Core Insights - AVITA Medical, Inc. has received New Technology Add-on Payment (NTAP) reimbursement approval from CMS for its RECELL system, effective October 1, 2025, for treating acute, non-burn trauma and surgical full-thickness wounds [1][2][8] - The NTAP will provide hospitals with supplemental reimbursement of up to $4,875 per case, in addition to standard CMS payments, and will remain in effect until September 30, 2026 [2][8] - The NTAP designation highlights the clinical value and innovation of RECELL, which reduces the need for donor skin and associated complications compared to traditional skin grafting methods [3][4] Company Overview - AVITA Medical is a leading therapeutic acute wound care company focused on optimizing wound healing and accelerating patient recovery through innovative solutions [5] - The RECELL System, approved by the FDA, utilizes a patient's own skin to create Spray-On Skin Cells, offering a transformative approach to wound treatment [5] - In addition to RECELL, AVITA Medical holds rights to manufacture and distribute PermeaDerm and Cohealyx™, enhancing its product portfolio in the wound care market [5] Clinical Evidence - A multicenter, randomized-controlled trial published in the Journal of Trauma and Acute Care Surgery (2024) demonstrated that RECELL, when used with a widely meshed autograft, achieved comparable wound closure to standard skin grafting while requiring 27% less donor skin [4] - The study indicated that healing and safety outcomes were similar between RECELL and traditional methods, suggesting that RECELL can mitigate donor site complications without compromising results [4]

Financial Data and Key Metrics Changes - The company reported net revenue of $23.4 million for Q1 2025, representing a 26% year-over-year growth, driven primarily by a 28% increase in sales of soft tissue repair products to $20.5 million [5][6] - Gross profit increased by $5 million or 30% to $21.6 million, with gross margin rising approximately 240 basis points to 92% of net revenue [22] - The net loss for Q1 2025 was $3.5 million or $0.41 per diluted share, compared to a net loss of $1.8 million or $0.21 per diluted share in the previous year [24] Business Line Data and Key Metrics Changes - In the Synera Surgical segment, adjusted EBITDA increased by $1.5 million year-over-year to $2.7 million, while the net loss increased by $200,000 to $600,000 [6][24] - The Tissue Health Plus segment reported a net loss of $2.9 million, up from a net loss of $1.4 million in the previous year, with a segment adjusted EBITDA loss of $2 million compared to a loss of $900,000 last year [24] Market Data and Key Metrics Changes - The company expanded its distributor network to over 400 partners, up from over 250 in Q1 2024, enhancing sales coverage in key markets across the U.S. [10] - The number of healthcare facilities served increased to over 1,300, compared to over 1,080 facilities in the prior year [11] Company Strategy and Development Direction - The company is focused on enhancing its new product pipeline and has secured distribution rights to two additional technologies [7] - The strategy includes investing in the Tissue Health Plus segment and launching a pilot program with a wound care provider later in Q2 2025 [6][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth opportunities ahead, particularly in the Synera Surgical segment, and expects improvements in profitability for 2025 [27] - The company is actively seeking financial partners to support the execution of its Tissue Health Plus strategy [27] Other Important Information - The company amended the terms of its debt facility to provide increased financial flexibility [7] - As of March 31, 2025, the company had $20.7 million in cash and $42.8 million in principal debt obligations outstanding [25] Q&A Session Summary Question: Can you provide more details on your penetration rates and strategy for improving penetration at existing facilities? - The company employs a coupled approach between regional sales managers and distributor expansion to penetrate existing accounts deeper [31] Question: Are there any signals on reorder rates for your products? - The company has not provided specific reorder rates but noted that once surgeons gain comfort with their products, they tend to continue using them across more procedures [33] Question: How should we think about gross margin cadence through the remainder of 2025? - Management indicated that while there may not be significant further leverage on gross margins, consistency with past modeling is advisable [38] Question: What metrics will define success for the pilot program in Tissue Health Plus? - Success will be measured through clinician-facing metrics, operational metrics, and adoption metrics, including protocol adherence and clinician satisfaction [41][45]