Core Points - AVITA Medical has appointed Cary Vance as Interim CEO following the departure of Jim Corbett from the CEO position and the Board [1][4] - The Board plans to engage an executive search firm to find a permanent CEO, considering both internal and external candidates [2] - Cary Vance has over 30 years of experience in the healthcare industry and has held leadership roles in several innovative companies [3] Company Overview - AVITA Medical specializes in therapeutic acute wound care, focusing on innovative solutions to optimize wound healing and accelerate patient recovery [7] - The company's flagship product is the RECELL System, which is FDA-approved for treating thermal burn and trauma wounds, utilizing a patient's own skin to create Spray-On Skin™ Cells [7][8] - AVITA Medical also holds exclusive rights to market and distribute PermeaDerm and Cohealyx™, enhancing its product portfolio in wound care [7] Financial Performance - Preliminary revenue for the third quarter of 2025 is expected to be approximately $17 million [5][9] - The company has secured a waiver for the third quarter 2025 trailing 12-month net revenue covenant with OrbiMed and is in discussions to redefine future covenants [5] Leadership Transition - Jan Stern Reed has been appointed as Lead Independent Director, supporting the transition in leadership [1][4] - Cary Vance expressed commitment to advancing the company's innovative solutions and focusing on unlocking the full potential of its product portfolio [4]

Hospitals may receive up to $4,875 in added reimbursement when using RECELL to treat non-burn full-thickness acute wounds resulting from trauma or surgery Effective October 1, the add-on payment eases financial barriers, supporting broader use of RECELL VALENCIA, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) -- AVITA Medical®, Inc. (ASX: AVH, NASDAQ: RCEL), a leading therapeutic acute wound care company, today announced that beginning October 1, 2025, hospitals across the U.S. will be eligible for New Technology A ...

Core Insights - AVITA Medical, Inc. reaffirms that the RECELL® System significantly reduces hospital length of stay (LOS) by an average of 36% compared to traditional split thickness skin grafts (STSG) for adult patients with deep partial thickness burns [1][2][8] - The RECELL System is clinically validated as a cost-effective option in modern burn management, improving patient outcomes and hospital efficiency [2][5] Company Overview - AVITA Medical is a leading therapeutic acute wound care company focused on delivering transformative solutions, with the RECELL System at the forefront [6] - The RECELL System utilizes a patient's own skin to create an autologous skin cell suspension autograft, enhancing recovery at the point of care [2][6] Economic Impact - The use of RECELL is associated with potential per patient cost savings exceeding $42,000, based on an average daily inpatient bed cost of $7,554 [3] - The reduction in LOS allows hospitals to treat 13 more patients per bed annually compared to STSG treatment [3] Clinical Findings - A matched analysis of 741 adults showed that RECELL-treated patients had an average 5.6-day reduction in hospital LOS, representing a 36% decrease compared to STSG [2][8] - In 2023, U.S. burn cases consumed over 110,000 ICU days, costing more than $676 million, highlighting the need for efficient burn care solutions [4] Regulatory Approvals - The RECELL System is approved for various applications in international markets, including thermal burn and trauma wounds, with approvals in Australia, Europe, and Japan [7]

Core Viewpoint - AVITA Medical, Inc. is actively engaging with investors through participation in three upcoming investor conferences in September 2025, highlighting its commitment to investor relations and market presence [1][2]. Company Overview - AVITA Medical is a leading therapeutic acute wound care company focused on delivering transformative solutions aimed at optimizing wound healing and accelerating patient recovery [4]. - The company's flagship product, the RECELL System, is FDA-approved for treating thermal burn and trauma wounds, utilizing the patient's own skin to create Spray-On Skin™ Cells for improved clinical outcomes [4]. - In addition to RECELL, AVITA holds exclusive rights in the U.S. for manufacturing and distributing PermeaDerm and Cohealyx™, both of which are innovative wound care products [4]. International Market Presence - The RECELL System is approved for a variety of applications in international markets, including Australia, Europe, and Japan, demonstrating its global reach and regulatory compliance [5]. Upcoming Events - AVITA Medical will host investor meetings at the Cantor Global Healthcare Conference on September 4, 2025, the Morgan Stanley 23rd Annual Global Healthcare Conference on September 8, 2025, and the Lake Street Capital Markets 9th Annual Best Ideas Growth Conference on September 11, 2025 [8]. - A live audio webcast of the Morgan Stanley fireside chat featuring CEO Jim Corbett will be available for replay for 90 days on the company's Investor Relations website [3].

