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 revised its Q4 2024 commercial revenue expectations to approximately $18.4 million, representing 30% growth year-over-year, down from the previously guided $22.3-24.3 million range. Full-year 2024 revenue is now expected at $64.3 million, up 29% from 2023 but below the earlier guidance of $68-70 million.
The revenue shortfall is primarily attributed to slower purchasing activity, with hospital accounts adjusting year-end inventory levels more significantly than anticipated. The company expects normal purchasing to resume in Q1 2025, including deferred Q4 purchases.
Despite the revision, AVITA Medical maintains a positive outlook, projecting 2025 revenue between $100-106 million, representing 55-65% growth. The company has updated its timeline for achieving cashflow break-even and GAAP profitability to Q4 2025, delayed from Q3 2025. Key growth drivers include the recent launches of PermeaDerm®, RECELL GO™, RECELL GO mini, and Cohealyx™.
AVITA Medical (NASDAQ: RCEL) has received FDA approval for RECELL GO mini, a new disposable cartridge designed for treating smaller wounds up to 480 square centimeters, compared to the standard RECELL GO's 1,920 square centimeters capacity. The device, part of the RECELL GO platform, uses the same multi-use processing device but features a modified cartridge optimized for smaller skin samples, reducing resource use and minimizing waste.
This approval addresses a critical need in the full-thickness skin defect market, particularly targeting high-volume smaller wounds. The company plans to begin rollout in trauma and burn centers during Q1 2025, aiming to provide an entry point for clinicians who may not have previously used the RECELL GO platform for smaller wounds.
AVITA Medical (NASDAQ: RCEL) has received FDA 510(k) clearance for Cohealyx, a collagen-based dermal matrix co-developed with Regenity Biosciences. The product is designed for tissue integration and revascularization in full-thickness wound treatment. Preclinical studies showed Cohealyx generated robust tissue supporting skin grafts faster than leading competitors.
This strategic addition complements AVITA's existing RECELL and PermeaDerm portfolio, expected to triple the company's addressable market in burns. The company plans to initiate clinical studies in early 2025 and launch full commercialization efforts in Q2 2025.
AVITA Medical (NASDAQ: RCEL), a regenerative medicine company specializing in wound care management and skin restoration devices, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. CEO Jim Corbett will deliver a presentation on Thursday, January 16, 2025, at 9:00 a.m. Pacific Time. The presentation will be available via live audio webcast on the company's investor relations website, with a replay option available after the event concludes.
AVITA Medical (NASDAQ: RCEL) has announced its participation in the upcoming Piper Sandler 36th Annual Healthcare Conference. CEO Jim Corbett will deliver a presentation on Tuesday, December 3, 2024, at 11:30 a.m. Eastern Time. The company, which specializes in regenerative medicine and first-in-class devices for wound care management and skin restoration, will provide a live webcast of the fireside chat through their investor relations website. The presentation will remain available for replay after the event concludes.
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.
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