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AVITA Medical reports developments in therapeutic acute wound care, led by the RECELL platform for Spray-On Skin used in burn and trauma wounds. Company news commonly covers FDA-cleared wound-care indications, RECELL GO automation, international regulatory clearances, and the U.S. commercial portfolio that includes Cohealyx, a collagen-based dermal matrix, and PermeaDerm, a biosynthetic wound matrix.
Updates also include clinical data presentations, BARDA emergency-preparedness agreements, quarterly financial results, investor-conference participation, and board or executive governance changes. The recurring news themes connect AVITA Medical's product platform with acute burn care, trauma wound treatment, commercialization, reimbursement, and capital resources.
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AVITA Medical (NASDAQ: RCEL) will release its first quarter 2023 financial results on May 11, 2023, after U.S. markets close. A conference call is scheduled for the same day at 1:30 PM PT (6:30 AM AEST on May 12) to discuss these results and recent business updates. The RECELL System, a leading regenerative medicine technology for skin restoration, is a highlight of AVITA's offerings, approved by the FDA for treating burns. It prepares Spray-On Skin™ cells from a patient's own skin, enhancing treatment outcomes and reducing donor skin needs. Internationally, RECELL has gained regulatory approvals across several regions, including CE-mark in Europe and TGA registration in Australia. More details can be found on their Investor Relations website.
AVITA Medical, Inc. (NASDAQ: RCEL) announced that its automated device, RECELL GO, continues to hold the FDA Breakthrough Device designation for treating acute wounds. This device enhances the existing RECELL technology by streamlining the cell disaggregation process, reducing training needs and easing operational burdens for healthcare providers. CEO Jim Corbett expressed that RECELL GO is pivotal for the company's growth trajectory. A Premarket Approval (PMA) supplement for the device is expected to be submitted to the FDA by June 30, 2023, anticipating a prioritized review and potential approval by January 2024. AVITA Medical's RECELL System has already transformed burn treatment by allowing for the creation of Spray-On Skin™ cells using a patient’s own skin, promoting improved clinical outcomes and cost-efficiency.
AVITA Medical (NASDAQ: RCEL) announced the appointment of Robert McNamara to its Board of Directors, effective April 1, 2023. With over 25 years of experience in medical device industries, McNamara has held leadership roles, including CFO positions at several public companies. His expertise in operations and financial management is expected to strengthen AVITA's growth objectives. The firm is known for its RECELL System, which utilizes patients' own skin for advanced burn treatment, already treating over 15,000 patients globally and showing positive outcomes.
AVITA Medical, Inc. (NASDAQ: RCEL) announced the appointment of Cary Vance to its Board of Directors, effective April 1, 2023. Vance brings over 25 years of healthcare leadership experience, including current roles as CEO of Titan Medical and former leadership positions at XCath, OptiScan Biomedical, and Hansen Medical. His expertise in medical technology commercialization is expected to help strengthen AVITA's market share in burn treatments and future applications. The company is known for its RECELL System, which utilizes patients' own skin to enhance healing in burn cases, currently approved in several countries.