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.
Summary not available.
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.
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.