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 reports developments in therapeutic acute wound care, led by the RECELL platform for Spray-On Skin used in burn and trauma wounds. Company news commonly covers FDA-cleared wound-care indications, RECELL GO automation, international regulatory clearances, and the U.S. commercial portfolio that includes Cohealyx, a collagen-based dermal matrix, and PermeaDerm, a biosynthetic wound matrix.
Updates also include clinical data presentations, BARDA emergency-preparedness agreements, quarterly financial results, investor-conference participation, and board or executive governance changes. The recurring news themes connect AVITA Medical's product platform with acute burn care, trauma wound treatment, commercialization, reimbursement, and capital resources.
AVITA Medical (NASDAQ: RCEL, ASX: AVH) has appointed Robin VanDenburgh as Senior Vice President of U.S. Commercial Sales, effective August 6, 2024. VanDenburgh, previously Vice President of Key Accounts at Smith & Nephew, brings over 25 years of experience in healthcare sales leadership. CEO Jim Corbett expressed confidence in VanDenburgh's ability to expand market presence and drive sales growth for AVITA's wound care solutions, particularly the RECELL GO product.
VanDenburgh's extensive background includes 12 years at Smith & Nephew in senior sales management roles within their advanced wound division. She has also held key positions at Aureon Biosciences, St. Jude Medical, and Ethicon Endo-Surgery. Her expertise in building high-performing sales teams and driving new product adoption is expected to accelerate AVITA Medical's commercial success in the U.S. market.
AVITA Medical (NASDAQ: RCEL, ASX: AVH) has entered an exclusive multi-year development and distribution agreement with Regenity Biosciences for a unique collagen-based dermal matrix. Following FDA 510(k) clearance, expected in Q4 2024, AVITA will have exclusive rights to market, sell, and distribute the product in the U.S. and potentially in EU countries, Australia, and Japan.
The collaboration aims to enhance AVITA's wound care portfolio by integrating Regenity's bioresorbable materials with AVITA's RECELL technology. AVITA plans to initiate clinical studies in 2025 to demonstrate improved outcomes and establish a new standard of care for full-thickness wounds.
The agreement includes a $2 million payment upon 510(k) clearance and up to $3 million by January 2026 for manufacturing support. Revenue sharing starts at 50% for the first two years, increasing to 60% thereafter.
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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