Core Viewpoint - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - FGI Industries Ltd. (FGI) is up 278% at $15.02 [3] - Senmiao Technology Limited (AIHS) is up 96% at $4.22 [3] - Conifer Holdings, Inc. (CNFR) is up 86% at $2.11 [3] - WEBTOON Entertainment Inc. (WBTN) is up 39% at $20.81 [3] - Nukkleus Inc. (NUKK) is up 18% at $6.08 [3] - Tantech Holdings Ltd (TANH) is up 12% at $2.13 [3] - Check-Cap Ltd. (CHEK) is up 9% at $2.33 [3] - Ivanhoe Electric Inc. (IE) is up 8% at $9.71 [3] - Wolfspeed, Inc. (WOLF) is up 8% at $3.21 [3] - Bolt Projects Holdings, Inc. (BSLK) is up 5% at $3.95 [3] Premarket Losers - Envirotech Vehicles, Inc. (EVTV) is down 17% at $2.27 [4] - Dave & Buster's Entertainment, Inc. (PLAY) is down 15% at $20.40 [4] - NanoVibronix, Inc. (NAOV) is down 12% at $9.37 [4] - ADTRAN Holdings, Inc. (ADTN) is down 10% at $9.37 [4] - Rain Enhancement Technologies Holdco, Inc. (RAIN) is down 10% at $6.00 [4] - CNS Pharmaceuticals, Inc. (CNSP) is down 7% at $8.50 [4] - AVITA Medical, Inc. (RCEL) is down 7% at $6.22 [4] - Vince Holding Corp. (VNCE) is down 7% at $2.60 [4] - Monte Rosa Therapeutics, Inc. (GLUE) is down 6% at $6.50 [4] - Meiwu Technology Company Limited (WNW) is down 6% at $2.06 [4]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against AVITA Medical, Inc. for possible violations of federal securities laws and unlawful business practices, particularly related to a significant backlog of unpaid claims affecting the company's financial performance [1][3]. Financial Performance - On August 7, 2025, Avita reported a six-month backlog in unpaid provider claims for its Recell procedures, which negatively impacted demand in the first half of the year [3]. - The backlog was attributed to contractors from the Centers for Medicare & Medicaid Services failing to assign adequate pricing and timely adjudication of claims, leading to uncertainty among providers [3]. - Following the announcement, Avita's stock price fell by $1.13, or approximately 21%, from $5.38 to $4.25 per share [3]. Legal Investigation - The law firm is encouraging investors who suffered losses in Avita to contact them to discuss their legal rights and options [1][4]. - The investigation aims to determine if Avita's actions constituted violations of securities laws, which could have implications for investors [1]. Company Background - AVITA Medical, Inc. is involved in the wound care sector, specifically with its product Recell, which has faced operational challenges due to the backlog of claims [3]. - Bragar Eagel & Squire, P.C. is a recognized law firm that represents investors in complex litigation across various jurisdictions [5].

Core Viewpoint - Avita Medical's RECELL GO system has received CE certification under EU MDR, which is expected to enhance its market presence in Europe and improve treatment options for burn and skin defect patients [1] Group 1: Product Development - The RECELL GO system is an advanced device for harvesting autologous cells to treat burns and skin defects [1] - Compared to traditional skin grafting, RECELL offers several advantages, including improved healing, reduced donor skin usage, less pain, faster wound closure, better aesthetic outcomes, fewer required surgeries, and shorter hospital stays for certain burns [1] Group 2: Operational Efficiency - RECELL GO simplifies the preparation of skin cell spraying, reduces training requirements, enhances operating room efficiency, and ensures optimal cell yield and viability [1] Group 3: Management Commentary - Avita Medical's CEO, Jim Corbett, emphasized that the CE certification is a significant milestone for both the company and patients, enabling the introduction of this option to burn centers and clinicians in Europe to support the treatment of acute trauma patients [1]

Core Insights - AVITA Medical has received the CE Mark for its RECELL GO device, allowing commercialization in Europe and other CE Mark-recognizing markets [1][2] - The RECELL GO device enables healthcare professionals to prepare a suspension of a patient's own skin cells to promote healing in burns and traumatic or surgical wounds [2] - Clinical data presented at the 2025 European Burns Association Congress showed a 36% reduction in hospital stays for adults with deep partial-thickness burns treated with RECELL compared to traditional grafting [3] Company Overview - AVITA Medical is a leading therapeutic acute wound care company focused on optimizing wound healing and accelerating patient recovery [5] - The RECELL System, which includes RECELL GO, is approved by the U.S. FDA for treating thermal burn and trauma wounds, utilizing a patient's own skin to create Spray-On Skin™ Cells [5][6] - In addition to RECELL, AVITA Medical holds exclusive rights to manufacture and distribute PermeaDerm and Cohealyx™, enhancing its product portfolio in wound care [5]

