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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 (NASDAQ: RCEL) will release its second quarter 2022 financial results on August 11, 2022. A conference call and webcast are scheduled for 2:00 p.m. PT / 5:00 p.m. ET to discuss these results. AVITA Medical focuses on regenerative medicine and offers the RECELL® System for treating acute thermal burns using patients' own skin cells. This technology is FDA-approved and has shown significant improvement in clinical outcomes.
AVITA Medical (RCEL) reported financial results for Q1 2022, showing a significant 61% increase in commercial revenue to $7.4 million compared to Q1 2021. However, total revenue was $7.5 million, down from $8.8 million in the prior year due to a decline in BARDA revenue. The company reported a net loss of $9.5 million, a 58% increase from the previous year's loss. Looking ahead, AVITA expects 2022 commercial revenue of approximately $30 million, a 20% increase year-over-year, despite reduced BARDA revenues.
AVITA Medical (NASDAQ: RCEL) announced that discussions regarding the RECELL System will occur at the SCALE dermatology meeting in Nashville, TN from May 11-15, 2022. Key presentations include Dr. Jeffrey Carter discussing burn treatment and Dr. Seemal Desai reviewing a clinical trial for vitiligo treatment. AVITA is conducting a pivotal trial for stable vitiligo and aims to share topline data later this year. The RECELL System is FDA-approved for acute thermal burns and offers innovative solutions in regenerative medicine.
AVITA Medical (NASDAQ: RCEL) has announced it will release its Q1 2022 financial results on May 12, 2022, followed by a conference call at 1:30 p.m. PT. The company focuses on regenerative medicine, developing technology for autologous skin restoration to address unmet medical needs. Its RECELL® System, FDA-approved in 2018, uses a patient's skin cells for treating acute burns, showing significant advancements in clinical outcomes and cost efficiency. The live call will be accessible via telephone and the company's website.
AVITA Medical (NASDAQ: RCEL) announced the resignation of Louis Drapeau from the Board of Directors, effective April 29, 2022, citing personal reasons. Drapeau has been a non-executive Director since January 2016 and previously chaired the Audit Committee, which has now been taken over by James Corbett as of February 23, 2022. The company expressed gratitude for Drapeau's six years of service. AVITA develops regenerative medicine technologies, particularly the RECELL® System for skin restoration, approved by the FDA in September 2018.
AVITA Medical (NASDAQ: RCEL) announced 15 presentations at the American Burn Association Annual Meeting, showcasing the efficacy and cost-saving benefits of the RECELL® System for treating burn wounds. The event, taking place April 5-8 in Las Vegas, is expected to attract over 2,000 burn care professionals. With real-world application data from over 15,000 patients, the RECELL System has proven advantageous over traditional methods. AVITA aims to expand RECELL's indications beyond burns to include soft-tissue repair and vitiligo, pending FDA approval.
AVITA Medical (NASDAQ: RCEL) announced the presentation of a clinical trial protocol for the RECELL® System at the Global Vitiligo Foundation Annual Scientific Symposium. This trial aims to assess the safety and effectiveness of RECELL in treating stable vitiligo lesions. With enrollment now complete, the company anticipates releasing results from its blinded, randomized study soon. Vitiligo affects 2% of the global population, significantly impacting patients' quality of life. The RECELL System, approved by the FDA in 2018, utilizes patients' skin cells for regenerative treatments.
AVITA Medical announced that the Biomedical Advanced Research and Development Authority (BARDA) has modified its contract to fund the ongoing pivotal clinical trial for the RECELL System aimed at soft tissue reconstruction.
The trial compares conventional autografting with RECELL in treating acute non-burn full-thickness skin defects, targeting fewer donor skin needs without compromising healing. BARDA’s support highlights the potential of RECELL in expanding treatment indications beyond burns, acknowledging its significance for patients suffering trauma.
AVITA Medical announced a group purchasing agreement with Premier, Inc. that facilitates the access of approximately 4,440 U.S. hospitals to its RECELL System for treating severe burns. This agreement allows Premier members to utilize special pricing and terms, ensuring timely patient treatment. The RECELL System allows healthcare providers to produce a suspension of Spray-On Skin™ Cells from a small skin sample for effective burn treatment. CEO Dr. Mike Perry highlighted the importance of this agreement for improving patient care.
AVITA Medical (NASDAQ: RCEL) reported strong financial results for the quarter ending December 31, 2021, with revenue increasing by 37% to $14.0 million. The fourth quarter saw a revenue growth of 35% to $6.9 million compared to the prior year. The company achieved significant milestones including FDA approval of the enhanced RECELL® system and completed enrollment for pivotal clinical trials aimed at soft tissue reconstruction and vitiligo. However, net losses widened by 52% to $8.5 million. Moving forward, AVITA projects a revenue of approximately $30 million in 2022, marking a 20% increase year-over-year.
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