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AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) is a commercial-stage regenerative medicine company that is pioneering innovative solutions for skin restoration and wound care management. The company's flagship product, the RECELL® System, is a revolutionary device that transforms a small sample of a patient's skin into Spray-On Skin™ Cells within just 30 minutes. This technology aims to reduce or eliminate the need for skin grafts, providing an advanced treatment option for burns, full-thickness skin defects, and stable depigmented vitiligo lesions.
The RECELL System has gained regulatory approvals across several regions, including the U.S. Food and Drug Administration (FDA), Australia's Therapeutic Goods Administration (TGA), the European Union's CE-mark, and Japan's PMDA. However, AVITA Medical primarily focuses its marketing efforts in the United States, which hosts approximately 136 burn centers where the RECELL System is being rolled out.
The company has made significant strides recently, including the approval and launch of RECELL GO in the U.S., which boasts enhanced features to streamline the preparation of Spray-On Skin™ Cells, improving workflow efficiency and reducing the training burden on medical staff. This next-generation device is expected to further drive adoption and improve clinical outcomes.
AVITA Medical also holds exclusive rights to market and distribute PermeaDerm®, a biosynthetic wound matrix, in the United States, expanding its product portfolio beyond RECELL.
Financially, AVITA Medical has shown robust growth, with commercial revenue increasing significantly year-over-year. For the fourth quarter of 2023, commercial revenue surged by 50% compared to the same period in 2022. Despite a net loss due to increased operating expenses related to expanding its commercial and R&D efforts, the company remains optimistic about its financial stability and future growth.
The company continues to make strategic international inroads, including plans to launch in Japan through a distribution partner and future market expansions. In addition, AVITA Medical is engaged in various ongoing clinical trials to expand the indications and applications of the RECELL System further.
Overall, AVITA Medical remains at the forefront of transforming wound care management and skin restoration, committed to improving patient outcomes through its innovative products and strategic initiatives.
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.
AVITA Medical (NASDAQ: RCEL) announced plans to release its fiscal Q3 2021 financial results on May 13, 2021, post market close. A conference call and webcast will follow at 1:30 PM PT to discuss these results alongside recent company highlights. AVITA specializes in regenerative medicine, utilizing its patented RECELL System for autologous skin restoration in treating burns and chronic wounds. The system has shown clinical advancements and is FDA approved, enhancing treatment efficacy and reducing donor skin requirements.
AVITA Medical announced the acceptance of nine abstracts at the 43rd Annual John A. Boswick Burn & Wound Care Symposium, highlighting the clinical and cost-effectiveness of the RECELL System in treating burns. The symposium will take place from April 17-22, 2021, in Maui, Hawaii. CEO Dr. Mike Perry emphasized the system's versatility in treating varying burn depths and its benefits when combined with other surgical technologies. Data from randomized clinical trials and real-world use support the RECELL System as a significant advancement in burn treatment.
AVITA Medical (NASDAQ: RCEL) announced the acceptance of 15 abstracts showcasing the benefits of its RECELL System at the American Burn Association's upcoming annual meeting. This marks the highest number of presentations since the RECELL's FDA approval in 2018. Over 80% of U.S. burn surgeons are now certified in using the system, which demonstrates a growing adoption in treating diverse burn injuries. The findings emphasize both clinical outcomes and cost-effectiveness, supporting the RECELL System as a significant advancement in burn care.
AVITA Medical (Nasdaq: RCEL) has appointed Michael Holder as Chief Financial Officer effective March 22, 2021. Mr. Holder brings over 25 years of finance experience, previously serving as CFO at ImmuneCyte and CEO at Carolina Longevity Institute. His role will encompass global finance, accounting, M&A, and investor relations. CEO Dr. Mike Perry emphasized Holder's experience will enhance the leadership team. AVITA Medical focuses on regenerative medicine addressing burns and chronic wounds through its RECELL® System, FDA-approved since September 2018.
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