Core Points - AVITA Medical, Inc. has successfully completed a private placement to raise approximately US$15 million (around A$23 million) through the issuance of about 17.2 million New CDIs at an offer price of A$1.32 per New CDI, which represents an 11% discount to the last closing price of A$1.48 on August 12, 2025 [1][4][8] - The proceeds from the placement will be utilized for working capital and to support the growth of the Company's therapeutic acute wound portfolio, expected to sustain operations until free cash flow begins in 2026 [2] - The New CDIs are set to be settled on August 19, 2025, and will commence trading on the ASX on August 20, 2025, ranking equally with existing CDIs [5][6] Company Overview - AVITA Medical is a leading company in therapeutic acute wound care, focusing on innovative solutions that enhance wound healing and accelerate patient recovery [7] - The company's flagship product, the RECELL® System, is FDA-approved for treating thermal burn and trauma wounds, utilizing the patient's own skin to create Spray-On Skin™ Cells [7][9] - AVITA Medical also holds exclusive rights to manufacture and distribute PermeaDerm® and Cohealyx™, further expanding its product offerings in the wound care market [9]

Financial Results - Commercial revenue for Q2 2025 was $18.4 million, representing a 21% increase compared to $15.2 million in Q2 2024 [8][12] - Net loss for Q2 2025 improved to $9.9 million, or a loss of $0.38 per share, compared to a net loss of $15.4 million, or a loss of $0.60 per share in Q2 2024 [8][16] - Total operating expenses decreased to $26.1 million in Q2 2025 from $28.7 million in Q2 2024, primarily due to reductions in sales and marketing expenses [8][14] Business Update - Demand for RECELL was dampened in the first half of 2025 due to delays in provider payments, leading to a backlog of unpaid claims [6][9] - The Centers for Medicare and Medicaid Services (CMS) approved New Technology Add-on Payment (NTAP) for the RECELL System for inpatient trauma wounds [8][10] - AVITA anticipates recovery in RECELL demand in the second half of 2025 as claims backlog is resolved [10] Clinical Highlights - RECELL reduces hospital stays by 36% based on real-world analysis from the national burn registry over five years [5][8] - Cohealyx achieves autograft readiness in as little as five days, with first clinical results published [8] Strategic Developments - The company amended credit terms with OrbiMed, lowering revenue covenants and issuing common stock in lieu of cash payment [8][11] - Michael Tarnoff, MD, FACS, was appointed to the Board of Directors, bringing extensive healthcare leadership experience [8] Guidance Adjustments - Full-year 2025 revenue guidance was revised to a range of $76 million to $81 million, down from previous guidance of $100 million to $106 million [11][15] - The company expects to reach cash flow break-even in Q2 2026 and GAAP profitability in Q3 2026, later than previously anticipated [11][15]

Core Insights - AVITA Medical, Inc. has appointed Dr. Michael Tarnoff as a non-executive Director to its Board of Directors, effective August 6, 2025, to enhance its focus on patient-centric wound-healing technologies [1][2] - The company has also announced the resignation of Lou Panaccio as Board Chair, with Cary Vance elected to take over the position effective August 7, 2025 [2][3] Company Developments - Dr. Tarnoff's extensive experience includes 23 years at Tufts Medical Center and leadership roles at Medtronic and Covidien, which will contribute to AVITA's growth in therapeutic acute wound care [4][7] - Cary Vance, with over 25 years of executive leadership in the healthcare industry, is expected to drive innovation and support the company's mission [5][7] Product and Technology Focus - AVITA Medical specializes in therapeutic acute wound care, with its flagship product, the RECELL System, designed to optimize wound healing and accelerate patient recovery [6][8] - The RECELL System is FDA-approved for treating thermal burn wounds and trauma wounds, utilizing a patient's own skin to create Spray-On Skin Cells [6][8]

