AVITA Therapeutics States 1st Patient Enrolled in Pivotal Study Evaluating the RECELL System for Repigmentation of Stable Vitiligo
AVITA Therapeutics Chief Executive Officer, “The initiation of the vitiligo clinical study is a milestone in advancing AVITA Therapeutic’s pipeline to leverage the utility and full potential of our innovative RECELL technology platform to address unmet medical needs in dermatological applications.
AVITA Medical Receives U.S. FDA Investigational Device Exemption Approval of Pivotal Study Evaluating RECELL System for Soft Tissue Reconstruction
“FDA approval of our IDE for a soft tissue reconstruction pivotal clinical trial is an important next step in expanding the potential indications of our RECELL System technology platform. We are pleased with the strong interest expressed by the clinical community in participating in this study and we look forward to working with physicians and their patients upon study commencement,” said Dr. Michael Perry, Chief Executive Officer of AVITA Medical.
The 26-week, single-arm, observational study included 16 patients treated at three hospitals in the United Kingdom, including Manchester Royal Infirmary, Kings College Hospital and Northwick Park Hospital.
The U.S. sales team of Regenerative Tissue Specialists and Clinical Training Specialists that joined AVITA Medical in November 2018 has been trained and fully deployed across the U.S. in support of the nationwide launch of the RECELL System.
AVITA Medical Announces Commencement of Randomized Controlled Clinical Study of RECELL System in Treatment of Children with Burn Injuries
10/25/18: Avita Medical reports the clinical study is being conducted in Brisbane, Australia in collaboration with the Queensland University of Technology and Lady Cilento Children’s Hospital.
AVITA Medical Announces Acquisition of Manufacturing Facility to Support Planned U.S. Launch of RECELL Device
“Having direct control over the manufacturing of RECELL will ensure that we have the capacity to meet commercial demand, including the planned U.S. launch and the BARDA procurement, and provide us further control over our production processes and timelines,” said Dr. Michael Perry, Chief Executive Officer. “Acquiring this facility that has a track record of producing RECELL allows us to realize the benefits of inhouse production while maintaining the continuity of proven manufacturing and quality processes and systems.”
“This first landmark economic model examines the continuum of definitive care in burns and can bring value to the burn community by estimating the likely economic impact of new treatments for burns,” said Pinar Bilir, IQVIA.
RECELL Pivotal Trial in Third-Degree Burns Meets Co-Primary Endpoints and Shows Statistically Significant Reduction in Donor Skin Requirements
ReCell pivotal, controlled clinical trial in the treatment of deep full-thickness (third-degree) burns with the RECELL® Autologous Cell Harvesting Device achieved its co-primary endpoints, demonstrating a statistically significant reduction in donor skin requirements versus standard of care while achieving comparable definitive wound closure.
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