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, ASX: AVH), a leader in regenerative medicine and wound care management, has announced its participation in the 8th Annual Best Ideas Growth (BIG8) Conference organized by Lake Street Capital Markets. The event is scheduled for September 12, 2024, in New York.
CEO Jim Corbett will be present to conduct one-on-one meetings with institutional investors throughout the day. This conference provides AVITA Medical with an opportunity to showcase its first-in-class devices for wound care and skin restoration to potential investors.
Interested parties are encouraged to contact their Lake Street representative for more information or to schedule a meeting with AVITA Medical's management team.
AVITA Medical (NASDAQ: RCEL, ASX: AVH), a leader in regenerative medicine for wound care and skin restoration, has announced an upcoming investor webinar briefing on August 13, 2024, at 4:00 p.m. PDT (August 14, 2024, at 9:00 a.m. AEST). The presentation will be led by CEO Jim Corbett and CFO David O'Toole, covering financial and business results from the company's recent second-quarter 2024 earnings.
Shareholders and potential investors are invited to attend the webinar, which will include a Q&A session. Participants can submit questions through the registration page. The event will be hosted via Zoom, with a replay available on the AVITA Medical website following the presentation.
AVITA Medical (NASDAQ: RCEL) reported strong Q2 2024 financial results, with commercial revenue reaching $15.1 million, a 29% increase year-over-year. The company achieved a gross profit margin of 86.2%. Key highlights include FDA approval of RECELL GO™ and submission of a PMA supplement for RECELL GO mini™. AVITA entered an exclusive agreement with Regenity Biosciences for a collagen-based dermal matrix.
The company expects Q3 2024 commercial revenue between $19.0-$20.0 million and full-year 2024 revenue of $68.0-$70.0 million. AVITA anticipates achieving cashflow break-even and GAAP profitability by Q3 2025. Despite strong growth, the company reported a net loss of $15.4 million for Q2 2024, compared to $10.4 million in Q2 2023. As of June 30, 2024, AVITA had $54.1 million in cash and equivalents.
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.
FAQ
What is the current stock price of Avita Medical (RCEL)?
What is the market cap of Avita Medical (RCEL)?
What is AVITA Medical, Inc.?
What is the RECELL® System?
Where is the RECELL System approved for use?
Is the RECELL System available for sale in the United States?
What recent advancements has AVITA Medical made?
What other products does AVITA Medical offer?
What are AVITA Medical's recent financial highlights?
Is AVITA Medical involved in any clinical trials?
Where is AVITA Medical headquartered?
How can I learn more about AVITA Medical's products and financial performance?
