Welcome to our dedicated page for Avita Medical news (Ticker: RCEL), a resource for investors and traders seeking the latest updates and insights on Avita Medical stock.
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) announced successful outcomes in its clinical trial for the RECELL® System used in soft tissue repair. The study achieved its co-primary endpoints, demonstrating statistically significant donor skin sparing and non-inferiority in healing compared to standard care. These results position RECELL as a potential new standard for soft tissue repair. The company expects to submit its Premarket Approval (PMA) application to the FDA in December 2022, following a re-analysis of healing data that confirmed non-inferiority.
AVITA Medical, a leader in regenerative medicine, has announced that the FDA granted the RECELL System Breakthrough Device designations for soft tissue repair and vitiligo indications. This designation aims to expedite development and review processes for devices addressing serious medical conditions. The RECELL System, approved for acute thermal burns, utilizes a patient's own skin for treatment, significantly improving clinical outcomes and reducing donor skin requirements. AVITA anticipates this recognition will enhance patient access to their innovative therapies.
AVITA Medical (NASDAQ: RCEL) is set to release its Q3 2022 financial results on November 10, 2022, after U.S. market close. The company will hold a conference call at 1:30 PM PT to discuss the results and recent highlights. AVITA Medical specializes in regenerative medicine and is known for its RECELL® System, a technology that uses a patient's own skin cells for burn treatment. RECELL has received FDA approval and shows significant clinical benefits over standard care.
AVITA Medical (NASDAQ: RCEL) has appointed James Corbett as its new Chief Executive Officer, effective immediately. Mr. Corbett, who previously served on the Board, brings nearly 40 years of life sciences experience, including leadership roles at Microtherapeutics and Boston Scientific. His appointment comes as the company looks to capitalize on growth opportunities with its RECELL® System, which has shown significant advancements in treating acute burns. Corbett succeeds Dr. Michael Perry, who has led the company since June 2017. This leadership change aims to strengthen strategic direction and commercial growth.
AVITA Medical (NASDAQ: RCEL) announces an investor webinar on September 20, 2022, led by CEO Dr. Mike Perry and CFO Michael Holder. The session will present highlights from the June 2022 quarter, showcasing a 39% increase in commercial revenue year-over-year, alongside updates on its developmental pipeline. The webinar will conclude with a Q&A session. AVITA's RECELL System, FDA-approved for the treatment of burns, demonstrates significant clinical benefits and cost savings, positioning the company as a leader in regenerative medicine.
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.
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