Core Insights - AVITA Medical, Inc. will report its second quarter 2025 financial results on August 7, 2025, after U.S. market close [1] - A conference call and webcast will be held on the same day to discuss financial results and business highlights [1] Company Overview - AVITA Medical is a leading therapeutic acute wound care company focused on delivering transformative solutions [3] - The company's flagship product, the RECELL System, is FDA-approved for treating thermal burn wounds and full-thickness skin defects, utilizing a patient's own skin to create Spray-On Skin Cells [3] - In the U.S., AVITA Medical has exclusive rights to manufacture and distribute PermeaDerm®, a biosynthetic wound matrix, and Cohealyx™, a collagen-based dermal matrix [3] International Market Presence - The RECELL System is approved for various applications in international markets, including burns and full-thickness skin defects [4] - The system is TGA-registered in Australia, has received CE mark approval in Europe, and has PMDA approval in Japan [4]

Core Insights - AVITA Medical's RECELL technology demonstrates significant clinical benefits, including reduced hospital stays for burn patients, as highlighted in a recent study presented at the British Burn Association Annual Meeting [1][3] - The RECELL system utilizes a small sample of a patient's skin to create Spray-On Skin™ Cells, which leads to faster healing and less pain compared to traditional skin grafting methods [2][5] - The analysis of over 6,300 patients indicates a reduction in hospital stay by an average of 6.2 days or 35.7% when treated with RECELL compared to split-thickness autografts, resulting in approximately $300 million in cost savings over five years [8] Company Overview - AVITA Medical is a leader in therapeutic acute wound care, focusing on innovative solutions that enhance wound healing and accelerate patient recovery [5] - The RECELL System is FDA-approved for treating thermal burn wounds and full-thickness skin defects, and it is used in over 130 burn centers across the United States [4][5] - The company also holds exclusive rights to manufacture and distribute other wound care products, including PermeaDerm and Cohealyx™ [5] Market Impact - The RECELL technology is gaining traction in international markets, with approvals in Australia, Europe, and Japan for various skin healing applications [6] - The findings from the national registry analysis provide a clearer understanding of how RECELL influences clinical decisions and patient outcomes, reinforcing its economic value in healthcare [3][8]

Core Insights - AVITA Medical, Inc. announced the first clinical publication evaluating Cohealyx™, a collagen-based dermal matrix, which showed significantly faster wound bed vascularization and autograft readiness compared to conventional matrices, achieving readiness in 5 to 10 days instead of the typical two to four weeks [1][2][3] Company Overview - AVITA Medical is a leading therapeutic acute wound care company focused on delivering transformative solutions to optimize wound healing and accelerate patient recovery [6] - The company’s flagship product, the RECELL System, is FDA-approved for treating thermal burn wounds and full-thickness skin defects, utilizing a patient's own skin to create Spray-On Skin Cells [6][7] Clinical Findings - In a case series at The Ohio State University Wexner Medical Center, two patients with complex hand wounds treated with Cohealyx achieved autograft readiness in 7 to 13 days, demonstrating accelerated integration and vascularization [2][3] - The publication highlights that these outcomes can significantly reduce patient burden and lower associated complication risks [2] Technological Innovation - Cohealyx is bioengineered using proprietary TetraPure Technology, featuring crosslinked, purified collagen types I and III, which supports optimal cellular migration and rapid revascularization [3] - Preclinical studies indicated wound bed readiness as early as day 7, and the recent publication serves as the first clinical validation of these findings [3] Publication Details - The full paper titled "A Bovine Dermal Collagen Matrix (BDCM) Advances Readiness to Autografting: A Case Series" is available online, providing further insights into the clinical efficacy of Cohealyx [4]