Avita Medical Inc Stock Price, News & Analysis

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.

AVITA Medical, Inc. (NASDAQ: RCEL) announced preliminary financial results for Q4 2021, projecting revenues between $9.5 million and $9.7 million, surpassing prior guidance of $8.2 million to $8.6 million. The increase is driven by strong sales of the RECELL® product, with commercial revenue expected to rise by 55% to 60% year-over-year. This growth aligns with a surge in burn treatments as normal activities resume post-COVID-19. Full financial results will be revealed on August 25, 2021.

AVITA Medical has announced the FDA's approval for the RECELL System to treat full-thickness acute burn wounds for pediatric and adult patients, removing previous age restrictions. This expanded indication allows treatment of burns greater than 50% total body surface area (TBSA). The RECELL System generates Spray-On Skin™ Cells from a patient's skin, achieving efficient healing with fewer surgical grafting procedures. The update supports the growing demand for effective burn treatment solutions, particularly important given the high incidence of burn cases in children.

AVITA Medical (Nasdaq: RCEL) announces the appointment of James Corbett and Jan Stern Reed to its Board of Directors, effective July 1, 2021. Corbett brings 40 years of experience in medical devices, having served as CEO of various companies, while Reed has over 35 years of legal and management experience, notably with Walgreens Boots Alliance. Their expertise is expected to strengthen AVITA’s leadership in medical device commercialization and corporate governance as the company focuses on expanding its market share in skin restoration treatments.

AVITA Medical (NASDAQ: RCEL) reported strong financial results for Q3 FY2021, with RECELL® revenue reaching $8.8 million, up 126% year-over-year. Procedural volumes rose to 492 from 408 in Q3 2020, with 99 burn center accounts now in use. The company trained 244 burn surgeons, achieving an 81% penetration rate. Despite a net loss of $6.0 million, down from $15.0 million last year, and operating expenses decreasing to $13.2 million, gross margin fell to 76% due to lower pricing from BARDA contracts. The company expects Q4 revenue between $8.2-$8.6 million.