AVITA Medical, Inc., through its subsidiaries, engages in the development and and commercialization of medical devices used in regenerative medicine. The company is headquartered in Valencia, CA.
相关临床试验
15
2 进行中
药物批准
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监管机构
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进行中（未招募）
2
13.3%
已完成
10
66.7%
终止
3
20.0%
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- AVITA Medical's PermeaDerm-I randomized controlled trial met its primary endpoint, demonstrating a 70% economic advantage over cadaveric allograft based on product cost per percent total body surface area treated (p<0.001). - Mean treatment cost was $148.70 per 1% TBSA with PermeaDerm versus $497.10 for allograft, representing savings of approximately $348 per %TBSA. - PermeaDerm reduced preparation time by 95.7% while delivering comparable clinical outcomes, including graft take, wound healing, and safety, with no adverse events attributed to the product. - The multicenter study enrolled 40 patients across 11 U.S. burn centers, supporting PermeaDerm as a clinically comparable, economically advantaged alternative for wound temporization.
- AVITA Medical presented the first UK clinical experience with RECELL GO at the 2026 British Burn Association Annual Meeting, detailing outcomes from 17 patients treated at Stoke Mandeville Hospital. - All patients achieved uncomplicated donor-site healing, complete graft take, and successful discharge without complications, with the automated system demonstrating reduced procedural variability and improved operating room efficiency. - RECELL GO combines a reusable processing device with a single-use preparation kit to standardize autologous cell harvesting at the point of care, and has received CE-marking in Europe and the UK as well as regulatory authorization in Australia and New Zealand. - Clinicians noted the system integrates seamlessly into clinical practice while maintaining outcomes comparable to the manual RECELL system, potentially expanding access to advanced autologous cell therapies globally.
- AVITA Medical's Board of Directors has appointed Cary Vance as President and Chief Executive Officer effective immediately, following his successful six-month tenure as Interim CEO since October 2025. - The appointment follows a thorough search process conducted with an international executive search firm, with the Board unanimously concluding that Vance is the right leader for the company's growth period. - Vance brings 30 years of healthcare executive experience and has demonstrated decisive leadership in stabilizing the business, sharpening strategic focus, and rebuilding confidence among employees, customers, and shareholders. - Jan Stern Reed has been elected as Chair of the AVITA Medical Board, bringing over 35 years of legal and business management experience in the healthcare industry.
- AVITA Medical has secured a 10-year agreement with BARDA worth up to $25.5 million to strengthen U.S. national preparedness for burn mass casualty incidents. - The contract ensures rapid nationwide access to 3,000 units of RECELL, an FDA-approved spray-on skin technology, for emergency deployment during mass casualty events. - AVITA will maintain ready inventory and provide logistics support, with $3.97 million in guaranteed revenue over 10 years plus additional procurement options. - The partnership builds on a decade-long collaboration between AVITA and BARDA to advance burn care innovation and public health emergency readiness.
- Surgeons reported the first integrated use of RECELL, PermeaDerm, and Cohealyx technologies in challenging wound cases, demonstrating a comprehensive staged care approach for complex wounds. - New histological data from clinical trials showed PermeaDerm supported organized tissue formation without increased inflammation, while Cohealyx promoted cellular infiltration and blood vessel formation within two weeks. - A systematic review of 27 studies confirmed RECELL's clinical benefits, including smaller donor sites, faster healing times, and reduced hospital stays by up to 16 days in elderly burn patients. - Registry analysis revealed that adults with deep partial-thickness burns treated with RECELL spent one-third less time in hospital compared to traditional grafting approaches.
- AVITA Medical received CE Mark approval for RECELL GO under EU Medical Device Regulation, enabling commercialization across Europe and other CE Mark-recognizing markets. - The point-of-care device creates Spray-On Skin Cells from patients' own healthy skin samples to promote healing in burns and traumatic wounds. - Clinical data from the 2025 European Burns Association Congress showed RECELL treatment reduced hospital stays by 36% compared to traditional grafting for deep partial-thickness burns. - The company will begin commercialization in Germany, Italy, and the United Kingdom through partnerships with burn centers and clinical partners.
- Real-world data from the U.S. national burn registry shows RECELL System reduces hospital length of stay by 36% compared to traditional skin grafting in adults with deep second-degree burns. - The treatment achieves potential cost savings exceeding $42,000 per patient and enables hospitals to treat 13 more patients per bed annually. - AVITA Medical's FDA-approved RECELL GO mini system launched in 2024 addresses smaller wounds and expands the addressable market from $455 million to over $3.5 billion in the U.S. - The company expects to achieve cash flow break-even by Q2 2026 and GAAP profitability by Q3 2026 following resolution of Medicare reimbursement issues.
- AVITA Medical reported Q1 2025 commercial revenue of $18.5 million, representing a 67% increase compared to the same period in 2024, with a strong gross profit margin of 84.7%. - The company has transformed from a single-product burn-focused company to a multi-product platform with the launch of RECELL GO mini in February and nationwide rollout of Cohealyx in April 2025. - AVITA Medical reaffirmed its 2025 guidance, projecting full-year commercial revenue between $100-106 million, with expectations to generate free cash flow in the second half of 2025 and achieve GAAP profitability by Q4.
- New clinical data demonstrates PermeaDerm's effectiveness as a temporary wound coverage solution in burn management, offering an alternative to higher-priced cadaver skin while preserving wound integrity. - A randomized multicenter trial shows PermeaDerm reduces dressing change frequency compared to traditional silver-based dressings, with its transparency enabling continuous wound monitoring. - AVITA Medical continues to expand its acute wound care portfolio, which includes the FDA-approved RECELL System for thermal burns and full-thickness skin defects, alongside Cohealyx and PermeaDerm products.
- AVITA Medical has commercially launched Cohealyx, a collagen-based dermal matrix co-developed with Regenity Biosciences, designed to facilitate cellular migration and revascularization for wound healing. - Pre-clinical studies demonstrated that Cohealyx prepares wounds for grafting faster than leading competitors, potentially reducing hospital stays for patients with full-thickness acute wounds. - The product expands AVITA's therapeutic wound care portfolio, complementing its FDA-approved RECELL System and PermeaDerm, creating an integrated approach to the two-stage standard of care for full-thickness wounds.
