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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 announced positive topline results from a pivotal trial evaluating the RECELL® System for treating stable vitiligo. The study demonstrated that 56% of RECELL treatments resulted in over 50% repigmentation, compared to just 12% for standard treatment. Additionally, 36% of RECELL treatments achieved at least 80% repigmentation, establishing super-superiority. The company plans to submit an application to the FDA by the end of 2022.
AVITA Medical announced that its RECELL System has received insurance coverage in Japan for treating acute burns, with reimbursement aligned to U.S. pricing. The approval from the Japanese MHLW marks a significant step for AVITA and its partner, COSMOTEC, in launching the product in Japan. The RECELL System utilizes a patient's own skin to prepare Spray-On Skin™ Cells, reducing donor skin needed for treatment. AVITA aims to leverage this opportunity to enhance clinical outcomes and cost savings, supporting burn patients' recovery.
AVITA Medical, Inc. (NASDAQ: RCEL) announced a poster presentation on the RECELL® System for treating stable vitiligo at an upcoming conference in Santa Barbara, CA, scheduled for August 19-21, 2022. The presentation will focus on the cell characterization and potential clinical benefits of the RECELL platform. CEO Dr. Mike Perry expressed hopes for the FDA’s review, indicating that the RECELL System could provide a significant treatment option for vitiligo patients. Additionally, AVITA is completing a pivotal trial for the RECELL System, anticipating FDA approval in 2023.
AVITA Medical reported its second quarter financial results for 2022, showing commercial revenue of $8.2 million, a 23% increase from the previous year. Total revenue, including BARDA revenue, was $8.3 million, down from $10.3 million due to a decrease in BARDA contributions. Gross profit margin improved to 83%. Year-to-date commercial revenue reached $15.7 million, up 39%. However, the net loss increased 33% to $6.3 million, and total operating expenses grew by 3%. The company projects commercial revenues of $30 million for the year, excluding BARDA revenue.
AVITA Medical announced positive topline results from its pivotal trial evaluating the RECELL System for soft tissue reconstruction, targeting donor skin harvesting reduction. The trial showed statistically superior donor sparing (p<0.001) versus conventional skin grafting. Although the healing endpoint did not achieve statistical non-inferiority, healing results were comparable. The company plans to submit a PMA supplement to the FDA by the end of 2022 and anticipates significant market potential, with a total addressable market of approximately $1 billion for soft tissue repair.
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.
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