VALENCIA, Calif., June 09, 2025 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a leading therapeutic acute wound care company delivering transformative solutions, today highlighted data presented by researchers at the British Burn Association (BBA) Annual Meeting demonstrating reduced length of hospital stay among burn patients treated with RECELL®. The session, titled The Clinical Impact of Skin Cell Suspension Autograft from a National Registry Perspective, represents the largest real-w ...

VALENCIA, Calif., June 05, 2025 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a leading therapeutic acute wound care company delivering transformative solutions, today announced the first clinical publication evaluating Cohealyx™, an AVITA Medical-branded collagen-based dermal matrix, published in the Journal of Surgery (Akpunonu et al., 2025). According to the investigators, Cohealyx demonstrated significantly faster wound bed vascularization and autograft readiness compared to conventi ...

VALENCIA, Calif., June 03, 2025 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a leading therapeutic acute wound care company delivering a portfolio of transformative solutions, today announced that RECELLⓇ, including RECELLⓇ GO, has been recognized as the “Best New Technology Solution – Surgical” in the 2025 MedTech Breakthrough Awards. RECELL, FDA-approved for thermal burn wounds and full-thickness skin defects, has treated over 30,000 patients worldwide. RECELL requires significantly l ...

Core Insights - AVITA Medical, Inc. has been recognized for its RECELLⓇ technology, winning the "Best New Technology Solution – Surgical" at the 2025 MedTech Breakthrough Awards, highlighting its innovative approach in acute wound care [1][4] Company Overview - AVITA Medical is a leading therapeutic acute wound care company focused on delivering transformative solutions, with its flagship product being the RECELL System, which is FDA-approved for treating thermal burn wounds and full-thickness skin defects [6][7] - The RECELL System utilizes a patient's own skin to create Spray-On Skin™ Cells, optimizing wound healing and accelerating recovery times [6] Product Benefits - RECELL has treated over 30,000 patients globally and requires significantly less donor skin compared to traditional grafting methods, which reduces donor-site pain and accelerates healing [2][4] - The introduction of RECELL GO enhances procedural consistency and surgical team coordination, making it suitable for high-volume burn and trauma centers [3] Recognition and Awards - In addition to the MedTech Breakthrough Award, Dr. Katie Bush, Senior Vice President of Scientific & Medical Affairs at AVITA Medical, received the 2025 Emerald Pinnacle Healthcare Award for her contributions to innovation and leadership in the medical device sector [5] Market Approvals - The RECELL System is approved for various applications in international markets, including burns and vitiligo, and has received regulatory approvals in Australia, Europe, and Japan [7]

Financial Data and Key Metrics Changes - Revenue for the first quarter increased by 67% compared to the same period in the prior year, reaching $18.5 million [6][25] - Gross profit margin for the first quarter was 84.7%, down from 86.4% in the same period of 2024 [26] - Net loss for the first quarter was $13.9 million, improving from a net loss of $18.7 million in the same period in 2024 [30] Business Line Data and Key Metrics Changes - The launch of ReCell Go Mini and Co Helix is expected to significantly contribute to revenue growth throughout 2025 [25][32] - The commercial lineup now includes ReCell, ReCell Go, ReCell Go Mini, Co Helix, and Permeoderm, providing a broad spectrum of products for both burn and trauma centers [14][15] Market Data and Key Metrics Changes - The US addressable market for the company has expanded from approximately $500 million to over $3.5 billion annually, marking a seven-fold increase [6][22] - The trauma market is estimated to have approximately 270,000 cases annually in the US, which ReCell Go Mini targets [10] Company Strategy and Development Direction - The company is focusing on acute wound care, stepping back from further commercial investment in the vitiligo indication due to uncertainty in reimbursement [21][56] - A significant shift in the commercial model has been implemented, transitioning from a service-oriented approach to a more focused selling-oriented approach [16][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the potential for strong results driven by the expanded product portfolio and operational efficiencies [22][32] - The company expects to generate free cash flow in the second half of the year and achieve GAAP profitability in Q4 of 2025 [31][32] Other Important Information - The company has secured a waiver for its first-quarter trailing twelve-month revenue covenant with OrbiMed, which had been set at $73 million [31] - The annual meeting of stockholders is scheduled for June 4 [32] Q&A Session Summary Question: Can you share any response or performance impressions of Co Helix? - Management noted that early feedback has been positive, with a case from Ohio State demonstrating a seven-day graft readiness, which is faster than other dermal matrices [36][37] Question: How is the rollout of ReCell Go Mini going? - The response has been good, particularly from existing accounts in the trauma area, with opportunities to provide more value to trauma surgeons [41][42] Question: What are the expected revenue contributions from the new launches? - Management indicated that while they are not ready to provide specific guidance, they expect these products to be material contributors to revenue [45] Question: Is the sales force adequately staffed to meet revenue targets? - Management expressed confidence in the current staffing levels and the reconfigured sales model, which focuses on a selling-oriented approach [47][49] Question: What is the expected revenue cadence for the rest of the year? - Management anticipates steady sequential growth throughout the year, with some weighting towards the back end as new products gain traction [51][52] Question: What is the current status of the vitiligo initiative? - The company has paused spending on vitiligo due to uncertainty in reimbursement and is focusing resources on acute wound care instead [56][58]

Core Insights - AVITA Medical has transitioned from a single-product company focused on burn treatment to a multi-product platform in the therapeutic acute wound care market, with a market opportunity expanding from $455 million to over $3.5 billion [3][6]. Financial Performance - For Q1 2025, AVITA Medical reported commercial revenue of $18.5 million, a 67% increase from $11.1 million in Q1 2024, driven by deeper customer penetration and new product launches [6][9]. - The gross profit margin for the quarter was 84.7%, down from 86.4% in the same period last year, primarily due to volume discounts and product mix [10]. - Total operating expenses increased to $27.5 million from $26.8 million in Q1 2024, with a notable rise in sales and marketing expenses [11]. Product Developments - The company launched RECELL GO mini in February 2025, targeting smaller wounds in U.S. trauma centers, and initiated the nationwide launch of Cohealyx on April 1, 2025 [6][9]. - AVITA Medical aims to drive adoption of RECELL GO and Cohealyx while continuing to develop clinical data for its products [7]. Future Guidance - The company expects full-year 2025 commercial revenue to be between $100 million and $106 million, reflecting a growth of approximately 55% to 65% compared to 2024 [7]. - AVITA Medical anticipates generating free cash flow in the second half of 2025 and achieving GAAP profitability in Q4 2025 [7]. Cash Position and Liabilities - As of March 31, 2025, AVITA Medical had approximately $25.8 million in cash and marketable securities, with a waiver secured for the first quarter trailing 12-month revenue covenant [14]. - Total liabilities stood at $74.1 million, with long-term debt at $41.5 million [23].