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) has completed enrollment in its pivotal trial for the RECELL® System aimed at treating stable vitiligo, a skin condition affecting up to 2% of the population. The trial's completion is a significant step toward potential regulatory approval and commercialization slated for 2023. Dr. Mike Perry emphasized this milestone's importance for expanding RECELL's applications beyond burn treatment. The company plans to share topline data from the trial in the second half of 2022, highlighting the RECELL System's potential as a vital treatment option for vitiligo.
AVITA Medical (NASDAQ: RCEL) announced the adjournment of its 2021 Annual Stockholder Meeting set for December 14, 2021, due to insufficient quorum, with only 49% of shares represented. The meeting is rescheduled for December 22, 2021, at 1:00 p.m. PT. Valid proxies will remain valid unless revoked. The company continues to solicit votes to meet the quorum requirement for proposals filed with the SEC and ASX. If the quorum is not achieved again, additional costs will incur due to further adjournment.
AVITA Medical (NASDAQ: RCEL) announces upcoming presentations at major investor conferences. The company will present at the Canaccord Genuity MedTech Forum on November 18, 2021, at 10:30 AM EST, with a live webcast available. Additionally, AVITA will participate in the 33rd Annual Piper Sandler Virtual Healthcare Conference on December 2, 2021, with a replay accessible from November 22. AVITA Medical specializes in regenerative medicine, notably developing the RECELL® System for treating burns and chronic wounds using the patient’s own skin cells.
AVITA Medical (RCEL) reported a 39% increase in first-quarter revenue, reaching $7.0 million, up from $5.1 million in Q1 2021. Gross profit margin improved to 85% from 82%. Operating expenses decreased by 18% to $12.3 million, leading to a reduced net loss of $5.9 million ($0.24 per share), down from a loss of $10.2 million ($0.48 per share) last year. The company continues to face challenges due to hospital staffing shortages but sees ongoing enrollment in its soft tissue reconstruction trial. Revenue guidance for Q2 2022 remains at approximately $7.0 million.
AVITA Medical announced that the Centers for Medicare & Medicaid Services (CMS) has approved a new reimbursement code for its RECELL® System, effective January 1, 2022. This code allows separate payment for RECELL devices used in outpatient facilities, promoting access for Medicare burn patients. The new reimbursement structure aims to enhance treatment options and supports future indications, with a market opportunity of $450 million. Over the last three years, more than 85% of burn surgeons have been certified to use the RECELL System, which has shown significant reductions in donor skin requirements and pain.
AVITA Medical has announced a series of presentations showcasing the RECELL® System at upcoming burn conferences, highlighting its effectiveness and cost benefits in treating burns. The Southern Region Burn Conference will occur from November 4-7 in New Orleans, followed by the Northeast Region Conference on November 12-13 in Burlington, VT. Key data includes pediatric treatment outcomes and numerous case studies, emphasizing the system’s broad clinical utility. The RECELL System, FDA-approved since September 2018, uses a patient’s skin to promote healing and is positioned to address unmet needs in regenerative medicine.
AVITA Medical plans to release its fiscal Q1 2022 financial results on November 8, 2021, after market close. A conference call will follow to discuss the financial results and recent highlights. The RECELL System, the company's first U.S. product approved by the FDA in September 2018, treats acute thermal burns using the patient's own skin cells. This innovative technology addresses unmet medical needs in skin restoration, including burns and chronic wounds.
AVITA Medical has announced its participation in the 2021 Cantor Virtual Global Healthcare Conference on September 27, 2021, at 4:00 p.m. EDT. The audio webcast will be accessible via their website, with a replay available for 90 days post-event. AVITA focuses on regenerative medicine and has developed the RECELL System, a patented technology approved by the FDA for treating acute thermal burns. The system uses a patient’s own skin cells to promote healing, significantly reducing the need for donor skin.
AVITA Medical (NASDAQ: RCEL) announced its participation in the Lake Street 2021 BIG5 Conference on September 14, 2021. The company specializes in regenerative medicine, focusing on autologous skin restoration for burns, chronic wounds, and aesthetics. Its flagship product, the RECELL® System, approved by the FDA in September 2018, allows for innovative treatment using the patient’s own skin cells. AVITA aims to address significant medical needs with its patented technology, which has demonstrated promising clinical outcomes.
AVITA Medical (NASDAQ: RCEL) reported significant growth in Q4 FY2021, with total net revenue climbing 166% to $10.3 million, surpassing guidance of $6.0-6.2 million. The company achieved a gross profit margin of 80%, up from 77% year-over-year, and reduced net loss to $4.7 million ($0.19 per share) from $12.9 million ($0.60 per share) in Q4 FY2020. Full-year revenue rose 105% to $29.2 million, with total operating expenses decreasing by 10% to $51.9 million. FDA approval expanded the RECELL® System use for burn treatments, further enhancing market potential.