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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 first quarter 2023 financial results on May 11, 2023, after U.S. markets close. A conference call is scheduled for the same day at 1:30 PM PT (6:30 AM AEST on May 12) to discuss these results and recent business updates. The RECELL System, a leading regenerative medicine technology for skin restoration, is a highlight of AVITA's offerings, approved by the FDA for treating burns. It prepares Spray-On Skin™ cells from a patient's own skin, enhancing treatment outcomes and reducing donor skin needs. Internationally, RECELL has gained regulatory approvals across several regions, including CE-mark in Europe and TGA registration in Australia. More details can be found on their Investor Relations website.
AVITA Medical, Inc. (NASDAQ: RCEL) announced that its automated device, RECELL GO, continues to hold the FDA Breakthrough Device designation for treating acute wounds. This device enhances the existing RECELL technology by streamlining the cell disaggregation process, reducing training needs and easing operational burdens for healthcare providers. CEO Jim Corbett expressed that RECELL GO is pivotal for the company's growth trajectory. A Premarket Approval (PMA) supplement for the device is expected to be submitted to the FDA by June 30, 2023, anticipating a prioritized review and potential approval by January 2024. AVITA Medical's RECELL System has already transformed burn treatment by allowing for the creation of Spray-On Skin™ cells using a patient’s own skin, promoting improved clinical outcomes and cost-efficiency.
AVITA Medical (NASDAQ: RCEL) announced the appointment of Robert McNamara to its Board of Directors, effective April 1, 2023. With over 25 years of experience in medical device industries, McNamara has held leadership roles, including CFO positions at several public companies. His expertise in operations and financial management is expected to strengthen AVITA's growth objectives. The firm is known for its RECELL System, which utilizes patients' own skin for advanced burn treatment, already treating over 15,000 patients globally and showing positive outcomes.
AVITA Medical, Inc. (NASDAQ: RCEL) announced the appointment of Cary Vance to its Board of Directors, effective April 1, 2023. Vance brings over 25 years of healthcare leadership experience, including current roles as CEO of Titan Medical and former leadership positions at XCath, OptiScan Biomedical, and Hansen Medical. His expertise in medical technology commercialization is expected to help strengthen AVITA's market share in burn treatments and future applications. The company is known for its RECELL System, which utilizes patients' own skin to enhance healing in burn cases, currently approved in several countries.
AVITA Medical, a regenerative medicine company, announced that CEO Jim Corbett will present at the TD Cowen 43rd Annual Health Care Conference in Boston on March 7, 2023, at 9:10 a.m. Eastern Time. A live webcast will be available on the company's website, with a replay accessible for 30 days post-presentation. AVITA’s RECELL System, FDA-approved for treating acute thermal burns, utilizes a patient's own skin to create Spray-On Skin™ cells, enhancing clinical outcomes and reducing donor skin requirements. The company aims to expand its cellular therapies for various indications, following its growth in international markets.
AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) invites shareholders and investors to an investor webinar on February 28, 2023, at 4:00 PM PST. The presentation, led by CEO Jim Corbett and acting CFO Sean Ekins, will highlight Q4 2022 commercial revenue growth of 37%, business updates, and future revenue guidance, followed by a Q&A session. Attendees can register via the provided Zoom link. The RECELL System, approved by the FDA, utilizes the patient’s own skin to create Spray-On Skin™ cells, enhancing treatment for burns and offering cost savings. For more details, visit avitamedical.com.
AVITA Medical (NASDAQ: RCEL) reported its financial results for Q4 and full-year 2022, highlighting a 36% rise in commercial revenue to $34.1 million, excluding BARDA revenue. Total revenue increased by 4% to $34.4 million. The company achieved an impressive gross profit margin of 82% and a significant 37% decrease in net loss to $5.4 million. Key developments include the FDA granting Breakthrough Device designations for the RECELL® System and the submission of PMA applications for both soft tissue repair and vitiligo indications. Looking ahead, AVITA anticipates FDA approvals in June 2023 and projects commercial revenue of $49 million to $51 million for the year.
AVITA Medical, Inc. (NASDAQ: RCEL) announced it will report its Q4 and full year 2022 financial results on February 23, 2023, post U.S. market close. The company will hold a conference call at 1:30 PM PT to discuss the results and provide 2023 revenue guidance. AVITA specializes in regenerative medicine, particularly with its RECELL® System for skin restoration, which received FDA approval for treating acute thermal burns. The company emphasizes its innovative approach to healing severe burns by using a patient's own skin to create Spray-On Skin™ cells, enhancing clinical outcomes and reducing costs.
AVITA Medical (NASDAQ: RCEL) announced significant changes to its management structure to enhance strategic growth under newly appointed CEO James Corbett. Effective January 19, 2023, product development, operations, and regulatory affairs will report directly to the CEO, streamlining operations for sustained growth. Chief Operating Officer Kathy McGee is leaving, and the company will not fill the position. Additionally, Chief Financial Officer Michael Holder has departed, with Senior VP of Finance Sean Ekins assuming the interim CFO role as the company searches for a new CFO. Financial results for Q4 2022 will be reported on February 23, 2023, along with first quarter and full year 2023 revenue guidance.
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