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 (NASDAQ: RCEL) reported robust financial results for Q3 2022, with commercial revenue reaching $9.0 million, a 30% increase from the prior year. Total revenue, including BARDA funding, was $9.1 million, up from $7.0 million. The company achieved a gross profit margin of 83% and met co-primary endpoints in pivotal trials for its RECELL® System, paving the way for FDA submissions in December. AVITA also secured marketing approval in Japan, with plans to expand its commercial footprint. For 2022, full year commercial revenue guidance has been raised to $33.0-34.0 million.
AVITA Medical (NASDAQ: RCEL) announced successful outcomes in its clinical trial for the RECELL® System used in soft tissue repair. The study achieved its co-primary endpoints, demonstrating statistically significant donor skin sparing and non-inferiority in healing compared to standard care. These results position RECELL as a potential new standard for soft tissue repair. The company expects to submit its Premarket Approval (PMA) application to the FDA in December 2022, following a re-analysis of healing data that confirmed non-inferiority.
AVITA Medical, a leader in regenerative medicine, has announced that the FDA granted the RECELL System Breakthrough Device designations for soft tissue repair and vitiligo indications. This designation aims to expedite development and review processes for devices addressing serious medical conditions. The RECELL System, approved for acute thermal burns, utilizes a patient's own skin for treatment, significantly improving clinical outcomes and reducing donor skin requirements. AVITA anticipates this recognition will enhance patient access to their innovative therapies.
AVITA Medical (NASDAQ: RCEL) is set to release its Q3 2022 financial results on November 10, 2022, after U.S. market close. The company will hold a conference call at 1:30 PM PT to discuss the results and recent highlights. AVITA Medical specializes in regenerative medicine and is known for its RECELL® System, a technology that uses a patient's own skin cells for burn treatment. RECELL has received FDA approval and shows significant clinical benefits over standard care.
AVITA Medical (NASDAQ: RCEL) has appointed James Corbett as its new Chief Executive Officer, effective immediately. Mr. Corbett, who previously served on the Board, brings nearly 40 years of life sciences experience, including leadership roles at Microtherapeutics and Boston Scientific. His appointment comes as the company looks to capitalize on growth opportunities with its RECELL® System, which has shown significant advancements in treating acute burns. Corbett succeeds Dr. Michael Perry, who has led the company since June 2017. This leadership change aims to strengthen strategic direction and commercial growth.
AVITA Medical (NASDAQ: RCEL) announces an investor webinar on September 20, 2022, led by CEO Dr. Mike Perry and CFO Michael Holder. The session will present highlights from the June 2022 quarter, showcasing a 39% increase in commercial revenue year-over-year, alongside updates on its developmental pipeline. The webinar will conclude with a Q&A session. AVITA's RECELL System, FDA-approved for the treatment of burns, demonstrates significant clinical benefits and cost savings, positioning the company as a leader in regenerative medicine.
AVITA Medical announced positive topline results from a pivotal trial evaluating the RECELL® System for treating stable vitiligo. The study demonstrated that 56% of RECELL treatments resulted in over 50% repigmentation, compared to just 12% for standard treatment. Additionally, 36% of RECELL treatments achieved at least 80% repigmentation, establishing super-superiority. The company plans to submit an application to the FDA by the end of 2022.
AVITA Medical announced that its RECELL System has received insurance coverage in Japan for treating acute burns, with reimbursement aligned to U.S. pricing. The approval from the Japanese MHLW marks a significant step for AVITA and its partner, COSMOTEC, in launching the product in Japan. The RECELL System utilizes a patient's own skin to prepare Spray-On Skin™ Cells, reducing donor skin needed for treatment. AVITA aims to leverage this opportunity to enhance clinical outcomes and cost savings, supporting burn patients' recovery.
AVITA Medical, Inc. (NASDAQ: RCEL) announced a poster presentation on the RECELL® System for treating stable vitiligo at an upcoming conference in Santa Barbara, CA, scheduled for August 19-21, 2022. The presentation will focus on the cell characterization and potential clinical benefits of the RECELL platform. CEO Dr. Mike Perry expressed hopes for the FDA’s review, indicating that the RECELL System could provide a significant treatment option for vitiligo patients. Additionally, AVITA is completing a pivotal trial for the RECELL System, anticipating FDA approval in 2023.
AVITA Medical reported its second quarter financial results for 2022, showing commercial revenue of $8.2 million, a 23% increase from the previous year. Total revenue, including BARDA revenue, was $8.3 million, down from $10.3 million due to a decrease in BARDA contributions. Gross profit margin improved to 83%. Year-to-date commercial revenue reached $15.7 million, up 39%. However, the net loss increased 33% to $6.3 million, and total operating expenses grew by 3%. The company projects commercial revenues of $30 million for the year, excluding BARDA revenue.