Core Viewpoint - The Schall Law Firm is investigating AVITA Medical, Inc. for potential violations of securities laws, focusing on misleading statements and undisclosed information that may have affected investors [1][2]. Company Summary - AVITA Medical, Inc. (NASDAQ: RCEL) reported a significant backlog in unpaid provider claims for RECELL procedures, which impacted demand in the first half of 2025 [2]. - The backlog was attributed to failures by contractors from the Centers for Medicare & Medicaid Services, leading to uncertainty among providers regarding payment expectations and timelines [2]. Legal Context - The investigation by the Schall Law Firm aims to determine if AVITA Medical misled investors regarding its financial health and operational challenges [1][2]. - Shareholders who have suffered losses are encouraged to participate in the investigation [2].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by AVITA Medical, Inc. and its officers or directors, following significant financial issues reported by the company [1][3]. Financial Performance - On August 7, 2025, AVITA reported a six-month backlog in unpaid provider claims for Recell procedures, which negatively impacted first-half demand [3]. - The backlog was attributed to contractors from the Centers for Medicare & Medicaid Services failing to assign adequate pricing and timely adjudication of claims, leading to uncertainty among providers and reduced utilization of Recell procedures [3]. - Following the announcement, AVITA's stock price dropped by $1.13, or 21%, closing at $4.25 per share on August 8, 2025 [3].

Core Insights - AVITA Medical, Inc. is under investigation for possible securities fraud, with a potential class action being considered for affected investors [1][2] - The company's second quarter 2025 financial results revealed a significant backlog in unpaid provider claims for its Recell procedures, which negatively impacted demand [3] - Following the announcement of the backlog, AVITA's share price dropped approximately 21%, from $5.38 to $4.25 [4] Financial Performance - AVITA reported a six-month backlog in unpaid provider claims for Recell procedures, which was attributed to issues with pricing and claim adjudication by contractors from the Centers for Medicare & Medicaid Services [3] - The backlog led to reduced utilization of the Recell product during the first half of 2025, indicating a direct impact on the company's financial performance [3] Market Reaction - The announcement of the backlog and its implications resulted in a significant decline in AVITA's stock price, reflecting investor concerns over the company's operational challenges [4]

Core Viewpoint - AVITA Medical, Inc. is under investigation for potential violations of federal securities laws or unlawful business practices following the release of its second quarter 2025 financial results, which indicated a significant backlog in unpaid provider claims for its Recell procedures [1]. Financial Performance - On August 7, 2025, AVITA Medical reported its second quarter 2025 financial results, highlighting a six-month backlog in unpaid provider claims for its Recell procedures [1].

Group 1 - Morgan Stanley is hosting its 23rd Global Healthcare Conference, showcasing various interesting stories in the healthcare sector [1] - The conference aims to provide insights into companies like AVITA, highlighting their current status and future direction [2]

Summary of AVITA Medical FY Conference Call Company Overview - **Company**: AVITA Medical (NasdaqCM: RCEL) - **Industry**: Healthcare, specifically focused on therapeutic acute wound care Core Product and Technology - **RECELL Platform**: A spray-on skin graft technology that utilizes a small autologous biopsy from the patient, disaggregated and delivered as a spray onto wounds, significantly reducing the amount of skin needed for grafting by approximately 97% [4][5] - **Benefits**: - Rapid healing due to cell proliferation on the wound [5] - A study presented at the European Burn Association meeting showed a **36% reduction in length of hospital stay** for patients using RECELL compared to traditional grafts, translating to about a **six-day improvement** [6][7][10] Financial Performance and Guidance - **Q2 Performance**: Experienced year-on-year growth but missed expectations due to issues with a new CPT code affecting reimbursement [16][18] - **Revenue Impact**: Estimated a loss of about **$10 million in revenue** due to uncertainty in reimbursement processes during Q1 and Q2 [18] - **Future Guidance**: Projected a **24% year-over-year growth** despite the setbacks, with expectations of profitability in Q2 and Q3 of the following year [18][24] Gross Margins and Product Mix - **Gross Margins**: - RECELL: ~87% - PermeaDerm: ~60% - Cohealyx: ~50% - As the product mix shifts towards Cohealyx and PermeaDerm, overall gross margins are expected to decrease [20][21] Market Strategy and Expansion - **Sales Strategy**: Transitioned from a high percentage of clinical specialists to a more sales-focused approach, allowing for increased selling activity throughout the treatment process [13][15] - **Total Addressable Market (TAM)**: Estimated at **$3.5 billion** across trauma, surgery, and outpatient settings [47][52] - **International Expansion**: Plans to enter European markets and Japan, leveraging local distribution partners for market expertise [53][54] Reimbursement and Adoption Challenges - **Reimbursement Process**: The value analysis committee process is critical for adoption, with hospitals needing to see the economic benefits of using AVITA's products [26][30] - **NCAP Reimbursement**: Expected to positively impact the adoption of RECELL for non-burn trauma wounds starting October 1 [28] Product Development and Innovation - **RECELL GO Mini**: A new product aimed at smaller wounds, showing positive early traction in outpatient settings [35][36] - **Future Innovations**: Exploring adjacent markets such as antimicrobial treatments and anti-scarring technologies [22][23] Conclusion - **Outlook**: Despite challenges in the first half of the year, AVITA Medical is positioned for growth with a strong product portfolio and a clear path to profitability [56]