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.
Avita Medical Inc (RCEL) delivers breakthrough regenerative medicine solutions through its FDA-approved RECELL system, transforming wound care and skin restoration. This news hub provides investors and medical professionals with essential updates on clinical advancements, regulatory milestones, and strategic initiatives.
Access authoritative information about RCEL's innovative approach to burn treatment and skin repair, including FDA clearances, international regulatory progress, and partnerships shaping the future of point-of-care cell therapy. Our curated collection features press releases on product innovations, peer-reviewed research validations, and market expansion activities.
Key content categories include clinical trial outcomes, regulatory submissions, financial performance updates, and technological refinements to the RECELL platform. Users benefit from centralized access to verified information supporting informed analysis of this medical device innovator.
Bookmark this page for streamlined tracking of Avita Medical's progress in advancing regenerative wound care solutions. Check regularly for updates demonstrating how RCEL's patented technology continues to redefine standards in acute burn treatment and complex wound management.
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.
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.
