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, 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.
AVITA Medical, a regenerative medicine company, announced that CEO Jim Corbett will present at the TD Cowen 43rd Annual Health Care Conference in Boston on March 7, 2023, at 9:10 a.m. Eastern Time. A live webcast will be available on the company's website, with a replay accessible for 30 days post-presentation. AVITA’s RECELL System, FDA-approved for treating acute thermal burns, utilizes a patient's own skin to create Spray-On Skin™ cells, enhancing clinical outcomes and reducing donor skin requirements. The company aims to expand its cellular therapies for various indications, following its growth in international markets.
AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) invites shareholders and investors to an investor webinar on February 28, 2023, at 4:00 PM PST. The presentation, led by CEO Jim Corbett and acting CFO Sean Ekins, will highlight Q4 2022 commercial revenue growth of 37%, business updates, and future revenue guidance, followed by a Q&A session. Attendees can register via the provided Zoom link. The RECELL System, approved by the FDA, utilizes the patient’s own skin to create Spray-On Skin™ cells, enhancing treatment for burns and offering cost savings. For more details, visit avitamedical.com.
AVITA Medical (NASDAQ: RCEL) reported its financial results for Q4 and full-year 2022, highlighting a 36% rise in commercial revenue to $34.1 million, excluding BARDA revenue. Total revenue increased by 4% to $34.4 million. The company achieved an impressive gross profit margin of 82% and a significant 37% decrease in net loss to $5.4 million. Key developments include the FDA granting Breakthrough Device designations for the RECELL® System and the submission of PMA applications for both soft tissue repair and vitiligo indications. Looking ahead, AVITA anticipates FDA approvals in June 2023 and projects commercial revenue of $49 million to $51 million for the year.
AVITA Medical, Inc. (NASDAQ: RCEL) announced it will report its Q4 and full year 2022 financial results on February 23, 2023, post U.S. market close. The company will hold a conference call at 1:30 PM PT to discuss the results and provide 2023 revenue guidance. AVITA specializes in regenerative medicine, particularly with its RECELL® System for skin restoration, which received FDA approval for treating acute thermal burns. The company emphasizes its innovative approach to healing severe burns by using a patient's own skin to create Spray-On Skin™ cells, enhancing clinical outcomes and reducing costs.
AVITA Medical (NASDAQ: RCEL) announced significant changes to its management structure to enhance strategic growth under newly appointed CEO James Corbett. Effective January 19, 2023, product development, operations, and regulatory affairs will report directly to the CEO, streamlining operations for sustained growth. Chief Operating Officer Kathy McGee is leaving, and the company will not fill the position. Additionally, Chief Financial Officer Michael Holder has departed, with Senior VP of Finance Sean Ekins assuming the interim CFO role as the company searches for a new CFO. Financial results for Q4 2022 will be reported on February 23, 2023, along with first quarter and full year 2023 revenue guidance.
AVITA Medical, Inc. (NASDAQ: RCEL) has submitted a Premarket Approval (PMA) application to the FDA for its RECELL® System, aiming to include stable vitiligo treatment. The pivotal trial demonstrated significant repigmentation success, achieving its primary endpoint. If approved, the RECELL's indication expansion is expected to tap into a large market, with the potential launch in January 2025. The RECELL System, already FDA-approved for acute burns, received Breakthrough Device designation, ensuring prioritized review from the FDA.
AVITA Medical, a leader in regenerative medicine, held its 2022 Annual Meeting of Stockholders virtually on December 12, 2022. All five director nominees were elected, including Louis Panaccio and CEO James Corbett. Stockholders ratified Grant Thornton LLP as independent auditors for 2022 and approved several grants of stock units and options for executive compensation. Notably, Corbett received options valued at $1 million. However, a proposal to amend the quorum requirement for stockholder meetings was not approved. Full voting results are available on the Company's website.
AVITA Medical, Inc. (NASDAQ: RCEL) announced the submission of a Premarket Approval (PMA) supplement to the FDA for its RECELL® System, aiming to expand its indication to soft tissue repair. CEO Jim Corbett highlighted this submission as a major milestone, potentially tripling the market opportunity and starting growth as early as July 2023. The pivotal trial for soft tissue repair met its endpoints, showing RECELL's effectiveness in donor sparing and healing outcomes. The FDA has granted Breakthrough Device designation, ensuring prioritized review of the application.
AVITA Medical, Inc. (NASDAQ: RCEL) invites investors to its webinar on November 23, 2022, at 4:00 PM PST, showcasing its successful September quarter with a 30% rise in commercial revenue year-over-year. The session, led by CEO Jim Corbett and CFO Michael Holder, will discuss key developments, future goals, and include a Q&A. AVITA specializes in regenerative medicine through the RECELL® System, enhancing skin restoration for burns and other conditions. Participants can register via the provided Zoom link, with a replay available on their website post-event.