Avita Medical Inc Stock Price, News & Analysis

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.

AVITA Medical announced FDA approval to amend its pivotal clinical trial for the RECELL® System, moving from a 3-arm study of 84 subjects to a streamlined single-arm design evaluating 23 subjects across 15 clinical sites. This change reflects confidence in the treatment's safety and anticipated efficacy in repigmenting stable vitiligo lesions. The new trial design aims for a timely market entry by H2 2023, targeting a significant unmet need affecting approximately 6.5 million people in the U.S. with no current cure for vitiligo.

AVITA Medical, Inc. (NASDAQ: RCEL) will announce its fiscal Q4 2021 financial results on August 26, 2021, after market close. The company will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET to discuss these results. AVITA focuses on regenerative medicine, particularly with its RECELL® System, which utilizes patient-derived skin cells for skin restoration. This platform addresses needs in burns and chronic wounds and has been FDA-approved since September 2018.

AVITA Medical, Inc. (NASDAQ: RCEL) was added to the Russell 3000^® Index effective June 28, 2021, marking a significant milestone for the regenerative medicine company. As part of the annual reconstitution, this inclusion will broaden the company’s stockholder base and automatically place it in the Russell 2000 Index. The Russell indexes are influential benchmarks for investment managers, encompassing approximately $10.6 trillion in assets. AVITA Medical’s technology addresses unmet needs in skin restoration, specifically through its RECELL^® System, approved by the FDA for treating burns.