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) has signed an exclusive distribution agreement with Revolution Surgical Pty to expand into the Australian and New Zealand markets. The agreement covers the distribution of the RECELL® product platform, including RECELL GO® (pending regulatory approval). This strategic partnership represents RECELL's return to Australia, where the technology was originally developed, and aims to enhance product availability and accessibility in these regions.
AVITA Medical (NASDAQ: RCEL) has announced an upcoming investor webinar briefing scheduled for November 12, 2024, at 2:00 p.m. PST. The presentation will be led by CEO Jim Corbett and CFO David O'Toole, covering financial and business results from their recent third-quarter 2024 earnings webcast. The event will include a Q&A session, with participants able to submit questions through the registration page. The webinar will be available for replay on the company's investor relations website after the presentation.
AVITA Medical (NASDAQ: RCEL) reported strong Q3 2024 results with commercial revenue of $19.5 million, up 44% year-over-year. The company achieved a gross profit margin of 83.7%. Key developments include a distribution agreement with Regenity Biosciences for Cohealyx™ and an amended credit agreement with OrbiMed. The company expects Q4 2024 revenue between $22.3-24.3 million and maintains full-year guidance of $68.0-70.0 million. However, net loss widened to $16.2 million ($0.62 per share) compared to $8.7 million ($0.34 per share) in Q3 2023, with operating expenses increasing to $30.2 million.
AVITA Medical (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company specializing in wound care management and skin restoration devices, has announced it will release its third quarter 2024 financial results on Thursday, November 7, 2024, after the U.S. financial markets close. The company will host a conference call and webcast at 1:30 p.m. Pacific Time on the same day (8:30 a.m. AEDT on November 8, 2024) to discuss the results and recent business highlights.
Investors can access the live webcast through the Events & Presentations section of AVITA Medical's website. For telephone participation, pre-registration is required. A replay of the webcast will be available on the Investor Relations website shortly after the event.
AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a leader in regenerative medicine and wound care management, has announced its participation in the 2024 Cantor Global Healthcare Conference. David O'Toole, the company's Chief Financial Officer, will present on Wednesday, September 18, 2024, at 9:10 a.m. Eastern Time.
Investors and interested parties can access a live webcast of the presentation through the Events & Presentations section of AVITA Medical's website at https://ir.avitamedical.com. For those unable to attend the live event, a replay of the webcast will be made available following the conclusion of the conference.
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.
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