. ReCell became Avita Medical’s first regenerative medicine product to reach the market. The system is used during a bedside procedure in which a small sample of the patient’s skin is processed into a cell suspension for application to a wound. The company has described the procedure as requiring approximately 25 minutes and as not requiring off-site tissue culture, laboratory infrastructure, or specialized cell-culture personnel. Its principal clinical rationale is that a small donor sample can be expanded across a larger wound area, potentially preserving healthy skin for patients with extensive injuries. Avita pursued regulatory and commercial development in several regions. ReCell has been marketed or approved in Australia, Europe, the Middle East, Africa, and China, while the United States program progressed through compassionate-use access, clinical studies, and a Premarket Approval application. In September 2017, the company submitted a U.S. FDA PMA application for burn treatment. The submission incorporated randomized controlled trial data from U.S. burn centers, including evidence relating to donor-skin reduction, healing, and scarring. On September 20, 2018, the FDA approved ReCell for the treatment of burn injuries in the United States. The U.S. development program was supported by federal initiatives. In 2009, the United States Armed Forces Institute of Regenerative Medicine awarded the company a US$1.45 million grant intended to accelerate ReCell’s U.S. regulatory progress. Avita also worked with the Biomedical Advanced Research and Development Authority under a Project BioShield contract. The base contract provided US$16.9 million in support for clinical and regulatory work and procurement of more than 5,000 devices; a later option valued at approximately US$24.3 million supported additional pediatric-burn research, health-economic work, and an extension through September 2022. These figures refer to announced government support and contract options rather than reported company revenue. Beyond burns, Avita has described additional regenerative medicine products and applications. ReNovaCell has been associated with aesthetic and plastic-surgery uses, including treatment of skin trauma, while ReGenerCell has been positioned for chronic wounds. The company’s stated market scope therefore extends from acute burn care into wound management and procedure-based skin restoration. ReCell has also been investigated for scars and other indications, although regulatory status and clinical development have varied by market and indication. Avita Medical has been traded in Australia under the ticker AVH and on the U.S. over-the-counter market under AVMXY according to the cited historical reference material. The supplied company information identifies RCEL as its public-market ticker. Because the available material does not establish a single current exchange presentation, this dossier records the supplied ticker without inferring an exchange. Avita Medical’s overall positioning is that of a specialized medical-technology and regenerative-medicine company rather than a consumer healthcare brand: its products are intended for use by clinicians in hospitals, burn centers, wound-care settings, and relevant surgical practices.

Avita Medical developed from an Australian company originally known as Clinical Cell Culture. The predecessor business was listed on the Australian Securities Exchange under the ticker C3. In June 2008, it restructured and adopted the Avita Medical name, reflecting a strategic emphasis on regenerative medicine and cell-based approaches to tissue repair. The company’s initial activities were not limited to regenerative medicine. Its portfolio included respiratory products, notably Breath-a-Tech and Funhaler. In 2015, Avita completed a strategic divestment of that respiratory business. The transaction allowed management to concentrate resources, research, and commercial activity on regenerative products, particularly ReCell and related skin-repair technologies. ReCell became the company’s central platform and its first regenerative medicine product to reach the market. The device is designed to process a small sample of a patient’s own skin at the treatment site and create a cell suspension that can be sprayed onto a wound or skin defect. The point-of-care model distinguishes ReCell from approaches that require tissue to be transported to a laboratory for culture. Avita has stated that the procedure can be completed at the bedside in approximately 25 minutes and does not require dedicated external laboratory facilities or specialized cell-culture staff. The initial clinical and commercial focus was burn care. Avita developed a U.S. regulatory program supported by government and defense-related research initiatives. In 2009, the United States Armed Forces Institute of Regenerative Medicine provided a US$1.45 million grant to help accelerate the ReCell kit’s path toward U.S. approval. The company subsequently worked with the Biomedical Advanced Research and Development Authority through a Project BioShield contract. A base agreement announced in the reference material provided US$16.9 million for the U.S. clinical and regulatory program and procurement of more than 5,000 ReCell devices. A later option, announced in 2017, was valued at approximately US$24.3 million and supported pediatric-burn research, health-economic research, and an extension of the program through September 2022. These arrangements also contemplated additional clinical studies and potential surge capacity. In September 2017, Avita submitted a Premarket Approval application to the U.S. Food and Drug Administration for ReCell in burn treatment. The application included data from two randomized controlled U.S. trials conducted at 12 leading burn centers, as well as a review of 55 compassionate-use cases involving extensive burns. The company reported that the clinical evidence included substantial reductions in donor skin harvesting for certain burn categories, together with comparable near-term healing and longer-term scar outcomes in the relevant study populations. The FDA expanded access to ReCell under a Compassionate Use Investigational Device Exemption program in February 2018. The fifth protocol expansion increased the number of potentially treatable U.S. patients by 20, to as many as 88 people with life-threatening injuries, including severe burns, who lacked sufficient healthy skin for standard grafting and had no suitable alternative treatment in the view of their physicians. On September 20, 2018, ReCell received FDA Premarket Approval for burn treatment in the United States. Avita’s regenerative product range has also included ReNovaCell and ReGenerCell. ReNovaCell has been associated with aesthetic and plastic applications, including skin trauma, while ReGenerCell has been described as a product for chronic wounds. ReCell itself has been approved or marketed in Australia, Europe, the Middle East, Africa, and China according to the cited reference material, with U.S. development and commercialization forming an important part of the company’s strategy. The company has also investigated scar treatment and other potential indications. Avita Medical’s corporate history therefore reflects a narrowing from a diversified healthcare-product portfolio to a specialized regenerative-medicine business. Its principal value proposition is the clinical use of autologous cells at the point of care, particularly where conventional grafting may be limited by the amount of healthy donor skin available. The supplied materials do not establish a current executive roster, precise headquarters city, founding year, or a definitive present-day exchange listing for the supplied RCEL ticker, so those details are left unresolved in this dossier.

