Welcome to our dedicated page for Avita Medical news (Ticker: RCEL), a resource for investors and traders seeking the latest updates and insights on Avita Medical stock.
News and updates on AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) focus on its role as a therapeutic acute wound care company centered on the RECELL System and related wound care technologies. Company news frequently highlights developments in thermal burn and trauma treatment, clinical evidence for its products, and regulatory milestones in key markets.
Investors following RCEL news can expect coverage of financial results, revenue updates, and capital structure actions such as credit agreements and equity placements, as disclosed in Form 8-K filings and press releases. AVITA Medical regularly reports quarterly and annual financial performance, adjustments to revenue outlook, and steps taken to align operating expenses with its growth priorities.
News flow also includes clinical and scientific updates. AVITA Medical has reported data presentations at medical conferences, including systematic reviews of peer-reviewed literature and real-world registry analyses supporting the RECELL System in acute wound treatment. These items describe outcomes such as reduced donor site burden, faster healing, shorter hospital stays, and favorable economic impact in burn care.
Regulatory and market access developments are another recurring theme. The company has announced CE Mark approval for RECELL GO under the EU Medical Device Regulation, regulatory clearances for RECELL in Europe, Australia, and Japan, and support from Australia’s Medical Services Advisory Committee for the use of autologous skin cell suspension prepared with RECELL in severe burns. Corporate governance updates, such as board appointments and executive transitions, are also disclosed through AVITA Medical’s news releases.
For readers tracking RCEL, this news stream provides insight into the company’s clinical progress, regulatory status, financial performance, and leadership changes, all of which shape its position in the acute wound care and medical device landscape.
AVITA Medical announced FDA approval to amend its pivotal clinical trial for the RECELL® System, moving from a 3-arm study of 84 subjects to a streamlined single-arm design evaluating 23 subjects across 15 clinical sites. This change reflects confidence in the treatment's safety and anticipated efficacy in repigmenting stable vitiligo lesions. The new trial design aims for a timely market entry by H2 2023, targeting a significant unmet need affecting approximately 6.5 million people in the U.S. with no current cure for vitiligo.
AVITA Medical, Inc. (NASDAQ: RCEL) will announce its fiscal Q4 2021 financial results on August 26, 2021, after market close. The company will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET to discuss these results. AVITA focuses on regenerative medicine, particularly with its RECELL® System, which utilizes patient-derived skin cells for skin restoration. This platform addresses needs in burns and chronic wounds and has been FDA-approved since September 2018.
AVITA Medical, Inc. (NASDAQ: RCEL) was added to the Russell 3000® Index effective June 28, 2021, marking a significant milestone for the regenerative medicine company. As part of the annual reconstitution, this inclusion will broaden the company’s stockholder base and automatically place it in the Russell 2000 Index. The Russell indexes are influential benchmarks for investment managers, encompassing approximately $10.6 trillion in assets. AVITA Medical’s technology addresses unmet needs in skin restoration, specifically through its RECELL® System, approved by the FDA for treating burns.
AVITA Medical, Inc. (NASDAQ: RCEL) announced preliminary financial results for Q4 2021, projecting revenues between $9.5 million and $9.7 million, surpassing prior guidance of $8.2 million to $8.6 million. The increase is driven by strong sales of the RECELL® product, with commercial revenue expected to rise by 55% to 60% year-over-year. This growth aligns with a surge in burn treatments as normal activities resume post-COVID-19. Full financial results will be revealed on August 25, 2021.
AVITA Medical has announced the FDA's approval for the RECELL System to treat full-thickness acute burn wounds for pediatric and adult patients, removing previous age restrictions. This expanded indication allows treatment of burns greater than 50% total body surface area (TBSA). The RECELL System generates Spray-On Skin™ Cells from a patient's skin, achieving efficient healing with fewer surgical grafting procedures. The update supports the growing demand for effective burn treatment solutions, particularly important given the high incidence of burn cases in children.
AVITA Medical (Nasdaq: RCEL) announces the appointment of James Corbett and Jan Stern Reed to its Board of Directors, effective July 1, 2021. Corbett brings 40 years of experience in medical devices, having served as CEO of various companies, while Reed has over 35 years of legal and management experience, notably with Walgreens Boots Alliance. Their expertise is expected to strengthen AVITA’s leadership in medical device commercialization and corporate governance as the company focuses on expanding its market share in skin restoration treatments.
AVITA Medical (NASDAQ: RCEL) reported strong financial results for Q3 FY2021, with RECELL® revenue reaching $8.8 million, up 126% year-over-year. Procedural volumes rose to 492 from 408 in Q3 2020, with 99 burn center accounts now in use. The company trained 244 burn surgeons, achieving an 81% penetration rate. Despite a net loss of $6.0 million, down from $15.0 million last year, and operating expenses decreasing to $13.2 million, gross margin fell to 76% due to lower pricing from BARDA contracts. The company expects Q4 revenue between $8.2-$8.6 million.
AVITA Medical (NASDAQ: RCEL) announced plans to release its fiscal Q3 2021 financial results on May 13, 2021, post market close. A conference call and webcast will follow at 1:30 PM PT to discuss these results alongside recent company highlights. AVITA specializes in regenerative medicine, utilizing its patented RECELL System for autologous skin restoration in treating burns and chronic wounds. The system has shown clinical advancements and is FDA approved, enhancing treatment efficacy and reducing donor skin requirements.
AVITA Medical announced the acceptance of nine abstracts at the 43rd Annual John A. Boswick Burn & Wound Care Symposium, highlighting the clinical and cost-effectiveness of the RECELL System in treating burns. The symposium will take place from April 17-22, 2021, in Maui, Hawaii. CEO Dr. Mike Perry emphasized the system's versatility in treating varying burn depths and its benefits when combined with other surgical technologies. Data from randomized clinical trials and real-world use support the RECELL System as a significant advancement in burn treatment.
AVITA Medical (NASDAQ: RCEL) announced the acceptance of 15 abstracts showcasing the benefits of its RECELL System at the American Burn Association's upcoming annual meeting. This marks the highest number of presentations since the RECELL's FDA approval in 2018. Over 80% of U.S. burn surgeons are now certified in using the system, which demonstrates a growing adoption in treating diverse burn injuries. The findings emphasize both clinical outcomes and cost-effectiveness, supporting the RECELL System as a significant advancement in burn care.