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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, ASX: AVH), a commercial-stage regenerative medicine company, announced it will report its Q2 2024 financial results on August 8, 2024, after U.S. market close. The company will host a conference call and webcast to discuss the results and recent business highlights at 1:30 p.m. PT (August 9, 2024, at 6:30 a.m. AEST). The live webcast can be accessed via AVITA Medical's Investor Relations website, where a replay will also be available. To join the call by telephone, prior registration is required to receive dial-in details and a personal PIN.
AVITA Medical (NASDAQ: RCEL), a leader in regenerative medicine devices for wound care and skin restoration, announced the appointment of Nicole Linda Kelsey as Chief Legal and Compliance Officer and Corporate Secretary, effective July 1, 2024. Kelsey, with over 20 years of executive legal experience in M&A, securities, and governance, previously held senior roles at Amyris, Criteo, and Medtronic. Her international expertise is expected to bolster AVITA's legal and compliance strategies, aiding its commercial growth.
Donna Shiroma, the outgoing General Counsel, retires after six years of distinguished service. AVITA's CEO, Jim Corbett, praised Shiroma's contributions and leadership, which have significantly impacted the company's growth.
AVITA Medical has achieved a significant milestone with the first use of its FDA-approved RECELL GO System at the Joseph M. Still Burn Center. The RECELL GO System is an advanced cell harvesting device designed to treat thermal burn wounds and full-thickness skin defects using a patient's own skin cells. This next-generation device enhances healing, reduces pain, and minimizes the need for donor skin. AVITA plans to roll out RECELL GO to top U.S. burn centers in June, with a full deployment throughout the year. The device promises to streamline medical procedures and improve patient outcomes.
AVITA Medical announced FDA approval for its advanced autologous cell harvesting device, RECELL GO. This next-gen device improves treatment for thermal burn wounds and full-thickness skin defects by harnessing a patient's own skin. Key advantages include faster healing, reduced pain, improved aesthetics, and fewer procedures. Enhanced features streamline the preparation of Spray-On Skin Cells and improve workflow efficiency. RECELL GO will launch in top U.S. burn centers in June, with broader adoption expected through the year.
AVITA Medical (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company, will host an investor webinar briefing on May 21, 2024, at 4:00 p.m. PDT. The event will feature presentations from CEO Jim Corbett and CFO David O'Toole, focusing on financial and business results from the recent Q1 2024 earnings webcast. A Q&A session will follow the main presentation. Interested parties can register via a provided Zoom link and submit questions either through the registration page or during the webinar. A replay will be available on AVITA's website after the event.
AVITA Medical (NASDAQ: RCEL) reported Q1 2024 financial results. Key highlights include a 5.8% increase in commercial revenue to $11.1 million, and a gross profit margin of 86.4%. The company launched PermeaDerm, a biosynthetic wound matrix, in March.
Future milestones involve RECELL GO, undergoing a 180-day FDA review, with expectations to submit a PMA supplement for RECELL GO mini by year-end. Financial guidance projects Q2 revenue between $14.3-$15.3 million and full-year revenue at the lower end of $78.5-$84.5 million.
Expenses rose to $26.8 million due to increased sales, marketing, and R&D costs. Net loss widened to $18.7 million, or $0.73 per share, compared to $9.2 million, or $0.37 per share, in Q1 2023.
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