• 2018

  FDA expands compassionate-use protocol

  [1]Avita Medicalen.wikipedia.org

  The FDA approved an expansion allowing up to 88 eligible U.S. patients with severe, life-threatening injuries to receive ReCell under the compassionate-use protocol.

• 2018

  ReCell receives U.S. FDA approval

  [1]Avita Medicalen.wikipedia.org

  The FDA granted Premarket Approval for ReCell for the treatment of burn injuries on September 20, 2018.

• 2017

  U.S. ReCell PMA application submitted

  [1]Avita Medicalen.wikipedia.org

  Avita submitted a U.S. FDA Premarket Approval application for ReCell in burn treatment, supported by clinical and compassionate-use data.

• 2015

  Respiratory business divested

  [1]Avita Medicalen.wikipedia.org

  Avita divested its Breath-a-Tech and Funhaler respiratory products to concentrate on regenerative medicine.

• 2009

  Regenerative-medicine grant awarded

  [1]Avita Medicalen.wikipedia.org

  The United States Armed Forces Institute of Regenerative Medicine provided a US$1.45 million grant to support development and U.S. approval efforts for ReCell.

• 2008

  Clinical Cell Culture reorganizes as Avita Medical

  [1]Avita Medicalen.wikipedia.org

  The company formerly known as Clinical Cell Culture restructured under the Avita Medical name in June 2008, reinforcing its focus on regenerative medicine.

A specialist regenerative-medicine and medical-device company centered on point-of-care use of a patient’s own skin cells to support wound closure, burn treatment, and skin repair.

• Autologous cell-harvesting and spray-on skin device

  ReCell

  ReCell is Avita Medical’s flagship regenerative-medicine device. It allows clinicians to take a small sample of a patient’s own skin, process the sample at the point of care, and apply the resulting cell suspension to burns, wounds, or other skin defects. The bedside workflow is intended to reduce reliance on external tissue-culture laboratories and limit the quantity of healthy donor skin required for grafting. ReCell has been used or developed for burn care and has also been investigated in scar-related applications. Regulatory status differs by country and indication.

• Regenerative skin-repair product

  ReNovaCell

  ReNovaCell is described in the reference material as a regenerative product intended for aesthetic and plastic applications, including the treatment of skin trauma. It represents an extension of Avita Medical’s autologous-cell approach beyond acute burn care into procedure-based skin restoration and related surgical settings. The available material does not provide a specific launch date or a complete market-by-market regulatory description.

• Chronic-wound regenerative medicine product

  ReGenerCell

  ReGenerCell is identified as a product for chronic-wound treatment within Avita Medical’s regenerative product range. Its positioning broadens the company’s addressable clinical use cases from acute burns to wounds that may require prolonged or specialized management. The supplied reference material does not specify its launch date, precise device configuration, approval status, or current commercial availability.

• 2018

  Obtain U.S. approval for ReCell in burn careProduct launch

  Background

  ReCell had undergone U.S. clinical development, compassionate-use treatment, and regulatory review for burn injuries.

  Action taken

  The FDA granted Premarket Approval for ReCell for the treatment of burn injuries on September 20, 2018.

  Aftermath

  The approval established a U.S. regulatory foundation for commercial use of Avita’s flagship regenerative-medicine device in the approved burn indication.

  Source

• 2017

  Advance ReCell through the U.S. PMA pathwayOther

  Background

  Avita had generated clinical evidence from U.S. randomized controlled trials and compassionate-use treatment of extensive burns.

  Action taken

  The company submitted a Premarket Approval application to the U.S. FDA for ReCell in burn treatment.

  Aftermath

  The application proceeded to FDA approval in September 2018.

  Source

• 2015

  Concentrate the portfolio on regenerative medicineStrategy

  Background

  Avita maintained both respiratory and regenerative products before 2015, including Breath-a-Tech and Funhaler alongside its skin-repair activities.

  Action taken

  The company divested its respiratory business and redirected strategic attention toward regenerative medicine.

  Aftermath

  The divestment left ReCell and related regenerative technologies at the center of Avita Medical’s product and development strategy.

  Source

• 2019-10-31

  AVITA Medical reports first-quarter fiscal 2020 results[3]AVITA Medical公布2020财年第一季度业绩finanznachrichten.de

  Reported: 2019-10-31

  AVITA Medical reported financial results for the fiscal first quarter ended September 30, 2019, including A$4.6 million in U.S. RECELL System product sales.

1. 1Avita Medicalen.wikipedia.org
2. 2Avita Medical official websiteavitamedical.com
3. 3AVITA Medical公布2020财年第一季度业绩finanznachrichten.de
4. 4AVITA Medical Reports First Fiscal Quarter 2022 Financial Resultsfinance.yahoo.com
5. 5AVITA Medical Reports Third Quarter Fiscal 2020 Financial Results and Company Updatefinanznachrichten.de